Clovis Oncology (CLVS) Q3 2019 Earnings Call Transcript

Clovis Oncology (CLVS)
Q3 2019 Earnings Call
Nov 07, 2019, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Clovis Oncology third-quarter 2019 earnings conference call. [Operator instructions] I would now like to hand the conference over to Ms. Breanna Burkart, vicw president, investor relations. Please go ahead.

Breanna Burkart -- Vice President, Investor Relations

Thank you, Dennis. Good morning, and welcome to the Clovis Oncology third-quarter 2019 conference call. Thank you for joining us. You have likely seen this morning's news release.

If not, it is available on our website at clovisoncology.com. As a reminder, this conference call is being recorded and webcast. Remarks may be accessed live on our website during the call and will be available in our archive for the next several weeks. Today's agenda includes the following, Patrick Mahaffy, our president and CEO, will discuss the key components and highlights of today's corporate update; then Dan Muehl, Clovis' chief financial officer, will cover the quarter's financial results in greater detail.

Patrick will make a few closing remarks, and then we will open the call for Q&A, during which time, Dr. Lindsey Rolfe, our chief medical officer, will also be available to answer questions. Before we begin, please note that during today's conference call, we may make forward-looking statements within the meaning of the federal securities laws, including statements concerning our financial outlook and expected business plan. All of these statements are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forwarding statements.

Please refer to our current filings with the SEC for a full review of the risks and uncertainties associated with our business. Forward-looking statements speak only as of the date on which they are made, and Clovis undertakes no obligation to update or revise any forward-looking statement. Now I'd like to turn the call over to Patrick Mahaffy.

Patrick Mahaffy -- President and Chief Executive Officer

Thanks, Breanna. Welcome, everybody. We appreciate you taking the time. I'll begin with a commercial update for Rubraca.

I'm pleased to report that our global revenue for this quarter was $37.6 million, up 14% over the last quarter and 65% over Q3 2018. This growth was driven by encouraging progress in new patient starts and in duration of use. We also continued to make slow progress in reducing the supply of free goods. Our key near-term objectives remain the same: To grow U.S.

ovarian cancer revenues by increasing market share in and adoption of the maintenance treatment indication in the recurrent ovarian cancer setting; to increase EU revenues through launches in England, Italy, France, and Spain, along with continued revenue growth in Germany; and as early as mid-2020, grow revenue through the addition of a potential new indication beyond ovarian in the U.S. with BRCA-mutant advanced prostate cancer. And that brings us to our most near-term development program in the advanced prostate cancer setting. As you know, we have two ongoing studies in the TRITON program, TRITON2 and TRITON3, and we continue to enroll patients into both studies.

I'll focus on the data presented at ESMO and the regulatory path moving forward. In September, we presented updated TRITON2 data in patients with metastatic castration-resistant prostate cancer at the ESMO 2019 congress in Barcelona. The updated TRITON2 data presented -- showed a 43.9% confirmed objective response rate by investigator assessment in 57 RECIST-evaluable patients with a BRCA1 or 2 mutation and results by independent radiological review, which is the primary end point of the trial, were consistent at 40.4%. In addition, a 52% confirmed prostate-specific antigen, or PSA, response rate was observed in 98 PSA response evaluable patients with a BRCA1 or 2 mutation.

Confirmed radiographic responses were durable with 60% lasting 24 weeks or longer. Preliminary safety data for Rubraca in men in this indication were consistent with those observed in prior reports from TRITON2 and in patients with ovarian cancer and other solid tumors. These TRITON2 data presented at ESMO will be included in our planned supplemental NDA filing for Rubraca in BRCA1 or 2-mutant advanced prostate cancer, although the supplemental NDA dataset will also include additional patients and additional data maturity for the patients reported at ESMO. The filing will be based on confirmed RECIST responses.

Following the successful pre-supplemental NDA meeting with FDA in October, we continue to file -- continue to plan to file our supplemental NDA submission for accelerated approval for Rubraca as treatment for men with BRCA1 or 2-mutated advanced prostate cancer by the end of this year. Our other planned monotherapy study is the pan-tumor or basket study that we first discussed with you earlier this year. It is designed to support registration for Rubraca across solid tumors in patients with deleterious mutations in homologous recombination repair genes. We anticipate that the study will initiate by year-end 2019 or perhaps early next year.

Next, I'd like to briefly highlight our combination studies with BMS for both Rubraca and lucitanib, and then discuss our newest compound FAP-2286. We remain very enthusiastic about our ongoing clinical collaboration with Bristol-Myers Squibb, and I'll take a moment to review our combination studies for both Rubraca and lucitanib with nivolumab. I'll begin with the Rubraca combinations. The new BMS-sponsored Phase II combination study of Opdivo and Yervoy with Rubraca for the treatment of advanced gastric cancer is moving forward with the planned initiation in early 2020 as an arm of the FRACTION advanced gastric cancer study.

This will be the first sponsored study that explores this triplet combination. The BMS-sponsored CHECKMATE 9KD Phase II trial in metastatic castrate-resistant prostate cancer continues to enroll. The Clovis-sponsored Phase III ATHENA trial in first-line maintenance of advanced ovarian cancer continues to enroll well, and we anticipate completing enrollment in this 1,000-patient study by midyear 2020. With ATHENA, we believe we are uniquely positioned to evaluate Rubraca in terms of two key outcomes: as monotherapy versus placebo in the first-line maintenance setting in the HRD population inclusive of BRCA, and in the all-comers or intent-to-treat population, as well as any potential advantage for the combination of Rubraca and Opdivo in the same patient population.

ATHENA is the first frontline switch maintenance study designed to show both part monotherapy and part plus PD-1 combination therapy in one study design. It may be helpful to make sure that everyone understands the statistical analysis planned here. First, probably in the second half of 2021, we will see the results of Rubraca monotherapy versus placebo in all study populations. And then a year or more later, we will see the results of Rubraca plus Opdivo versus Rubraca in all study populations.

In each of these analyses, we will first evaluate outcomes in the HRD population, inclusive of BRCA, and then step down to the entire intent-to-treat population. To wrap up Rubraca and move to lucitanib, let's turn to SEASTAR, our Clovis-sponsored Phase Ib/II study that includes multiple single-arm rucaparib combination studies, which currently includes following cohorts: Rubraca in combination with lucitanib in ovarian cancer, which is currently enrolling the dose-finding Phase Ib portion of the study; and also Rubraca in combination with Immunomedics' sacituzumab govitecan for the treatment of advanced metastatic triple-negative breast cancer, relapsed platinum-resistant ovarian cancer and metastatic urothelial cancers, which is currently enrolling the Phase Ib dose-finding portion of the study in patients with solid tumors. Now to lucitanib. Lucitanib is an investigational inhibitor of tyrosine kinases, including vascular endothelial growth factors receptors one through three, platelet-derived growth factor receptors alpha and beta and fibroblast growth factor receptors one through three.

As we've discussed on prior calls, there are very encouraging data in studies of a drug similar to lucitanib, which inhibits these same three pathways when combined with a PD-1 inhibitor. This provides a compelling clinical rationale for the development of lucitanib in combination with a PD-1. We believe the combination of lucitanib with a PD-1 targeting monoclonal antibody represents a large potential market opportunity in multiple solid tumor types. Angiogenesis has been shown to be immunosuppressive within the tumor microenvironment, dampening antitumor immune responses.

Preclinical data demonstrate that the anti-tumor activity of the PD-1 inhibitor is enhanced through the inhibition of angiogenesis by lucitanib, which targets three relevant pro-angiogenic pathways, as well as simultaneously targeting tumor cell proliferation and anti-VEGF receptor therapy resistance driven by PDGF and FGF receptors. Earlier this year, we announced the expansion of our clinical collaboration with Bristol-Myers Squibb to include both combinations of Opdivo with lucitanib. Our Clovis-sponsored Phase Ib/II study of lucitanib in combination with Opdivo is now enrolling patients with gynecological and other solid tumors. We hope to have preliminary data from this study and the rucaparib-lucitanib combination that is part of the SEASTAR study at medical meetings beginning in mid-2020.

In addition, as posted on ClinicalTrials.gov this week, a Phase I/II combination study sponsored by BMS will evaluate multiple combinations with Opdivo, including an arm in combination with lucitanib in patients with stage IV non-small cell lung cancer that has spread or reoccurred after failure of chemotherapy and immunotherapy. This study is expected to start by the end of the year. As a reminder, we have global rights to lucitanib, excluding China. And in terms of intellectual property, lucitanib's composition of matter in the U.S.

expires in 2030 and in Europe in 2028 with up to five years patent term extensions available in each jurisdiction. For an updated overview of lucitanib, please visit the events and presentations page on our website. Now I'd like to briefly describe the newest addition to the closest pipeline, FAP-2286. In September, we and 3B Pharmaceuticals announced a global licensing and collaboration agreement with an initial focus on at FAP-2286, a peptide-targeted radionuclide therapy and imaging agent targeting fibroblast activation protein alpha or FAP.

FAP is highly expressed in cancer-associated fibroblast or CAFs, which are found in the majority of cancer types, potentially making it a suitable target across a wide array of solid tumors. It is highly expressed in many epithelial cancers, including more than 90% of breast, lung, colorectal and pancreatic carcinomas. Clovis will conduct global clinical trials since it obtained U.S. and global rights, excluding Europe, where 3BP retained rights.

We are currently planning to file an IND for FAP-2286 in the second half of 2020. We and 3BP have also agreed to collaborate on a discovery program directed at three additional targets for radionuclide therapies to which we have global rights. We are very enthusiastic about the opportunity to develop this novel class of targeted radiopharmaceutical therapies with an initial focus on FAP-2286. We were drawn to this program for many reasons, not the least of which is our opportunity to be a leader in the emerging field of targeted radiotherapy.

While we are as enthusiastic as everybody is about the potential of immuno-oncology, it is an extremely crowded field dominated by larger pharmaceutical companies. And clearly, there remains significant unmet medical need in multiple tumor types. In this case, we have the opportunity to be the first to clinically develop a FAP-targeted radionuclide, and we are also enthusiastic about the targets that are subjects of our planned discovery collaboration. Finally, while our initial development focus is on monotherapy, there is an evident biological rationale to combine targeted radionuclide therapy with an anti-PD-1 agent, as well as with Rubraca, and we intend to explore these combinations preclinically and potentially clinically, as well.

Now some of you may be familiar with the history of PSMA-targeted radionuclides, in particular, Lu-PSMA-617, which was used under named patient use in hundreds of patients in Germany and certain other countries prior to initiation of any formal clinical development program. Already, one of these German centers has begun to image and treat patients with FAP-2286 under the same name patient use guidelines that were applied to the PSMA-targeted products. It is important to note here that this is not a clinical trial, and that the treating physician is solely responsible for any imaging or treatment decision. As a result of this use, it is possible that the physicians who administer FAP-2286 under named patient use guidelines may describe their clinical experience at upcoming medical meetings, and we will keep you up to date on any such presentations as appropriate.

And with that, I'll turn the call over to Dan to discuss third-quarter 2019 financial results.

Dan Muehl -- Chief Financial Officer

Thanks, Pat, and good morning, everyone. The Q3 2019 financial results are included in today's press release. We reported net product revenue for Rubraca of $37.6 million for Q3 2019, which included U.S. net product revenue of $36.5 million and ex U.S.

net product revenue of $1.1 million, compared to the all-U.S. net product revenue for Q3 2018 of $22.8 million. This represents a 14% increase over Q2 2019 and a 65% increase year over year. U.S.

net product revenue increased 12% sequentially from Q2 2019 and 60% year over year. Ex U.S. revenue increased sequentially from Q2 2019 to Q3 2019, as anticipated. The supply of free drug distributed to eligible patients through the Rubraca patients assistance program for Q3 2019 was lower at 20% of overall commercial supply, compared to 22% in Q2 2019.

This represented $9 million in commercial value for Q3 2019, compared to $9.3 million in Q2 2019. Gross-to-net adjustments were flat from Q2 2019 to Q3 2019 at 14.2% and 14.1%, respectively. Last quarter, we provided global net product revenue guidance for 2019 in the range of $137 million to $147 million for the full year. Today, we update that guidance to a range of $141 million to $147 million to reflect the potential for continued growth during the fourth quarter of 2019.

Turning now to a discussion of cash. As of September 30th, we had $354.1 million in cash, cash equivalents and available-for-sale securities. In August, we raised $255 million in net proceeds from a private placement sale of $263 million of convertible notes due in 2024. A total of $171.8 million of those proceeds were used to repurchase $190.3 million of par value of convertible notes due in 2021 with the remaining $83.2 million available for general corporate purposes.

In addition, as of September 30th, we still had up to $154 million remaining to draw under the TPG financing for the ATHENA clinical trial financing agreement to fund the expenses of ATHENA trials through Q3 2022. Based on the company's anticipated revenues, spending, available financing sources and existing cash, cash equivalents and available-for-sale securities, we believe we have sufficient cash, cash equivalents and available-for-sale securities to fund our operating plan into the second half of 2021. This does not include any cash repayment that may be required to pay off unless you refinance the remaining $97 million principal amount of convertible notes at their maturity in September 2021. Cash used in operating activities was $57 million for Q3 2019 and $253.5 million for the first nine months of 2019, compared with $72.5 million for Q3 2018 and $283.3 million for the first nine months of 2018.

It's worth mentioning that on a sequential basis, Q3 operating cash used was 42% lower than Q2 2019. In addition to these decreases in cash used in operations, the TPG ATHENA financing provided $12.2 million in cash in Q3, resulting in a net cash reduction of $44.8 million during the quarter. We reported a net loss for Q3 2019 of $94.1 million or $1.72 per share and $300.9 million or a net loss of $5.62 per share for the first 9 months of 2019. Net loss for Q3 2018 was $89.9 million or $1.71 per share and $268.8 million or a net loss of $5.18 per share for the first nine months of 2018.

Net loss for Q3 and the first nine months of 2019 included share-based compensation expense of $14 million and $41.7 million, compared to $10.9 million and $37.7 million for the comparable periods of 2018. Research and development expenses totaled $77.9 million for Q3 2019 and $210.7 million for the first nine months of 2019, compared to $63.9 million and $160.1 million for the comparable periods in 2018. The increase is primarily due to higher research and development costs for Rubraca clinical trials. We expect research and development costs to trend lower for the full year starting in 2020 and in the following years compared to 2019, as the largest of our sponsored clinical trials near completion and as the company reduce the spending related to clinical programs and other activities.

Selling, general and administrative expenses totaled $41.8 million for Q3 2019 and $137.6 million for the first nine months of 2019, compared to $42.5 million and $126.6 million for the comparable periods in 2018. Selling, general and administrative expenses decreased year over year for Q3 2019 and also sequentially by 13% from $48 million in Q2 2019 to $41.8 million in Q3 2019 based on cost reduction efforts by the company. Now I'll turn it back to Pat.

Patrick Mahaffy -- President and Chief Executive Officer

Thanks, Dan. We're pleased with our progress in the third quarter. We demonstrated strong sales performance in the U.S. market with Rubraca in the second-line ovarian cancer maintenance setting, where we remain focused on growing our share of the ovarian cancer PARP space, as well as expanding the second-line maintenance PARP opportunity overall.

We're seeing initial progress in the EU with Rubraca now reimbursed through the Cancer Drugs Fund in England, and we continue to focus on Germany and prepare to bring on additional EU countries later in 2019 and early 2020. In addition to our sales progress, we also showed a significant reduction on our net cash burn, which was reduced to $45 million in Q3. We presented updated data for Rubraca in advanced prostate cancer patients in September, and our Q4 2019 supplemental NDA filing in BRCA1 and 2-mutant advanced prostate cancer is planned before year-end with potential for U.S. revenues from the prostate indication beginning in mid-2020.

Our clinical collaboration with BMS now includes the additional BMS-sponsored combination study of Opdivo and Yervoy with Rebecca in advanced gastric cancer as an arm of the FRACTION study, and we continue to have active discussions about other possible combination studies. We remain very enthusiastic about the potential for lucitanib with two combination studies now open for enrollment, one with Rubraca in advanced ovarian cancer as part of SEASTAR, as well as one in combination with Opdivo in advanced gynecological cancers and other solid tumors. We hope to have initial data from these trials at medical meetings next year beginning as early as mid-2020. In addition, the Phase I/II combination study sponsored by BMS will evaluate lucitanib in combination with Opdivo in patients with stage IV non-small cell lung cancer that has spread or reoccurred after failure of chemotherapy and immunotherapy.

And lastly, we are enthusiastic about the opportunity to develop FAP-2286 and potentially up to three additional preclinical radionuclide therapies. 3B Pharmaceuticals is an expert in this emerging field. And through this collaboration, we believe we have the opportunity to become a leader in the development of an important new treatment modality for multiple tumor types. And with that, I'd be happy to answer any questions you may have.

Questions & Answers:

Operator

[Operator instructions] And your first question is from the line of Kennen MacKay with RBC Capital Markets. Please go ahead.

Kennen MacKay -- RBC Capital Markets -- Analyst

Hi. Thanks for taking the question. And congrats on the quarter and continued growth there. Dan, maybe just a quick question on your narrowed guidance and some of the commentary there.

Last quarter, you provided some positive commentary that we could expect continued growth ahead. In Q3, we saw that. Just wondering if that's how we should be thinking about Q4. And again, whether the majority of the growth coming ahead in Q4 is coming from U.S.

or Europe. And then, secondly, taking a very different strategy, bringing Rubraca to frontline ovarian versus some of the other competitive agents out there, as well as prostate, wondering maybe what the feedback from physicians has been on these combo therapy approaches in sort of broader patient populations, especially coming out of the ESMO conference, where some of these I/O PARP combinations were really in focus. Thanks so much for taking the question.

Patrick Mahaffy -- President and Chief Executive Officer

Sure. We did up the lower end of the range in our guidance. On the last call, I said we were beginning to see some green shoots in the United States in terms of both commercial new patient starts and in terms of duration. And I think that is seen now in the Q3 numbers.

We're cautiously optimistic. You'll note that we didn't take the lower end of our guidance markedly higher than what we delivered in Q3. And we'd caution everybody that this is a quarter-by-quarter effort where we're really pleased with our progress and the effort being made in the field, but it remains an effort to convince many physicians to move beyond observation or watch and wait and to consider active PARP therapy. And the more progress we make in converting those physicians and their patients and frankly, the more progress our classmates make in making that same effort, we're going to see continued growth for the class and continued growth, hopefully, for us.

We do anticipate now, as we launched formally under reimbursement in the U.K. You may recall we were selling in the U.K. to the sort of 5% to 6% of patients who are private pay. But that is pretty limited.

Now with reimbursement in the U.K., we formally launched in mid-October. We anticipate the launch in Italy before the end of the year. We anticipate launches in Spain and France in the first quarter. So we will begin to see contribution to our growth in sales from these European countries.

As to the frontline strategy, I think the enrollment in the trial speaks to the enthusiasm physicians have for the potential for this combination. The enrollment in this 1,000-patient study will take somewhere probably less than two years to fully enroll, which is a really rapid trial enrollment, especially in light of competing trials and commercially available product for limited populations in this class. And if there's anything that came out of the important data presentations and the reaction to those data presentations at ESMO is that particularly in the HRD and biomarker-negative population, there is a need for combinations that can deliver greater duration of benefit and potentially a curative regimen, at least in a population of those treated. And I will say that the enthusiasm for the trial remains as high as it's been and for looking not only at the monotherapy results, which we'll see first for Rubraca, but also looking beyond that to the combination with Opdivo.

Kennen MacKay -- RBC Capital Markets -- Analyst

And, Pat, I think that was referring to ovarian cancer. Maybe also similarly for the strategy in prostate, moving up in terms of sort of post chemo into some of the earlier lines of therapy there, as well, potentially in combination.

Patrick Mahaffy -- President and Chief Executive Officer

We didn't have a ton of conversation at ESMO about the combination of, for instance, PD-1 with Rubraca in prostate. There was a lot of focus on the TRITON2 results with great enthusiasm by both the medical oncology community and -- not so much at ESMO, but at other meetings, then one-on-ones with the urology community here in the United States. I think that it's interesting. If approved, it will be one of, if not the first approved in a targeted population in prostate.

And the community is excited about having a targeted therapy that may provide meaningfully greater benefit than chemo or other agents in an all-comers population. And I think the adoption, unlike we've seen in maintenance in ovarian, which kind of capped out at 35% or 40%, and now we're slowly, gradually improving that, I think given that this is a treatment regimen and particularly for men with an advanced stage of disease, I think we're going to see a much more rapid adoption for the class in the treatment of prostrate. The enthusiasm for it is very high.

Kennen MacKay -- RBC Capital Markets -- Analyst

Got you. Thank you again.

Operator

Your next question is from the line of Tazeen Ahmad with Bank of America. Please go ahead.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

Hi, good morning. Thanks for taking my questions. Pat, just your view about the European market. We've talked now for a while about some of the dynamics that have impacted the ability of Rubraca to have uptake in the U.S.

I was just wondering if you can share with us some of your thoughts about certain dynamics that might be specific to the European markets and how you're thinking about the general ramp opportunity there versus how it ramped here in the U.S. And then I have a follow-up. Thanks.

Patrick Mahaffy -- President and Chief Executive Officer

Yeah. It's going to be very similar and have some of its own nuances, and some of those will differ by territory. In general, the adoption of maintenance thus far, second-line maintenance in ovarian appears to be kind of following the U.S. example, where there is a group of early adopters that take adoption to a kind of 35% rate, and it's going to take an effort by us and our competitor and peers to drive that higher.

It looks to us, as I interpret and do a currency change to the GSK number in Europe, that they're doing on an annualized basis around $135 million. So they've seen some success in Europe in penetrating, and they're still in launch mode in several territories. So I think it represents the fact that there is an opportunity for us as we gain approvals in these territories to come into a market with a differentiated offering and some degree of physician population who are committed to and interested in prescribing a PARP inhibitor in the second-line maintenance setting. One difference compared to the United States is that in certain countries, only niraparib is reimbursed for patients beyond BRCA.

So olaparib is reimbursed in all second-line maintenance patients who are mutant BRCA, but in only about half the territories do they have an approval for use beyond the BRCA population. So while we will continue to -- or plan to compete for those BRCA patients, the competition for the BRCA wild type patients, which represents 75% of the patient population, is going to be limited to us and niraparib. So there will be a different dynamic territory by territory. But I think the sales performance by ZEJULA represents the fact that there is an opportunity in Europe even at the much lower prices that were reimbursed at compared to in the United States.

And so we look forward to these launches.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

OK. Thank you. And then on the commercial opportunity for prostate. You've talked about your -- some of your early thoughts about what kind of commercial organization you would need.

And I just wanted to get some more updated thoughts from you about whether or not you can leverage any of your current sales force to move into prostate. And if you did need to increase your sales organization, by how much do you think you would need to do that? And what would be your areas of focus at the early part of the launch?

Patrick Mahaffy -- President and Chief Executive Officer

Yeah. We're going to leverage all of our commercial organization in the United States to launch into the prostate market. And our intent now is not to add field-based personnel to support the launch. We have around 140 people in the field right now.

We may increase it slightly, but this includes a mix of sales reps; of regional account managers to allow us to have a dialogue at both the business and physician level within large, important centers; nurse educators to provide support for the nursing and administrative staff at the clinics; and of course, not a commercial group, but the MSL group is also in the field, able to answer any medical inquiries. We think we're well situated to address all the medical oncology centers that we address today for Rubraca, and the focus for us will be primarily to the medical oncology community, but we do believe that for these larger urology practices that have a history of, for instance, prescribing abiraterone or enzalutamide, that the organization we have will be able to call on these, which are almost always adjacent to these large medical, primarily academic hospital.

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

OK. Thank you.

Patrick Mahaffy -- President and Chief Executive Officer

You bet.

Operator

Your next question is from the line of Gena Wang with Barclays. Please go ahead.

Gena Wang -- Barclays -- Analyst

Thank you for taking my questions. The first one will still be the commercial question. I'm thinking this quarter has a strong quarter. Pat, just wondering if you can give a little bit more color regarding how much is driven by the new patients.

And how much is driven by the longer treatment or duration of treatment of the drug?

Patrick Mahaffy -- President and Chief Executive Officer

It's pretty hard to give you a distinct quantitative view of what the primary driver is. We are pleased with the new patient starts we're seeing, and particularly, to be fair, the commercial new patient starts given the modest reduction in the amount of patients -- number of patients or percentage of patients who are getting access to free drug through the PAP program. The duration continues to improve in relatively modest increments, but we now know that the duration of use is somewhere between -- it's definitely over seven months. It's probably around seven and a half months, and we think it's continuing to improve.

So we will see a benefit as that continues. It does speak to the general tolerability of Rubraca. One of the things we talk about a lot is that in oncology in the United States, only about 50% go off therapy because they have progressive disease. The remainder go off therapy because of side effects or because they're just having difficulty just being on continuous treatment.

The fact that we're seeing this increase in duration kind of flies in the face of that and speaks to the general tolerability of Rubraca.

Gena Wang -- Barclays -- Analyst

OK. And then second question I have is the CHECKMATE 9KD in prostate cancer trial. Just wondering, I think that the trial started already in 4Q '17. I'm wondering when should we see the data?

Patrick Mahaffy -- President and Chief Executive Officer

Don't really have an answer for that. We have a great clinical collaboration with Bristol-Myers and a close relation to them. But they are in charge of both enrollment in that trial, management of that trial and any predicted time for any reported data from that trial is going to be on them. We don't really have the ability to say.

Gena Wang -- Barclays -- Analyst

Maybe I rephrase. Like the trial is still enrolling patients. Do you have a sense or can you share with us like how many patients already enrolled and the status of the enrollment?

Patrick Mahaffy -- President and Chief Executive Officer

No. We're pretty comfortable with our policy of letting Bristol-Myers speak to their trial activities. The trial does continue to enroll. And I would imagine that when they have completed enrollment, that would go up on ClinicalTrials.gov, and we would certainly report that as and when it does.

Gena Wang -- Barclays -- Analyst

OK. Thank you.

Patrick Mahaffy -- President and Chief Executive Officer

You bet.

Operator

Your next question is from the line of Cory Kasimov with JP Morgan. Please go ahead.

Unknown speaker

This is Gavin on for Cory. Thanks for taking our question. We had one on prostate as well, actually. How are you viewing the prostate market with Astra in a similar time frame, but with PFS data in a randomized trial? Just trying to get your thoughts kind of on the potential competitive landscape there.

Does this make the outlook more challenging? Or are you confident enough in the TRITON2 data that we've seen? Thank you.

Patrick Mahaffy -- President and Chief Executive Officer

Yes. So you're right. There will likely be two of us in the market in 2020, and can't know for sure when they or, for that matter, when we will be approved. But we are planning as if we're going to be approved on a relatively consistent time frame.

It is true that their approval will be based on PFS, based on a randomized trial. It will also be true that the number of patients treated in that trial and in their package, their NDA package is going to be the same or slightly lower in terms of number of BRCA1/2 patients. So I think that it isn't necessarily going to be an advantage to come in with what is still a fairly limited data set compared to the package that we'll be submitting by the end of the year. As to PFS versus response rate, the reality is these are both important end points to treating physicians.

Response rate is a little easier for patients to understand because it's evidence that the tumor is going away, which is what they really want to see. So I've never believed that a somewhat more abstract end point like PFS is more important than response, which is how a patient thinks about what's happening inside his body. And further, what we both will probably focus on and certainly, the treating physician of the patients will focus on, is in fact PSA response. Now those will be in the publications.

That will be a subject of discussion. We did not see PSA data for AstraZeneca in their presentation at ESMO. I'm confident it's good. But I would imagine that this is how most advanced and, for that matter, even earlier-stage prostate cancer patients and their physicians think mostly about the benefit or sadly, the progression they're seeing on any given treatment.

Unknown speaker

Great. Thank you for the color.

Patrick Mahaffy -- President and Chief Executive Officer

You bet.

Operator

Your next question is from the line of Paul Choi with Goldman Sachs. Please go ahead.

Paul Choi -- Goldman Sachs -- Analyst

Hi, good morning, everyone. And thank you for taking my questions. I had two pipeline questions on lucitanib. First, Pat, I think I heard you say earlier that the initial data with Rubraca could potentially be seen mid next year from the SEASTAR study.

But I was also wondering, what would the potential timing be for the combination arm with the sacituzumab govetican ADC. Is that something we could see in 2020, as well? And if not, what is sort of the gating factor there?

Patrick Mahaffy -- President and Chief Executive Officer

I think I said that we would expect to see -- hope to see data for, just to be clear, for both lucitanib plus Rubraca and lucitanib plus Opdivo by middle of 2020. So to be clear, there were two populations or regimens for which we hope to have data. Oddly enough, well, I haven't discussed with the team when we think we would have data for the combination with Immunomedics, and I don't know to what extent the team has had much dialogue with Immunomedics. So I'm not going to give you a date.

I'm not going to give you a date for that combination. But I would hope we would see initial data before the end of next year.

Paul Choi -- Goldman Sachs -- Analyst

OK, great. Thank you for that. And then with regard to the combination with nivolumab. I think ClinicalTrials indicates that your initial starting dose for the lucitanib portion would be 6 mg QID to start.

And I guess since in prior trials, you down dosed it from 15 mg down to 10 mg, I guess you should potentially have visibility on a go-forward dose for the Phase II dose expansion portion relatively quickly. Is that the right way to think about it? And when would you, I think, be in a position to sort of talk about the go-forward Phase II dose for the nivolumab-lucitanib combination? Thank you very much for taking our questions.

Patrick Mahaffy -- President and Chief Executive Officer

You bet. You're right. Starting dose is 6 mg. And we purposely chose a dose that was lower than what ultimately was a monotherapy dose of 10 milligrams with the belief that we would at least go up one-dose level.

By the end of this year, we'll have treated patients at both 6 mg and 8 mg. My expectation is that around the end of the year or early next year, we will choose between the 6 mg and 8 mg dose as our go-forward dose, and that would be the time when we would initiate the expansion cohorts in gynecological and other solid tumors. At the time we do initiate those expansion cohorts, we would -- at JP Morgan, if it's then or at our February call, make sure everyone is aware of the dose we chose and the fact that we were, at that time, be beginning those expansion cohorts. But that's kind of the general time frame and the general dose that I would estimate are going to be one of the two doses that we would choose to move forward.

Paul Choi -- Goldman Sachs -- Analyst

Great. Thanks for taking our questions.

Patrick Mahaffy -- President and Chief Executive Officer

You bet.

Operator

[Operator instructions] Your next question is from the line of Andrew Berens with SVB Leerink. Please go ahead.

Andrew Berens -- SVB Leerink -- Analyst

Thanks. Hi, Pat. I just wanted to go a little deeper into the prostate opportunity and Lynparza. What are your expectations for their potential label in regards to ATM? And what are the commercial implications if they actually get ATM on their label?

Patrick Mahaffy -- President and Chief Executive Officer

So I don't think that it's going to have any impact on the opportunity of mutant BRCA if they have ATM or if they don't have ATM. These are going to be distinct populations, and physicians will make a choice about how they treat ATM patients in the same way they're going to make a choice about how they treat BRCA patients. Obviously, for them and if for them, potentially for us from TRITON3, the ATM population would nearly double the number of patients that would be eligible for PARP inhibitor therapy from 12% to 15% for mutant BRCA to a total of something like 25%. So for -- as a commercial opportunity, it's important.

Its impact on the BRCA population, I think, will be limited. As to whether they get it in their label or not, it's hard for us to interpret the data as they were presented at ESMO, and it's important to us because it has implications for how we think about what may happen with TRITON3. So we're obviously kind of conflicted. We never wish them well because we're competitors.

But in this case, I kind of hope they get ATM because I think that would be good for us in the context of filing for approval based on TRITON3. So the big issue is what is the benefit in ATM patients? And does it matter? So they definitely hit their primary end point of the combination population of BRCA and ATM populations. So that's -- they hit it. The ATM data at the median, we didn't see hazard ratios, so we didn't see the Kaplan-Meier curves, so we can't really dissect it.

But at the median, showed pretty similar results in terms of median PFS. It's going to be up to FDA to decide how they're going to interpret that and whether to go with the fact that they hit it for all comers or all comers being BRCA and ATM or whether they're going to look at the distinct populations individually and determine for those subset populations, in this case, BRCA and ATM, what the benefit is. The benefit in BRCA2 was superb as one would expect. ATM, not so much.

And it's consistent with data we've reported and others have reported for olaparib when you look at responses for patients on ATM. The one thing that would be really helpful to see in those curves is if there were a reasonable number of dropouts that were censored because of a PSA site that didn't count as progressive disease because they never got to the point of radiological progression. So if that number is a reasonably high number, that's going to impact on the FDA's view of benefit in the ATM population. But we weren't able to interpret those data because they didn't show them at ESMO.

Andrew Berens -- SVB Leerink -- Analyst

OK. Thanks for that color. Do you get a sense from physicians that if they do get the ATM on the label, there could be the perception that Lynparza is a more active drug in prostrate? Or is this going to be like ovarian cancer where most of the physicians feel like the drugs are basically the same on efficacy, and there may be some differences on safety and tolerability?

Patrick Mahaffy -- President and Chief Executive Officer

I for sure think, whether I like to think this or not, that it's going to be the latter. I don't think that evidence of a modest PFS benefit, an almost indistinguishable PFS benefit versus an unapproved agent in this indication, second-line abiraterone or enzalutamide, is going to sway anybody's belief that PARP inhibitors as a class or all that active in ATM patients. I think they're going to be seen as generally similar.

Andrew Berens -- SVB Leerink -- Analyst

OK. And then just one last one on prostate. Do you get a sense that the bar at the FDA could change based on the availability of a drug from a randomized trial with a PFS end point?

Patrick Mahaffy -- President and Chief Executive Officer

Well, I don't have a lot to say about that. We're confident based on the pre-sNDA meeting that we have a very good and encouraging dialogue with FDA, and it is highly related to the data set that we presented them. So I think that for instance, if you're asking about an accelerated approval versus a full approval, you may note that on the QUADRA data set, which was an exceptionally limited data set, they actually achieved the full approval for that. So FDA has a lot of discretion.

Andrew Berens -- SVB Leerink -- Analyst

OK. And then just one last question, and then I'll jump back in the queue. Can you just give us some color on the free drug decrease in the patient assistance program? Is that an overall trend we should see in other -- in the market and in other drugs? And is it sustainable going forward?

Patrick Mahaffy -- President and Chief Executive Officer

If there is a trend, you see it's a modest reduction in the use of PAP from 22% to 20%. So it's not dramatic. For us, what's important is it isn't the 26% we saw on average last year. I think we're going to continue to see it slowly go down for two reasons specific to second-line ovarian and in our case, to Rubraca.

One is we work really closely with our third-party provider of this assistance program to ensure they are actively looking at multiple options for reimbursement for the patients. And so I think we've done a better job of ensuring those who are not really eligible for the program don't benefit from the program. So some of that is on us through efforts to make sure those who truly need it get the free drug. But those who don't, do not.

And then the second fact is last year, after a little bit of funding in Q1 of the foundations that do provide copay assistance to patients in ovarian, that funding dried up and was nonexistent for the majority of it, not all of post January 2018. This most recent quarter and this year, it isn't every day, and our provider checks every day at the foundations, but there has been intermittent funding of the foundation. So some additional support has been available to patients with Medicare and ovarian cancer.

Andrew Berens -- SVB Leerink -- Analyst

OK. And I did just have one more question, if you'll allow me. You mentioned the program with Immunomedics and sacituzumab as being something in 2021 or beyond. What type of dosing protocol are you guys thinking about to limit some of the overlapping tox with myelosuppression?

Patrick Mahaffy -- President and Chief Executive Officer

First, I'll say -- I said, I hope we have data by the end of next year. I just don't want to commit to it, but that's what I said at the end of 20 -- before the end of 2020. Lindsey is on the phone, and it might be better, Lindsey, if you answered the dosing strategy question.

Lindsey Rolfe -- Chief Medical Officer -- Analyst

Yes, you're welcome, Pat. Thanks for the question, Andy. You're right, there are potential overlapping toxicities. And that means that we start with lower doses of both rucaparib and sacituzumab in the clinical trial.

And I would not anticipate that this would be a very straightforward path, but we will make our way forward, adjusting the dose of one or both drugs as necessary.

Andrew Berens -- SVB Leerink -- Analyst

OK. Could it be like a maintenance-type setting like in ovarian cancer?

Lindsey Rolfe -- Chief Medical Officer -- Analyst

Ultimately, we could consider that. But the trial that we're doing at the moment is a classical Phase Ib portion that looks at treatment in patients who have exhausted standard therapy.

Andrew Berens -- SVB Leerink -- Analyst

OK. Thanks for all the questions, guys. And congrats on growing the top line and shrinking the expenses.

Patrick Mahaffy -- President and Chief Executive Officer

Thank you.

Operator

Your next question is from the line of Joe Catanzaro with Piper Jaffray. Please go ahead.

Joe Catanzaro -- Piper Jaffray -- Analyst

Hey, guys. Thanks for taking the question. Congrats on the nice quarter here. Just a quick one here on ATHENA.

So we've seen some other competitive frontline maintenance combination trials incorporate an adaptive design that allows them to sort of adjust how they randomize patients based on how standard of care evolves, and I'm talking about BRCA patients receiving PARP maintenance. And I'm just curious whether you're seeing any hesitance from physicians with ATHENA in terms of enrolling BRCA patients and potentially enrolling them onto non-PARP arms? Or has BRCA enrollment sort of proceeded in line with your expectations?

Patrick Mahaffy -- President and Chief Executive Officer

Lindsey?

Lindsey Rolfe -- Chief Medical Officer -- Analyst

Thanks, Joe, for the question. So ATHENA is enrolling in very many countries. In some countries, PARP inhibitor is available as standard of care for frontline maintenance of patients with BRCA mutant disease. And in many other countries, it's not.

So generally speaking, in the countries where there is no standard PARP inhibitor therapy available, we're seeing BRCA enrollment at or above the expected level. And then in countries where it is available, correspondingly, we're seeing BRCA enrollment less frequently. But overall, the trial is designed to minimize any risks associated with that, and I'm confident with the stat plan analysis that Pat described from HRD to ITT, and based on the strong results in frontline maintenance studies of other PARP inhibitors, not only in BRCA, but also in BRCA wild-type HRD positive patients, that we're well-positioned for success here.

Joe Catanzaro -- Piper Jaffray -- Analyst

OK, great. That's super helpful. And then maybe just one quick one for Dan around cash utilization. So should we expect net cash in operations to continue along in line with what we saw this quarter? Or were there some onetime items that will go away?

Dan Muehl -- Chief Financial Officer

No onetime items necessarily, but we tried to give the end range into second half of '21 to address some of the volatility by quarter, but we've guided previously to a lower cash burn on our last call. And so it won't be necessarily exactly the same, but it's at a lower rate compared to what it was before.

Joe Catanzaro -- Piper Jaffray -- Analyst

OK, great. Thanks for taking the questions.

Patrick Mahaffy -- President and Chief Executive Officer

You bet.

Operator

And today's final question will come from the line of Michael Schmidt with Guggenheim Securities. Please go ahead.

Yige Guo -- Guggenheim Partners -- Analyst

This is Yige on for Michael. Thanks for taking on the questions. Maybe two quick questions on TRITON2. You previously said FDA would want around 100 RECIST-evaluable BRCA patient for the sNDA.

Just wondering, based on your latest interaction with the FDA in October, are you still targeting 100 patients to be included in the NDA package. And then we also noticed there are some European clinical site enrolling patients for TRITON2. Just wondering what's your -- if you can help us understand your EU strategy for breast -- for prostate cancer. Are you -- more specifically, are you going to submit TRITON2 to EMA, as well? Or do they require a confirmatory Phase III or just TRITON3? Thank you.

Patrick Mahaffy -- President and Chief Executive Officer

Yeah. So the number of patients, I think, beginning in our May call, we said it's going to be in the range of 100. So we haven't given a precise number, but you should assume that the number that we have available for the sNDA is acceptable to FDA given our successful pre-sNDA meeting. As for the European side, yes, we are enrolling patients in Europe in TRITON2 and, for that matter, on TRITON3.

We are not optimistic that TRITON2 will be something that we can use for a submission in the EU. As we are approved in -- assuming an approval in the U.S., we may approach the EMA for discussion, but you're profoundly aware that EMA is not in love with single-arm studies as the basis of an approval. And also, TRITON3 is going to be near-term enough for us, and it's going to be a much more robust data set with a large number of patients, that we're likely to use TRITON3 as the basis of the -- with supporting data from TRITON2, but TRITON3 as the basis of an ultimate EMEA -- EMA submission.

Yige Guo -- Guggenheim Partners -- Analyst

That's it. Very helpful. Thank you.

Patrick Mahaffy -- President and Chief Executive Officer

Thank you.

Operator

And at this time, there are no further questions. Do you have any closing comments?

Breanna Burkart -- Vice President, Investor Relations

Thanks, Dennis. We thank all of you for your interest in Clovis. If you have any follow-up questions, please call me at (303) 625-5023 or Anna at (303) 625-5022. The call will be available via replay on our webcast at the website, clovisoncology.com beginning in about one hour.

Thank you, and have a good day. Goodbye.

Operator

[Operator signoff]

Duration: 57 minutes

Call participants:

Breanna Burkart -- Vice President, Investor Relations

Patrick Mahaffy -- President and Chief Executive Officer

Dan Muehl -- Chief Financial Officer

Kennen MacKay -- RBC Capital Markets -- Analyst

Tazeen Ahmad -- Bank of America Merrill Lynch -- Analyst

Gena Wang -- Barclays -- Analyst

Unknown speaker

Paul Choi -- Goldman Sachs -- Analyst

Andrew Berens -- SVB Leerink -- Analyst

Lindsey Rolfe -- Chief Medical Officer -- Analyst

Joe Catanzaro -- Piper Jaffray -- Analyst

Yige Guo -- Guggenheim Partners -- Analyst

More CLVS analysis

All earnings call transcripts