Significant spending on cancer research and development could be about to pay off for Clovis Oncology (CLVS -3.42%), Array BioPharma (ARRY), and Ariad Pharmaceuticals (NASDAQ: ARIA). All three of these companies are preparing for Food and Drug Administration decisions next year on cancer drugs that could reshape patient treatment.
Read on to learn more about these novel cancer drugs and how approvals could move the needle for investors in these companies.
No. 1: Rucaparib
Rucaparib is a PARP inhibitor developed by Clovis Oncology that is being considered for approval by the FDA under the priority review pathway as a treatment for patients with a BRCA-mutated ovarian cancer.
In phase 2 studies, patients receiving rucaparib had an overall response rate of 54%. That's important because the patient population studied in rucaparib's trials had already tried and failed on a median three chemotherapies. 39% of patients had received two prior therapies and 61% of patients had received three or more prior therapies. As a result, rucaparib could become the first PARP drug approved for use in patients who have previously received two therapies. Currently, Lynparza, which won approval in 2014, is only approved for use in patients who have received at least three chemotherapies.
Rucaparib's efficacy appears solid, however, there are some questions regarding the drug's safety and that means an approval isn't a sure bet. In trials, 100% of patients experienced an adverse event and 61% experienced a severe adverse event (grade 3 or higher).
Rucaparib's safety profile could derail an approval, but investors should remember that there's a significant unmet need for new treatment options for pre-treated ovarian cancer patients. Since it appears that dose interruption and dose reduction can effectively manage rucaparib's safety risks, an approval could still be likely.
No. 2: Binimetinib
Binimetinib is under FDA review for the treatment of NRAS-mutant melanoma. Array Biopharma's application for binimetinib was accepted by the FDA for review in September and an official go/no-go decision is anticipated next June.
In trials, patients receiving binimetinib had progression-free survival of 2.8 months versus 1.5 months for patients receiving the chemotherapy dacarbazine. Binimetinib patients that had previously been treated with an immunotherapy, such as Opdivo, had progression free survival of 5.5 months, versus 1.6 months for patients receiving dacarbazine. Also, the confirmed overall response rate was 15% for binimetinib and just 7% for dacabazine.
That efficacy may not sound like a substantial improvement, but this patient population has a very poor prognosis and since binimetinib was well-tolerated in trials, an FDA OK next summer is a good possibility. If the FDA does give binimetinib the nod, then it could become a welcome new alternative for the 20% of melanoma patients with NRAS-mutant melanoma. Last year, roughly 15,000 Americans were diagnosed with NRAS-melanoma.
No. 3: Brigatinib
Ariad Pharmaceuticals already markets the leukemia drug Iclusig, and if things go its way, it will add a second drug to its product lineup early next year.
The company completed its new drug application for brigatinib in Q3, and if it gets approved, it will be used to treat ALK+ non-small-cell lung cancer patients who are resistant to Pfizer's Xalkori.
In trials, progression-free survival was 12.9 months for patients receiving 180 mg with a seven day lead-in at 90 mg of brigatinib daily.
The company thinks it has a shot at an FDA decision in the first half of next year and if the FDA approves brigatinib, then it would begin competing in a market currently worth $348 million in the United States and $768 million globally.
Initially, brigatinib's addressable patient population will total roughly 4,000 patients annually, however, ongoing studies comparing brigatinib head-to-head against Xalkori could eventually double that number. To put the peak sales opportunity into perspective, Xalkori's sales are clocking in at an annualized $540 million pace.
Historically, less than 10% of cancer drugs in clinical trials have made their way to the market, so there's no guarantee that these drugs will get a green light from the FDA next year. That being said, each of these drugs treats patient populations where there's an important need for new treatment choices and that need, plus solid efficacy in trials, may help these three drugs overcome the odds.