In 2011, the World Health Organization compiled a list of every disease, disorder, and ailment known to man. The list eventually crested the 14,000-ailment mark when it was complete. But among all of these ailments, it's arguable that none draws more attention from drugmakers or the public than cancer.
Drugmakers turn their efforts to cancer
Cancer is a scary disease for two primary reasons. First, researchers don't have a very good understanding of what triggers cancer growth in the first place. Don't get me wrong; researchers have a general understanding of some of the high-risk factors behind the disease, including genetics/family history and smoking. But based on today's diagnostic tools, a physician or researcher wouldn't be able to concretely tell you why one person gets cancer and another does not.
Secondly, cancer can be a quick killer -- and most cancer types don't have cures. Although we've witnessed advances in some of the most common cancer types, such as breast cancer and prostate cancer, which have much improved five-year survival times compared to four decades ago, only marginal improvements have been seen in pancreatic or lung cancer, where five-year survival rates are still very low.
For drug developers, oncology is a hot investment, both to sustain business over the long run -- IMS Health recently predicted that global cancer sales could march higher from the $100 billion they generated in 2015 to as much as $147 billion by 2018 -- and to provide better quality of life for patients around the world.
Can you name the leading company in cancer care research?
With that being said, can you name the company that's responsible for leading the charge in cancer care research around the world?
Here's a big hint: it currently has 80 ongoing oncology-based clinical studies, including 32 phase 1 studies (which focus entirely on safety and dose-finding); 16 phase 2 studies (which primarily focus on safety and hint at efficacy); 28 phase 3 studies (which focus equally on safety and efficacy); and four registration studies which are being reviewed in the U.S. and/or EU.
Think you know the drug developer behind this impressive oncology pipeline? Did you say Pfizer, Novartis, or Johnson & Johnson? If so, you'd be wrong.
Swiss-based Roche (NASDAQOTH:RHHBY) is actually the company behind the world's most aggressive and impressive oncology pipeline.
Like most Big Pharma companies, Roche maintains a presence in other indications, including substantial efforts in neuroscience, immunology, and infectious diseases. But the vast majority of its research, and the primary hope of its current product portfolio, rests with its cancer research.
How Roche has helped cancer patients
In a moment we'll take a look at some of the new innovations that Roche will be looking to bring to market in the upcoming years. But first let's take a gander at some of the products Roche has put on pharmacy shelves to help cancer patients live longer and better.
Roche has three product portfolio rocks that it leans on heavily: MabThera/Rituxan, Herceptin, and Avastin. These three therapies combined for $5.3 billion in sales in the first quarter, and extrapolated out could easily translate into $20 billion-plus in annual sales.
Rituxan is indicated as a treatment for rheumatoid arthritis, but you'll see it used as a treatment for chronic lymphocytic leukemia, the most common form of leukemia in adults, as well as non-Hodgkin lymphoma. Herceptin gained the majority of its notoriety as a treatment of breast cancer in patients who express HER2. Lastly, Avastin, an angiogenesis (blood vessel) inhibitor, has a laundry list of approvals from the Food and Drug Administration, including metastatic HER2-negative breast cancer, first-line non-small cell lung cancer, and first- and second-line advanced colorectal cancer, to name a few.
However, one of the most exciting treatments Roche has brought to cancer patients in recent years is Perjeta, which is used for metastatic breast cancer patients who are HER2-positive. In the CLEOPATRA study the group of patients receiving Perjeta in combination with Herceptin and docetaxel had a median overall survival of 56.5 months. Comparatively, this was 15.7 months better than the control group that received Herceptin and docetaxel without Perjeta. Not only were the results of the study statistically significant, but the 56.5-month median overall survival marked the longest survival time ever recorded in an advanced cancer trial (regardless of cancer type) for any drug.
Where Roche is headed next
So, what's on the docket next for Roche? The company is now pushing heavily into cancer immunotherapies, which focus on enhancing the immune system of a patient to better locate and destroy cancer cells. Roche's leading immunotherapy compound is atezolizumab, an anti-PD-L1 agent that prevents cancer cells from evading detection from the immune system.
Although cancer immunotherapies are intriguing as monotherapies (and you'll certainly find monotherapy trials in Roche's pipeline), the real allure has been in combining them with already-approved cancer treatments. Thus, Roche has a pipeline that's absolutely littered with potential combination therapies involving atezolizumab. Some of the more intriguing late-stage studies that'll probably catch your eye include a phase 3 study in combination with Celgene's Abraxane as a first-line treatment for metastatic triple-negative breast cancer and a first-line non-squamous non-small cell lung cancer study in combination with chemotherapy and with or without Avastin. The only downside is both studies aren't expected to deliver results until 2018 or 2019.
However, in some indications an approval could be right around the corner. Roche's BRAF kinase inhibitor Zelboraf and Exelixis' cobimetinib led to a statistically significant improvement in median overall survival, and a marked improvement in overall response as a combo therapy in BRAF V600 mutation-positive metastatic melanoma patients in the coBRIM study. With a PDUFA decision date coming up in November, the chances of an approval appear high.
Understandably, we should keep in mind that not all drug trials will succeed. But with an oncology pipeline that's 80 ongoing studies/registrations deep, it's tough to see Roche not continuing to make a substantial impact in the fight against cancer going forward.
Sean Williams owns shares of Exelixis, but has no material interest in any other companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.
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