With close to 6,000 oncology drugs in development and more than 2,400 different mechanisms of action (MOAs), immunotherapy has been the hottest topic in oncology. Immunotherapies have started to enter the mainstream, with June being immunotherapy awareness month. Newsman Tom Brokaw and former president Jimmy Carter recently spoke about their treatments with this class of drugs, and several 60 Minutes segments covered immunotherapies. The immunotherapy market horizon includes more than 75 drugs in development for oncology. The race is now on for the next FDA-approved immunotherapy in cancer as well as expanded indications for Merck’s and BMS’s approved immunotherapies.
Kantar Health’s newly developed CancerLandscape™ platform identified 8 immunotherapy drugs in Phase 3 clinical trials in the U.S., with 13 in Phase 2 and 17 in Phase 1; 41 drugs that target PD-1 alone are in various stages of development, many in preclinical development that may never make it to clinical trials. The presence of immunotherapies at annual scientific meetings is growing. At the American Society of Clinical Oncology (ASCO) 2015 annual meeting, immunotherapy targets were mentioned in over 850 out of the 5,000 abstracts.1 The American Association for Cancer Research (AACR) 2015 meeting had more than 500 immunotherapy-related abstracts, skewed toward late-stage and approved targets (PD-1, PD-L1 and CTLA-4). However newer targets appear almost daily.
Immunotherapies have the ability to completely change treatment paradigms within a tumor. In melanoma, for example, the best option before immunotherapy was interleukin-2, which had an only 6% complete response rate2 with a very large side-effect profile. The level of unmet need was high, and Yervoy was able to reduce the risk of death by 32% in these patients. Recently, Opdivo showed an overall response rate of 32% in advanced melanoma patients and a one-year survival rate of 73%.3,4 In an indication with very few options and dismal outcomes, immunotherapy is allowing patients to live longer.
Not only are immunotherapies improving clinical outcomes, they also show the potential to affect management of cancer patients in other areas.
With immunotherapies moving further up in lines of therapies and quickly becoming the go-to option over chemotherapies, what will happen to the supportive care market? Supportive care drugs used to combat nasty side effects of chemotherapy could see a shrinking market as patients move to immunotherapies with fewer (or at least different) side effects. For example, some supportive care drugs are aimed at neutropenia, but the current approved immunotherapy drugs don’t show a significant amount of neutropenia. As immunotherapies become more ubiquitous one could see the supportive care market for neutropenia in cancer shrink.
How will immunotherapies change biomarker testing? Specifically, in melanoma, immunotherapy is moving earlier within the treatment paradigm, and treatments are efficacious regardless of BRAF. Will patients still need BRAF testing? If immunotherapy becomes standard of care in first- and second-line in melanoma, where does BRAF testing fit in?
What about histology? Immunotherapies in lung cancer seem equally effective in squamous and non-squamous subsets. If immunotherapies become the major treatment in lung cancer does it become necessary to separate the two by histology? Immunotherapy has the ability to not only completely shift a treatment paradigm within a tumor but also to affect other markets and possibly how patients are diagnosed.