Immunotherapies and the Race to Become the Standard of Care

A hot and promising new area of oncology treatment is immunotherapy, or IO drugs, which we discussed in a recent webinar. These therapies unlock immune system cells and help the immune system recognize and fight cancer tumors. To date, four IO drugs have been approved by the FDA: Yervoy (ipilimumab), Keytruda (pembrolizumab), Opdivo (nivolumab), and Tecentriq (atezolizumab). 

Recent advances in IO development have led to significant funding and research from manufacturers and even from the President’s National Cancer Moonshot InitiativeOne of the major goals of manufacturers and the National Cancer Moonshot Initiative is to test existing IO drugs in all cancer types. This indication expansion is currently happening, and with more attention and funding, competition for the IO drugs will heat up. Manufacturers of IO drugs are competing for market share across multiple cancer types and even within individual cancer types as they race to establish their products as the standard of care.

We previously examined two drugs that exemplify this competition between IO drugs: BMS’s Opdivo and Merck’s Keytruda. Both drugs are approved to treat Melanoma and NSCLC. NSCLC represents a $10 - $15 billion  dollar market. Approximately 85% - 90% of all lung cancer patients are diagnosed with the non-small cell variety (approximately 190,731 – 201,951 Americans diagnosed annually). Both Opdivo and Keytruda are approved to treat patients who have progressed on/or after chemotherapy; however, these drugs are now racing for approval in a first-line treatment setting.


BMS was dealt a setback recently when they announced that Opdivo did not demonstrate an improvement in progression-free survival (PFS)  in patients newly diagnosed with NSCLC whose tumor expressed at least 5% of PD-L1. BMS’s stock dipped and wiped $20 billion dollars off BMS’s market value. On the other hand, Merck’s shares increased by 8% when results were released that Keytruda demonstrated superior PFS and overall survival in newly diagnosed patients whose tumor expressed 50% or more of PD-L1. These results prompted the FDA to grant Keytruda “breakthrough therapy designation” and to priority review the drug for first-line NSCLC. While the Keytruda first-line patient population is narrower than that included in the Opdivo trial (50% expression vs. >5% expression), this will be a major step toward first-line treatment for Keytruda and a major hurdle for any other drugs seeking first-line indications in NSCLC. The race to capture all first-line NSCLC patients is still ongoing, and with the increase in funding to test all IO drugs in all cancer types, the possibilities for increased profitability are tremendous.

The Context Matters team will continue to closely monitor the IO space and will be presenting analysis in February 2017 at the World Pharma Pricing & Market Access Congress.