Shares of Bristol-Myers Squibb Co. (NYSE:BMY) continued their downhill slide after tumbling 15.99% on August 5 following the company announcement that CheckMate -026, a trial investigating the use of anti-PD-1 (programmed death receptor-1) immuno-oncology drug Opdivo (nivolumab) as a monotherapy, did not meet its primary endpoint of progression-free survival in patients with previously untreated advanced non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 (programmed death-ligand 1) at = 5%.
Investors might have hoped for a better outcome from the CheckMate -026 trial after Merck & Co., Inc. (NYSE:MRK) announced on June 16 that the rival anti-PD-1 drug Keytruda (pembrolizumab), met its primary endpoint in the KEYNOTE-024 trial in patients with previously untreated advanced NSCLC whose tumors expressed high levels of PD-L1, tumor proportion score of 50% or more.
Bristol-Myers Squibb's Opdivo, approved by the FDA in November 2015 for treatments of an advanced form of kidney cancer, generated sales of $840 million in the second-quarter 2016. So far, the FDA has also approved Opdivo for treatment of advanced melanoma, classical Hodgkin lymphoma and metastatic NSCLC, whose disease progressed during or after platinum-based chemotherapy. According to the company's financial statement, Opdivo’s revenue now accounts for over 50% of the company’s oncology product portfolio, compared to just under 5% a year ago.
Merck’s Keytruda was approved by the FDA for treatment of advanced melanoma in September 2014 and for metastatic NSCLC in October 2015. In the second-quarter 2016, Keytruda generated sales of $314 million, less than half of Opdivo’s revenues. On August 8, Keytruda received the latest FDA approval for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy. GlobalData forecasts that Keytruda will achieve peak sales of almost $500 million by 2024, in head and neck cancer treatment alone.
On May 18, 2016, South San Francisco-based Genentech, a member of the Roche Group (OTCQX:RHHBY) said the FDA granted accelerated approval to its PD-L1 drug Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC), a specific type of bladder cancer.
At the end of August, Genentech said its cancer immunotherapy Tecentriq met its co-primary endpoints in the Phase III study, OAK, and showed a statistically significant improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic NSCLC whose disease progressed on or after treatment with platinum-based chemotherapy. Genentech’s Biologics License Application (BLA) for NSCLC was granted Priority Review with an action date of October 19, 2016.