Back in June, Merck & Co. upstaged immuno-oncology rival Roche with data that analysts deemed superior in squamous non-small cell lung cancer. And thanks to a new approval, it now looks like it’s going to beat Roche to market, too.
Tuesday, the FDA greenlighted Merck standout Keytruda, in combination with chemo, as a treatment for previously untreated squamous NSCLC patients regardless of their levels of its targeted biomarker, PD-L1. It’s the first member of the PD-1/PD-L1 class of cancer-fighters to win that distinction, Merck pointed out, with Merck Research Laboratories President Roger Perlmutter, M.D., adding that squamous NSCLC “is particularly difficult to treat.”
The approval follows data rolled out at this year’s American Society of Clinical Oncology meeting that showed the Keytruda-chemo pairing could cut down the risk of disease worsening or death by 44% and the risk of death on its own by 36%. At the time, Roy Baynes, Merck's SVP and head of global clinical development, called the showing “truly remarkable.”
While Keytruda may be the only member of its class to boast this new approval, though, it’s not the only one out with positive data in the front-line setting. Also at ASCO, Roche’s Tecentriq, combined with chemo, showed that it could pare down the risk of disease worsening or death by 29%.
Industry watchers were quick to crown Keytruda the winner, though, despite the risks inherent in comparing differently conducted trials. Numbers aside, the overall survival data in Merck’s application may have helped the company leapfrog Roche, which was first to post top-line data but only had progression-free survival results to back its bid.
Meanwhile, the newest go-ahead helps cement Keytruda’s domination in the ultra-lucrative front-line lung cancer market. The drug also boasts two FDA nods in non-squamous NSCLC, compared with a combined zero from its in-class nemeses, including Bristol-Myers Squibb's Opdivo, AstraZeneca's Imfinzi and Pfizer and Merck KGaA's Bavencio in addition to Roche's Tecentriq.