After weeks of an inspection-related delay, Regeneron has finally won a much-anticipated FDA approval for Libtayo in newly diagnosed non-small cell lung cancer (NSCLC), opening another front to challenge Merck & Co.’s formidable Keytruda.
In a win for Regeneron, the new nod clears Libtayo along with chemotherapy in a broad first-line NSCLC population. It doesn’t limit Libtayo’s use to any specific cancer histology or by tumor PD-L1 expression status.
Libtayo’s price will stay the same, a Regeneron media aide told Fierce Pharma. A similar application is also under review at the European Medicines Agency, and a decision is expected in the coming month, according to the company.
The go-ahead makes Libtayo now the only other PD-1/L1 inhibitor besides Keytruda that boasts a U.S. chemo combo use in first-line NSCLC regardless of PD-L1 levels or histology, adding to a previous monotherapy approval for PD-L1-high expressers. But a Keytruda-matching indication doesn’t necessarily mean Libtayo could just split the market with the Merck PD-1 king.
For starters, Libtayo’s data aren’t differentiated. Libtayo’s combination with chemo cut the risk of death by 29% over chemo alone in the EMPOWER-Lung 3 trial. In a subgroup of patients with squamous cell carcinoma, Libtayo does appear to hold an advantage over Keytruda by cross-trial comparison. The Regeneron drug cut the risk of death by 44% in this population, versus 29% for Keytruda in a final analysis of the KEYNOTE-407 trial.
But Libtayo performed worse in the non-squamous subgroup with a death risk reduction of 21% in EMPOWER-Lung 3, whereas Keytruda is well known for its roughly 50% reduction in KEYNOTE-189. Between the two subtypes of NSCLC, non-squamous is the larger one, with about 70% representation of all cases.