China Approves Sintilimab Combo for Squamous NonSmall-Cell Lung Cancer
Innovent Biologics and Eli Lilly have won approval in China for sinitilimab in combination with gemcitabine and platinum chemotherapy as a first-line treatment for patients with unresectable squamous nonsmall-cell lung cancer (NSCLC).
The approval was supported by a phase 3 trial in 357 participants, which showed sinitilimab significantly improved progression-free survival vs. placebo, the companies said.
The approval marks sinitilimab’s third from China’s National Medical Products Administration. It was approved for treating relapsed of refractory Hodgkin’s lymphoma in December 2018 and as a first-line treatment for nonsquamous NSCLC in February.