Innovent Biologics, Inc. announced the results of the Phase III ORIENT-31 study evaluating sintilimab in combination with BYVASDA (bevacizumab biosimilar) for the treatment of non-squamous non-small cell lung cancer.  According to the press release, patients receiving sintilimab plus BYVASDA combined with chemotherapy (pemetrexed and cisplatin) demonstrated an improvement in progression-free survival compared with patients receiving chemotherapy alone.  The median progression-free survival was 6.9 months for the sintilimab-and-BYVASDA patients as compared with 4.3 months for the chemotherapy-only patients.

Sintilimab is a PD-1 inhibitor that is marketed as TYVYT in China, where it is approved to treat relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, as first-line treatment of nonsquamous non-small cell lung cancer when given in combination with pemetrexed and platinum chemotherapy, as first-line treatment of squamous non-small cell lung cancer when given in combination with gemcitabine and platinum chemotherapy, and as first-line treatment of hepatocellular carcinoma when given in combination with BYVASDA.

This past May, the FDA accepted for review a BLA for sintilimab in combination with pemetrexed and platinum chemotherapy for the first-line treatment of nonsquamous non-small cell lung cancer.