FDA Accepts Submission for Sintilimab in Combination With Pemetrexed/Platinum Chemotherapy in NSCLC
Posted: Friday, May 28, 2021
On May 18, the U.S. Food and Drug Administration (FDA) accepted a biologics license application for an injection of the PD-1 inhibitor sintilimab in combination with pemetrexed and platinum chemotherapy as first-line treatment for patients with nonsquamous non–small cell lung cancer (NSCLC). The goal date for the FDA to make a decision on the sintilimab application is March 2022.
The FDA submission was based on the results of the double-blind, phase III ORIENT-11 clinical trial. The trial investigated the efficacy and safety of sintilimab in combination with pemetrexed and platinum chemotherapy compared with pemetrexed and platinum chemotherapy.
Researchers enrolled 397 patients with advanced or metastatic nonsquamous NSCLC, with no sensitizing EGFR mutations or ALK rearrangements. They were randomly assigned to receive either 200 mg of sintilimab or a placebo in combination with pemetrexed and platinum chemotherapy every 3 weeks for up to four cycles. This was followed by either sintilimab or placebo plus pemetrexed maintenance therapy. Patients received treatment until radiographic disease progression, unacceptable toxicity, or any other conditions that required treatment discontinuation.
