Sugemalimab extends OS in stage IV non-small cell lung cancer
Click Here to Manage Email Alerts
The addition of sugemalimab to first-line chemotherapy significantly prolonged OS among patients with stage IV non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
Sugemalimab (EQRx Inc. and CStone Pharmaceuticals) is an investigational monoclonal antibody that targets PD-L1.
The randomized phase 3 GEMSTONE-302 trial included 479 patients in China with stage IV squamous or nonsquamous NSCLC.
Researchers assessed the addition of sugemalimab (n = 320) or placebo (n = 159) to carboplatin-based chemotherapy as first-line treatment.
Previously reported results showed the study met its primary endpoint, demonstrating a significant improvement in investigator-assessed PFS in the sugemalimab group (9 months vs. 4.9 months; HR = 0.48; 95% CI, 0.39-0.6).
Results from a planned interim analysis showed a significant improvement in OS, a key secondary endpoint, with the experimental regimen. Researchers observed clinical benefit with sugemalimab across subgroups, including those with squamous and nonsquamous disease, and regardless of PD-L1 expression levels.
The agent exhibited a safety profile consistent with the PD-1/PD-L1 class of therapies.
Complete results of GEMSTONE-302 will be submitted for presentation at a medical meeting.
“We are highly encouraged to see that sugemalimab in combination with chemotherapy demonstrates significant clinical benefit, including improvement in both PFS and OS, when compared [with] placebo plus chemotherapy across a broad spectrum of patients with stage IV non-small cell lung cancer,” Vince Miller, MD, physician-in-chief at EQRx, said in the release. “Price remains a barrier to accessing innovative therapies for many people with lung cancer around the world, despite the availability of multiple anti-PD-(L)1 therapies. We look forward to engaging with global regulatory authorities with the aim of delivering a lower-cost treatment option to patients upon approval.”
Read more about
Click Here to Manage Email Alerts