Sintilimab extends PFS for certain patients with NSCLC
The addition of sintilimab to chemotherapy prolonged PFS for patients with pretreated EGFR-mutated nonsquamous non-small cell lung cancer, according to topline data released by the agent’s manufacturer.
Sintilimab (Innovent Biologics/Eli Lilly), a PD-1 inhibitor, is approved in China for multiple indications. It is not approved in the United States.
The double-blind, multicenter ORIENT-31 study is designed to enroll 480 patients with EGFR-mutated locally advanced or metastatic nonsquamous NSCLC who progressed after prior EGFR tyrosine kinase inhibitor treatment.
Researchers randomly assigned patients to one of three treatment regimens: sintilimab plus bevacizumab biosimilar injection (Byvasda, Innovent Biologics) with pemetrexed and cisplatin; sintilimab with pemetrexed and cisplatin; or pemetrexed and cisplatin alone.
After four cycles of their assigned treatment, patients received maintenance therapy until disease progression, unacceptable toxicity or treatment discontinuation.
PFS by blinded independent review committee served as the primary endpoint. Secondary endpoints included OS, PFS by investigator assessment, objective response rate and safety.
Results of the first interim analysis showed a statistically significant PFS benefit with sintilimab, bevacizumab biosimilar injection and chemotherapy.
Complete results of ORIENT-31 will be submitted for presentation at a medical meeting.
“For patients with EGFR-mutated advanced nonsquamous NSCLC who have progressed following EGFR TKI treatment, platinum-based chemotherapy is the current standard of care, but with limited benefit,” trial investigator Shun Lu, MD, PhD, of the department of oncology at Shanghai Chest Hospital, said in an Innovent Biologics-issued press release. “New treatments are clearly imperative.
“ORIENT-31 is the first prospective, double-blind phase 3 study worldwide to demonstrate significant PFS benefit with an anti-PD-1 antibody combination therapy in this patient population,” Lu added. “This quadruple regimen has the potential to bring forth a new and more effective treatment option to patients with EGFR-mutated nonsquamous NSCLC following treatment with an EGFR TKI.”