ResearchTreatments

Sintilimab Meets Primary End Point in ORIENT-31 Trial for EGFR+ Non-Squamous NSCLC

By November 12, 2021No Comments

*October 2021*

Sintilimab with or without a bevacizumab biosimilar injection, combined with chemotherapy yielded promising findings in a population of patients with EGFR-mutant nonsquamous non–small cell lung cancer who have previously been treated with an EGFR tyrosine kinase inhibitor.

Sintilimab (Tyvyt) has yielded a promising improvement to progression-free survival (PFS) in patients with EGFR-mutant nonsquamous non–small cell lung cancer (nsqNSCLC) who have previously been treated with an EGFR tyrosine kinase inhibitor (TKI), according to the first interim analysis of the phase 3 ORIENT-31 trial (NCT03802240).

These data, which were made available after review by an independent data monitoring committee, revealed that patients within the intent-to-treat population experienced a statistically significant and clinically meaningful PFS benefit after being treated with sintilimab and a bevacizumab biosimilar injection (Byvasda) vs chemotherapy alone. Additionally, when combined with chemotherapy, sintilimab yielded a trend toward PFS benefit compared with chemotherapy alone, although investigators noted that the findings are not yet mature.

Findings from ORIENT-31 will be presented at an upcoming meeting, investigators stated.

“For patients with EGFR-mutated advanced nsqNSCLC who have progressed following EGFR-TKI treatment, platinum-based chemotherapy is the current standard of care, but with limited benefit. 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. It has shown the clinical value of adding sintilimab plus Byvasda (bevacizumab biosimilar injection) to platinum chemotherapy. This quadruple regimen has the potential to bring forth a new and more effective treatment option to patients with EGFR-mutated nsqNSCLC following treatment with an EGFR TKI,” Shun Lu, a professor of the Oncology Department of Shanghai Chest Hospital and principal investigator of the study, said in a press release.

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