Innovent Biologics Inc. and Eli Lilly and Co. (LLY) said that phase 3 ORIENT-3 study results showed that the anti-PD-1 monoclonal antibody sintilimab significantly improved overall survival for the second-line treatment of squamous non-small cell lung cancer patients.
ORIENT-3 is a randomized, open-label, Phase 3 clinical trial evaluating TYVYT or sintilimab injection versus docetaxel as a second-line treatment for advanced or metastatic squamous non-small cell lung cancer or sqNSCLC.
A total of 290 patients whose cancer had progressed following first-line treatment with platinum-based chemotherapy were enrolled.
Based on the primary analysis population--280 patients, excluding patients on the docetaxel arm who received immunotherapy prior to disease progression--, TYVYT demonstrated a statistically significant improvement in overall survival or OS compared to docetaxel, meeting the pre-specified primary endpoint, the companies said in a statement.
The median OS was 11.79 months for patients on the TYVYT arm and 8.25 months for those on the docetaxel arm.
The median progression-free survival as assessed by investigators was 4.30 months versus 2.79 months, and the confirmed objective response rate was 25.5 percent versus 2.2 percent, respectively. Safety was consistent with previous studies of TYVYT, and no new safety signals were identified.
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