Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, today announced that the sintilimab ORIENT-31 study has met its prespecified primary endpoint of progression-free survival (PFS) at the first interim analysis.
Globally, ORIENT-31 is the first prospective, double-blind, multi-center, Phase 3 study that has demonstrated significant PFS improvement of anti-PD-1 and anti-VEGF antibody combination therapy (i.e., sintilimab plus BYVASDA® [bevacizumab biosimilar injection] combined with chemotherapy [pemetrexed and cisplatin]) in patients with epidermal growth factor receptor (EGFR)-mutated nonsquamous non-small cell lung cancer (nsqNSCLC) that has progressed after treatment with an EGFR tyrosine kinase inhibitor (TKI).
In the first interim analysis reviewed by the Independent Data Monitoring Committee (IDMC), in the intent-to-treat (ITT) population, based on assessment by the Blinded Independent Radiographic Review Committee (BIRRC), sintilimab in combination with BYVASDA® (bevacizumab biosimilar injection) and chemotherapy demonstrated a statistically significant and clinically meaningful improvement in PFS compared with chemotherapy. Sintilimab in combination with chemotherapy also showed a trend of PFS benefit compared to chemotherapy alone (data is not yet mature). Additionally, the prespecified PFS futility analysis that compares sintilimab in combination with BYVASDA® (bevacizumab biosimilar injection) and chemotherapy to sintilimab in combination with chemotherapy did not cross futility stopping boundary. A numerical benefit of adding BYVASDA® (bevacizumab biosimilar injection) to sintilimab and chemotherapy combination can be observed. The safety profile of this study was consistent with that observed in previously reported studies of sintilimab and BYVASDA® (bevacizumab biosimilar injection), with no additional safety signals. The detailed results of ORIENT-31 will be presented at an upcoming medical meeting.
The principal investigator of the ORIENT-31, Prof. Shun Lu from the Oncology Department of Shanghai Chest Hospital, 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."
Dr. Hui Zhou, Senior Vice President of Innovent, stated, "Lung cancer has the highest mortality rate among all tumor types both in China and worldwide. In China, EGFR-mutated NSCLC accounts for 40% to 50% of nonsquamous NSCLC, and the treatment options for these patients after treatment with first, second and third generation EGFR-TKIs are very limited, representing a large unmet medical need. Through the joint efforts of investigators, ORIENT-31 achieved these encouraging research results. We are grateful for all the contributions made by the investigators and patients in this study – together we accomplished this important milestone."
About Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Lung cancer is the leading cause of cancer death worldwide, and the second most commonly diagnosed tumor type. Non-small cell lung cancer (NSCLC) accounts for about 80% to 85% of all lung cancer, in which about 70% of NSCLC patients present with locally advanced or metastatic disease that is not suitable for surgical resection at diagnosis. In China, nsqNSCLC accounts for 70% of NSCLC, in which about 40% to 50% of nsqNSCLC patients have an EGFR mutation. The standard first-line treatment for patients with advanced EGFR-mutated NSCL...
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