On September 20, 2020 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, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) that biomarker results from the ORIENT-11 study were released in a mini oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 (Press release, Innovent Biologics, SEP 20, 2020, View Source [SID1234565396]). The ORIENT-11 primary clinical results were released during the IASLC World Conference on Lung Cancer (WCLC) 2020 Virtual Presidential Symposium as an oral presentation and simultaneously published by the Journal of Thoracic Oncology.
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ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating TYVYT (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy as a first-line treatment for advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC) without sensitizing EGFR mutations or ALK rearrangements. The National Medical Products Administration (NMPA) of China has accepted the supplemental New Drug Application (sNDA) for this indication. Biomarker data analysis revealed that the MHC-II antigen presentation pathway played a key role in immunotherapy-chemotherapy combination. Higher gene expression of this pathway was significantly associated with longer progression-free survival (HR, 0.41; 95% CI, 0.23-0.76; P=0.0041) and could potentially serve as a predictive biomarker to select patients who can benefit from this regimen.
Professor Li ZHANG, Head of Department of Internal Medicine, Sun Yat-sen University Cancer Center, the primary investigator of the ORIENT-11 trial, stated: "Sintilimab in combination with pemetrexed and platinum chemotherapy showed improved efficacy and no new safety signals in locally advanced or metastatic nonsquamous NSCLC. These results will further our understanding of the performance of this combination in certain types of patients."
Dr. Wei XU, Vice President of New Drug Biology and Translational Medicine of Innovent, stated: "We were very pleased to release these biomarker results at the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. MHC-II antigen presentation pathway might predict clinical efficacy of immunotherapy-chemotherapy. This finding could improve our understanding of the mechanism of action of this combination and provide a scientific rationale for future selection of patients who could benefit most."
Dr. Li WANG, Senior VP of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center, stated: "Biomarker exploration is very important to advance cancer immunotherapy. We are very pleased that our discovery of a potential biomarker for immunotherapy will be shared at ESMO (Free ESMO Whitepaper). I would like to thank all the investigators, scientists and patients involved in the trial."
About ORIENT-11 Trial
ORIENT-11 is a randomized, double-blind, Phase 3 clinical trial evaluating the efficacy and safety of TYVYT (sintilimab injection) or placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy as a first-line treatment for advanced or recurrent nonsquamous non-small cell lung cancer (nsqNSCLC) without sensitizing EGFR mutations or ALK rearrangements (ClinicalTrials.gov, NCT03607539). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee based on RECIST v1.1. The key secondary endpoints include overall survival (OS) and safety profile.
A total of 397 subjects have been enrolled in the ORIENT-11 trial and randomized in a 2:1 ratio to receive either TYVYT (sintilimab injection) 200mg or placebo in combination with ALIMTA (pemetrexed) and platinum chemotherapy every three weeks for up to four cycles, followed by either TYVYT (sintilimab injection) or placebo plus ALIMTA (pemetrexed) maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.
About nsqNSCLC
Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 to 85 percent of lung cancer. Approximately 70 percent of NSCLC is locally advanced or metastatic at initial diagnosis, resulting in patients with having little to no chance of radical resection. Meanwhile, even after radical surgery, patients have a high chance of recurrence and eventually die from disease progression. About 70 percent of NSCLC in China is nonsquamous subtype and 50 percent of nsqNSCLC is without sensitizing EGFR mutations or ALK rearrangements. These patients do not respond well to targeted therapy and there are limited treatment options available to them.
About TYVYT (Sintilimab Injection)
TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019. In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy in nonsquamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint in the ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC.
TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.