On May 6, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) the results of a phase 3 study in China. The ORIENT-12 trial of TYVYT (sintilimab injection) in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy in first-line advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) met the predefined primary endpoint of progression-free survival (PFS) (Press release, ImmunoGen, MAY 6, 2020, View Source [SID1234557167]). This is the first randomized, double-blind phase 3 study evaluating the combination of anti-PD-1 antibody with Gemzar and platinum chemotherapy in the world.

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TYVYT in combination with gemcitabine and platinum chemotherapy demonstrated a statistically significant improvement in PFS compared to placebo in combination with gemcitabine and platinum chemotherapy, meeting the pre-defined endpoint. The safety profile of TYVYT in this trial was consistent with previously reported studies, and no new safety signals were identified. Relevant data will be presented at an upcoming medical conference.

Innovent and Lilly will initiate regulatory discussions for registration with the National Medical Products Administration (NMPA) of China in the near future.

"Lung cancer is the leading cause of cancer death (25.2%), of which NSCLC accounts for 80-85 percent, with about 35 percent of those patients having the squamous subtype. In the past 20 years, drug development to treat NSCLC has been mainly focused on nonsquamous NSCLC, while drug development of sqNSCLC has been slower due to its lack of driving mutation and its unique epidemiological, histopathological and molecular characteristics," Professor Caicun Zhou, Head of Department of Oncology, Shanghai Pulmonary Hospital. "The emergence of the anti-PD-1 antibody has brought a new treatment modality for patients with sqNSCLC. We are delighted to see that TYVYT in combination with gemcitabine and platinum chemotherapy has met the predefined primary endpoint in the ORIENT-12 study. Different from the KEYNOTE-407 study in a different chemotherapy regimen, ORIENT-12 has demonstrated for the first time significant PFS benefit with a PD-1 inhibitor in combination with gemcitabine and platinum in first-line sqNSCLC."

"Sintilimab is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL). It was officially approved by the NMPA in 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent. "Currently, we have several phase 3 randomized clinical trials ongoing in lung cancer. With the encouraging result of ORIENT-12 we are hopeful that sintilimab has the potential to benefit more patients with squamous NSCLC. For Innovent, this is the second randomized study of NSCLC that met its primary endpoint; the first was ORIENT-11, a randomized Phase 3 study of 1L non-squamous NSCLC (NCT03607539)."

"The Center for Drug Evaluation, NMPA just recently accepted a new drug application for sintilimab in combination with pemetrexed and platinum chemotherapy as first-line treatment for nonsquamous NSCLC. The promising results we see in the ORIENT-12 study demonstrate sintilimab’s potential in sqNSCLC," said Dr. Li Wang, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center. "We would like to express our gratitude to the patients and their families, investigators and clinical trial sites participating in the study, and to our colleagues from Innovent. We look forward to bringing this new treatment option to lung cancer patients in China."

About the ORIENT-12 Trial

ORIENT-12 is a randomized, double-blind, Phase 3 study to evaluate the efficacy and safety of TYVYT (sintilimab injection) or placebo in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy as first-line therapy for locally advanced or metastatic sqNSCLC (ClinicalTrials.gov, NCT03629925). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. The secondary endpoints include overall survival (OS) and safety profile.

A total of 357 subjects have been enrolled in ORIENT-12 trial and randomized in a 1:1 ratio to receive either TYVYT (sintilimab injection) 200mg or placebo in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy every 3 weeks for 4 – 6 cycles, followed by either TYVYT (sintilimab injection) or placebo 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 sqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, resulting in patients having little to no chance of radical resection. Meanwhile, even after radical surgery, patients still have a high chance of recurrence and eventually die from disease progression. About 35 percent of NSCLC in China are squamous subtype. Squamous NSCLC lacks a driver mutation, and response rate of first-line chemotherapy is approximately 30 percent. So far pembrolizumab in combination with carboplatin and paclitaxel is the only regimen with PD-1 antibody approved by FDA and NMPA for first-line sqNSCLC. There remains still a huge unmet medical need.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later 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.

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 with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.