Tyvyt® (Sintilimab Injection) Combined with Gemzar® (Gemcitabine for Injection) and Platinum Chemotherapy Met the Predefined Primary Endpoint in the Phase 3 ORIENT-12 Study as First-Line Therapy in Patients with Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

SUZHOU, China, May 6, 2020 /PRNewswire/ -- 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, today jointly announced 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). 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.

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.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully-integrated multifunctional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 23 valuable assets in the fields of oncology, autoimmune, metabolic diseases and other major therapeutic areas, with 16 in clinical development, 5 in Phase 3 or pivotal clinical trials, 4 under NDA reviews by the NMPA with priority review status, while TYVYT® (sintilimab injection), officially approved for marketing in China in 2018, has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to create medicines to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com and http://newsroom.lilly.com/social-channels.

About Innovent Biologics' strategic cooperation with Eli Lilly and Company

Innovent entered into a strategy collaboration with Lilly focusing on biological medicine in March 2015 – a groundbreaking partnership between a Chinese pharmaceutical company and a multinational pharmaceutical company. Under the agreement, Innovent and Lilly will co-develop and commercialize oncology medicines, including TYVYT® (sintilimab injection) in China. In October 2015, the two companies announced the extension of their existing collaboration to include co-development of three additional oncology antibodies targeting oncology indications. In August 2019, Innovent further entered a licensing agreement with Lilly to develop and commercialize a potentially global best-in-class diabetes medicine in China. Its collaboration with Lilly indicates that Innovent has established a comprehensive level of cooperation between China's innovative pharmaceuticals sector and the international pharmaceuticals sector in fields such as R&D, CMC, clinical development and commercialization.

GEMZAR^® is a registered trademark owned by or licensed to Eli Lilly and Company, its subsidiaries, or affiliates

Disclaimer:

1. This indication is still under clinical trial, which hasn't been approved in China.

SOURCE Innovent Biologics, Inc.