Innovent and Lilly Release Biomarker Results of TYVYT® (Sintilimab Injection) in Combination with ALIMTA® (Pemetrexed) and Platinum Chemotherapy as First-Line Treatment for Nonsquamous Non-Small Cell Lung Cancer at ESMO Virtual Congress 2020

SAN FRANCISCO and SUZHOU, China, Sept. 20, 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 oncology, metabolic, autoimmune and other major diseases, jointly announce 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) Virtual Congress 2020. 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.

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 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. 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.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop 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 cancer, metabolic, autoimmune 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 multi-functional 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 cancer, metabolic, autoimmune diseases and other major therapeutic areas, with three products, TYVYT® (sintilimab injection), BYVASDA® (bevacizumab injection) and SULINNO® (adalimumab injection), on market, one asset under NDA review with priority review status, four assets in Phase 3 or pivotal clinical trials, and additional 15 molecules in or close to clinical trials. TYVYT® (sintilimab injection) has been the only PD-1 inhibitor included in the NRDL since 2019.

Innovent has built an international team with expertise in cutting-edge biological drug development and commercialization. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Alector, MD Anderson Cancer Center, Hanmi and other international partners. 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 lilly.com/newsroom.

About Innovent Biologics' strategic collaboration with Eli Lilly and Company

Innovent entered into a strategic collaboration with Lilly focused 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 are co-developing and commercializing 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. In August, 2020, Lilly and Innovent announced a global expansion of their strategic alliance for TYVYT® (sintilimab injection), and Lilly will obtain an exclusive

license for TYVYT for geographies outside of China and plans to pursue registration of TYVYT in the U.S. and other markets.

TYVYT^® (sintilimab injection, Innovent)

ALIMTA^® and GEMZAR^® are trademarks 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.
2. Innovent does not recommend any off-label usage.
3. For medical and healthcare professional use only.

SOURCE Innovent Biologics, Inc.