Innovent and Lilly Jointly Release Phase 3 Results of TYVYT® (Sintilimab Injection) in Combination with GEMZAR® (Gemcitabine) and Platinum Chemotherapy as First-Line Treatment for Squamous 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, announce with Eli Lilly and Company ("Lilly", NYSE: LLY) that the results of the ORIENT-12 study were released in a mini oral presentation at the European Society of Medical Oncology (ESMO) Virtual Congress 2020.

ORIENT-12 is the first randomized, double-blind, Phase 3 clinical trial evaluating TYVYT® (sintilimab injection) or placebo in combination with GEMZAR® (gemcitabine) and platinum chemotherapy as first-line treatment for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). A total of 357 subjects were enrolled. In the interim analysis, TYVYT® (sintilimab injection) in combination with GEMZAR® (gemcitabine) and platinum chemotherapy demonstrated a statistically significant improvement in progression-free survival (PFS) compared with placebo in combination with GEMZAR® (gemcitabine) and platinum chemotherapy, meeting the prespecified primary endpoint. The updated analysis demonstrated that the median PFS assessed by IRRC was 5.5 months in the sintilimab combination arm versus 4.9 months in the placebo combination arm (HR=0.536, 95% CI: 0.422-0.681, P< 0.00001), while the median PFS assessed by the investigators was 6.7 months in the sintilimab combination arm versus 4.9 months in the placebo combination arm (HR=0.532, 95% CI: 0.419-0.674, P< 0.00001). The interim analysis suggested that the median overall survival (OS) data was not yet mature, but the sintilimab combination arm potentially showes an OS benefit over the placebo combination arm (HR=0.567, 95%CI: 0.353-0.909, P=0.01701). The safety profile was consistent with that in previously reported studies with sintilimab, and no new safety signals were identified.

Professor Caicun Zhou, Head of Department of Oncology, Shanghai Pulmonary Hospital, stated: "Lung cancer is the leading cause of cancer death (25.2%), of which NSCLC accounts for 80 to 85 percent. Approximately 70 percent of NSCLC patients are unresectable at initial diagnosis, and 30 to 60 percent of patients with Stage I-III NSCLC undergoing radical resection eventually develop recurrence or distant metastasis. In the past few decades, drug development of NSCLC has mainly focused on nonsquamous NSCLC, while drug development of squamous NSCLC has been slower due to its unique epidemiological, histopathological and molecular characteristics. ORIENT-12 is the first Phase 3 study to demonstrate a progression-free survival benefit by treatment with a PD-1 inhibitor in combination with gemcitabine and platinum chemotherapy for the first-line treatment of squamous NSCLC. The results of this study show a great clinical value. Gemcitabine in combination with cisplatin or carboplatin is one of the most commonly used first-line regimens of chemotherapy for squamous NSCLC in Asia. We are hopeful that the positive results of ORIENT-12 can help more squamous NSCLC patients."

"TYVYT® is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List," said Dr. Hui Zhou, Vice President and Head of Medical Science and Strategy Oncology of Innovent. "With the encouraging results of ORIENT-12 and the acceptance of the supplemental new drug application (sNDA) for this indication, we look forward to the potential approval of this combination with TYVYT® in China to help more patients with lung cancer to live longer without their disease worsening."

"We are excited about these results, showing TYVYT® plus GEMZAR® and platinum chemotherapy significantly delayed disease progression in this patient population. This study underscores the joint commitment from Lilly and Innovent to provide innovative treatment options to patients with lung cancer," said Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs. "We would like to thank the patients, the investigators, the clinical trial centers and our colleagues from Innovent that are involved in the study. We look forward to working together to bring this new treatment option to Chinese patients with squamous NSCLC."

About sqNSCLC

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 people with NSCLC have locally advanced or metastatic NSCLC at initial diagnosis, rendering the patients with 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 30 percent of people with NSCLC in China are of squamous subtype, and targeted therapy is not appropriate for advanced sqNSCLC patients without EGFR-sensitive mutations or ALK gene rearrangements. In China, there remains a huge unmet medical need.

About the ORIENT-12 Trial

ORIENT-12 is a randomized, double-blind, Phase 3 clinical trial to evaluate the efficacy and safety of TYVYT® (sintilimab injection) or placebo in combination with GEMZAR® (gemcitabine) and platinum chemotherapy (carboplatin or cisplatin) 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 were enrolled in ORIENT-12 trial and randomized in a 1:1 ratio to receive either sintilimab 200mg or placebo in combination with gemcitabine and platinum chemotherapy every three weeks for up to 4-6 cycles, followed by either sintilimab 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 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 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 Aug 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), an immunoglobulin G4 monoclonal antibody, can bind to PD-1 molecules on the surface of T-cells, block the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivate 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 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 at www.lilly.com and lilly.com/newsroom.

About Innovent Biologics' strategic cooperation 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 professionals only.

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SOURCE Innovent Biologics, Inc.

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