TYVYT® (Sintilimab Injection) ORIENT-2 Study Met its Primary Endpoint of Overall Survival in the Second-Line Treatment of Patients with Advanced or Metastatic Esophageal Squamous Cell Carcinoma

SUZHOU, China, May 13, 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 (NYSE: LLY) that the Phase 2 TYVYT® (sintilimab injection) ORIENT-2 study in China met its primary endpoint of overall survival (OS).

The randomized study, which evaluated TYVYT monotherapy compared to chemotherapy (paclitaxel or irinotecan) as a second-line treatment for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC), demonstrated a statistically significant improvement in OS. The safety profile of TYVYT is consistent with previously reported TYVYT study results, and no new safety signals were identified. The detailed results will be reported in an ASCO 2020 poster discussion session (No. 4511).

Innovent and Lilly plan to discuss these results with the Drug Evaluation Center (CDE) of the National Medical Products Administration (NMPA) in China.

The principal investigator of the ORIENT-2 study, Professor Jianming Xu from the Fifth Medical Center of the PLA General Hospital, stated: "The incidence of ESCC in Asian countries is much higher than that in Western countries. The current standard of treatment is still based on traditional chemotherapy and radiation therapy. Traditional chemotherapy drugs have shown a very limited effect on the second-line treatment of patients with advanced ESCC. Over the past 10 years, immunotherapy has made tremendous progress in multiple tumor types, but the drug development advancements in treating ESCC has been slower and there remains a huge unmet medical need. The ORIENT-2 study confirmed that TYVYT can prolong overall survival in the second-line treatment of people with ESCC. We have seen that sintilimab is more efficacious than chemotherapy and we are hopeful that TYVYT has the potential to be a new treatment option for these patients."

Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent, stated: "TYVYT was approved by the NMPA in 2018 for the treatment of relapsed or refractory classic Hodgkin's lymphoma after second-line or later systemic chemotherapy. We currently have more than 20 clinical studies ongoing to evaluate the efficacy of TYVYT in other types of tumors. The results of the ORIENT-2 study demonstrate the potential of TYVYT to treat patients with advanced ESCC in the second-line setting. We are also conducting a Phase 3 trial to evaluate TYVYT combined with chemotherapy (paclitaxel and cisplatin) as a first-line treatment of patients with advanced, recurrent or metastatic ESCC. We hope these clinical trials can provide more effective treatment options for clinicians and benefit more ESCC patients."

"From Hodgkin's lymphoma, lung cancer to esophageal cancer, we are glad to see that TYVYT's clinical efficacy has been demonstrated in multiple tumor types," said Dr. Li Wang, Senior Vice President of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center. "We are thankful to the patients and their families, investigators and clinical trial sites participating in the ORIENT-2 study, and to our colleagues from Innovent. We would not have seen these encouraging results without their efforts. We look forward to working to bring TYVT as a new treatment option to people with ESCC in China."

About the ORIENT-2 Study

ORIENT-2 is a randomized, open-label, Phase 2 study to evaluate the efficacy and safety of TYVYT with paclitaxel or irinotecan in patients with advanced or metastatic ESCC who failed first-line treatment (ClinicalTrials.gov, NCT03116152). The primary endpoint was OS.

A total of 190 subjects were enrolled in this study. They were randomly assigned 1:1 to receive TYVYT or the investigator's choice of paclitaxel or irinotecan, until disease progression, unacceptable toxicity, withdrawal of consent, death, or other reasons stated in the protocol, whichever occurs first.

About advanced ESCC

The incidence and mortality of esophageal cancer in China rank third and fourth, respectively. Squamous cell carcinoma accounts for approximately 90 percent of all esophageal cancer cases. A considerable proportion of patients with early-stage ESCC will develop recurrence or metastatic disease following resection surgery. Currently, the standard treatment for ESCC is limited to traditional chemotherapy and radiation therapy. There are few treatment options and no targeted therapies for ESCC, resulting in a large unmet clinical need.

About TYVYT^® (Sintilimab Injection)

TYVYT® (sintilimab injection), an innovative drug developed with global quality standards jointly developed by Innovent and Lilly in China, 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 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 supplemental new drug application for TYVYT in combination with ALIMTA® (pemetrexed) and platinum as first-line therapy in non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT 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 NSCLC.

TYVYT 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 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, five in Phase 3 or pivotal clinical trials, four under NDA reviews by the NMPA (three under 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.

About Innovent Biologics' strategic cooperation with Eli Lilly and Company

Innovent entered into a strategic collaboration with Lilly focusing on biological medicines 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 antibodies targeting oncology indications. In August 2019, Innovent entered into an additional 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.

SOURCE Innovent Biologics, Inc.

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