Sintilimab Plus Chemotherapy Meets Primary Endpoint in First-Line Treatment of Non-Squamous Non-Small Cell Lung Cancer

Suzhou, January 13, 2020 /PRNewswire/ -- Innovent Biologics (Hong Kong Stock Exchange stock code: 01801), a biopharmaceutical company dedicated to the research and development, production, and sales of innovative drugs for the treatment of major diseases such as cancer, autoimmune disorders, and metabolic diseases, today jointly announced with Eli Lilly and Company (New York Stock Exchange ticker symbol: LLY): The innovative PD-1 inhibitor Tyvyt, co-developed by both parties^®(Sintilimab Injection) A Randomized, Double-Blind, Phase 3 Controlled Clinical Study (ORIENT-11) -- Tyvyt^®(Sintilimab Injection) in Combination with Alimta^®(Pemetrexed Disodium for Injection) combined with platinum-based agents achieved the primary endpoint in the interim analysis of first-line treatment for advanced or recurrent non-squamous non-small cell lung cancer (nsqNSCLC) without EGFR sensitizing mutations or ALK gene rearrangements.

Based on the interim analysis conducted by the Independent Data Monitoring Committee (IDMC), Tyvyt^®(Sintilimab Injection) in Combination with Alimta^®(Pemetrexed Disodium for Injection) and Platinum versus Placebo Combined with Alimta^®(Pemetrexed Disodium for Injection) and platinum-based agents significantly prolonged progression-free survival (PFS), meeting the pre-specified superiority criteria, with a safety profile consistent with previously reported data for Tyvyt^®(Sintilimab Injection) The study results were consistent, with no new safety signals.

Relevant research findings will be announced at upcoming academic conferences. Based on the recommendations of the Independent Data Monitoring Committee (IDMC), Innovent Bio will soon initiate discussions with Eli Lilly and Company regarding the submission of a registration application to the National Medical Products Administration.

Professor Zhang Li, Director of the Department of Medical Oncology at Sun Yat-sen University Cancer Center, stated, “In 2019, the National Cancer Center released China’s cancer data for 2015, which showed that lung cancer had an overall incidence rate of 20% and a mortality rate of approximately 27%, ranking first among all cancers in both categories. For patients with non-squamous non-small cell lung cancer (NSCLC) who lack EGFR sensitizing mutations or ALK gene rearrangements, there is a need for more treatment options. The combination of anti-PD-1 monoclonal antibodies and chemotherapy has brought greater survival benefits to this patient population. We are very pleased to see that Tyvyt^®(Sintilimab Injection) This study met the prespecified primary endpoint at the interim analysis.

Dr. Zhou Hui, Vice President of the Medical Science and Strategic Oncology Department at Innovent Biologics Group, stated: “Currently, Tyvyt^®(Sintilimab Injection) is the only anti-PD-1 monoclonal antibody included in the National Reimbursement Drug List. It was approved by the National Medical Products Administration on December 24, 2018, for the treatment of relapsed or refractory classical Hodgkin lymphoma in patients who have received at least two lines of systemic chemotherapy. We are currently conducting multiple Phase III randomized controlled trials in lung cancer. The interim analysis results of the ORIENT-11 study are encouraging, and we anticipate that Tyvyt^®(Sintilimab Injection) has the potential to benefit more lung cancer patients, allowing them more time with their families.”

“These study results are exciting, demonstrating that Tyvyt”^®(Sintilimab Injection) Combined with Alimta^®(pemetrexed disodium for injection) and platinum-based agents can significantly delay disease progression in this patient population. “It also reaffirms the commitment of Eli Lilly and Innovent to providing innovative treatment solutions for patients with lung cancer,” said Dr. Wang Li, Senior Vice President of Eli Lilly China and Head of the Drug Development and Medical Affairs Center. “We would like to express our gratitude to all the participating patients, investigators, clinical trial centers, and our colleagues at Innovent. We look forward to bringing this novel treatment regimen to patients with lung cancer in China as soon as possible.”