Innovent Biologics (Innovent), China-based biopharmaceutical company that develops and commercializes high quality drugs, announced on September 20 that clinical trial data on cohort D of sintilimab clinical studies at the 2018 Annual Meeting of Chinese Society of Clinical Oncology (CSCO). In this phase 1b clinical trial (NCT02937116) patients suffering from first-line non-squamous non-small cell lung cancer (ns-NSCLC) were treated with sintilimab, a fully human anti-programmed cell death 1 (PD-1) monoclonal antibody, in combination with pemetrexed (Alimta®) and cisplatin.
The combination demonstrated an objective response rate (ORR) of 68.4%, based on data from 19 patients with at least one radiological assessment among totally the 21 patients in this cohort.
As of the data analysis cutoff on June 28, 2018, the median duration of response (DOR), progression free survival (PFS) and overall survival (OS) have not been reached. The study shows evidence of anti-tumor efficacy and an acceptable safety profile. Based on the efficacy and safety profile from this early phase clinical trial, we have initiated ORIENT-11, a randomized, double-blinded, multicenter, phase III study of sintilimab versus placebo, both in combination with pemetrexed (Alimta®) and platinum-based chemotherapy as first-line treatment for advanced or recurrent ns-NSCLC in China. This study is currently under recruitment and Innovent plans to enroll 378 patients.
"It was encouraging to learn the outstanding efficacy of sintilimab in combination with pemetrexed and cisplatin for first line treatment of NSCLC. I hope to see the approval of sintilimab for first line treatment of NSCLC in the near future allowing more patients suffering from NSCLC to benefit from it," said Professor Caicun Zhou, from the Shanghai Pulmonary Hospital.
"Lung cancer has the highest morbidity and mortality among malignant tumors in China. It causes unbearable suffering for the patient as well as one's immediate family. Thus the process of drug research and development is actually a race against time," said Michael Yu, Founder, Chief Executive Officer and Chairman of Innovent, "At present, Innovent has several clinical studies in the field of lung cancer. We hope these clinical trials in combination with sintilimab will lead to more effective treatment methods for cancer patients, giving the hope of survival and quality of life for these patients and their families."
About Advanced or Recurrent Non-squamous Non-Small Cell Lung Cancer
Lung cancer has the highest incidence and mortality among all malignancies in China. NSCLC accounts for about 80% to 85% of all lung cancer cases, and about 70% of NSCLC patients have locally advanced or metastatic at first diagnosis. In addition, many patients with early-stage NSCLC after undergoing potentially curative surgery, eventually die from disease progression after disease recurrence or distant metastasis. Of the 70% of NSCLC patients in China who present with non-squamous histology type, 40% harbor an EGFR mutation. EGFR inhibitors are recommended as first-line treatment for advanced NSCLC patients with EGFR mutations. An ALK re-arrangement occurs in about 3% of patients with ns-NSCLC and ALK inhibitors are recommended for this patients population. The first-line standard treatment for advanced ns-NSCLC patients without EGFR mutations or ALK re-arrangement in China is platinum-based doublet chemotherapy. The unmet medical needs for these patients are high.
Sintilimab is a fully human anti-PD-1 antibody. It binds to the PD-1 receptor on T cells, blocking the PD-L1 ligand from interacting with PD-1 to help restore T-cell response and immune response, thus destroying the tumor cells. Sintilimab is an anti-PD-1 monoclonal antibody jointly developed by Innovent and Eli Lilly and Company in China. National Medical Products Administration (NMPA, formerly known as CFDA) accepted the New Drug Application (NDA) submitted by Innovent for sintilimab on April 16, 2018, and granted it priority review status on April 23, 2018. The indication for the first new drug application is relapsed/refractory classical Hodgkin's Lymphoma.
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. Since its establishment from 2011, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities, and a pipeline of innovative and commercially promising monoclonal antibodies and other biologics in the fields of oncology, ophthalmology, autoimmune and metabolic diseases. Innovent has built up a pipeline of 17 antibody drug candidates, with four core products in late-stage clinical development in China and one that has a New Drug Application (NDA) accepted by the NMPA with priority review status.
Innovent has a highly talented international team, including many expert returnees with experience in innovative biopharmaceutical drug discovery, development, production and commercialization. The company has also entered into various key strategic alliances with Eli Lilly and Company, Adimab, and other biopharmaceutical companies. Innovent has raised 580 million USD in private financing from numerous world-renowned VC or PE firms, including Eight Roads and F-Prime Capital (which form part of the proprietary investment business of Fidelity), Lilly Asia Ventures, Capital Group, Legend Capital, Temasek, Rock Springs Capital, Cormorant Private Healthcare, Hillhouse Capital, China Life, Ally Bridge, Taikang Insurance Group, and State Development & Investment Corporation.