Thursday, 02 April 2020

Innovent presents clinical data of Sintilimab

20 September 2018 | News

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.

Representative Image

Representative Image

Innovent Biologics, a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs presented 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."

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