Innovent, Lilly Bag Third Approval for PD-1 Inhibitor Tyvyt in China

On June 3rd, Innovent Biologics, Inc. and Eli Lilly announced that its innovative PD-1 inhibitor, Tyvyt (sintilimab injection) in combination with gemcitabine and platinum chemotherapy was approved by China’s National Medical Products Administration (NMPA) to treat patients with unresectable locally advanced or metastatic squamous NSCLC (sqNSCLC).

The approval was based on Phase 3, ORIENT-12 study that evaluated Tyvyt or placebo in combination with gemcitabine and platinum chemotherapy in sqNSCLC patients. Results showed that the drug combo demonstrated a statistically significant improvement in progression-free survival and a potential overall survival benefit as compared to the placebo arm.

Professor Caicun Zhou, Head of the Oncology Department at Shanghai Pulmonary Hospital, stated that lung cancer is the leading cause of all cancer deaths, of which NSCLC accounts for about 80 to 85 percent. Over the past two decades, drug development has been very slow for sqNSCLC as opposed to nonsquamous NSCLC (nsqNSCLC) due to the former’s unique epidemiology, histopathology, and molecular biology. He added that Tyvyt’s approval provides a new clinical approach in China for the first-line treatment of advanced or metastatic sqNSCLC.

Third Approval for Tyvyt in China

This is Tyvyt’s third regulatory approval in China. The drug was previously approved by the NMPA for treating relapsed or refractory classical Hodgkin’s lymphoma in December 2018 and as a first-line treatment of nsqNSCLC in February 2021.

“As one of the most life-threatening diseases, cancer has always been a key focus for the pharmaceutical companies, researchers and clinicians that help develop oncology treatments. Innovent is committed to discovering and developing innovative medicines for diseases with unmet medical needs,” said Dr. Yongjun Liu, President of Innovent Biologics.

“This approval of Tyvyt in a third indication represents another remarkable achievement for our novel, high quality PD-1 inhibitor in cancer treatment. We are very excited about this approval, and we look forward to now offering this as a first-line treatment option for people with squamous non-small cell lung cancer,” he added.

Innovent and Lilly have initiated plans to obtain regulatory approval for Tyvyt in the US too. In March, the companies submitted a BLA to the FDA for Tyvyt plus pemetrexed and platinum chemo as first-line treatment for patients with advanced or metastatic nsqNSCLC. The agency accepted the application in May and has given a PDUFA date of March 2022.

“We are pleased the sintilimab submission is progressing. Our pursuit of this proposed indication in the U.S. reinforces Lilly’s and Innovent’s joint commitment to offer additional therapeutic options for people living with lung cancer and the healthcare providers who treat them,” said Anne White, President, Lilly Oncology at the time.

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Author

Rajaneesh K. Gopinath