Major gastric cancer treatment FDA approves the first first-line immunotherapy

On the 17th, the US FDA announced that Bristol-Myers Squibb (BMS)'s blockbuster PD-1 inhibitor Opdivo (nivolumab) was used in combination with chemotherapy as a treatment for advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer and First-line therapy for esophageal adenocarcinoma.

Stomach cancer is the fifth most common cancer in the world and the third leading cause of cancer death.

Opdivo developed by Bristol-Myers Squibb is a monoclonal antibody that targets PD-1.

This approval is supported by a randomized, open-label Phase 3 clinical trial, CheckMate-649.

In patients whose tumors express PD-L1 (CPS>5), the Opdivo combination therapy has a better effect, with a median OS of 14.

▲Lifetime data of CheckMate-649 (picture source: BMS official website)

"The first-line therapy approved today provides survival benefits for patients with advanced or metastatic gastric cancer for the first time in more than a decade (compared to standard treatments).

In China, Opdivo has been approved by the National Medical Products Administration of China in March last year for the treatment of advanced or recurrent gastric or gastroesophageal junctions who have received two or more systemic treatments in the past.

In addition to Opdivo, at the American Society of Clinical Oncology-Gastrointestinal Cancer Symposium at the beginning of this year, BeiGene and Zymeworks jointly developed the HER2 targeting bispecific antibody zanidatamab, Five Prime Therapeutics (recently acquired by Amgen) ) The FGFR2b monoclonal antibody bemarituzumab jointly developed with Zai Lab and the blockbuster PD-1 inhibitor Keytruda combination therapy have achieved positive results in first-line clinical trials for the treatment of gastric cancer.