On April 16, the US FDA announced that it approved the PD-1 inhibitor Opdivo (nivolumab) in combination with chemotherapy as a first-line treatment for advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma. FDA approved the first-line immunotherapy for gastric cancer.

The approval of Opdivo in combination with chemotherapy for the treatment of advanced or metastatic gastric cancer is based on the results of a key phase 3 clinical study (CheckMate-649). This is a randomized, multicenter, open-label study conducted in patients who have not previously received treatment, are not HER2-positive, unresectable advanced or metastatic gastric cancer, gastroesophageal junction cancer, or esophageal adenocarcinoma, evaluating Opdivo in combination with fluoride The effect and safety of pyrimidine and platinum combination chemotherapy and chemotherapy for first-line treatment.

The results of the study showed that Opdivo combined with chemotherapy significantly prolonged patients’ overall survival (median OS: 14.4 months vs 11.1 months) and progression-free survival (median PFS: 7.7 months vs 6.0 months). The risk of death was reduced by 29%, and 55% of patients were still alive after one year [1].

Opdivo

Opdivo belongs to PD-1 tumor immunotherapy. By inhibiting the signal pathway mediated by PD-1 immune checkpoint protein, it enhances the anti-cancer immune response of T lymphocytes, thereby inhibiting tumor growth. Since it was first approved by the FDA in 2014, it has been approved by more than 65 countries and regions in the world to treat a variety of cancer types including melanoma and non-small cell lung cancer.

In the treatment of patients with gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma, Opdivo is an immunotherapy method that significantly improves overall survival compared with chemotherapy alone. Opdivo combined with chemotherapy may become a new standard for the treatment of patients with advanced gastric cancer. .

In addition to Opdivo, the anti-FGFR2b monoclonal antibody bemarituzumab combined with an improved FOLFOX6 chemotherapy regimen (mFOLFOX6: fluoropyrimidine + leucovorin + oxaliplatin) also showed good results, improving the metastatic or locally advanced gastric or gastroesophageal junction ( GEJ) The overall survival and progression-free survival of patients with adenocarcinoma (median PFS: 14.1 months vs 7.3 months), the risk of death was reduced by 56%. At present, bemarituzumab has been granted breakthrough drug status by the U.S. Food and Drug Administration (FDA) and is expected to become a new first-line treatment [2].

In recent years, immunotherapy drugs and targeted therapy drugs have played an important role in the treatment of gastric cancer, significantly improving the survival of patients with advanced gastric cancer. We expect that with the continuous progress of targeted therapy and immunotherapy, patients with gastric cancer will be able to obtain more and better treatment options, and further extend the survival time of patients. More medicines for patients with gastric cancer can be found here If you want to know more about gastric cancer treatment, you can contact us by calling the hotline 400-086-8008.

Reference source:

[1] U.S. Food and Drug Administration Approves Opdivo® (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma, Regardless of PD-L1 Expression Status

[2] Amgen's Investigational Targeted Treatment Bemarituzumab Granted Breakthrough Therapy Designation

[3] AJCC TNM staging version 8.0 Gastric cancer