PD-1 inhibitors Opdivo and Keytruda are approved for new indications in the EU

Compilenewborn

Recently, two PD-1 inhibitors, Opdivo and Keytruda from Bristol-Myers Squibb and Merck, have received good news in EU regulation

For Bristol-Myers Squibb, the European Commission has approved Opdivo and Yervoy immunocombination therapy for the treatment of previous fluoropyrimidine-containing combined chemotherapy, tumors with mismatch repair defects (dMMR) or high microsatellite instability (MSI-H) Of adult patients with metastatic colorectal cancer (mCRC)

Opdivo+Yervoy is the first dual immunotherapy program approved by the European Union for the treatment of gastrointestinal tumors

The approval is based on the results of the Phase 2 CheckMate-142 trial

The specific data are: a minimum follow-up of 46.

For Merck, the European Commission has approved Keytruda combined with platinum and fluoropyrimidine chemotherapy for the first-line treatment of locally advanced unresectable or metastatic esophageal cancer with tumors expressing PD-L1 (CPS≥10) and HER2-negative gastroesophageal junction (GEJ) adenocarcinoma

Keytruda is the first PD-1 therapy approved by the European Union for the first-line treatment of advanced esophageal cancer or GEJ cancer in combination with chemotherapy, regardless of its histology

The approval is based on the results of the Phase 3 KEYNOTE-590 trial

——In all pre-designated study populations (n=749): Compared with chemotherapy (cisplatin+5-FU), Keytruda+chemotherapy (cisplatin+5-FU) reduces the risk of death by 27% (HR=0.

——In the study population (n=383/749) whose tumors express PD-L1 (CPS≥10): Compared with chemotherapy, Keytruda+chemotherapy reduces the risk of death by 38% (HR=0.

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