Immunotherapy for esophageal squamous cell carcinoma!

Bristol-Myers Squibb (BMS) recently announced that the European Medicines Agency (EMA) has accepted the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, nivolumab) class II change application: Opdivo combined anti CTLA-4 therapy Yervoy (ipilimumab, ipilimumab), Opdivo combined with chemotherapy (fluorouracil + cisplatin), first-line treatment of unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) adult patients

The prognosis of ESCC patients who only receive chemotherapy is still poor.

These applications are based on the results of the pivotal Phase 3 CheckMate-648 trial

Opdivo and Yervoy mechanism of action

CheckMate-648 is the first global phase 3 study that simultaneously evaluates immunotherapy + chemotherapy and dual immunotherapy for the treatment of advanced ESCC

The specific data are as follows: (1) Among patients with tumors expressing PD-L1, the median OS of the 1Opdivo+ chemotherapy group was 15.

According to BICR assessment, compared with chemotherapy, Opdivo+ chemotherapy regimen made a statistically significant and clinically significant improvement in PFS in patients whose tumors express PD-L1 (median PFS: 6.

In addition, compared with chemotherapy, the Opdivo+Yervoy regimen also reached the primary and secondary endpoints: in patients whose tumors express PD-L1 (median OS: 13.

In terms of duration of remission (DoR): (1) Among patients whose tumors express PD-L1, the median DoR of the Opdivo+ chemotherapy group was 8.

In terms of objective response rate (ORR), Opdivo+ chemotherapy also showed a clinically significant improvement: (1) Among patients whose tumors express PD-L1, the ORR of the Opdivo+ chemotherapy group was 53%, and the ORR of the Opdivo+Yervoy group was 35%.

The data of CheckMate-648 test is based on the data of CheckMate-649 test and CheckMate-577 test

Esophageal cancer is the eighth most common cancer and the sixth leading cause of cancer death in the world.

Opdivo belongs to PD-(L)1 tumor immunotherapy, which aims to use the body's own immune system to fight cancer, block the PD-1/PD-L1 signaling pathway to kill cancer cells, and has the potential to treat many types of tumors

For esophageal cancer, Opdivo has been approved for 3 treatment indications, specifically: (1) For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after receiving fluoropyrimidine and platinum chemotherapy Regardless of the expression level of PD-L1; (2) for adjuvant treatment of adult patients with esophagus or gastroesophageal junction (GEJ) cancer who have received neoadjuvant chemotherapy and radiotherapy (CRT) and residual pathological disease after complete resection; (3) combined Combination chemotherapy with fluoropyrimidine and platinum is the first-line treatment for adult patients with advanced or metastatic gastric cancer (GC), gastroesophageal junction (GEJ) cancer, and esophageal adenocarcinoma (EAC), regardless of PD-L1 expression status

In China, Opdivo was approved for listing in June 2018, becoming the first approved immuno-oncology (IO) therapeutic drug in the Chinese market

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Original source: EMA Validates Bristol Myers Squibb's Applications for Opdivo (nivolumab) + Yervoy (ipilimumab) and Opdivo + Chemotherapy as First-Line Treatments for Unresectable Advanced, Recurrent or Metastatic Esophageal Squamous Cell Carcinoma