Opdivo improves survival in oesophageal cancer

In interim results released yesterday, Bristol Myers Squibb's (BMS) Opdivo, a PD-(L)1 checkpoint inhibitor showed improved survival in oesophageal cancer from its phase 3 CHECKMATE-648 study.

Opdivo in combination with chemotherapy and a combination of Opdivo and Yervoy improved on chemotherapy alone in extending survival of patients with first-line oesophageal squamous cell carcinoma whose tumours are metastatic or can’t be surgically removed.

In data from the phase 3 CHECKMATE-648 study, a combination of Opdivo and chemotherapy showed an improvement over chemotherapy alone in reaching its primary overall survival (OS) and progression-free survival (PFS) endpoints in PD-(L)1-expressing tumours.

BMS said that while Opdivo plus Yervoy hit its OS primary endpoint, it missed the PFS co-primary endpoint.

These results for BMS’ PD-(L)1 checkpoint inhibitor show first-line efficacy across all upper GI tumour locations, including in the stomach, gastro-oesophageal junction and oesophagus.

The results from the phase 3 CHECKMATE-648 study support the results from the CHECKMATE-649 study, which tested Opdivo plus chemotherapy in first-line patients with advanced or metastatic gastric cancer, gastro-oesophageal junction cancer or oesophageal adenocarcinoma.

The US Food and Drug Administration (FDA) accepted a priority review for BMS’ Opdivo plus chemotherapy combination in stomach cancer earlier this year.

The US regulator will review the combination treatment for the first-line treatment of patients with advanced or metastatic gastric cancer, gastro-oesophageal junction cancer or oesophageal adenocarcinoma.

The FDA has set a prescription drug user fee act (PDUFA) goal date for a decision on BMS’ immunotherapy regimen of 25 May.