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BMS aims for US approval of Opdivo combo in stomach cancer

US regulator has set a goal date for a decision on 25 May

The US Food and Drug Administration (FDA) has accepted a priority review for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) plus chemotherapy combination in stomach cancer.

The US regulator will review the combo treatment for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer (GEJC) or oesophageal adenocarcinoma (EAC).

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

In the phase 3 CheckMate-649 trial, first-line treatment with Opdivo plus either FOLFOX or CapeOX chemotherapy regimens led to a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) in patients with advanced gastric cancer, GEJC or EAC with PD-L1-positive tumours.

“The positive results of the CheckMate-649 trial are potentially practice-changing, and we look forward to working with the FDA to possibly bring the first immunotherapy-based treatment option to front-line patients, for whom no novel therapies have been made available in the last decade,” said Ian Waxman, development lead, gastrointestinal cancers, BMS.

If Opdivo wins an approval for first-line gastric cancer, it could gain an advantage over Merck & Co’s (MSD) rival checkpoint inhibitor Keytruda (pembrolizumab).

Although Keytruda was approved in 2017 as a third-line option after chemotherapy for patients with PD-L1-positive gastric or gastroesophageal junction cancer, it subsequently failed to show a benefit in previously-untreated patients with these cancer types.

In the Keynote-062 trial, Keytruda plus chemotherapy was not found to be statistically superior for overall survival or progression-free survival compared to chemotherapy alone.

The immunotherapy did show benefit in a pre-specified subgroup of patients whose tumours expressed high levels of PD-L1, however, with Keytruda monotherapy demonstrating an OS improvement in these patients compared to chemotherapy alone.

Keytruda still remains the leader in the non-small cell lung cancer (NSCLC) indication, one of its main growth drivers since the checkpoint inhibitor first launched in 2014.

Although Opdivo lags behind Keytruda, BMS has been aiming for a number of new approvals and indications for the immunotherapy – as a monotherapy treatment and in combination with its CTLA-4 inhibitor Yervoy (Ipilimumab).

That includes an approval from the European Commission (EC) in June 2020 for Opdivo plus Yervoy alongside two cycles of chemotherapy for the first-line treatment of adults with metastatic NSCLC, with EGFR or ALK tumour mutations.

Article by
Lucy Parsons

21st January 2021

From: Regulatory



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