Please login to the form below

Not currently logged in

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



PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs


Add my company
McCann Health Medical Communications

We are the medical communications experts within McCann Health. Communicating science to bring meaning and positive change to people’s lives....

Latest intelligence

4 ways to recruit Alzheimer’s disease patients for your clinical trial
What key things do you need to remember to reach patients living with Alzheimer’s disease?...
competitive intelligence
Integrating competitive intelligence into business development, licensing and M&A strategy
The advantages of partnering with a competitive intelligence or knowledge management team...
reaching HCPs during pandemic
Reaching patients and HCPs during the pandemic
COVID-19 has caused unprecedented disruption to drug launches, but some pharma companies avoided costly delays by quickly pivoting to digital channels...