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BMS will not launch cancer drug Opdualag in Germany due to pricing pressures

The treatment was approved in the EU in 2022 for advanced melanoma

Bristol Myers Squibb

Bristol Myers Squibb (BMS) has decided against launching its cancer drug Opdualag (nivolumab and relatlimab) in Germany due to pricing pressures.

The treatment was originally approved by the European Commission in September 2022 as a first-line option for advanced melanoma in adults and adolescents aged 12 years and older.

This was based on an exploratory analysis of results from a phase 2/3 trial which showed the fixed-dose combination more than doubled the median progression-free survival compared to nivolumab monotherapy – an established standard of care.

Specifically, median progression-free survival was 6.7 months in patients receiving Opdualag compared to three months in those receiving nivolumab monotherapy.

Germany’s 2010 pricing law, however, means Opdualag would be unable to achieve a benefit rating from the G-BA (Gemeinsamer Bundesausschuss), which requires companies to demonstrate that their product has additional benefits over and above its appropriate comparator.

This would partly be due to BMS measuring Opdualag’s efficacy with progression-free survival, which is not considered a ‘patient-relevant endpoint’ by the country’s AMNOG law.

The incidence of melanoma, a type of skin cancer that develops when pigment-producing cells located in the skin grow uncontrollably, has been rising steadily over the past few decades, with nearly 325,000 new cases diagnosed worldwide in 2020.

Globally, the World Health Organization estimates that by 2035, melanoma incidence will reach 424,102, with 94,308 related deaths.

BMS’ latest decision will be a disappointing one for many after Opdualag became the first approved LAG-3-blocking antibody combination for advanced melanoma in the EU

“The RELATIVITY-047 study demonstrated the important benefit of inhibiting both LAG-3 and PD-L1 with our novel immunotherapy combination,” the company’s chief medical officer, Samit Hirawat, said at the time.

In February, BMS, along with Exelixis and Ipsen, reported positive three-year follow-up results from a phase 3 study of Opdivo (nivolumab) in combination with Cabometyx (cabozantinib) in advanced renal cell carcinoma, the most common type of kidney cancer in adults.

Results from the analysis of the CheckMate -9ER trial, which represent the longest reported follow-up in any phase 3 trial with an immunotherapy-tyrosine kinase inhibitor regimen in this population, showed sustained survival and response rate benefits with the combination treatment versus Pfizer’s sunitinib.

Article by
Emily Kimber

10th March 2023

From: Regulatory, Healthcare



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