Bristol Myers Squibb (BMY)

[DewDiligence]

Opdivo bests Adcetris in first-line-HL PFS—immature_OS_data_trending_in_favor_of_Opdivo:

https://www.fiercepharma.com/pharma/seagens-top-selling-drug-under-threat-bristol-myers-opdivo-beats-adcetris-lymphoma

Compared with Adcetris, Bristol Myers Squibb’s Opdivo significantly reduced the risk of cancer progression or death by 52% [i.e. the HR for PFS was 0.48—Dew] in adults and children with newly diagnosed stage 3 or 4 classical Hodgkin lymphoma, according to phase 3 data unveiled at the 2023 American Society of Clinical Oncology annual meeting. Both drugs were used on top of the AVD regimen of chemotherapy.

The collaborative group-conducted trial, coded SWOG S1826, randomized nearly 1,000 patients. The results point to Opdivo-AVD as “a new standard of care that is better tolerated and results in a higher proportion of patients with durable remissions” than Adcetris-AVD, Oreofe Odejide, M.D., from the Dana-Farber Cancer Institute and an invited ASCO expert, said in a statement.

…Opdivo is currently only allowed in HL following Adcetris treatment thanks to an FDA accelerated approval in 2016. The new SWOG trial will support an FDA filing for Opdivo in front-line treatment, Herrera told Fierce Pharma in an interview. It could also help Bristol Myers turn the original conditional nod into a full approval.

…The Opdivo regimen has yet to show a significant patient survival benefit. By the data cutoff, 11 (2.2%) deaths happened in the Adcetris arm, compared with four (0.8%) for Opdivo.

It will take a few years for the OS data from this trial to reach maturity.