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February 18, 2021

LoA Update: BMS Opdivo’s FDA approval shot in adjuvant muscle-invasive urothelial carcinoma increases by 12 points due to positive Phase III data

As of 10 February, the FDA likelihood of approval (LoA) for Bristol-Myers Squibb’s Opdivo (nivolumab) in the adjuvant setting of muscle-invasive urothelial carcinoma (UC) went up 12 points, according to GlobalData’s LoA data.

By Reynald Castañeda

As of 10 February, the FDA likelihood of approval (LoA) for Bristol-Myers Squibb’s Opdivo (nivolumab) in the adjuvant setting of muscle-invasive urothelial carcinoma (UC) went up 12 points, according to GlobalData’s LoA data. This update is on the heels of the Phase III CheckMate274 trial’s (primary endpoint reporting Opdivo improved disease-free survival (DFS) in surgically resected patients, as well as in a subgroup of patients who have tumours expressing PD-L1 of ≥1%.

Opdivo previously had a 44% LoA in this setting, which increased to 56% using GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. BMS has a market cap of $134.41bn (16 February). According to an 8 February media release, Opdivo delivered a median DFS of 21 months versus 10.9 months with placebo (p<0.001). In PD-L1 ≥1% patients, Opdivo’s DFS was not reached, which was 10.8 months with placebo (p<0.001).

On February 2020, this news service reported anti-PD1 Opdivo in this adjuvant setting drew expert pause if it would report of a negative result, which was seen previously with Roche’s Phase III anti-PDL1 Tecentriq (atezolizumab) in the same setting. Anti-PD1 may be more relevant in UC because of its superior data than anti-PDL1 approaches in later-line settings, some experts said. But others noted both anti-PD1 and anti-PDL1 have comparable efficacies in UC based on real-world experience, and that cross-setting comparisons may be inappropriate. However, experts agreed CheckMate274’s DFS primary endpoint has unclear clinical worth, noting the overall survival (OS) secondary endpoint is more clinically valuable. OS data is yet to be reported.

Reynald Castaneda is Associate Editor for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.


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