Dethroning Opdivo in bladder cancer falls to Niagara

AstraZeneca is bidding to join Bristol Myers Squibb at the high altar of adjuvant bladder cancer treatment, today declaring its Niagara trial of Imfinzi a success on the primary event-free survival endpoint, as well as on the key secondary of OS. Regulatory filings will apparently follow. Bristol’s Opdivo is the only anti-PD-(L)1 MAb currently approved in this setting, on the basis of disease-free survival in Checkmate-274, and Astra today claimed Niagara to have been the first trial of an immunotherapy regimen before and after surgery to extend survival in bladder cancer. At April’s European Association of Urology conference Checkmate-274 yielded its first OS data, from the first interim analysis, and this showed a 19.4-month median benefit favouring Opdivo, with 24% reduction in risk of death; however, the Bristol study concerns only the adjuvant setting, whereas Niagara had a neoadjuvant (chemo combo) stage as well, so Astra’s claim is technically correct. Meanwhile, Tecentriq failed the Imvigor-010 study in 2020, while Keytruda hit on DFS in the NCI-sponsored Keynote-123. However, the latter study failed to show an OS benefit, and Merck hasn’t said whether it has filed for approval.

Cross-trial comparisons in adjuvant treatment of bladder cancer

Notes: *also had a chemo-combo neoadjuvant stage; **hit p=0.0008 at primary analysis. Source: prescribing information, The Lancet, ASCO & EAU.