Despite Bavencio winning US approval in combination with Inlyta in first-line renal cell cancer today – a month earlier than expected – Pfizer and Merck KGaA’s anti-PD-L1 antibody appears to be more of an also-ran. Both Bristol-Myers Squibb’s Opdivo (in combination with Yervoy) and Merck & Co’s Keytruda (in combination with Inlyta) are already approved in this setting and each can claim to have an edge over Bavencio. Opdivo’s advantage is being first to market, having been approved in April 2018; Keytruda’s is trial data that appear to be superior – Bavencio looks worse on all of the key outcomes detailed below, and the disparity in the hazard ratios is particularly damning (Asco-GU 2019 – Checkpoint blockers might not be created equal after all, February 20, 2019). Bavencio did demonstrate superiority over Sutent, still the standard of care for now at least, boosting median PFS by more than five months over the older drug. Analysts from Bernstein state that renal cancer will be Bavencio’s main revenue driver, but that they expect Keytruda/Opdivo to “win” overall. They see peak Bavencio sales of $600m, $280m of which will go to Merck KGaA under a profit-share agreement.
|Cross-trial comparison in first-line renal cancer|
|Drug||Study||ORR||CR||PFS||HR for OS|
|Bavencio + Inlyta||Javelin Renal 101||52%||3%||13.8mth||0.78*|
|Keytruda + Inlyta||Keynote-426||59%||6%||15.1mth||0.53|
|Opdivo + Yervoy (int/poor)||Checkmate-214||42%||11%||11.6mth||0.66|
|Source: Asco-GU, Dr Lori Wood. Note: *data premature.|