ESMO 2023 – duelling PD-1 drugs
With Keytruda’s newly approved US perioperative lung cancer label scooping the Keynote-671 trial’s ESMO late-breaker, Merck & Co can rest assured of staying one step ahead of its rival Bristol Myers Squibb. The latter’s corresponding Checkmate-77T study of Opdivo, the subject of a separate ESMO late-breaker unveiled last night, has shown a similar event-free survival benefit but, unlike Keynote-671, has yet to yield an OS result. In first-line urothelial bladder cancer, meanwhile, Opdivo plus chemo has shown a 27% reduction in risk of death versus chemo alone (p=0.0171) in Checkmate-901, a trial notable for having yielded a failure for its Opdivo plus Yervoy cohort last year, before being delayed and upsized. Keytruda monotherapy carries a first-line label here, but has been restricted to platinum-ineligible patients. Keytruda is separately awaiting an FDA decision by 23 January 2024 on its use in first-line cervical cancer as part of a chemoradiation combo, where an ESMO late-breaker shows a positive PFS hit in Keynote-A18. Finally, the underrated Perla trial in first-line NSCLC, where GSK’s Jemperli numerically beat Keytruda on remission and PFS, has now shown a similar result for OS; the trial’s small size precludes anything being said about statistical superiority, however.
Selected ESMO late-breakers on anti-PD-1 drugs
Regimen | Trial | Data | Abstract |
---|---|---|---|
(Neo)adjuvant stage II-IIIB NSCLC | |||
Opdivo + chemo | Checkmate-77T | mEFS NR vs 18.4mth (HR=0.58, p=0.00025) | LBA1 |
Keytruda + chemo | Keynote-671 | mEFS NR vs 17.0mth (HR=0.58, p<0.0001) | LBA56 |
mOS NR vs 52.4mth (HR=0.72, p=0.0103) | |||
1st-line urothelial carcinoma | |||
Opdivo + chemo | Checkmate-901 | mOS 21.7mth vs 18.9mth (HR=0.78, p=0.0171) | LBA7 |
1st-line cervical cancer | |||
Keytruda + CRT | Keynote-A18 | mPFS NR vs NR (HR=0.70, p=0.0020); mOS immature (HR=0.73) | LBA38 |
1st-line NSCLC | |||
Jemperli vs Keytruda | Perla | mOS 19.4mth vs 15.9mth (HR=0.75, not stat sig) | LBA64 |
Source: ESMO.
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