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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

RegimenTrialDataAbstract
(Neo)adjuvant stage II-IIIB NSCLC
Opdivo + chemoCheckmate-77TmEFS NR vs 18.4mth (HR=0.58, p=0.00025)LBA1
Keytruda + chemoKeynote-671mEFS 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 + chemoCheckmate-901mOS 21.7mth vs 18.9mth (HR=0.78, p=0.0171)LBA7
1st-line cervical cancer
Keytruda + CRTKeynote-A18mPFS NR vs NR (HR=0.70, p=0.0020); mOS immature (HR=0.73)LBA38
1st-line NSCLC
Jemperli vs KeytrudaPerlamOS 19.4mth vs 15.9mth (HR=0.75, not stat sig)LBA64

Source: ESMO.

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