Accelerated approvals of checkpoint-blocking antibodies have generated controversy when not confirmed in larger studies, but Merck & Co’s latest win should sweep away doubt, and then some. The Keynote-826 study of Keytruda plus chemo in cervical cancer has today been toplined positive for overall and progression-free survival, and spells a win on all fronts: in the front-line setting, with or without Avastin, and irrespective of patients’ PD-L1 status. Keytruda already carries a cervical cancer label, but this is for second-line use in tumours expressing PD-L1 at ≥1%, and on an accelerated basis. Thus Keynote-826 will not only confirm this conditional green light, but could also expand the Merck drug’s use to front-line all-comers who can tolerate chemotherapy. Full data, to be revealed at a scientific meeting or perhaps on Keytruda’s label if approval comes quickly, will show the extent of the survival benefit versus chemo alone, and determine whether Avastin needs to be included in the mix. True, cervical cancer will account for just a fraction of Keytruda’s $26.9bn of forecast 2026 revenues, according to Evaluate Pharma sellside consensus, but the win is important: no other checkpoint antibodies carry a cervical cancer label.
| Selected cervical cancer studies | ||
|---|---|---|
| Study | Design | Result |
| Keynote-158 | Uncontrolled monotherapy trial in solid tumours | Cohort E showed 14% ORR in 2L PD-L1 ≥1% cervical cancer (accelerated approval Jun 2018) |
| Keynote-826 | Chemo combo +/- Avastin, vs chemo, in 1L cervical cancer | Positive for OS & PFS, with & w/o Avastin, irrespective of PD-L1 expression (Jun 2021) |
| Keynote-A18 | Chemo combo, vs chemo, in 1L cervical cancer | Primary completion Feb 2024; OS & PFS co-primaries |
| Source: clinicaltrials.gov. https://www.evaluate.com/vantage/articles/news/snippets/keytrudas-cervical-win-goes-beyond-confirmation | ||
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