Esmo 2021 – look out Agenus, Keytruda is about to put up a roadblock

Merck & Co’s Keytruda is the only anti-PD-(L)1 drug with a cervical cancer label, and it could move from second to first-line use, suggests a just unveiled Esmo late-breaking abstract on the Keynote-826 study. The full data are crucial to Agenus, which is seeking approval for its own anti-PD-1, balstilimab, in second-line cervical cancer, based only on remission rates in an uncontrolled trial that the FDA is due to review by a December 16 action date. In Keynote-826 Keytruda plus chemo beat chemo in terms of overall and progression-free survival in all-comers, and in PD-L1≥1% and PD-L1≥10% expressers, though the abstract does not split out survival for PD-L1 non-expressers. One quirk of this trial is that it also allowed Avastin in both cohorts, with no stratification, but the abstract states that Keytruda’s benefit was seen regardless of the Roche drug. Keynote-826 should see Keytruda approved front line as well as confirming its second-line accelerated green light. Will the FDA nod balstilimab through on an accelerated basis at a time when there could already be a marketed competitor boasting formal approval backed by a survival benefit? This is the daunting question Agenus will likely face.

Anti-PD-1 MAbs in cervical cancer
Project Setting Trial Data 2026e cervical cancer sales
Keytruda (Merck & Co) 2nd-line Keynote-158 cohort E 14% ORR (9 PRs, 2 CRs) $94m*
1st-line (chemo combo, +/- Avastin) Keynote-826 (all-comers) mOS 24.4 vs 16.5 mth (HR=0.67, p<0.001); mPFS 10.4 vs 8.2 mth (HR=0.65, p<0.001)
Keynote-826 (PD-L1 ≥1%) mOS NR vs 16.3 mth (HR=0.64, p<0.001); mPFS 10.4 vs 8.2 mth (HR=0.62, p<0.001)
Keynote-826 (PD-L1 ≥10%) mOS NR vs 16.4 mth (HR=0.61, p=0.001); mPFS 10.4 vs 8.1 mth (HR=0.58, p<0.001)
Balstilimab (Agenus) 2nd-line NCT03495882 14% ORR (24 PRs, 3 CRs) $143m^
Note: *out of a total $27.0bn; ^100% of 2026 forecast. Source: Esmo, Evaluate Pharma & prescribing information.

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