Another cervical cancer win for Keytruda

To the extent that cervical cancer remains a significant market, given the successes of screening campaigns and HPV vaccination, Merck & Co’s Keytruda is building itself a sizeable lead while others founder. Today Astrazeneca’s Imfinzi fell by the wayside as the phase 3 Calla study, combining it with chemoradiation in front-line disease, failed to show a progression-free survival benefit against chemoradiation alone. In recent months two other competitors have suffered major setbacks: Sanofi/Regeneron pulled a US filing for Libtayo in second-line use, after Agenus did the same for balstilimab. The latter was down to the unviability of uncontrolled data backing an approval once Keytruda secured a formal first and second-line label, while the former was probably a result of insufficient data on Libtayo’s effect in patients who were not PD-L1-positive. Notably the FDA had restricted Keytruda’s label to ≥1% PD-L1 expressers, even though the Keynote-826 study had shown an effect in all-comers. Libtayo’s benefit in all-comers in the Empower-Cervical-1 trial was driven by ≥1% PD-L1 expressers, but researchers had obtained PD-L1 data from less than half of enrolees. The next keenly awaited dataset concerns Roche’s combo of Tecentriq plus the anti-Tigit Mab tiragolumab.

Evaluate Vantage's latest report on developments and catalysts in the anti-PD-(L)1 space is available on free download.