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.

Selected cervical cancer trials
Company Trial Setting Design Primary endpoint Note
Merck & Co Keynote-826 1st-line Keytruda + chemo +/- Avastin, vs chemo +/- Avastin Positive for OS in all-comers & PD-L1+ves Backed full US approval 1st-line (PD-L1+ves) & 2nd-line
Seagen InnovaTV-204 2nd-line Tivdak (uncontrolled) 24% ORR Backed accelerated US approval
Agenus NCT03495882 2nd-line Balstilimab (uncontrolled) 14% ORR US filing withdrawn 2 mths before Pdufa date
Regeneron/ Sanofi Empower-Cervical-1 2nd-line Libtayo vs chemo Positive for OS in all-comers US filing withdrawn 2 days before Pdufa date
Iovance NCT03108495 2nd-line Lifileucel +/- Keytruda (uncontrolled) 44% ORR (57% for combo) Filing delayed, pending FDA discussions
Astrazeneca Calla 1st-line Imfinzi + CRT vs CRT Failed for PFS
Roche Skyscraper-04 2nd-line Tecentriq + tiragolumab, vs Tecentriq ORR Data due H2 2022
Pfizer/Merck KGaA Intr@pid Cervical 017 2nd-line Bintrafusp alfa (uncontrolled) ORR Ends Apr 2022
Intr@pid Cervical 046 1st-line Bintrafusp alfa + Avastin or various chemos (uncontrolled) Safety Ends May 2022
Source: company presentations &

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