
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 | |||||
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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Agenus | NCT03495882 | 2nd-line | Balstilimab (uncontrolled) | 14% ORR | US filing withdrawn 2 mths before Pdufa date |
Regeneron/ Sanofi | Empower-Cervical-1 | 2nd-line | Libtayo vs chemo | Positive for OS in all-comers | US filing withdrawn 2 days before Pdufa date |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 & clinicaltrials.gov. |
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