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Pfizer’s PD-L1 conjugate focus narrows

Pfizer recently began a phase 3 study with its PD-L1-targeting ADC fetrastobart vedotin in relapsed NSCLC – but a planned pivotal trial in first-line head and neck cancer is off, the company disclosed in its third-quarter presentation on Tuesday. A Pfizer spokesperson told ApexOnco this was a “business decision” unrelated to safety concerns. An evolving head and neck field might have spurred Pfizer’s move: Merus’s petosemtamab showed enough in the first line to secure an $8bn buyout from Genmab, while Johnson & Johnson’s Rybrevant recently looking promising in relapsed disease, with a pivotal front-line study in the works. Meanwhile, two Pfizer late-stage cancer readouts, which had been due in 2025, have been delayed: MagnetisMM-5, testing the BCMA-targeting T-cell engager Elrexfio, with or without Darzalex, in double-class exposed multiple myeloma; and Talapro-3, evaluating Talzenna plus Xtandi in first-line castration-sensitive prostate cancer. The spokesperson noted that these are event-driven trials, so couldn't speculate on exact timings, but added the company hopes to report results in the first half of 2026. An FDA decision on the full approval of Braftovi in first-line BRAFm colorectal cancer has also been pushed back to 2026; however, prospects here look good based on data from the Breakwater study.

 

Pfizer’s third-quarter oncology setbacks

ProjectDescriptionTrial/settingNote
Fetrastobart vedotinAnti-PD-L1 ADCPh3 in 1st-line head & neck cancerAbandoned; had been due to start H2 2025. Pfizer has 2nd-line NSCLC ph3 under way
ElrexfioAnti-BCMA T-cell engagerPh3 MagnetisMM-5, +/- Darzalex, in double class exposed MMData now due after YE 2025; had previously been expected H1, then H2 2025; primary completion now Dec 2025
Talzenna + XtandiPARP inhibitor; androgen receptor inhibitorPh3 Talapro-3 in 1st-line CSPCData now due after YE 2025; primary completion previously delayed from Dec 2024 to Sep 2025; now Feb 2026

Note: CSPC=castration-sensitive prostate cancer; MM=multiple myeloma. OncologyPipeline & company presentation.

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