ASCO 2025 – Bicara's ficerafusp claim turns to PD-L1 status

With Bicara's ficerafusp alfa no longer being developed for HPV-positive head and neck cancer, the company's boast against its rival Merus has turned to patients' PD-L1 status. The claim, made during Sunday's ASCO presentation of data from a phase 1 Keytruda combo trial in first-line PD-L1-positive head and neck cancer, is that overall survival with ficerafusp is similar irrespective of whether patients are 1-19% PD-L1 expressers (median OS of 22.0 months) or higher (20.6 months). However, in terms of response rates across these two PD-L1 expression subgroups the split looks similar to an analogous study of Merus's petosemtamab; no OS split has been revealed for the latter. This still looks like advantage Merus, which can claim activity in HPV-positive patients to boot; Bicara's trial included HPV-positives, but these data are no longer being presented, and ficerafusp's phase 3 trial enrols only HPV-negatives. Moffitt's Dr Christine Chung put ficerafusp's activity in low PD-L1 expressers down to this fusion protein's activity on TGF-β as well as EGFR. Petosemtamab, meanwhile, is a MAb against EGFR and LGR5. Chung also said 12 of 15 ficerafusp responders achieved at least 80% tumour shrinkage, but later admitted that 80% was an "arbitrary" definition of a deep response.

Cross-trial comparison in 1st-line PD-L1+ve head & neck cancer

Note: *Bicara data relate only to HPV-ve patients, while Merus’s are across all-comers. Source: OncologyPipeline & ASCO.