22 May 2025 saw the announcement that two highly anticipated trials would have presentations at the 2025 Annual Meeting of the American Society of Clinical Oncology (ASCO) to take place in the US city of Chicago from 30 May to 3 June. The first of these trials is a Phase II study of petosemtamab, Merus’ bispecific monoclonal antibody (mAB) targeting epidermal growth factor receptor (EGFR) and Leucine-rich repeat containing G-Protein coupled receptor 5 (LGR5), trialed in PDL1+ first-line (1L) head and neck squamous cell carcinoma (HNSCC) in combination with Merck’s Keytruda (pembrolizumab). The second presentation announced will cover Phase I/Ib data for Bicara’s ficerafusp alfa, a bispecific fusion protein targeting EGFR and transforming growth factor beta (TGF-β), also in combination with Keytruda in the same patient population.
Merus announced data from 43 evaluable patients who received the petosemtamab + Keytruda combination, confirming an overall response rate (ORR) of 63% (95% confidence interval [CI]: 49–75%), a median progression-free survival (PFS) of 9 months (95% CI: 5.2-12.9), and a 12-month overall survival (OS) of 79%. Bicara’s ficerafusp alfa + Keytruda combination posted an ORR of 53% (95% CI: 37–70%), a median PFS of 7.4 months (95% CI: 2.9–14.5%) and a 12-month OS of 61.5%. More details of these clinical trials’ outcomes will be presented at ASCO 2025.
The market favours one of these two announcements above the other: between May 22 and May 23, Merus’ stock price increased 32% while Bicara’s plummeted 41%. Merus and Bicara are continuing the clinical development of their respective assets into Phase III in this space. However, ficerafusp alfa is going with a narrower patient population, excluding patients who are positive for human papillomavirus (HPV).
Both petosemtamab and ficerafusp alfa reported better ORRs in the HPV-negative subgroups (65% and 64%, respectively), so Bicara is unlikely to carve out a niche for its asset in the clinic using this strategy. According to GlobalData’s analyst consensus forecast, petosemtamab will reach $1.2 billion in global sales by 2030, while ficerafusp alfa will reach $620 million in the same year.
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By GlobalData