Key Takeaways From Our Lunch With BCAX

研报英文原文证据摘录

Key Takeaways From Our Lunch With BCAX

May 26, 2026

of the ORR benchmark set by pembrolizumab monotherapy and

a positive OS trend (HR <1). At the time of the interim, Bicara

plans to share response rate and durability data. If ORR data are

positive, statistical alpha will be recycled to OS. The company may also

incorporate an interim OS analysis to support a faster full approval if

ORR data are positive.

●Petosemtamab's trial design changes. There has been substantial

investor discussion surrounding Genmab's decision to alter the design

of petosemtamab's ongoing Phase 3 trials in both 1L HNSCC (an

increase in sample size of n=~200) and 2L HNSCC (a change in primary

endpoint from ORR to OS). Bicara can only guess at why these changes

were made. Our take is that (1) Genmab clearly saw something that

warranted the adjustments, and (2) its change of direction establishes

credibility for Bicara, which took a very different strategy from the

beginning.

●Longer-term data updates. We haven't seen an updated dataset from

petosemtamab since a February 2025 datacut was presented at ASCO

last year. By now, DoR, mPFS, and OS are likely to be mature. Investors

can speculate about the decision to refrain from providing an update,

but Bicara notes that its more regular disclosures are having an impact

with physicians in terms of increased engagement and upticks in

clinical trial enrollment.

●The CPS=0 study. Bicara is also conducting a Phase 1b study in

a population of HPV-negative 1L HNSCC patients that are CPS=0.

Demonstrating activity in this setting could meaningfully extend

ficerafusp's reach and represents a strategically important opportunity

given the potential for JNJ's (NC) OrigAMI-5 regimen (amivantamab +

pembrolizumab + chemotherapy) to compete in this population. Initial