Ficerafusp alfa

Bicara CEO Claire Mazumdar, Ph.D., told Fierce Biotech that the analysts who are calling the race for Merus are “missing the key aspect of head and neck.”\n Several analysts are hailing Merus as the sure winner in the race to a new treatment for head and neck squamous cell carcinoma (HNSCC). But the chase is still in its early days and is likely too soon to call.Yesterday, Bicara shared updated data for its bifunctional antibody paired with Keytruda in HNSCC, including a first look at overall survival (OS) data for HPV-negative patients, a subpopulation that typically has worse treatment outcomes than HPV-positive patients.A phase 1/1b trial demonstrated a two-year OS rate of 46% among patients with first-line, PD-L1-positive recurrent or metastatic HNSCC. Bicara’s EGFR/TGF-β asset, dubbed ficerafusp alfa, was also tied to a median OS of 21.3 months for 28 HPV-negative patients.In a June 2 note, analysts at Leerink Partners said Bicara’s “data do not tip the scale meaningfully,” and that they favored Merus, a Dutch biotech that touts a clinical bispecific targeting EGFR and LGR5 in HNSCC. Leerink provides coverage for Merus, which has about a $4 billion market cap, and does not cover Bicara, which has a $500 million market cap.Recently, Merus recorded a 79% 12-month OS rate in a phase 2 trial for patients with PD-L1-positive recurrent or metastatic HNSCC—regardless of HPV status. Merus’ asset, called petosemtamab, was also paired with Keytruda.Leerink said they believe Merus’ meaningfully higher 12-month OS rate, compared to a 62% OS at 12 months for Bicara’s program, bodes well for petosemtamab’s eventual OS duration.The analyst also cited the median progression free survival (PFS) rates, which was nine months for Merus and 7.4 months for Bicara in an HPV-unselective population. However, Bicara’s mPFS rose to 9.9 months when evaluated in only HPV-negative patients.Bicara CEO Claire Mazumdar, Ph.D., told Fierce Biotech that the analysts who are calling the race for Merus are “missing the key aspect of head and neck.” “If you talk to any investigator, what they\'ll tell you is that these 12-month landmarks really mean nothing in the context of prolonged overall survival,” Mazumdar said on the sidelines of this year’s American Society of Clinical Oncology conference. “The key message for us is really that our data is resonating far more with the people that matter, which are the head and neck oncologists, and really the fact that we\'ve listened to them understand that these are different diseases, HPV-negative and HPV-positive.”Several studies have shown that patients with HPV-positive HNSCC have significantly better survival outcomes after standard-of-care treatment compared to HPV-negative patients, with several reasons emerging for this difference, including risk factors such as smoking and alcohol use association.Mazumdar underscored how treatment is influenced by patients’ baseline characteristics and subsequent therapies, which is why she said the “more statistically stable endpoint” of a median of two-years follow up.  “A lot of what the investigators have been telling us that our data points are far stronger from that perspective, because we have a long-term dialogue,” the Bicara leader said.Eric Schmidt with Cantor Fitzgerald views the data from Bicara and Merus as “more similar than different at this stage,” and noted that both are highly promising, according to a June 1 analyst note. It’s decidedly too soon to call a winner, Schmidt said. When looking at phase 3 timelines, Merus has the upper hand, but the analyst writes that it would be premature to “call how the battle for 1L market share might play out based on these single-arm datasets.”Cantor’s Schmidt did list several differences between petosemtamab and ficerafusp that could “turn the tables” in favor of the latter, including ficerafusp\'s TGF-beta mechanism that provides potential for more durable responses. He also highlighted the design of Bicara’s ongoing pivotal trial, which features a HPV-negative population that is more responsive to EGFR inhibition.The biotech is currently enrolling for the pivotal phase 2/3 trial, with an expected enrollment of 650 patients.“The head and neck community, I think, have been burned by so many of these high response rates [and] one-year landmark OS that didn\'t translate to anything,” Mazumdar said. “So, that\'s really the community we\'re developing this for. It\'s for the patients. And I do think there is a part of the investor community that\'s realizing the true potential of this, but they were swayed by a flashy headline two weeks ago.”