The race to develop a new treatment for head and neck squamous cell carcinoma (HNSCC) is drawing significant attention within the biotech industry. While several analysts have recently favored Merus, a Dutch biotech company, as the frontrunner, the competition remains in its early stages, and definitive conclusions are premature.
Merus is advancing petosemtamab, a clinical bispecific antibody targeting EGFR and LGR5, in combination with Keytruda for patients with PD-L1-positive recurrent or metastatic HNSCC. The company recently reported a 79% 12-month overall survival (OS) rate in a phase 2 trial, encompassing both HPV-positive and HPV-negative patients. This compares to Bicara's reported 62% 12-month OS rate in a similar patient population.
Bicara, with a market capitalization of approximately $500 million, has presented updated phase 1/1b trial data for its bifunctional antibody, ficerafusp alfa, combined with Keytruda. The trial included a focus on HPV-negative patients, a subgroup known for poorer treatment outcomes compared to HPV-positive cases.
Key findings from Bicara's data include a two-year OS rate of 46% for first-line, PD-L1-positive recurrent or metastatic HNSCC patients, and a median OS of 21.3 months among 28 HPV-negative patients. Additionally, the median progression-free survival (mPFS) was 7.4 months in an HPV-unselected population but improved to 9.9 months in HPV-negative patients.
Bicara CEO Claire Mazumdar, Ph.D., emphasized the importance of long-term survival data over early landmark metrics such as 12-month OS rates. Speaking at the American Society of Clinical Oncology conference, Mazumdar noted, “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.” She further highlighted that Bicara's data resonate strongly with head and neck oncologists, particularly due to the recognition that HPV-positive and HPV-negative HNSCC are distinct diseases requiring tailored approaches.
Analyst opinions differ regarding the leading candidate. Leerink Partners, which covers Merus but not Bicara, expressed a preference for Merus in a June 2 note, citing Merus' higher 12-month OS and longer median progression-free survival of nine months compared to Bicara's 7.4 months in an HPV-unselective group.
However, Eric Schmidt from Cantor Fitzgerald, reviewing data from both companies on June 1, characterized their results as “more similar than different” at this stage. Schmidt pointed out that while Merus currently holds an advantage in phase 3 timelines, it remains too early to predict first-line market dominance based on single-arm trial data. He identified features of Bicara's ficerafusp, such as its TGF-beta mechanism potentially leading to more durable responses and a pivotal trial focused on HPV-negative patients, which may shift competitive dynamics.
Bicara is actively enrolling patients for its pivotal phase 2/3 trial, aiming to recruit 650 participants. The company's leadership stresses the importance of understanding patient subgroups and long-term outcomes, reflecting the cautious stance of the head and neck oncology community. Mazumdar commented, “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.”
She also remarked on the investor reaction, stating that some have been swayed by recent “flashy headlines,” but a growing portion of the investor base is beginning to appreciate the potential of Bicara's approach.
