Bicara's Head and Neck Cancer Drug Shows Promise, But Merus Retains Edge

Bicara Therapeutics has unveiled promising results for its head and neck cancer drug ficerafusp alfa at the American Society of Clinical Oncology (ASCO) conference in Chicago. However, analysts suggest that rival Merus still holds the advantage in this competitive space.

Ficerafusp Alfa: Encouraging Data with Caveats

Bicara's Phase 1/1b data revealed a two-year overall survival (OS) rate of 46% for HPV-negative patients with head and neck squamous cell carcinoma (HNSCC) treated with ficerafusp alfa in combination with Keytruda. The median OS for these patients was 21.3 months, with a confirmed objective response rate (ORR) of 54%.

Dr. Christine H. Chung from the Moffitt Cancer Center, who has worked on Bicara-funded studies, described the results as "impressive," noting that they "reflect the enhanced ability of ficerafusp alfa to remodel the tumor microenvironment allowing the tumor penetration of immune cells."

Despite these positive outcomes, analysts from BMO and Leerink Partners expressed skepticism about ficerafusp alfa's competitiveness against Merus' bispecific antibody. Leerink Partners analysts stated, "BCAX's ficerafusp alfa final data do not tip the scale meaningfully."

Merus Maintains Lead in HNSCC Treatment

Merus recently made waves with its bispecific antibody for head and neck cancer, reporting a survival rate of nearly 80% at 12 months. This announcement led to a 40% slump in Bicara's share price last month.

Comparing the two drugs, analysts noted that Merus' 12-month OS landmark rate of 79% surpassed ficerafusp alfa's 62%. Additionally, when considering all patients rather than just the HPV-negative group, ficerafusp alfa's median progression-free survival dropped to 7.4 months, which Leerink called a "more apples-to-apples comparison" with Merus' drug.

Merck's Keytruda Advances in HNSCC Treatment

Merck, the manufacturer of Keytruda, also presented HNSCC data at ASCO. Their findings showed that Keytruda was more effective when administered after chemoradiation rather than concurrently. Earlier this year, Merck reported that using Keytruda around surgery could reduce the risk of certain head and neck cancers returning.

The FDA is expected to decide this month on the approval of Keytruda as a neoadjuvant and adjuvant treatment for early-stage HNSCC, potentially expanding its application in this cancer type.

Head and neck cancer, the sixth most common cancer globally, affects nearly two-thirds of patients at the locally advanced stage upon diagnosis. As the field continues to evolve, the competition between Bicara, Merus, and established players like Merck highlights the ongoing efforts to improve outcomes for HNSCC patients.