Bicara's Ficerafusp Alfa Shows Promise in Head and Neck Cancer Treatment

Bicara Therapeutics has unveiled encouraging data for its bifunctional antibody, ficerafusp alfa, in combination with Keytruda for the treatment of head and neck squamous cell carcinoma (HNSCC). The results, presented at this year's American Society of Clinical Oncology (ASCO) conference in Chicago, highlight significant progress in addressing the unmet needs of patients with this aggressive form of cancer.

Impressive Survival Rates in HPV-Negative Patients

The phase 1/1b trial evaluating ficerafusp alfa and Keytruda in first-line, PD-L1-positive recurrent or metastatic HNSCC patients has yielded promising outcomes. For the HPV-negative subset, which comprised 28 patients, the two-year overall survival (OS) rate was 46%, with a median OS of 21.3 months. These results are particularly noteworthy given the historically poor prognosis for this patient population.

Dr. Christine Chung, chair of the department of head and neck-endocrine oncology at the Moffitt Cancer Center, commented on the significance of these findings: "These latest phase 1/1b data are impressive, particularly the duration of response, which represents a significant advance over historical controls in patients with HPV-negative recurrent/metastatic head and neck squamous cell carcinoma, including anti-PD-1 combinations with chemotherapy or EGFR inhibitors."

Robust Response Rates and Tumor Shrinkage

The efficacy of ficerafusp alfa extends beyond survival metrics. In the HPV-negative cohort, the confirmed objective response rate (ORR) was 54%, with an additional 10% of patients showing unconfirmed responses. Notably, 21% of patients in this group achieved complete responses.

Among the 15 patients with confirmed ORRs, 12 experienced at least 80% tumor shrinkage. The median duration of response (mDOR) for this group was an impressive 21.7 months, underscoring the potential for durable clinical benefit.

Advancing to Pivotal Trials

Based on these encouraging results, Bicara Therapeutics is currently enrolling patients for a pivotal phase 2/3 trial of ficerafusp alfa. The study is expected to include 650 patients, further evaluating the efficacy and safety of this novel therapeutic approach.

While the data from Bicara's trials have been met with enthusiasm, the competitive landscape in HNSCC treatment remains dynamic. Recent data from Merus on their bispecific antibody targeting EGFR and LGR5 has also shown promise, with a reported 79% 12-month survival rate in PD-L1-positive recurrent or metastatic HNSCC patients.

As the field continues to evolve, the development of ficerafusp alfa represents a significant step forward in the treatment of head and neck cancer, particularly for patients with HPV-negative disease. The ongoing pivotal trial will be crucial in determining the full potential of this innovative therapy in addressing the unmet needs of HNSCC patients.