Bicara’s Ficerafusp Alfa Shows 46% 2-Year Survival Rate for Head and Neck Cancer Subset at ASCO 2025

Bicara Therapeutics presented data at ASCO 2025 for its investigational bifunctional antibody, ficerafusp alfa, in combination with pembrolizumab (Keytruda) for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC)234.

Ficerafusp alfa targets both EGFR and TGF-β to improve tumor penetration and has shown deep and durable responses, especially among PD-L1-positive patients24.

In the presented trial, ficerafusp alfa combined with Keytruda achieved an overall response rate (ORR) of 53%, a median progression-free survival (PFS) of 7.4 months, and a 12-month overall survival (OS) rate of 61.5%3.

A key highlight was a 46% overall survival rate at two years for a subset of head and neck cancer patients, as referenced in recent presentations2.

Tumor shrinkage was notable, with 12 of 15 responders experiencing at least 80% reduction, though this metric was described as arbitrary by researchers4.

Bicara is focusing future studies of ficerafusp alfa on HPV-negative tumors, as data for HPV-positive patients are no longer being developed or presented4.

The results position Bicara's ficerafusp alfa as a competitive option in this cancer subtype, though Merus's rival antibody (petosemtamab) may have a broader application due to activity seen in HPV-positive disease as well34.

Sources:

2. https://ir.bicara.com/news-releases/news-release-details/bicara-therapeutics-demonstrates-deep-and-durable-responses

3. https://www.clinicaltrialsarena.com/analyst-comment/asco-2025-merus-bicara-head-neck-cancer/

4. https://www.oncologypipeline.com/apexonco/asco-2025-bicaras-ficerafusp-claim-turns-pd-l1-status