The open-label trial assessed the asset along with pembrolizumab in head and neck squamous cell carcinoma patients. Credit: steph photographies / Shutterstock.

Bicara Therapeutics has released updated interim findings from its ongoing Phase I/Ib clinical trial of ficerafusp alfa for treating human papillomavirus (HPV)-negative recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).

A bifunctional antibody, ficerafusp alfa targets both the epidermal growth factor receptor (EGFR) and transforming growth factor beta (TGF-β).

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The open-label trial assessed the asset along with pembrolizumab in HNSCC patients.

Trial results indicated that the combination regimen offered clinically meaningful anti-tumour activity.

Furthermore, the treatment resulted in an overall response rate (ORR) of 64%, with an 18% complete response (CR) rate.

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The median progression-free survival (mPFS) was reported to be 9.8 months in trial subjects.

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These findings suggest a significant therapeutic potential for ficerafusp alfa in this patient population.

The trial also highlighted the favourable tolerability of the asset.

Acneiform rash, fatigue and hypophosphatemia were reported to be the most common treatment-related adverse events (TRAEs) observed in the trial.

Bicara Therapeutics chief medical officer David Raben said: “Data from our ongoing Phase I/Ib clinical trial reflected a substantial increase over the historical 19% ORR observed in a Phase III trial with pembrolizumab monotherapy, the current standard of care in R/M HNSCC.”

“Now with at least a year of follow-up on this cohort, it is encouraging to see a number of patients experience durable responses with the CR and mPFS data that have emerged. We believe these data indicate that ficerafusp alfa in combination with pembrolizumab may become a new chemotherapy-free standard of care treatment for HPV-negative first-line R/M HNSCC.”