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).

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.

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

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

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.”