# Bicara Therapeutics Announces Promising Phase 1/1b Results for Ficerafusp Alfa
## Phase 1/1b Trial Results
Bicara Therapeutics Inc. has revealed positive results from its Phase 1/1b clinical trial of ficerafusp alfa, a bifunctional antibody, in combination with pembrolizumab for patients with HPV-negative head and neck squamous cell carcinoma (HNSCC). The trial reported a median duration of response of 21.7 months, with 80% of responders achieving at least 80% tumor shrinkage. Median overall survival was recorded at 21.3 months, accompanied by a two-year overall survival rate of 46% in HPV-negative participants. This data supports ficerafusp alfa’s potential to improve treatment outcomes for this high-risk patient population, and the company plans to pursue further development through a pivotal Phase 2/3 trial. A conference call to discuss these findings is set for today.
## Key Positives
– **Effective Response Rate**: The median duration of response reached 21.7 months, with 80% of responders experiencing deep responses.
– **Overall Survival Improvements**: A median overall survival of 21.3 months and a two-year survival rate of 46% for HPV-negative patients suggests improved outcomes.
– **High Disease Control Rate**: An 89% disease control rate demonstrates significant therapeutic benefits in a historically challenging population.
– **Safety Profile**: The safety of ficerafusp alfa aligns with earlier data, supporting its viability for further study.
## Potential Concerns
– **Forward-Looking Statements**: The press release contains forward-looking statements, which may create uncertainty about future efficacy and investor confidence.
– **Survival Comparisons**: The reported median overall survival of 21.3 months may not compare favorably to existing treatments for recurrent/metastatic HNSCC.
– **Benchmark Reliance**: Comparisons to historical efficacy data may raise questions about the trial’s robustness and ficerafusp alfa’s market viability.
## Frequently Asked Questions
### What are the key findings from the Phase 1/1b trial of ficerafusp alfa?
The trial showed a median duration of response of 21.7 months, with 80% of responders achieving deep responses.
### How does ficerafusp alfa work in treating HNSCC?
Ficerafusp alfa combines two established targets to enhance tumor penetration and improve responses to treatment.
### What are the overall survival rates for patients using ficerafusp alfa?
The median overall survival was 21.3 months, with a two-year survival rate of 46% in HPV-negative HNSCC patients.
### When is the conference call regarding ficerafusp alfa updates?
The conference call is scheduled for June 1, 2025, at 3:00 p.m. CT / 4:00 p.m. ET.
### What is the significance of this trial for HPV-negative HNSCC patients?
This trial indicates a meaningful advancement in addressing treatment needs for HPV-negative HNSCC patients.
## Insider Trading Activity
Insiders at $BCAX have engaged in two stock trades over the past six months, all being sales, totaling 79,146 shares amounting to approximately $1,021,210.
## Analyst Ratings
Wall Street analysts have reviewed $BCAX, with 0 buy ratings and 1 sell rating.
## Price Targets
Two analysts recently issued price targets for $BCAX. One target is $8.0 from Wells Fargo and another is $48.0 from Stifel Nicolaus, indicating varying expectations.
## Conclusion
Bicara Therapeutics’ promising trial results for ficerafusp alfa may represent a significant development for patients with HPV-negative HNSCC, pending future evaluations and ongoing trials.# Bicara Therapeutics Presents Promising Results for Ficerafusp Alfa in HNSCC
### Key Trial Findings
Bicara Therapeutics shared significant insights from a Phase 1/1b trial examining ficerafusp alfa combined with pembrolizumab in patients with first-line recurrent or metastatic (R/M) HPV-negative head and neck squamous cell carcinoma (HNSCC). The combination showed greater overall survival (OS) compared to historical benchmarks.
In the HPV-negative efficacy evaluable population (n=28):
– **Median Duration of Response:** 21.7 months (15 responders).
– **Median OS:** 21.3 months; 2-year OS rate reached 46%.
– **Objective Response Rates:**
– 54% confirmed objective response rate (ORR) (15/28).
– Including unconfirmed responses, the ORR is 64% (18/28).
– Complete response rate stands at 21% (6/28).
– **Deep Responses:** 80% of responders (12/15) achieved ≥80% tumor shrinkage.
– **Disease Control Rate:** 89% (25/28).
– **Median Progression-Free Survival:** 9.9 months.
– **Safety Profile:** Remains manageable with known adverse events.
### Expert Commentary
Dr. Christine H. Chung, chair at Moffitt Cancer Center, highlighted the impressive duration of response, noting it represents a significant improvement over past treatments. She emphasized ficerafusp alfa’s role in enhancing the tumor microenvironment to facilitate immune cell infiltration, potentially improving patients’ quality of life.
### Conference Call and Webcast
Bicara Therapeutics will hold a conference call and webcast on June 1, 2025, at 3:00 p.m. CT/4:00 p.m. ET. Registration is available via their website.
### Background on HNSCC
Head and neck squamous cell carcinomas arise from mucosal epithelium in various regions and are among the most prevalent global cancers. By 2030, the incidence may reach one million new cases annually. Approximately 10% of patients present with metastatic disease, and up to 30% experience recurrence.
Most HNSCC cases are due to mutations from carcinogenic exposures. Notably, about 80% of R/M HNSCC patients are HPV-negative, often facing severe complications and offering unmet medical needs for effective therapies.
### About Ficerafusp Alfa
Ficerafusp alfa is a first-in-class bifunctional antibody designed to penetrate tumors by addressing barriers in the tumor microenvironment. It combines an EGFR-targeting monoclonal antibody with a domain that binds TGF-β, facilitating better tumor access and enhancing response durability. It is currently under evaluation in a pivotal Phase 2/3 trial.
### About Bicara Therapeutics
Bicara Therapeutics focuses on developing bifunctional therapies for solid tumors, with ficerafusp alfa as a leading candidate aimed at addressing significant medical needs in oncology.
### Forward-Looking Statements
This announcement contains forward-looking statements about Bicara’s clinical developments, which involve risks and uncertainties. Actual results may differ from expectations due to various factors, including clinical trial outcomes, regulatory developments, and cash resource management.
### Contacts
**Investors:**
Rachel Frank
[email protected]
**Media:**
Amanda Lazaro, 1AB
[email protected]
This article presents factual updates regarding ongoing clinical trials and development efforts by Bicara Therapeutics.
