Bicara Therapeutics Reports Updated Interim Phase 1/1b Data of Ficerafusp Alfa (BCA101) in 1L HPV-negative Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
June 27 2024 - 8:00AM
Business Wire
First-in-class bifunctional EGFR/TGF-β
inhibitor, ficerafusp alfa, in combination with pembrolizumab has
demonstrated clinically meaningful anti-tumor activity and
significant improvement over standard of care in HNSCC with at
least 12 months of follow-up
In HPV-negative HNSCC, data demonstrated an 64%
ORR, 18% CR rate and mPFS of 9.8 months; median duration of
response and median overall survival not yet reached
Bicara Therapeutics, a clinical-stage biotechnology company
developing transformative bifunctional therapies for patients with
solid tumors, today announced the presentation of updated interim
data from its ongoing, open-label Phase 1/1b dose expansion study
of ficerafusp alfa (BCA101) at the 3rd Hawaii Global Summit on
Thoracic Malignancies, taking place from June 25-29, 2024.
Ficerafusp alfa is a bifunctional antibody that combines two
clinically validated targets: an epidermal growth factor receptor
(EGFR) directed monoclonal antibody with a domain that binds to
human transforming growth factor beta (TGF-β).
In the Phase 1/1b clinical trial, ficerafusp alfa in combination
with pembrolizumab has demonstrated clinically meaningful
anti-tumor activity, with a 64% overall response rate (ORR), 18%
complete response (CR) rate and median progression free survival
(mPFS) of 9.8 months in frontline human papillomavirus
(HPV)-negative, recurrent/metastatic (R/M) head and neck squamous
cell carcinoma (HNSCC), along with a favorable tolerability
profile.
“Data from our ongoing Phase 1/1b clinical trial reflected a
substantial increase over the historical 19% ORR observed in a
Phase 3 trial with pembrolizumab monotherapy, the current standard
of care in R/M HNSCC,” said David Raben, M.D., chief medical
officer of Bicara Therapeutics. “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.”
“Ficerafusp alfa has the potential to exert potent anti-tumor
activity by simultaneously blocking both cancer cell intrinsic EGFR
survival and proliferation, as well as immunosuppressive TGF-β
signaling within the tumor microenvironment to lead to durable
responses and improved survival,” said Claire Mazumdar, Ph.D., MBA,
chief executive officer of Bicara Therapeutics. “Given these data,
we intend to initiate a pivotal Phase 2/3 trial of ficerafusp alfa
in combination with pembrolizumab in frontline R/M HNSCC excluding
HPV-positive patients. We also remain excited about the potential
of ficerafusp alfa to expand into other populations of HNSCC
patients and across other squamous cell tumor types where there is
a strong biologic rationale for the dual inhibition of both EGFR
and TGF-β.”
Presentation Highlights:
- Updated interim data (April 2024 cut-off date) from the Phase
1/1b dose expansion cohort of BCA101 in combination with
pembrolizumab include 39 evaluable frontline R/M HNSCC patients
with a PD-L1 combined positive score (CPS) of ≥1. 28 patients were
HPV-negative and 11 patients were HPV-positive, as determined by
p16 testing.
- 54% ORR in total evaluable study population (21/39 patients),
including 3 unconfirmed responses1.
- 15% complete response (CR) rate (6/39 patients). 26% (10/39) of
patients with 100% reductions in target lesions.
- Favorable tolerability profile with the most common
treatment-related adverse events (TRAEs) including acneiform rash
(76%, with majority being Grade 1/2 in severity), fatigue (43%),
and hypophosphatemia (38%).
- In HPV-negative population (n=28):
- 64% ORR (18/28 patients) with responses observed across
different levels of PD-L1 expression, including 3 unconfirmed
responses1.
- 18% complete response (CR) rate (5/28 patients). 29% (8/28) of
patients with 100% reductions in target lesions.
- Median progression free survival (mPFS) of 9.8 months.
- With at least 12 months of follow-up, median duration of
response (DOR) and median overall survival (OS) have not yet been
reached.
Presentation Details:
Title: Altering the HNSCC
landscape: Breaking through the Tumor Defense with EGFR-TGF-β
blockade Presentation Date and Time:
Thursday, June 27, 2:50 p.m. HST Presenter: Dr. David Raben
About Head and Neck Squamous Cell Carcinoma
Head and neck squamous cell carcinomas (HNSCCs) develop from the
mucosal epithelium in the oral cavity, pharynx and larynx and are
the most common malignancies that arise in the head and neck. HNSCC
is one of the most common cancers in the United States and globally
with a rising incidence anticipated to reach one million new global
cases annually by 20302. Ten percent of HNSCC patients are
diagnosed with metastatic disease and up to 30% develop a
recurrence or metastases over time after initial treatment for
advanced HNSCC.
Most cases of HNSCC are believed to arise from mutations that
accumulate due to carcinogenic exposure, such as tobacco smoke, or
by HPV. Approximately 80% of patients with R/M HNSCC are
HPV-negative. HPV-negative HNSCC tumors typically recur locally and
are associated with an increased risk of fatal tumor bleeding,
excruciating pain and difficulty swallowing. Thus, there remains a
significant unmet need for therapies with a durable anti-tumor
response in this population.
About Ficerafusp Alfa (BCA101)
Ficerafusp alfa is a bifunctional antibody designed to inhibit
the epidermal growth factor receptor (EGFR) and disable
transforming growth factor beta (TGF-β) directly at the tumor site.
This approach is designed with the intent to allow ficerafusp alfa
to inhibit tumor proliferation, while restoring the cytolytic
activity of the local immune cells.
Ficerafusp alfa is currently being evaluated in a dose expansion
phase of an open-label Phase 1/1b study in combination with
pembrolizumab in HPV-negative patients with R/M HNSCC, advanced
squamous non-small cell lung cancer (SqNSCLC), or squamous cancer
of the anal canal (SCAC) and as a monotherapy for cutaneous
squamous cell carcinoma (cSCC).
About Bicara Therapeutics
Bicara Therapeutics is a clinical-stage biotechnology company
developing bifunctional therapies engineered to combine the
precision of well validated, tumor-targeting antibodies with the
power of tumor microenvironment modulators. The Company’s
bifunctional antibodies are designed to deliver an immunomodulatory
payload directly to the tumor microenvironment to ramp up immune
cell activity, offering the potential for synergistic therapeutic
impact at the site of the tumor. Bicara’s lead product candidate,
ficerafusp alfa, is a EGFR/TGF-β-trap bifunctional antibody in
clinical development for multiple tumor types. For more
information, please visit www.bicara.com or follow us on LinkedIn
or X.
1Of 3 unconfirmed responses, all three were in HPV-negative
patients. One patient had progressive disease at confirmatory scan,
and the other two patients withdrew from study due to
non-treatment-related adverse events prior to confirmatory
scan.
2Johnson, D.E., Burtness, B., Leemans, C.R. et al. Head and neck
squamous cell carcinoma. Nat Rev Dis Primers 6, 92 (2020).
https://doi.org/10.1038/s41572-020-00224-3
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Investors Hannah Deresiewicz Precision AQ
hannah.deresiewicz@precisionaq.com
Media Dan Budwick 1AB dan@1abmedia.com