— Mec-V demonstrates median OS of 21.5 months in patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma compared with approximately 12 months with approved agents
— Mec-V safety profile as monotherapy, and in combination with anti-PD-1 antibody, was manageable and consistent with conditional binding of the AXL target restricted to the tumor microenvironment
Nov. 07, 2025 -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced clinical data in a poster titled “Median OS of 21.5 months among 44 patients with treatment-refractory leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma treated with mecbotamab vedotin, an AXL-targeting ADC,” at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting, being held November 5–9, 2025, in National Harbor, Maryland.
Mec-V is a CAB antibody–drug conjugate (ADC) targeting AXL, a receptor tyrosine kinase overexpressed in various solid tumors including sarcoma. Mec-V, developed using BioAtla’s proprietary CAB technology, conditionally binds to AXL under acidic-pH conditions, enabling tumor-specific delivery of its cytotoxic payload while minimizing off-tumor toxicity.
In the Phase 2 clinical trial, 79 patients with advanced soft tissue sarcomas were treated with Mec-V either as monotherapy (n=54) or in combination with anti–PD-1 antibody (n=25). A focused efficacy analysis of OS was performed among the subset of 44 patients who had treatment-refractory leiomyosarcoma, liposarcoma, or undifferentiated pleomorphic sarcoma.
"The data presented at SITC 2025 underscore the potential of Mec-V to meaningfully extend survival in patients with treatment-refractory soft tissue sarcomas—a population with few effective options,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla. “The prolonged overall survival observed suggests that early exposure to Mec-V may change the long-term clinical outcome among patients suffering from these advanced sarcomas, potentially by helping to selectively eliminate AXL-expressing cancer cells that contribute to subsequent treatment resistance and poor outcomes."
Patients (n=44) with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma were heavily pretreated, having received a median of 2 prior lines of therapy (range 0–10).
Mec-V was administered every two weeks either as monotherapy (n=33) or in combination with anti–PD-1 antibody (n=11); data reflect a March 25, 2025 cutoff.
Median overall survival was 21.5 months across all patients, with 22.9 months observed in the combination arm and 18.4 months in the monotherapy arm.
In addition, the 12-month OS rate was 73%, compared to approximately 50% historically reported for approved agents in similar populations.
Two patients also achieved partial responses: one with leiomyosarcoma (combination therapy) and one with undifferentiated pleomorphic sarcoma (monotherapy).
Disease control rate (DCR) was 52% across all patients.
Adverse events were generally low-grade, transient, and manageable; no treatment-related deaths were reported.
Grade 3/4 treatment-related adverse events included neutropenia (21%), hepatic transaminase elevations (16%), and hyperglycemia (3%); no ocular or pulmonary toxicities were observed.
Presentation details:
Title: Median OS of 21.5 Months Among 44 Patients with Treatment-Refractory Leiomyosarcoma, Liposarcoma, and Undifferentiated Pleomorphic Sarcoma Treated with Mecbotamab Vedotin, an AXL-Targeting ADC
Presenter: Mihaela Druta, MD, Moffitt Cancer Center
Abstract Number: 523
Date & Time: Friday, November 7, 2025 | 12:15–1:45 p.m. ET & 5:35–7 p.m. ET
Location: Gaylord National Resort and Convention Center Lower-Level Atrium Prince George's ABC
Mecbotamab Vedotin (Mec-V) is a CAB-platform antibody–drug conjugate (ADC) targeting AXL, a receptor tyrosine kinase overexpressed in many solid tumors that has been shown to be associated with treatment resistance and poor clinical outcomes. Engineered using BioAtla’s proprietary CAB technology, Mec-V selectively binds to AXL in the acidic tumor microenvironment while sparing healthy tissue. This pH-dependent binding mechanism reduces off-tumor toxicity and improves the therapeutic index. Mec-V is a Phase 2 stage clinical asset targeting multiple solid tumor indications, including the treatment of patients with mKRAS NSCLC who have previously experienced progression on or after PD-1/L1, epidermal growth factor receptor and/or ALK inhibitor therapies. In this population, Mec-V achieved landmark overall survival rate of 66% and 58%, at one-year and two-years, respectively.
BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets includes methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products.
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