BioAtla Presented Phase 2 Clinical Trial Data At The IASLC 2023 North America Conference On Lung Cancer And Virtual KOL Event

Author: Benzinga Newsdesk | December 05, 2023 09:07am

Results from the Phase 2 BA3011 clinical non-small cell lung cancer (NSCLC) study demonstrated promising clinical benefits in heavily pre-treated non-squamous histology patients across key endpoints

 

BA3011 is a CAB-AXL antibody-drug conjugate (ADC) being studied in refractory NSCLC patients

SAN DIEGO, Dec. 05, 2023 (GLOBE NEWSWIRE) -- 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, presented a poster and discussion entitled "Phase 2 Trial of Mecbotamab Vedotin (BA3011), a CAB-AXL-ADC, Alone or in Combination with Nivolumab in Patients with Non-Squamous NSCLC" at the IASLC Conference December 1–3 and at a virtual KOL Event held December 4, 2023.

"Patients with AXL-positive treatment-refractory NSCLC have an unusually poor prognosis, few treatment options, and we don't typically see clinical benefit in these patients," said Dr. Gay, MD, PhD, Assistant Professor, Department of Thoracic-Head & Neck Medical Oncology at MD Anderson Cancer Center. "Observing promising antitumor activity, including mulltiple partial responses (PRs) and over 4 months duration of response, following BA3011 is particularly exciting and a significant achievement in heavily pre-treated refractory patients."

"The results from the Phase 2 trial in NSCLC continue to show the potential of BA3011 in refractory NSCLC," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. "Our recent regulatory feedback as well as the benefit-risk profile we have observed to date with our 1.8 mg/kg Q2W BA3011 dosing regimen support advancing this dose in a potentially registrational study. Furthermore, the meaningful antitumor activity among patients with AXL expression of only 1% supports the development of BA3011 in target agnostic populations. Taken together, we believe BioAtla has a significant commercial opportunity to access a larger market and treat more patients with our CAB-AXL-ADC asset."

Data highlights from the poster presentation and KOL event include:

• In the BA3011 monotherapy arm (n = 23), 1.8 mg/kg BA3011 Q2W showed encouraging efficacy signals:
  • AXL-positive patients were enrolled and had received a median of at least 3 prior lines of therapy
  • Patients who previously experienced PD-1/L1 treatment failure were evaluable for efficacy at 12 weeks (n=18); objective response rate (ORR) was 27.8% and disease control rate (responses plus stable disease) was 55.6%
  • Five of 15 evaluable patients (33.3%) with EGFR wild-type NSCLC who previously experienced PD-1/L1 treatment failure responded to BA3011 monotherapy; among these five responders, two patients with AXL TmPS of 1% experienced a PR
  • Median duration of response was estimated to be 4.8 months (range, 2.3–12.1+ months)
• Overall, treatment with BA3011 was well-tolerated with a manageable safety profile
  • The most frequent treatment-emergent AEs (TEAEs) of any grade observed (>20%) were fatigue, diarrhea, constipation, and decreased appetite; no grade 4+ TEAEs among most frequent
  • TEAEs leading to treatment discontinuation occurred in 1/23 patients (4.3%) who received monotherapy and 1/17 patients (5.9%) who received combination therapy
• In summary, the observations of multiple responses among such heavily pre-treated patients, including those with AXL TmPS of only 1%, support further evaluation of BA3011 in a Phase 3 registrational study
  
   

More details, including the IASLC poster and KOL event slides and recorded KOL webcast, are available on BioAtla's website at https://www.bioatla.com/publications under the "Publications" section and https://ir.bioatla.com under the "Events and Presentations" section, respectively.

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