BioAtla presented Phase 2 trial data at IASLC 2023 on lung cancer

BioAtla 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. “The results from the Phase 2 trial in NSCLC continue to show the potential of BA3011 in refractory NSCLC,” said Jay 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, 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; objective response rate was 27.8% and disease control rate was 55.6%; Five of 15 evaluable patients 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; Overall, treatment with BA3011 was well-tolerated with a manageable safety profile; The most frequent treatment-emergent AEs of any grade observed were fatigue, diarrhea, constipation, and decreased appetite; no grade 4+ TEAEs among most frequent; TEAEs leading to treatment discontinuation occurred in 1/23 patients who received monotherapy and 1/17 patients 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