BCAB - BioAtla Presenting Phase 1 Evalstotug Clinical Trial Data Demonstrating Clinical Benefit at the Upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting | Benzinga
Multiple refractory PD1 failure patients experienced prolonged progression free survival (10 months ongoing); confirmed responses observed in patients receiving evalstotug
High doses of evalstotug as either a monotherapy or in combination with PD1 are associated with manageable safety with relatively low incidence and severity of immune-mediated AEs allowing patients to continue treatment for extended intervals
On track for completion of Phase 1 dose-escalation of evalstotug at 1 gram (14.2 mg/kg for a 70 kg person) and Phase 2 monotherapy study with multiple scans in refractory melanoma and carcinoma patients; ongoing enrollment in 1st line combination therapy expansion cohorts for 2H readout
A Phase 3 trial of evalstotug in first-line metastatic, unresectable BRAF-mutated melanoma is
anticipated to initiate in 2H of 2024 following planned FDA meeting
SAN DIEGO, May 23, 2024 (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, today announced expanded data at an upcoming presentation entitled, "Phase 1 study of evalstotug (BA3071), an anti-CTLA-4 Conditionally Active Biologic, in combination with nivolumab in advanced solid tumors", demonstrating confirmed responses with a potentially differentiated tolerability profile with the Company's novel, conditionally active anti-CTLA-4 agent, evalstotug, in combination with anti-PD-1 therapy. The poster will be presented at the upcoming 2024 American Society of Clinical Oncology (ASCO) Annual Meeting at the McCormick Place Convention Center in Chicago, Illinois on Saturday, June 1, 2024.
"Given the emerging clinical profile observed, we believe evalstotug has the potential to be best-in-class CTLA-4 antibody and holds the promise to be used as often as a PD-1 inhibitor," said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. "Strikingly, we have observed prolonged PFS of greater than 10 months and confirmed responses at high doses (350 mg), of evalstotug, suggesting increased exposure of CTLA-4 blockade in combination with PD-1 inhibition drives clinical benefit. We continue to enroll in the Phase 2 first-line melanoma and mutated NSCLC combination cohorts at the 700 mg flat dose and we anticipate moving to the 1 gram flat dose in June following clearance of the DLT observation period and remain on track for monotherapy and combination data readouts later this year. We anticipate enabling a Phase 3 trial of evalstotug in first-line metastatic or unresectable BRAF-mutated melanoma in the second half of this year.
Data highlights from poster include:
- A Phase 1 dose-escalation study evaluated evalstotug (7 mg – 1 g Q3W) in combination with nivolumab (240 mg), conducted in 21 patients
- Data cut of March 29, 2024 unless otherwise specified
- Patients received a median of 3 prior lines of systemic therapy
- All patients had experienced failure of anti–PD-1 therapy
- Patients treated with 350 mg evalstotug received more doses (mean, 7.2) compared with reported ipilimumab ...