AIM ImmunoTech Shows 50% ORR, 21% Complete Responses in Phase 2 Ovarian Cancer Trial
AIM ImmunoTech reported a 50% objective response rate including 21% complete responses in its UPMC Phase 2 recurrent ovarian cancer trial combining Ampligen, pembrolizumab and cisplatin, with a 79% clinical benefit rate and median overall survival of 32.5 months. No Grade 4 or 5 toxicities were observed.
1. Trial Design and Collaboration
The single-arm Phase 2 study at UPMC evaluated Ampligen® combined with pembrolizumab and intraperitoneal cisplatin in 24 patients with recurrent ovarian cancer. The trial, supported by a Merck grant, aimed to overcome the immunosuppressive tumor microenvironment through locoregional and systemic immune activation strategies.
2. Efficacy Outcomes and Safety
Topline data showed a 50% objective response rate, including 21% complete responses, and a 79% clinical benefit rate. Median overall survival reached 32.5 months, with durable responses exceeding 70 months in select patients, and no Grade 4 or 5 toxicities reported.
3. Next Steps and Development Plans
Collection of progression-free survival and other secondary endpoint data is expected by January 2027. With intellectual property protection extending to 2039, AIM plans to advance Ampligen into later-stage trials and pursue strategic partnerships to expand its immuno-oncology pipeline.