Infinity Pharmaceuticals reports data from MARIO-1 Phase 1b study
Infinity Pharmaceuticals announced that data to be presented at the 33rd Annual Meeting of the Society for Immunotherapy of Cancer demonstrated preliminary evidence that IPI-549 in combination with Opdivo is clinically active in indications not expected to respond to Opdivo alone. In particular, evidence of reversal of resistance to Opdivo included a partial response in a patient with metastatic melanoma who progressed on immediate prior Opdivo therapy. IPI-549 plus Opdivo also resulted in a 26% reduction of tumor target lesions in a patient with chemotherapy-resistant triple negative breast cancer, a tumor type intrinsically resistant to checkpoint inhibition. The data also included long-term follow up on sustained partial responses in two patients from combination dose escalation: one with microsatellite stable gallbladder cancer and one with adrenocortical carcinoma. The observed early clinical activity from the combination expansion, in addition to findings from the monotherapy cohorts, including associated translational data, support on-mechanism proof of concept for IPI-549. Infinity is evaluating IPI-549 in MARIO-1, a Phase 1b study in approximately 200 patients with advanced solid tumors. Additionally, Infinity is planning to initiate MARIO-275, a global, randomized Phase 2 study to evaluate the effect of adding IPI-549 to Opdivo in approximately 150 checkpoint-inhibitor naive advanced urothelial cancer patients who have progressed or recurred following treatment with platinum-based chemotherapy.