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Ascentage, Merck To Evaluate APG-115 In Combination With KEYTRUDA In Advanced Solid Tumors

Ascentage Pharma said that it reached a clinical collaboration with Merck & Co (MRK) to evaluate the combination of APG-115, Ascentage's MDM2-p53 inhibitor, and KEYTRUDA or pembrolizumab, Merck's anti-PD-1 therapy, for the treatment of patients with advanced solid tumors.

As per the deal, Ascentage will sponsor an open-label, multicenter, phase Ib/II study (NCT03611868) is designed to evaluate the safety and efficacy of APG-115 with KEYTRUDA in multiple cohorts of solid tumors. i,e., NSCLC, melanoma, Urothelial cancer, Liposarcoma, MPNST and ATM mutated/p53 WT tumors resistant or relapsed to PD-1/PD-L1 treatment or without previous PD-1/PD-L1 treatment.

The Phase II portion of the study has initiated and is expected to enroll 80 patients at multiple sites in the US.

Merck and Ascentage will use a joint development committee to exchange information about the study.

Preclinical studies demonstrated that APG-115 promoted the production of proinflammatory cytokines in T cells, enhanced CD4+ T cell activation, and increased PD-L1 expression on various tumor cells. Enhanced antitumor activity was demonstrated in various tumor models after APG-115 was combined with PD-1 blockade.

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