MEDIOLA: A phase I/II, open-label trial of olaparib in combination with durvalumab (MEDI4736) in patients (pts) with advanced solid tumours

Abstract

Background: Olaparib (Lynparza) is a potent, oral PARP inhibitor that induces synthetic lethality in tumours deficient in homologous recombination repair. Durvalumab is a selective, high-affinity, engineered, human IgG1 mAb that blocks PD-L1 binding to PD-1 and CD80, preventing PD-L1-mediated inhibition of T-cell activation, and promoting antitumour immune responses. In a Phase I study (NCT02484404), olaparib plus durvalumab was tolerable, and a recommended combination dose was determined (Lee et al, ASCO 2016). MEDIOLA (NCT02734004) is using this combination dose to assess olaparib and durvalumab, which may have complementary mechanisms of action, in pts selected using criteria that predict sensitivity to olaparib.