Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer
Benjamin J Solomon, Cai Cun Zhou, Alexander Drilon, Keunchil Park, Jürgen Wolf, Yasir Elamin, Hannah M Davis, Victoria Soldatenkova, Andreas Sashegyi, Aimee Bence Lin, Boris K Lin, Herbert H F Loong, Silvia Novello, Edurne Arriola, Maurice Pérol, Koichi Goto, Fernando C Santini, Benjamin J Solomon, Cai Cun Zhou, Alexander Drilon, Keunchil Park, Jürgen Wolf, Yasir Elamin, Hannah M Davis, Victoria Soldatenkova, Andreas Sashegyi, Aimee Bence Lin, Boris K Lin, Herbert H F Loong, Silvia Novello, Edurne Arriola, Maurice Pérol, Koichi Goto, Fernando C Santini
Abstract
Selpercatinib, a novel, highly selective and potent, inhibitor of RET, demonstrated clinically meaningful antitumor activity with manageable toxicity in heavily pretreated and treatment-naive RET fusion-positive non-small-cell lung cancer patients in a Phase I/II clinical trial. LIBRETTO-431 (NCT04194944) is a randomized, global, multicenter, open-label, Phase III trial, evaluating selpercatinib versus carboplatin or cisplatin and pemetrexed chemotherapy with or without pembrolizumab in treatment-naive patients with locally advanced/metastatic RET fusion-positive nonsquamous non-small-cell lung cancer. The primary end point is progression-free survival by independent review. Key secondary end points include overall survival, response rate, duration of response and progression-free survival. Clinical trial registration: NCT04194944 (ClinicalTrials.gov).
Keywords: Phase III trial; RET fusion-positive; RET kinase inhibitor; RET rearrangement; non-small-cell lung cancer; selpercatinib; targeted therapy.
Source: PubMed