Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer

Solomon, Benjamin J.; Zhou, Cai Cun; Drilon, Alexander; Park, Keunchil; Wolf, Jurgen; Elamin, Yasir; Davis, Hannah M.; Soldatenkova, Victoria; Sashegyi, Andreas; Lin, Aimee Bence; Lin, Boris K.; Loong, Herbert H. F.; Novello, Silvia; Arriola Aperribay, Edurne; Pérol, Maurice; Goto, Koichi; Santini, Fernando C.

doi:http://dx.doi.org/10.2217/fon-2020-0935

Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer

Citation

Solomon BJ, Zhou CC, Drilon A, Park K, Wolf J, Elamin Y, Davis HM, Soldatenkova V, Sashegyi A, Lin AB, Lin BK, F Loong HH, Novello S, Arriola E, Pérol M, Goto K, Santini FC. Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncol. 2021;17(7):763-73. DOI: 10.2217/fon-2020-0935

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).