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

doi:10.2217/fon-2020-0935

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

Thoracic Head & Neck Medical Oncology

Research output: Contribution to journal › Article › peer-review

28 Scopus citations

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.

Original language	English (US)
Pages (from-to)	763-773
Number of pages	11
Journal	Future Oncology
Volume	17
Issue number	7
DOIs	https://doi.org/10.2217/fon-2020-0935
State	Published - Mar 2021

Keywords

Phase III trial
RET fusion-positive
RET kinase inhibitor
RET rearrangement
non-small-cell lung cancer
selpercatinib
targeted therapy

ASJC Scopus subject areas

Oncology
Cancer Research

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10.2217/fon-2020-0935

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Solomon, B. J., Zhou, C. C., Drilon, A., Park, K., Wolf, J., Elamin, Y., Davis, H. M., Soldatenkova, V., Sashegyi, A., Lin, A. B., Lin, B. K., Loong, H. H. F., Novello, S., Arriola, E., Pérol, M., Goto, K., & Santini, F. C. (2021). Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer. Future Oncology, 17(7), 763-773. https://doi.org/10.2217/fon-2020-0935

Solomon, BJ, Zhou, CC, Drilon, A, Park, K, Wolf, J, Elamin, Y, Davis, HM, Soldatenkova, V, Sashegyi, A, Lin, AB, Lin, BK, Loong, HHF, Novello, S, Arriola, E, Pérol, M, Goto, K & Santini, FC 2021, 'Phase III study of selpercatinib versus chemotherapy ± pembrolizumab in untreated RET positive non-small-cell lung cancer', Future Oncology, vol. 17, no. 7, pp. 763-773. https://doi.org/10.2217/fon-2020-0935

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

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.",

keywords = "Phase III trial, RET fusion-positive, RET kinase inhibitor, RET rearrangement, non-small-cell lung cancer, selpercatinib, targeted therapy",

author = "Solomon, {Benjamin J.} and Zhou, {Cai Cun} and Alexander Drilon and Keunchil Park and J{\"u}rgen Wolf and Yasir Elamin and Davis, {Hannah M.} and Victoria Soldatenkova and Andreas Sashegyi and Lin, {Aimee Bence} and Lin, {Boris K.} and Loong, {Herbert H.F.} and Silvia Novello and Edurne Arriola and Maurice P{\'e}rol and Koichi Goto and Santini, {Fernando C.}",

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doi = "10.2217/fon-2020-0935",

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AU - Loong, Herbert H.F.

AU - Novello, Silvia

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AU - Goto, Koichi

AU - Santini, Fernando C.

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

Abstract

Keywords

ASJC Scopus subject areas

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