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Article History

Accepted: 31 October 2022

First Online: 2 December 2022

Declarations

:

: This study (NCT00697632) was supported by Mirati Therapeutics Inc. Funding for a professional medical writer with access to the data was provided by Mirati Therapeutics Inc.

: Herbert Hurwitz, Christian Kollmannsberger, Keunchil Park, and Sunil Sharma have no potential conflicts of interest to declare. Lyudmila Bazhenova reports consulting fees/honoraria from Bayer, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sanko, Genentech, Janssen Pharmaceuticals, Merck, Mirati Therapeutics, Neuvogen, Novartis, ORIC Pharmaceuticals, Regeneron Pharmaceuticals, Sanofi, Takeda, and Turning Point Therapeutics (outside of the described work), and stock ownership in Epic Sciences. Byoung Chul Cho reports consulting fees/honoraria from AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, MedPacto, Novartis, Ono Pharmaceuticals, Pfizer, Roche, and Yuhan; grants from AbbVie, AstraZeneca, Bayer, Blueprint Medicines, Champions Oncology, Dizal Pharma, Dong-A ST, Eli Lilly, GIInovation, Interpark Bio, Janssen Pharmaceuticals, MedPacto, MOGAM Institute, MSD, Novartis, Ono Pharmaceuticals, and Yuhan; royalties from Champions Oncology (all outside of the described work); and stock ownership for BridgeBio Therapeutics, Cyrus Therapeutics, Gencurix, Interpark Bio Convergence, KANAPH Therapeutics, and TheraCan Vac. David Hong reports consulting fees/honoraria from Abbvie, Adaptimmune Therapeutics, Alkermes, Alpha Insights, Amgen, Aucta Pharmaceuticals, AUM Biosciences, Axiom, Baxter, Bayer, Boxer Capital, BridgeBio, COR2ED, COG, Cowen, Deciphera Pharmaceuticals, Ecor1, Gennao Bio, Genentech, Gilead, GLG, Group H, Guidepoint, HCW Precision, ImmunoGen, Infinity Pharmaceuticals, Janssen, Liberum, MedaCorp, Medscape, Numab, Oncologia Brasil, Pfizer, Pharma Intelligence, POET Congress, Prime Oncology, RAIN, SeaGen, STCube, Takeda, Tavistock, Trieza Therapeutics, Turning Point Therapeutics, WebMD, YingLing Pharma, and Ziopharm Oncology; grants from AbbVie, Adaptimmune, Adlai-Nortye, Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Daiichi-Sankyo, Deciphera Pharmaceuticals, Eisai, Endeavor Pharmaceuticals, Erasca, Fate Therapeutics, Genentech, Genmab, Ignyta, Infinity, Kite Pharma, Kyowa Kirin, Lilly, Loxo Oncology, Merck, Medimmune, Mirati Therapeutics, Mologen, Navier Medical, NCI-CTEP, Novartis, Numab Therapeutics, Pfizer, Pyramid Biosciences, Roche, SeaGen, Takeda, TCR² Therapeutics, Teckro, Turning Point Therapeutics, and VM Oncology (all outside of the described work); and ownership interests in Molecular Match, OncoResponse, and Telperian. Karen L. Reckamp reports research funding to her institution from Blueprint Medicines, Calithera, Daiichi Sanko, Elevation Oncology, Genentech, Janssen, and Mirati Therapeutics (outside of the described work); and consulting fees/honoraria from Amgen, AstraZeneca, Blueprint Medicines, Daiichi Sanko, EMD Sereno, Genentech, GlaxoSmithKline, Janssen Pharmaceuticals, Lilly, Merck KGA, Mirati Therapeutics, Seattle Genetics, and Takeda (outside of the described work). Geoffrey I. Shapiro reports research funding from Bristol Myers Squibb, Eli Lilly, Merck KGaA/EMD-Serono, Merck & Co., Sierra Oncology, and Tango Therapeutics; and consulting fees/honoraria from Artios, Atrin, Bayer, Bicycle Therapeutics, Blueprint Medicines, Boehringer Ingelheim, Concarlo Holdings, Cybrexa Therapeutics, CytomX Therapeutics, Eli Lilly, Fusion Pharmaceuticals, ImmunoMet, Janssen, Kymera Therapeutics, Merck KGaA/EMD-Serono, Pfizer, Syros, Xinthera, and Zentalis (outside of the described work). He also reports a patent (also issued to Cyclacel Pharmaceuticals) entitled “Dosage regimen for sapacitabine and seliciclib”, and a pending patent (with Liam Cornell) entitled “Compositions and Methods for Predicting Response and Resistance to CDK4/6 Inhibition”. Richard Chao, James Christensen, Hirak Der-Torissian, and Vanessa Tassell report employment and stock ownership for Mirati Therapeutics. Diane Potvin reports prior employment for Mirati Therapeutics. Demiana Faltaos reports prior employment and stock ownership for Mirati Therapeutics.

: Study conception and design: JGC, RC, HDT, DF, VT. Investigation: CK, HH, LB, BCC, DH, KP, KLR, SS, GS. Data analysis: DP, DF. Data interpretation: All authors. Manuscript reviewing and editing: All authors. Manuscript original draft: No authors, see medical writing acknowledgment. All authors reviewed and approved the final draft of the manuscript for publication and agree to be accountable for all aspects of the work.

: At Mirati Therapeutics, we are committed to patient care, advancing scientific understanding, and enabling the scientific community to learn from and build upon the research we have undertaken. To that end, we will honor legitimate requests for our clinical trial data from qualified researchers and investigators for conducting methodologically sound research. We will share clinical trial data, clinical study reports, study protocols, and statistical analysis plans from clinical trials for this study. Sharing is subject to the protection of patient privacy and respect for patient informed consent. In general, data will be made available for specific requests approximately 24 months after clinical trial completion from our in-scope interventional trials. For additional information on proposals with regard to data-sharing collaborations with Mirati, please email medinfo@mirati.com.

: Not applicable.

: This study was conducted in accordance with the Declaration of Helsinki, International Conference on Harmonisation Guidelines for Good Clinical Practice, and local regulatory requirements. The study protocol was approved by the Institutional Review Board at each participating study site.

: Patients provided written, informed consent

: All authors gave approval for the final version to be published.