Journal article
Selpercatinib (LOXO-292) in patients with RET-mutant medullary thyroid cancer.
- Shah, Manisha H. Ohio State University Comprehensive Cancer Center, Columbus, OH;
- Sherman, Eric Jeffrey Memorial Sloan Kettering Cancer Center, New York, NY;
- Robinson, Bruce Royal North Shore Hospital, St. Leonards, Australia;
- Solomon, Benjamin J. Peter MacCallum Cancer Centre, Melbourne, VIC, Australia;
- Kang, Hyunseok University of California, San Francisco, CA;
- Lorch, Jochen H. Dana-Farber Cancer Institute, Boston, MA;
- Worden, Francis P. University of Michigan Rogel Cancer Center, Ann Arbor, MI;
- Brose, Marcia S. Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA;
- Leboulleux, Sophie Institut Gustave Roussy, Villejuif, France;
- Godbert, Yann Bergonié Institute Cancer center, Bordeaux, France;
- Meurer, Marie Hospital La Timone, Marseille, France;
- Morris, John C. Mayo Clinic, Rochester, MN;
- Owonikoko, Taofeek Kunle Winship Cancer Institute of Emory University, Atlanta, GA;
- Tan, Daniel Shao-Weng National Cancer Centre, Singapore, Singapore;
- Gautschi, Oliver University of Berne and Cantonal Hospital of Lucerne, Lucerne, Switzerland;
- Patel, Jyoti D. Lurie Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL;
- Yang, Luxi Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company, Stamford, CT;
- Kherani, Jennifer Loxo Oncology Inc., a wholly owned subsidiary of Eli Lilly and Company, Stamford, CT;
- Cabanillas, Maria E. The University of Texas MD Anderson Cancer Center, Houston, TX;
- Wirth, Lori J. Massachusetts General Hospital Cancer Center and Harvard University, Boston, MA;
Published in:
- Journal of Clinical Oncology. - American Society of Clinical Oncology (ASCO). - 2020, vol. 38, no. 15_suppl, p. 3594-3594
English
3594 Background: Selpercatinib (LOXO-292) is a highly selective and potent small molecule RET kinase inhibitor. Here we report an update on the efficacy and safety of selpercatinib in RET-mutant medullary thyroid cancer (MTC). Methods: Patients with RET-mutant MTC were enrolled to the Phase 1/2 LIBRETTO-001 trial (NCT03157128), a global, multicenter trial (16 countries, 89 sites). Following the Phase 1 dose escalation portion of the trial, patients received the recommended dose of 160 mg orally twice daily. Each cycle was 28 days. The primary endpoint was objective response rate (ORR) per RECIST 1.1. Secondary endpoints included duration of response (DoR) and safety. Per health authority agreement, the primary analysis set was defined as the first 55 consecutively enrolled patients previously treated with multikinase inhibitors cabozantinib and/or vandetanib. Patients naïve to cabozantinib and vandetanib treatment were analyzed separately. All analyses were based on a 16-Dec-2019 data cutoff date. Results: In the primary analysis set of prior cabozantinib and/or vandetanib-treated patients with MTC (n = 55), the ORR by investigator assessment was 62% (95% CI 47.7–74.6, n = 34/55) and the median DoR was not reached (95% CI 18.4 months–not estimable) despite a median follow-up of 14.8 months. In cabozantinib/vandetanib treatment-naïve patients (n = 88), the ORR by investigator assessment was 69% (95% CI 58.6–78.7, n = 61/88, including 2 responses pending confirmation). Of the 59 confirmed responding patients, with a median follow-up of 8 months, responses were ongoing for 57 responders at the time of the analysis. In the safety analysis set consisting of all selpercatinib dosed patients (N = 702), the most common treatment-related adverse events (TRAEs) that occurred in ≥15% of patients were dry mouth (33.3%), increased AST (24.5%), increased ALT (23.8%), hypertension (23.2%), diarrhea (19.7%), and fatigue (16.8%). Only 2% (14 of 702) of patients discontinued selpercatinib for TRAEs. Conclusions: Selpercatinib use was associated with marked and durable antitumor activity in prior cabozantinib and/or vandetanib-treated patients and in cabozantinib/vandetanib-naïve patients with RET-mutant MTC, with the majority of responses ongoing in both cohorts. Selpercatinib was well tolerated. Efficacy data assessed by independent review committee based on the 16-Dec-2019 data cutoff date will be presented. Clinical trial information: NCT03157128 .
- Language
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- English
- Open access status
- closed
- Identifiers
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- DOI 10.1200/jco.2020.38.15_suppl.3594
- ISSN 0732-183X
- Persistent URL
- https://sonar.ch/global/documents/60824
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