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7 results on '"Hu, M. I."'

1. Results from the registrational phase I/II ARROW trial of pralsetinib (BLU-667) in patients (pts) with advanced RET mutation-positive medullary thyroid cancer (RET+ MTC)

Author

Keam, B., Hu, M. I., Subbiah, V., Wirth, L., Schuler, Martin, Mansfield, A. S., Brose, M. S., Curigliano, G., Leboulleux, S., Zhu, V. W., Matos, I., Adkins, D., Baik, C. S., Lopes, G., Godbert, Y., Sarker, D., Zhang, H., Turner, C. D., Taylor, M. H., and Lin, C.-C.

Subjects
Medizin, ComputingMethodologies_GENERAL
Abstract

Poster-Abstract

Published
2020

6. Phase 3 Trial of Selpercatinib in Advanced RET-Mutant Medullary Thyroid Cancer.

Author

Hadoux, J., Elisei, R., Brose, M. S., Hoff, A. O., Robinson, B. G., Gao, M., Jarzab, B., Isaev, P., Kopeckova, K., Wadsley, J., Fohrer, D., Keam, B., Bardet, S., Sherman, E. J., Tahara, M., Hu, M. I., Singh, R., Lin, Y., Soldatenkova, V., and Wright, J.

Subjects
*MEDULLARY thyroid carcinoma, *CLINICAL trials, *PROGRESSION-free survival, *TERMINATION of treatment, *ADVERSE health care events
Abstract

BACKGROUND Selpercatinib, a highly selective, potent RET inhibitor, has shown efficacy in advanced RET-mutant medullary thyroid cancer in a phase 1-2 trial, but its efficacy as compared with approved multikinase inhibitors is unclear. METHODS We conducted a phase 3, randomized trial comparing selpercatinib as first-line therapy with the physician's choice of cabozantinib or vandetanib (control group). Eligible patients had progressive disease documented within 14 months before enrollment. The primary end point in the protocol-specified interim efficacy analysis was progression-free survival, assessed by blinded independent central review. Crossover to selpercatinib was permitted among patients in the control group after disease progression. Treatment failure-free survival, assessed by blinded independent central review, was a secondary, alpha-controlled end point that was to be tested only if progression-free survival was significant. Among the other secondary end points were overall response and safety. RESULTS A total of 291 patients underwent randomization. At a median follow-up of 12 months, median progression-free survival as assessed by blinded independent central review was not reached in the selpercatinib group and was 16.8 months (95% confidence interval ICI], 12.2 to 25.1) in the control group (hazard ratio for disease progression or death, 0.28; 95% CI, 0.16 to 0.48; P<0.001). Progression-free survival at 12 months was 86.8% (95°/0 CI, 79.8 to 91.6) in the selpercatinib group and 65.7% (95% CI, 51.9 to 76.4) in the control group. Median treatment failurefree survival as assessed by Minded independent central review was not reached in the selpercatinib group and was 13.9 months in the control group (hazard ratio for disease progression, discontinuation due to treatment-related adverse events, or death, 0.25; 95% CI, 0.15 to 0.42; P<0.001). Treatment failure-free survival at 12 months was 86.296 (95% CI, 79.1 to 91.0) in the selpercatinib group and 62.1% (95% CI, 48.9 to 72.8) in the control group. The overall response was 69.4°/o (95°/o CI, 62.4 to 75.8) in the selpercatinib group and 38.896 (95% CI, 29.1 to 49.2) in the control group. Adverse events led to a dose reduction in 38.9°6 of the patients in the selpercatinib group, as compared with 77.3% in the control group, and to treatment discontinuation in 4.7% and 26.8%, respectively. CONCLUSIONS Selpercatinib treatment resulted in superior progression-free survival and treatment failure-free survival as compared with cabozantinib or vandetanib in patients with RET-mutant medullary thyroid cancer. (Funded by Loxo Oncology, a subsidiary of Eli Lilly; LIBRETTO-531 ClinicalTrials.gov number, NCT0421133Z) [ABSTRACT FROM AUTHOR]

Published
2023
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7. Weight gain in patients with RET aberrant cancers treated with brain penetrant RET selective inhibitors.

Author

Gouda MA, Hu MI, Cabanillas ME, Wu J, Meric-Bernstam F, and Subbiah V

Subjects
Humans, Brain metabolism, Weight Gain, Protein Kinase Inhibitors pharmacology, Proto-Oncogene Proteins c-ret genetics, Lung Neoplasms
Abstract

Competing Interests: Disclosure MH reports steering committee and study principle investigator support from Eli Lilly and Co and no personal financial conflicts or honoraria. FM-B reports consulting for AbbVie, Aduro BioTech Inc., Alkermes, AstraZeneca, Daiichi Sankyo Co. Ltd., Calibr (a division of Scripps Research), DebioPharm, Ecor1 Capital, eFFECTOR Therapeutics, F. Hoffman-La Roche Ltd., GT Apeiron, Genentech Inc., Harbinger Health, IBM Watson, Infinity Pharmaceuticals, Jackson Laboratory, Kolon Life Science, Lengo Therapeutics, Menarini Group, OrigiMed, PACT Pharma, Parexel International, Pfizer Inc., Protai Bio Ltd, Samsung Bioepis, Seattle Genetics Inc., Tallac Therapeutics, Tyra Biosciences, Xencor, Zymeworks; advisory committee participation for Black Diamond, Biovica, Eisai, FogPharma, Immunomedics, Inflection Biosciences, Karyopharm Therapeutics, Loxo Oncology, Mersana Therapeutics, OnCusp Therapeutics, Puma Biotechnology Inc., Seattle Genetics, Sanofi, Silverback Therapeutics, Spectrum Pharmaceuticals, Theratechnologies, Zentalis; sponsored research (to the institution) from Aileron Therapeutics, Inc. AstraZeneca, Bayer Healthcare Pharmaceutical, Calithera Biosciences Inc., Curis Inc., CytomX Therapeutics Inc., Daiichi Sankyo Co. Ltd., Debiopharm International, eFFECTOR Therapeutics, Genentech Inc., Guardant Health Inc., Klus Pharma, Takeda Pharmaceutical, Novartis, Puma Biotechnology Inc., Taiho Pharmaceutical Co.; and travel-related support from European Organisation for Research and Treatment of Cancer (EORTC), European Society for Medical Oncology (ESMO), Cholangiocarcinoma Foundation. VS was affiliated with UT MD Anderson Cancer Center, Houston, TX, USA when this paper was submitted. Currently he is affiliated with Sarah Cannon Research Institute, Nashville, TN, USA. He reports research funding/grant support for clinical trials from AbbVie, Agensys, Inc., Alfasigma, Altum, Amgen, Bayer, BERG Health, Blueprint Medicines Corporation, Boston Biomedical, Inc., Boston Pharmaceuticals, Celgene Corporation, D3 Bio, Inc., Dragonfly Therapeutics, Inc., Exelixis, Fujifilm, GlaxoSmithKline, Idera Pharmaceuticals, Inc., Incyte Corporation, Inhibrx, Loxo Oncology, MedImmune, MultiVir, Inc., NanoCarrier, Co., National Comprehensive Cancer Network, NCI-CTEP, Northwest Biotherapeutics, Novartis, PharmaMar, Pfizer, Relay Therapeutics, Roche/Genentech, Takeda, Turning Point Therapeutics, UT MD Anderson Cancer Center, and Vegenics Pty Ltd.; travel support from ASCO, ESMO, Helsinn Healthcare, Incyte Corporation, Novartis, and PharmaMar; consultancy/advisory board participation for Helsinn Healthcare, Jazz Pharmaceuticals, Incyte Corporation, Loxo Oncology/Eli Lilly, MedImmune, Novartis, QED Therapeutics, Relay Therapeutics, Daiichi-Sankyo, and R-Pharm US; and other relationship with Medscape. All other authors have declared no conflicts of interest.

Published
2023
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