(Thyroid Cancer) Is Selpercatinib Monotherapy Effective?
(Thyroid Cancer) Is Selpercatinib Monotherapy Effective?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
(Thyroid Cancer) Is Selpercatinib Monotherapy Effective?
- October 9, 2020
- Reading time: 2 minutes
On August 27, 2020, Lori J. Wirth published in the medical journal 'The New England Journal of Medicine' the efficacy and safety results of the LIBRETTO-001 Phase I/II clinical trial of the RET inhibitor Selpercatinib (LOXO-252) in patients with RET-altered thyroid cancer.
This Phase I/II clinical trial enrolled patients with prior treatment experience with sorafenib and cabozantinib for RET-altered medullary thyroid cancer (N=55), treatment-naive RET-altered medullary thyroid cancer (N=88), and prior treatment for RET fusion-positive thyroid cancer (N=19), using Selpercatinib monotherapy. The primary endpoint was objective response rate, and secondary endpoints included progression-free survival.
The trial was conducted because approximately 70% of medullary thyroid cancer patients are known to have RET gene mutations, while RET fusion gene mutations are rare in other thyroid cancers. The clinical utility of RET inhibitors in patients with RET-altered thyroid cancer was unclear, so this trial was initiated to evaluate the effectiveness of the RET inhibitor Selpercatinib.
The results of this trial showed the following objective response rates (primary endpoint): 69% in the previously treated RET-altered medullary thyroid cancer group, 73% in the treatment-naive RET-altered medullary thyroid cancer group, and 79% in the previously treated RET fusion-positive thyroid cancer group.
The one-year progression-free survival rates (secondary endpoint) were: 82% in the previously treated RET-altered medullary thyroid cancer group, 92% in the treatment-naive RET-altered medullary thyroid cancer group, and 64% in the previously treated RET fusion-positive thyroid cancer group.
Regarding safety, the most common Grade 3 adverse events observed in the majority of patients were hypertension, ALT elevation (11%), AST elevation (9%), hyponatremia (8%), and diarrhea (6%). Treatment discontinuation due to adverse events occurred in 2%.
Based on the results of the LIBRETTO-001 clinical trial, Lori J. Wirth concluded: "In patients with RET-altered thyroid cancer treated with the RET inhibitor Selpercatinib monotherapy, in addition to demonstrating good anti-tumor efficacy, the incidence of high-grade adverse events is low and patients tolerate the drug well."
[Disclaimer] "Medical Supporter" translations of overseas clinical trial data and medical information do not promote participation in clinical trials or use of new drugs. Additionally, translated materials are for reference only and are not treatment guidelines. Please consult with healthcare providers and refer to the original article below for accurate information.
Data source: Efficacy of Selpercatinib in RET-Altered Thyroid Cancers (N Engl J Med. 2020 Aug 27;383(9):825-835. doi: 10.1056/NEJMoa2005651.)
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