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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, September 6, 2024
Ying Cheng, MD, of Jilin Cancer Hospital, Changchun, China, and colleagues previously reported on the LIBRETTO-431 trial, which evaluated the efficacy and safety of selpercatinib in RET-positive non–small cell lung cancer (NSCLC) and met its primary endpoint of improved progression-free survival. During the 2024 American Society of Clinical Oncology (ASCO) Breakthrough conference (Abstract 214), these investigators presented efficacy and safety data from patients in East Asia, which support the use of this RET inhibitor as a first-line agent in this patient population, regardless of geography.
“We cannot always assume that effective therapies in a general population will still be effective and safe in subpopulations,” stated David R. Spigel, MD, Chief Scientific Officer of the Sarah Cannon Research Institute, in an ASCO press release. (Dr. Spigel was not a study author.) “These outstanding results provide confidence that selpercatinib is an effective and safe treatment for East Asian patients with newly diagnosed RET-altered NSCLC.”
This open-label, phase III trial evaluated selpercatinib (n = 75) vs control (platinum/pemetrexed with or without pembrolizumab; n = 41) in patients from East Asia. Endpoints included progression-free survival, duration of response, and objective response rate by blinded independent central review.
The median follow-up was 19.4 months with selpercatinib and 21.2 months with the control, respectively. The median progression-free survival in the control arm was 11.1 months, and it was not reached in the selpercatinib arm; the 12-month progression-free survival rates were 41.7% and 72.8%, respectively. The objective response rate was higher among patients treated with selpercatinib vs the control (86.7% vs 61.0%).
Of note, the results from the East Asian population were similar to those of the overall intent-to-treat population. Participants who received selpercatinib experienced adverse events such as elevated liver function enzymes, increased bilirubin, diarrhea, and hypertension; those on the control regimen reported leukopenia, neutropenia, elevated liver function enzymes, and anemia.
Disclosure: Dr. Cheng reported no conflicts of interest. For full disclosures of the other study authors, visit coi.asco.org.
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