Study Supports Use of RET Inhibitor in RET Fusion–Positive Lung Cancer
Posted: Thursday, October 8, 2020
According to researchers from The University of Texas MD Anderson Cancer Center, the selective RET kinase inhibitor selpercatinib may prove to be an efficacious treatment for kinase-driven tumors. In fact, the objective response rates were 85% in previously untreated patients with RET fusion–positive non–small cell lung cancer (NSCLC) and 64% in those who had received at least platinum-based chemotherapy. These findings from the phase I/II LIBRETTO-001 trial were published in The New England Journal of Medicine.
“Moving from the first-in-human phase I trial to FDA approval in less than 3 years is a testament to the fact that patients benefited a great deal from this treatment,” said co-principal investigator Vivek Subbiah, MD, in a press release from MD Anderson.
A total of 144 patients with RET fusion–NSCLC were enrolled in this international trial and were required to have been previously diagnosed with an advanced or metastatic tumor. Selpercatinib was administered orally for the duration of the study, ranging from 20 mg once daily to 240 mg twice daily.
In patients who had previously received at least platinum-based chemotherapy, the objective response rate was 64%. In the 39 previously untreated patients, the objective response rate was 85%, and among the 11 patients with measurable central nervous system metastasis at the start of the study, the objective intracranial response rate reached 91%. The median duration of response was 17.5 months in the previously treated patients; at a median follow-up of 12.1 months, 63% of the responses were ongoing. As for the previously untreated patients, at 6 months, 90% of the responses were ongoing.
Hypertension, increased alanine and aspartate aminotransferase levels, hyponatremia, and lymphopenia were the most common grade 3 or higher adverse events reported in the study. A drug-related adverse event resulted in selpercatinib discontinuation in 2% of patients.
Disclosure: For full disclosures of study authors, see nejm.org.