"Historically, patients with RET fusion-positive NSCLC have had very few safe and effective treatment options outside of standard of care available for tumors without targetable oncogenic drivers," the authors say.
Pralsetinib, a highly potent, oral, selective RET inhibitor, is a "well-tolerated, promising, once-daily oral treatment option for patients with RET fusion-positive NSCLC," they report.
Interim analyses of the ongoing ARROW study, which formed the basis of its U.S. Food and Drug Administration approval of pralsetinib (Gavreto) for metastatic RET fusion-positive NSCLC, are now published in The Lancet Oncology. Blueprint Medicines makes pralsetinib and is funding the study.
According to Dr. Justin Gainor with Massachusetts General Hospital in Boston and colleagues, overall responses to pralsetinib 400 mg once daily were recorded in 53 (61%) of 87 patients with previous platinum-based chemotherapy, including five (6%) patients with a complete response.
"In patients who previously received platinum-based chemotherapy, median progression-free survival was 17.1 months. Median duration of response was not yet reached, but the lower bound of the 95% (confidence interval) was 15.2 months, attesting to the durability of response," the authors say.
Pralsetinib also showed favorable activity in treatment-naive patients who were not candidates for standard therapies; responses were observed in 19 (70%) of 27 treatment-naive patients, including three (11%) with a complete response.
"Overall, pralsetinib was well tolerated at a dose of 400 mg once-daily in patients with RET fusion-positive NSCLC, with adverse events being predominantly grade 1-2 in severity," the authors report.
Rates of dose reductions and treatment discontinuations due to treatment-related adverse events were low and there were no treatment-related deaths.
"We have shown that pralsetinib elicits clinically meaningful and durable responses in advanced RET fusion-positive NSCLC in both the treatment-naive and standard of care-refractory population, including intracranial responses, and has a manageable safety profile," the authors conclude.
"These results not only show the activity of pralsetinib in advanced RET fusion-positive NSCLC, but also underscore the need to investigate selective RET inhibitors in other RET-altered tumors, outcomes for which are also being evaluated in the ongoing ARROW study," they note.
Several authors disclosed financial relationships with Blueprint Medicines.
SOURCE: https://bit.ly/35mBUrx The Lancet Oncology, online Jun 9, 2021.
By Reuters Staff
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