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Pralsetinib Efficacy for Patients With Advanced RET Fusion-Positive NSCLC
Results from the phase 1/2 ARROW trial found that pralsetinib, a potent, selective RET inhibitor, exhibited lasting clinical activity along with a well-tolerated safety profile among Chinese patients with RET fusion-positive non-small cell lung cancer (NSCLC).
This open-label, first-in-human trial enrolled 68 patients with advanced RET fusion-positive NSCLC, classified into 2 cohorts, those who had received prior platinum-based chemotherapy (n = 37), and those who were treatment-naïve (n = 31). All patients received 400 mg pralsetininib once daily. The primary endpoints were objective response rate (ORR) and safety.
For patients with measurable lesions at baseline, the confirmed ORR among those patients in the previously treated cohort was 66.7%, including 1 (3%) complete response and 21 (63.6%) partial responses. In the treatment-naïve cohort, the ORR was 83.3%, including 2 (6.7%) complete responses and 23 (76.7%) partial responses.
The most notable grade 3/4 treatment-related adverse events among all patients were anemia (35.3%) and decreased neutrophil count (33.8%). There were 8 patients (11.8%) who discontinued pralsetinib due to treatment-related adverse events.
Study investigators concluded, “Pralsetinib showed robust and durable clinical activity with a well-tolerated safety profile in Chinese patients with RET fusion-positive NSCLC.”
Source:
Zhou Q, Zhao J, Chang J, et al. Efficacy and safety of pralsetinib in patients with advanced RET fusion-positive non–small cell lung cancer. Cancer. Published online June 6, 2023. doi:10.1002/cncr.34897
