Important findings from the ARROW trial include shrinking tumors in 70% of cases and effectiveness across different RET fusion subtypes.
A new publication in the Journal of Clinical Oncology reports final results from the ARROW clinical trial, the landmark study evaluating pralsetinib (GAVRETO®) in people with RET fusion–positive non-small cell lung cancer (NSCLC). The findings confirm what many in the RET+ community have been hoping to see: durable tumor responses, meaningful survival outcomes, and a safety profile that remained consistent over long-term follow-up.
Pralsetinib Shows Durable Responses and Manageable Safety in RET Fusion–Positive non-small cell lung cancer (NSCLC)
Final results from the phase I/II ARROW clinical trial evaluating the specific RET inhibitor pralsetinib (GAVRETO®) in patients with metastatic RET-altered NSCLC have now been published in the Journal of Clinical Oncology (Besse, Benjamin et al). The study reports on key outcomes including efficacy and safety over extended follow-up. The findings highlight sustained efficacy and manageable safety profile. For more details find the publication here and the press release from Rigel Pharmaceuticals here.
Some of the key points of the study are summarized below:
- In the ARROW trial, pralsetinib was generally well tolerated, and no new safety concerns were identified.
- The treatment helped shrink tumors in about 70% of patients (overall response rates (ORR) 70%).
- Pralsetinib demonstrated an ORR of 78% in treatment-naïve patients and 63% in patients previously treated with platinum-based chemotherapy.
- Patients were able to stay on treatment for a median of 15 months.
- The median overall survival (OS) was 44.3 months. In subgroup analyses, median OS was 50.1 months in treatment-naïve patients and 39.7 months in patients previously treated with platinum-based chemotherapy. By geographic region, median OS was 62.4 months in the United States, 44.5 months in Asia, and 29.6 months in Europe.
- Median progression-free survival (PFS) was 13.1 months overall but was longer in patients in the United States (25.9 months) vs. Asia (12.6 months) or Europe (12.8 months).
- The treatment was effective across different RET fusion subtypes, with longer duration of response (median duration of response (DOR)) in CCDC6 fusions (47.9 months) compared to KIF5B (13.1 months).
- In patients whose cancer had spread to the brain, pralsetinib demonstrated intracranial activity, with response rates of 53% overall and 73% in response evaluable patients.
