SOUTH SAN FRANCISCO, Calif., USA, March 31, 2026
Rigel Pharmaceuticals has announced the publication of final Phase 1/2 ARROW clinical trial data for GAVRETO® (pralsetinib) in patients with RET fusion-positive non-small cell lung cancer (NSCLC), demonstrating robust and durable responses along with a manageable safety profile. Published in the Journal of Clinical Oncology, the data provide long-term evidence supporting pralsetinib as a targeted precision oncology therapy with significant survival benefits.
Strong Clinical Efficacy and Long-Term Survival Outcomes
The final ARROW study results highlight significant clinical efficacy, with an overall response rate (ORR) of 70% among patients with measurable disease, including both complete and partial responses. Notably, treatment-naïve patients achieved an even higher ORR of 78%, while previously treated patients showed a 63% response rate, underscoring the therapy’s effectiveness across different patient populations.
The study also demonstrated remarkable long-term survival outcomes, with a median overall survival (OS) of 44.3 months across the overall population. Patients treated in the United States showed even greater benefit, with median OS reaching 62.4 months, highlighting regional variations in outcomes and potential real-world effectiveness. Additionally, progression-free survival (PFS) reached 13.1 months, further supporting the durability of response.
Importantly, pralsetinib showed promising activity in patients with central nervous system (CNS) metastases, achieving a 53% intracranial response rate, which is a critical advancement in managing metastatic lung cancer with brain involvement.
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Favorable Safety Profile and Targeted Mechanism
GAVRETO demonstrated a manageable safety profile consistent with previous studies, with no new safety signals identified during extended follow-up. While some treatment-related adverse events, including infections and hypertension, were observed, these were generally manageable with appropriate clinical monitoring and intervention.
Pralsetinib is a selective RET inhibitor designed to target RET gene fusions, which are implicated in approximately 1–2% of NSCLC cases. By specifically inhibiting RET-driven tumor growth, the therapy represents a precision medicine approach, offering improved outcomes compared to conventional chemotherapy.
The data also emphasize the importance of early biomarker testing, enabling clinicians to identify eligible patients and initiate targeted therapy sooner, thereby improving overall treatment outcomes.
Implications for Precision Oncology and Future Treatment Strategies
The publication of final ARROW trial data reinforces pralsetinib’s role as a potential first-line treatment option for RET fusion-positive NSCLC, particularly in patients with advanced or metastatic disease. The ability to deliver durable responses, extended survival, and CNS activity positions GAVRETO as a key therapy in the evolving landscape of targeted oncology treatments.
With lung cancer remaining the leading cause of cancer-related deaths globally, innovations such as pralsetinib are critical in addressing unmet clinical needs. The results also highlight the growing importance of targeted therapies and biomarker-driven treatment strategies, which are transforming cancer care by improving precision and patient outcomes.
A Major Advancement in Targeted Lung Cancer Therapy
The final ARROW study results confirm that GAVRETO (pralsetinib) delivers clinically meaningful and durable benefits for patients with RET-positive NSCLC, supporting its continued use and future development in oncology. As precision medicine continues to evolve, therapies like pralsetinib are expected to play an increasingly central role in personalized cancer treatment and improved survival outcomes.
Source: Rigel Pharmaceuticals press release
