PR Newswire·Oct 19, 2026, 8:05 AM ET

Rigel Highlights New GAVRETO® (pralsetinib) Data Across RET Fusion-Positive Cancers in Oral and Poster Presentations at ESMO Congress 2026

RIGL

Rigel Pharmaceuticals announced pooled efficacy & safety data from the ARROW & TAPISTRY trials for GAVRETO (pralsetinib) in RET fusion-positive solid tumors at ESMO Congress 2026 in Madrid.
Pooled analysis of 49 patients (excluding NSCLC & thyroid cancer) showed a 53% overall response rate (ORR) & median duration of response of 12.2 months.
Previously treated pancreatic tumor patients demonstrated an 88% ORR (7/8) in the pooled analysis.
TAPISTRY trial results for RET fusion-positive thyroid cancer (16 patients) showed an 81.3% ORR & manageable safety profile.
First-line pralsetinib treatment in ARROW trial NSCLC patients yielded a 75% investigator-assessed ORR compared to 26% for prior standard of care.
First-line pralsetinib in NSCLC showed longer median times to progression, treatment discontinuation, & next treatment or death compared to prior therapies.
75% or more of evaluable NSCLC patients experienced improved or stable Health-Related Quality of Life (HRQoL) scores at Cycle 12 Day 1.
GAVRETO carries a boxed warning for serious infections including opportunistic infections which can lead to hospitalization or death.
Other warnings include Interstitial Lung Disease (ILD)/pneumonitis, hypertension, hepatotoxicity, hemorrhagic events, Tumor Lysis Syndrome, impaired wound healing, & embryo-fetal toxicity.
Common adverse reactions (≥25%) include musculoskeletal pain, constipation, hypertension, diarrhea, fatigue, edema, pyrexia, & cough.
GAVRETO is indicated for metastatic RET fusion-positive NSCLC & advanced/metastatic RET fusion-positive thyroid cancer in patients 12 years & older who are radioactive iodine-refractory.