Efficacy data for GAVRETO
Study design in the RET+ advanced thyroid cancer population1,2
Efficacy and safety with GAVRETO (400 mg orally once daily) were evaluated in patients with advanced or metastatic RET fusion+ thyroid cancer in the ARROW study, a phase 1/2, nonrandomized, open-label, single-arm, multicohort, multicenter clinical trial. All patients with RET fusion-positive thyroid cancer were required to have disease progression following standard therapy and measurable disease by RECIST. All patients must also have had an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1.
RECIST=Response Evaluation Criteria in Solid Tumors; RET+=rearranged during transfection positive.
Demographic characteristics at baseline1
RET fusion-positive thyroid cancer (n=9)* | |||||
Median age (range), years | Gender | Race/ ethnicity | ECOG status | History of CNS metastases at baseline | Patient identification |
61 years (46-74) | 33% female 67% male | 78% White 22% Asian 11% Hispanic/ Latino | 0-1: 100% | 56% | 89% NGS 11% FISH |
*All patients had papillary thyroid cancer. All patients had metastatic disease. Patients had received a median of 2 prior therapies (range 1-8). Prior systemic treatments included prior radioactive iodine (100%) and prior sorafenib and/or lenvatinib (56%).
CNS=central nervous system; FISH=fluorescence in situ hybridization; NGS=next-generation sequencing.
Clinical Results for GAVRETO
Response rate with GAVRETO seen in patients with RET+ advanced thyroid cancer1
Overall Response Rate (n=9)1
89% ORR*
(95% CI: 52%-100%)
Duration of and Time to Response (n=8)1,3,4
- 100% of patients continued to respond to treatment at 6 months1†
- Median time to first response was 1.9 months
(range: 1.8 months-5.5 months)3,4†
Patients enrolled by July 11, 2019. Data cutoff: May 22, 2020.
*ORR and DoR were assessed by BICR, according to RECIST v1.1.
†Based on observed duration of response.
BICR=blinded independent central review; NE=not estimable; NR=not reached; ORR=overall response rate.
Disease control rates in RET fusion+ thyroid cancer4
All (n=9)
Patients enrolled by July 11, 2019. Data cutoff: May 22, 2020.
CR=complete response; PR=partial response.
Disease control rate (DCR), a secondary endpoint, was assessed in the subsets of patients in the efficacy populations with sufficient evidence of a RET rearrangement and baseline measurable disease confirmed on blinded independent central review. DCR is defined as ORR (CR + PR) + SD.3
- Importantly, SD can reflect the natural history of the disease and may not be due to a direct therapeutic effect. Therefore, please interpret these results with caution
SD=stable disease.
See RET+ advanced thyroid cancer safety for GAVRETO
Explore the safety results for all RET+ advanced thyroid cancer patients studied.
GAV_THR-25010 0525
References:
1. GAVRETO® [Package insert], South San Francisco, CA: Rigel Pharmaceuticals, Inc.
2. Phase 1/2 study of the highly-selective RET inhibitor, pralsetinib (BLU-667), in participants with thyroid cancer, non-small cell lung cancer, and other advanced solid tumors (ARROW). https://clinicaltrials.gov/ct2/show/NCT03037385. Accessed May 7, 2025.
3. GAVRETO: Data on file, Rigel Pharmaceuticals, Inc. June 2024.
4. Subbiah V, Hu M, Wirth LJ, et al. Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study. Lancet Diabetes Endocrinol. 2021:S2213-8587(21)00120-0. doi:10.1016/S2213-8587(21)00120-0.