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Association details:
| Biomarker: | RET fusion |
|---|---|
| Cancer: | Thyroid Gland Carcinoma |
| Drug: | Gavreto (pralsetinib) (RET inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Published date:
12/01/2020
Excerpt:
GAVRETO is a kinase inhibitor indicated for treatment of Adult and pediatric patients 12 years of age and older with advanced or
metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).
Source:
Title:
ESMO Clinical Practice Guideline update on the use of systemic therapy in advanced thyroid cancer
Published date:
04/28/2022
Excerpt:
Recommendations...pralsetinib is an option to treat adults and adolescents ≥12 years of age with advanced or metastatic RET fusion-positive DTC who require systemic therapy and are RAI-refractory…
DOI:
https://doi.org/10.1016/j.annonc.2022.04.009
Source:
Title:
Genentech Announces FDA Approval of Gavreto (pralsetinib) for the Treatment of Adults With Metastatic RET Fusion-Positive Non-Small Cell Lung Cancer
Published date:
09/04/2020
Excerpt:
FDA also granted Priority Review to Gavreto for the treatment of people with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer
Source:
Title:
A study of BLU-667 in patients with lung cancer, and thyroid cancer, and other solid tumors
Excerpt:
...Diagnosis during dose expansion (Phase 2) – All patients (with the exception of patients with MTC enrolled in Groups 3, 4 and 9) must have an oncogenic RET fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local testing of tumor or circulating tumor nucleic acid in blood; as detailed below. ...
Trial ID:
Source:
Title:
A Phase 1 Study of the Highly-Selective RET Inhibitor, BLU 667, in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer (NSCLC) and Other Advanced Solid Tumors
Excerpt:
...Diagnosis during dose expansion (Part 2) – All patients (with the exception of Groups 3, 4 and 9) must have an oncogenic RET fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor, as determined by local or central testing of tumor or circulating tumor nucleic acid in blood; as detailed below. ...
Trial ID:
More C2 evidence
Source:
Title:
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
Excerpt:
...- participants must have pathologically documented, definitively diagnosed locally advanced or metastatic NSCLC with a RET fusion previously treated with a platinum-based chemotherapy....
Trial ID:
Source:
Title:
Pre-Approval Access Program (PAAP) for Pralsetinib (BLU-667) in Patients With Unresectable or Metastatic NSCLC or MTC
Excerpt:
...Pathologically documented and definitively diagnosed non-resectable or metastatic NSCLC with a RET fusion for patients who are either treatment naïve, or who have been previously treated with systemic therapy....
Trial ID:
Less C2 evidence
Source:
Title:
1654P - Updated ARROW data: Pralsetinib in patients (pts) with advanced or metastatic RET-altered thyroid cancer (TC)
Published date:
09/05/2022
Excerpt:
Pts with previously treated RET-fp TC had an ORR of 84% (21/25; 95% CI 63.9–95.5; 4 CR; 17 PR); median DoR was 23.6 months (95% CI 15.1–NE) and median PFS 25.4 months (95% CI 17.0–NE)…In this updated analysis (ITT population), pralsetinib continued to show efficacy and an acceptable safety profile in pts with RET-altered TC.
Trial ID:
Source:
Title:
Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study
Published date:
06/09/2021
Excerpt:
Among patients with baseline measurable disease who received pralsetinib...overall response rates were...eight (89%) of nine (95% CI 52–100) in patients with RET fusion-positive thyroid cancer...
DOI:
https://doi.org/10.1016/S2213-8587(21)00120-0
Trial ID:
Source:
Title:
Clinical activity of the RET inhibitor pralsetinib (BLU-667) in patients with RET fusion–positive solid tumors.
Published date:
01/11/2021
Excerpt:
Here, we present data on the clinical activity of pralsetinib in patients with RET fusion–positive solid tumor types...the ORR (blinded central review) in response-evaluable patients with RET fusion–positive thyroid cancer was 91% (10/11; 95% CI: 59/100) and disease control rate was 100% (95% CI: 72/100).
Trial ID:
Source:
Title:
Clinical activity of the RET inhibitor pralsetinib (BLU-667) in patients with RET fusion+ solid tumors.
Published date:
05/13/2020
Excerpt:
In patients with thyroid cancer that is RET fusion+, ORR (investigator assessment) was 75% (9/12; all confirmed).
DOI:
10.1200/JCO.2020.38.15_suppl.109
Trial ID:
