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Association details:
Biomarker:RET fusion
Cancer:Solid Tumor
Drug:Gavreto (pralsetinib) (RET inhibitor)
Direction:Sensitive
Evidence:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Non Small Cell Lung Cancer)
New
Excerpt:
GAVRETO is a kinase inhibitor indicated for treatment of:...Adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer as detected by an FDA approved test (NSCLC).
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Go to data
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)

Excerpt:
...- Participant must have a documented RET-fusion...
More C2 evidence
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

External Control, Observational, Retrospective Study Comparing Pralsetinib to Best Available Therapy in Patients With RET-Fusion Positive NSCLC

Excerpt:
...- Must have a diagnosis of locally advanced (non-resectable) or metastatic RET-fusion positive NSCLC...
Trial ID:
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
Title:

A study of BLU-667 in patients with lung cancer

Excerpt:
...Patient must meet 1 of the following 2 criteria: a. Have a documented RET fusion using either tissue or plasma as determined by a local test. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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. ...
Evidence Level:
Sensitive: C2 – Inclusion Criteria
New
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. ...
Less C2 evidence
Evidence Level:
Sensitive: C3 – Early Trials
Source:
Title:

Pan-cancer efficacy of pralsetinib in patients with RET fusion-positive solid tumors from the phase 1/2 ARROW trial

Published date:
08/12/2022
Excerpt:
ARROW ( NCT03037385 , ongoing) was designed to evaluate pralsetinib efficacy and safety in patients with advanced RET-altered solid tumors...Median duration of response, progression-free survival and overall survival were 12 months, 7 months and 14 months, respectively.
DOI:
10.1038/s41591-022-01931-y
Trial ID: