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Molecular Profile RET fusion
Therapy Selpercatinib
Indication/Tumor Type lung non-small cell carcinoma
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
RET fusion lung non-small cell carcinoma sensitive Selpercatinib Phase III Actionable In a Phase III trial (LIBRETTO-431), first-line Retevmo (selpercatinib) treatment resulted in superior median progression-free survival (PFS) compared to platinum-based chemotherapy with (24.8 vs 11.2 mo, HR=0.46, p<0.001) or without ((24.8 vs 11.2 mo, HR=0.48, p<0.001) Keytruda (pembrolizumab) in advanced non-small cell lung cancer patients harboring a RET fusion, and improved intracranial (IC) response rate (82.4% vs 58.3%) and median IC PFS (16.1 vs 10.4 mo) (PMID: 38807655; NCT04194944). 38807655
RET fusion lung non-small cell carcinoma sensitive Selpercatinib Guideline Actionable Retevmo (selpercatinib) is included in guidelines as a first-line therapy for patients with metastatic non-small cell lung cancer harboring RET fusions (PMID: 36872130; ESMO.org). 36872130 detail...
RET fusion lung non-small cell carcinoma sensitive Selpercatinib FDA approved - On Companion Diagnostic Actionable In a Phase I/II trial (LIBRETTO-001) that supported FDA approval, Retevmo (selpercatinib) treatment resulted in an objective response rate (ORR) of 64% (64/105) in patients with RET fusion-positive non-small cell lung cancer, with a median duration of response of 17.5 months, ORR was 85% (33/39) and 91% (10/11) in previously treated patients and patients with measurable CNS metastasis, respectively (PMID: 32846060; NCT03157128). detail... 32846060 detail...
PubMed Id Reference Title Details
ESMO Clinical Practice Guidelines Full reference...
Full reference...
Retevmo (selpercatinib) FDA Drug Label Full reference...
(32846060) Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. Full reference...
(36872130) Oncogene-addicted metastatic non-small-cell lung cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Full reference...
(38807655) LIBRETTO-431: Confirming the Superiority of Selpercatinib to Chemotherapy and the Lack of Efficacy of Immune Checkpoint Inhibitors in Advanced RET Fusion-Positive (RET+) NSCLC, Another Unique Never-Smoker Predominant Molecular Subtype of NSCLC. Full reference...