Therapy Detail

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Therapy Name BLU-667
Synonyms
Therapy Description

BLU-667 selectively inhibits activated Ret, which may result in decreased tumor growth (Mol Cancer Ther 2018;17(1 Suppl):Abstract nr B151).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
BLU-667 BLU667|Pralsetinib RET Inhibitor 39 Pralsetinib (BLU-667) is a small molecule inhibitor that selectively targets activated Ret, which may result in antitumor activity including inhibition of tumor growth and tumor regression (PMID: 29657135, PMID: 32493697).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
RET L629P RET D631_R635delinsG RET V637R thyroid gland medullary carcinoma predicted - sensitive BLU-667 Phase I Actionable In a Phase I trial, a patient with medullary thryoid cancer harboring RET D631_R635delinsG, L629P, and V637R demonstrated a partial response, with maximal tumor reduction of 47% at 10 months, following treatment with BLU-667 (PMID: 29657135; NCT03037385). 29657135
RET C634W thyroid gland medullary carcinoma sensitive BLU-667 Preclinical - Cell line xenograft Actionable In a preclinical study, BLU-667 inhibited Ret signaling and proliferation of a medullary thyroid cancer cell line harboring RET C634W in culture, and inhibited tumor growth in xenograft models (PMID: 29657135). detail... 29657135
RET fusion Advanced Solid Tumor predicted - sensitive BLU-667 Phase Ib/II Actionable In a Phase I/II trial (ARROW), Pralsetinib (BLU-667) treatment was well-tolerated, resulted in an objective response rate of 60% (3/5) in patients with RET fusion positive advanced solid tumors other than thyroid cancer and non-small cell lung cancer (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 109-109; NCT03037385). detail...
RET fusion lung non-small cell carcinoma predicted - sensitive BLU-667 Phase Ib/II Actionable In a Phase I/II trial (ARROW), Pralsetinib (BLU-667) treatment was well-tolerated, resulted in an objective response rate of 65% (75/116) and a disease control rate of 93% in patients with RET fusion positive non-small cell lung cancer, with tumor size reduction in 96% of the patients (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 9515-9515; NCT03037385). detail...
RET fusion colon cancer predicted - sensitive BLU-667 Case Reports/Case Series Actionable In a Phase I/II trial (ARROW), Pralsetinib (BLU-667) treatment was well-tolerated, resulted in stable disease in 2 patients with RET fusion positive colon cancer, with a duration of response of 7.3 and 9.3 months, respectively (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 109-109; NCT03037385). detail...
RET fusion intrahepatic cholangiocarcinoma predicted - sensitive BLU-667 Case Reports/Case Series Actionable In a Phase I/II trial (ARROW), Pralsetinib (BLU-667) treatment was well-tolerated, resulted in a partial response in a patient with RET fusion positive intrahepatic cholangiocarcinoma, with a duration of response of 7.5 months (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 109-109; NCT03037385). detail...
RET fusion thyroid gland papillary carcinoma predicted - sensitive BLU-667 Phase Ib/II Actionable In a Phase I/II trial (ARROW), Pralsetinib (BLU-667) treatment was well-tolerated, resulted in an objective response rate of 75% (9/12) and a median duration of response of 14.5 months in patients with RET fusion positive papillary thyroid cancer (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 109-109; NCT03037385). detail...
RET fusion pancreatic cancer predicted - sensitive BLU-667 Case Reports/Case Series Actionable In a Phase I/II trial (ARROW), Pralsetinib (BLU-667) treatment was well-tolerated, resulted in a partial response in 2 of 2 patients with RET fusion positive pancreatic cancer, with a duration of response of 5.5 and 7.4 months, respectively (J Clin Oncol 38, no. 15_suppl (May 20, 2020) 109-109; NCT03037385). detail...
RET M918T thyroid gland medullary carcinoma predicted - sensitive BLU-667 Phase I Actionable In a Phase I trial, a patient with sporadic medullary thryoid cancer harboring RET M918T demonstrated a partial response, with maximal tumor reduction of 47% following treatment with BLU-667 (PMID: 29657135; NCT03037385). 29657135

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03037385 Phase Ib/II BLU-667 Phase 1/2 Study of the Highly-selective RET Inhibitor, Pralsetinib (BLU-667), in Patients With Thyroid Cancer, Non-Small Cell Lung Cancer, and Other Advanced Solid Tumors (ARROW) Recruiting
NCT04222972 Phase III Carboplatin + Pembrolizumab + Pemetrexed Disodium BLU-667 Cisplatin + Gemcitabine Carboplatin + Gemcitabine Cisplatin + Pemetrexed Disodium Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium AcceleRET Lung Study of Pralsetinib for 1L RET Fusion-positive, Metastatic NSCLC Recruiting


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