Blueprint medicines registration#
After the selection of a recommended Phase 2 combination dose regimen, the company plans to initiate an expansion cohort with registration potential in biomarker-selected second-line patients, as well as an expansion cohort in front-line patients, by the end of 2022.
Blueprint medicines trial#
Based on these promising data, we plan to rapidly expand development of BLU-945 in combination with osimertinib and other agents to address important medical needs across all lines of therapy."īlueprint Medicines is initiating a SYMPHONY trial cohort assessing BLU-945 in combination with osimertinib in patients with second-line or later EGFR-mutant NSCLC, following disease progression on osimertinib. "We are excited to see the preclinical profile of BLU-945 translated in the clinic, with early dose escalation data showing evidence of clinical activity, broad EGFR mutation coverage and tolerability. As a result, BLU-945 has significant potential as a combination partner with other targeted therapies and broad-acting agents," said Fouad Namouni, M.D., President, Research & Development at Blueprint Medicines.
Blueprint medicines driver#
"We believe BLU-945 is distinguished from other EGFR-directed therapies, based on its ability to inhibit the most difficult-to-target EGFR mutations while maintaining a wide therapeutic index over wild-type EGFR, a known driver of toxicity. "The initial BLU-945 data reported today, which highlight its potential to address resistance to current standard of care therapies including osimertinib and enable well-tolerated, broad-acting combinations, are an important step forward toward improving outcomes for patients with EGFR-mutant lung cancer." Innovative treatment strategies, including targeted therapy combinations, are urgently needed to prevent or treat this mutational heterogeneity and prolong patient benefit," said Elaine Shum, M.D., assistant professor in the Department of Medicine and a medical oncologist at NYU Langone Health's Perlmutter Cancer Center, and an investigator on the SYMPHONY trial. "Today, targeted therapies are the mainstay treatment for EGFR-mutant lung cancer, but tumor resistance emerges in the majority of patients, driving mutational heterogeneity and disease progression. The maximum tolerated dose and recommended Phase 2 dose have not yet been identified, and dose escalation is continuing. BLU-945 was generally well-tolerated, with no significant adverse events (AEs) associated with wild-type EGFR inhibition. Pharmacokinetic results showed BLU-945 exposures at higher doses were associated with broad EGFR mutation coverage, including the activating L858R mutation with or without the osimertinib-resistant C797S mutation. The data were reported today at the American Association for Cancer Research (AACR) Annual Meeting 2022 in New Orleans.Įarly data from the ongoing Phase 1 dose escalation part of the SYMPHONY trial showed dose-dependent decreases in circulating tumor DNA (EGFR variant allele fractions) and radiographic tumor reductions, including a partial response (PR) in a patient treated with 400 mg once daily (QD), the highest dose tested as of the data cutoff date. The trial results showed early evidence of safety and clinical activity consistent with preclinical data, supporting plans to expand development of BLU-945 in combination with multiple agents including osimertinib, with the goal of preventing or treating tumor resistance to prolong patient benefit. Blueprint Medicines to host investor conference call and webcast on Friday, April 8 at 2:00 pm ET -ĬAMBRIDGE, Mass., Ap/PRNewswire/ - Blueprint Medicines Corporation (NASDAQ: BPMC) today announced proof-of-concept data from the Phase 1/2 SYMPHONY clinical trial of BLU-945, an investigational precision therapy for advanced EGFR-mutant non-small cell lung cancer (NSCLC). Clinical trial supply agreement signed with AstraZeneca to provide osimertinib for combination development in ongoing BLU-945 and BLU-701 trials. Initiating SYMPHONY trial cohort to evaluate BLU-945 in combination with osimertinib. Generally well-tolerated with most AEs Grade 1 or 2, supporting continued dose escalation. Early dose escalation data show dose-dependent reductions in ctDNA and tumor burden.
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