Full Press Release Details
-- Breadth of pipeline featured in multiple early clinical data presentations, reflecting diversity of fundamental growth drivers across development programs --
CDK2 is a cell cycle regulator and important cancer target across a broad range of malignancies, including HR+/HER2- breast cancer. Based on the underlying science on the role of CDK2 inhibition in cancer, and the potential for this mechanism to impact large populations of patients, BLU-222 represents one of the most important programs within Blueprint Medicines' early clinical development pipeline. The data reported at ASCO begin to demonstrate the clinical profile of BLU-222, a highly selective and potent oral CDK2 inhibitor.
VELA trial: BLU-222 in HR+/HER2- metastatic breast cancer and other advanced cancers Abstract number: 3095 Presentation location and time: Hall A; Saturday, June 3 from 8:00 a.m. — 11:00 a.m. CT
Results from the ongoing dose escalation part of the VELA trial of BLU-222 (n=27) showed encouraging safety and evidence of cell cycle pathway modulation consistent with the treatment's best-in-class preclinical profile. Based on these data, Blueprint Medicines is continuing monotherapy dose escalation to identify a maximum tolerated dose, and has initiated dose escalation of BLU-222 in combination with the CDK4/6 inhibitor, ribociclib, and the estrogen receptor antagonist, fulvestrant, in patients with HR+/HER2- metastatic breast cancer.
CONCERTO trial: BLU-451 in advanced NSCLC driven by EGFR exon 20 insertions or atypical mutations Abstract number: 9064 Presentation location and time: Hall A; Sunday, June 4 from 8:00 a.m. — 11:00 a.m. CT
Results from the ongoing dose escalation part of the CONCERTO trial of BLU-451 in heavily pretreated patients with NSCLC driven by EGFR exon 20 insertions (n=48) or atypical mutations (n=9) showed evidence of safety and clinical benefits, including central nervous system (CNS) activity. The data support continued dose escalation to determine the recommended Phase 2 dose (RP2D), and further development in patients with EGFR exon 20 insertions as well as additional patients with atypical EGFR mutations. Collectively, these mutations represent approximately 20 percent of EGFR-mutant NSCLC cases.
SYMPHONY trial: BLU-945 monotherapy and in combination with osimertinib in late-line, EGFR-mutant NSCLC Abstract number: 9011 Presentation location and time: S406; Monday, June 5 from 11:30 a.m. — 12:30 p.m. CT
Updated results from the dose escalation part of the SYMPHONY trial showed the safety and clinical activity of BLU-945 as a monotherapy (n=112) and in combination with osimertinib (n=55) in patients with late-line, osimertinib-refractory, EGFR-mutant NSCLC. Based on the unprecedented and favorable safety profile for the combination of BLU-945 and osimertinib observed to-date, dose escalation is continuing which impacts the timeframe to establish the RP2D and begin the randomized, first-line treatment portion of the study. Consequently, the company no longer anticipates presenting initial dose expansion data for BLU-945 in combination with osimertinib in first-line, EGFR L858R-positive NSCLC by the end of 2023.
Copies of Blueprint Medicines data presentations from the ASCO Annual Meeting are available in the "Science—Publications and Presentations" section of the company's website at www.blueprintmedicines.com .
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