Black Diamond Therapeutics Inc（BDTX）のニュースとイベントBDTXBlack Diamond Therapeutics Inc

Black Diamond Therapeutics' Silevertinib Shows Robust Clinical Activity

"Silevertinib continued to demonstrate robust clinical activity and durable responses in frontline patients with non-classical EGFR-mutant NSCLC, as presented at ASCO in May," said Mark Velleca, President and Chief Executive Officer of Black Diamond Therapeutics. "We are particularly encouraged that no patients developed de novo brain metastases and that the CNS ORR was 86% in patients with baseline brain metastases. Approximately 80% of all patients with non-classical EGFR mutations progress in the brain, and approximately 40% of patients with non-classical EGFR-mutant NSCLC present with brain metastases at diagnosis, underscoring silevertinib's potential to address this significant unmet medical need. We look forward to engaging with the FDA and providing an update on the pivotal development path for silevertinib in frontline NSCLC in the fourth quarter."

Black Diamond Therapeutics Advances Silevertinib Development

"We continue to focus on advancing silevertinib for the treatment of patients with EGFRm NSCLC and EGFR altered GBM," said Mark Velleca, president and CEO of Black Diamond Therapeutics. "We look forward to presenting updated results from the Phase 2 NSCLC trial in both the frontline and recurrent settings, including preliminary DOR and PFS data for frontline patients, at a medical meeting in the second quarter of 2026. We also expect to initiate our randomized Phase 2 trial in newly diagnosed GBM in the second quarter this year."

Black Diamond Therapeutics Announces Phase 2 Trial Data for Silevertinib in NSCLC

Black Diamond Therapeutics announced topline data from its Phase 2 trial of silevertinib in frontline non-small cell lung cancer, NSCLC, patients with non-classical epidermal growth factor receptor, EGFR, mutations, NCMs, and outlined plans for a randomized Phase 2 trial of silevertinib in patients with newly diagnosed glioblastoma. Silevertinib Phase 2 1L NSCLC Initial Clinical Results and Program Update: For the 43 patients enrolled, preliminary efficacy data is as follows: 25 confirmed partial responses, 1 confirmed complete response; 60% Objective Response Rate; 86% CNS ORR; 91% disease control rate. GBM Program Update and Phase 2 Plans: Key trial highlights include: Expected to enroll approximately 150 newly diagnosed patients, randomized to receive TMZ or silevertinib + TMZ; Initial focus will be on EGFRvIII-positive patients who are MGMT-negative; Randomization and treatment will begin after patients have had their surgical resection and radiation; Primary endpoint is PFS, with an interim analysis; secondary endpoint is overall survival; Trial will be governed by an Independent Data Monitoring Committee