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Exelixis Announces Initial Dose-Escalation Results from the First-in-Human Phase 1 Trial Evaluating XL102 in Patients with Advanced Solid Tumors at SABCS 2022
– In the QUARTZ-101 trial, XL102 — a novel cyclin-dependent kinase 7 inhibitor — was well tolerated at evaluated dose levels – ALAMEDA, Calif.--(BUSINESS
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– In the QUARTZ-101 trial, XL102 — a novel cyclin-dependent kinase 7 inhibitor — was well tolerated at evaluated dose levels –\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced initial results from the ongoing dose-escalation stage of QUARTZ-101, a phase 1 clinical trial evaluating XL102, a potent, selective, irreversible and orally bioavailable small molecule cyclin-dependent kinase 7 (CDK7) inhibitor, in patients with advanced solid tumors. The data are being presented on Thursday, December 8 during the poster session (abstract P4-01-35) at 7:00 a.m. CST at the 2022 San Antonio Breast Cancer Symposium (SABCS).\n\n“Preclinical data for XL102 showed anti-proliferative activity and an ability to induce cell death across various cancer cell lines,” said Amita Patnaik, M.D., Co-Director of Clinical Research at the START San Antonio Center for Cancer Care and lead author of the study. “With the initial dose-escalation results now in hand, I am excited to explore further in the QUARTZ-101 trial how XL102 may benefit patients with advanced solid tumors who have exhausted treatment options.”\n\nQUARTZ-101 is enrolling patients with solid tumors that are confirmed to be inoperable, locally advanced, metastatic or recurrent. As of the September 7, 2022 data cutoff, 26 enrolled patients had been treated with single-agent oral XL102 at five dose levels: 20 mg once daily (n=3), 40 mg once daily (n=3), 80 mg once daily (n=7), 120 mg once daily (n=4) and 40 mg twice daily (n=9). The most common types of cancer for patients enrolled were hormone receptor-positive breast cancer (n=12), pancreatic cancer (n=3) and sarcoma (n=3). Median age was 63 years. Seventy-three percent of patients had an Eastern Cooperative Oncology Group score of 1, and 77% had received at least three prior lines of systemic anti-cancer therapy for metastatic disease.\n\n“We are pleased to share these data from QUARTZ-101 at SABCS, providing a first look of our novel CDK7 inhibitor in heavily pretreated patients with advanced cancers,” said Vicki L. Goodman, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “As the trial continues, we look forward to learning more about the potential of XL102, alone and in combination, across various cancer types that have strong unmet treatmen...