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Zentalis Announces Intermittent Azenosertib Monotherapy Dosing Nearly Doubles Efficacy Over Continuous Dosing
ORR of 36.8% in heavily pretreated platinum-resistant ovarian cancer and USC patients treated with intermittent dosing Establishes monotherapy RP2D of 400 mg
About this update from Zentalis Pharmaceuticals, Inc.
[{"type":"text","content":" ORR of 36.8% in heavily pretreated platinum-resistant ovarian cancer and USC patients treated with intermittent dosing Establishes monotherapy RP2D of 400 mg QD with 5:2 dosing schedule; New RP2D more than doubles exposure levels, maintains safety and improves tolerability with no treatment-related discontinuations Company plans to update efficacy data from Phase 1 monotherapy dose optimization study and provide program timeline updates for three azenosertib Phase 2 monotherapy trials currently enrolling patients at the RP2D in the second half of 2023 Investor call at 8:00 a.m. ET today to review azenosertib monotherapy data supporting dose selection and chemotherapy combination data presented at ASCO NEW YORK and SAN DIEGO, June 06, 2023 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced the monotherapy recommended Phase 2 dose (RP2D) for azenosertib, the Company's potentially first-in-class WEE1 inhibitor. Based on encouraging Phase 1 dose optimization clinical data, the RP2D for azenosertib as a monotherapy is 400 mg daily (QD) on a 5 days on, 2 days off (5:2) weekly administration schedule. This intermittent dosing schedule more than doubled steady state drug exposure in comparison to continuous dosing, and achieved promising efficacy signals, while maintaining safety and improving tolerability. \"With this new optimized monotherapy dosing schedule for azenosertib, we believe we have unlocked the therapeutic potential of WEE1 inhibition, achieving monotherapy activity levels few oncology agents have been able to attain,” said Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. “Having demonstrated favorable anti-tumor activity as both a monotherapy and in combination with chemotherapy, we are confident azenosertib has tremendous promise to help patients with difficult-to-treat cancers. With our focus on platinum-resistant ovarian cancer for azenosertib as a monotherapy and platinum-sensitive ovarian cancer for azenosertib in chemotherapy combinations, we have the potential to address the majority of ovarian cancer patients. We are committed to rapidly advancing our azenosertib clinical strategy, concentrat...