Zentalis reports interim overall‑survival benefit for azenosertib in Cyclin E1‑positive ovarian cancer

Zentalis Pharmaceuticals presented interim data from the DENALI Part 1b study of its WEE1 inhibitor azenosertib in heavily pretreated platinum‑resistant ovarian cancer patients. Median overall survival was 15.9 months for Cyclin E1‑positive patients versus 7.5 months for Cyclin E1‑negative patients. The trial enrolled 102 patients with one to five prior therapy lines and showed a safety profile consistent with earlier reports. The results support ongoing Phase 3 DENALI Part 2 and ASPENOVA trials.

The company says the survival separation strengthens the biomarker‑driven development strategy and could improve the probability of accelerated approval for azenosertib. Investors should watch the upcoming Phase 3 readouts, which will determine whether the interim benefit translates into regulatory approval.

  • 1The interim analysis included 102 patients with platinum‑resistant ovarian cancer who had received 1–5 prior lines of therapy.
  • 2Median overall survival was 15.9 months (95 % CI 8.7–21.2) in Cyclin E1‑positive patients (n=48).
  • 3Median overall survival was 7.5 months (95 % CI 5.8–12.3) in Cyclin E1‑negative patients (n=46).
  • 4Median relative dose intensity of azenosertib was 84.6 %.
  • 5Objective response rate in Cyclin E1‑positive patients was 33.3 % (95 % CI 20.4–48.4).
  • 6Median duration of response was 5.5 months (95 % CI 4.5–15.9).

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