Zentalis trial results announced on October 23, 2026, showed median overall survival of 15.9 months in Cyclin E1-positive patients receiving azenosertib for platinum-resistant ovarian cancer, compared with 7.5 months in Cyclin E1-negative patients. The interim DENALI Part 1b findings highlight a difference between biomarker groups, but do not establish a survival advantage over another treatment.
Key Takeaways
- The interim analysis covered 102 patients with heavily pretreated platinum-resistant ovarian cancer.
- Cyclin E1-positive patients had a 37.2% objective response rate and median response duration of 5.5 months.
- Treatment-related adverse events led to dose interruptions in 56.9% of patients; azenosertib remains investigational.
Table of Contents
- Zentalis trial results point to biomarker differences
- Response findings come with treatment interruptions
- DENALI remains part of an investigational program
- Conclusion
Zentalis trial results point to biomarker differences
Zentalis presented the findings at the European Society for Medical Oncology Congress 2026 in Madrid. Participants had received multiple prior treatments, including bevacizumab and PARP inhibitors.
The analysis assessed outcomes by Cyclin E1 status, measured using immunohistochemistry, or IHC. Median overall survival in the IHC-positive group was more than twice that observed in the IHC-negative group.
That comparison concerns two biomarker-defined groups receiving the investigational drug, rather than azenosertib versus a standard treatment. It therefore does not, by itself, show that the drug caused the survival difference or is superior to another therapy.
| Item | Details |
|---|---|
| Analysis population | 102 patients in DENALI Part 1b |
| Median overall survival | 15.9 months for Cyclin E1 IHC-positive patients; 7.5 months for IHC-negative patients |
| Objective response rate | 37.2% in Cyclin E1-positive patients |
| Median response duration | 5.5 months in Cyclin E1-positive patients |
| Dose interruptions | 56.9% due to treatment-related adverse events |
| Serious adverse events | Reported in 21.6% of patients |
Response findings come with treatment interruptions
Among Cyclin E1-positive patients, the objective response rate was 37.2%, with a median duration of response of 5.5 months. Response rate measures tumor shrinkage under the study’s assessment criteria; it is distinct from the overall survival measure.
Zentalis described safety outcomes as consistent with earlier studies, with adverse events including nausea, fatigue and anemia. Treatment-related adverse events prompted dose interruptions in more than half of patients, while serious adverse events were reported in 21.6%. Those measures describe different aspects of safety and should not be treated as interchangeable.
DENALI remains part of an investigational program
Azenosertib, also known as ZN-c3, is an oral WEE1 inhibitor. Zentalis’ DENALI clinical trial overview describes a multi-part Phase 2 study evaluating the drug’s efficacy and safety in platinum-resistant ovarian cancer. The company also states that azenosertib has not been approved by any regulatory agency.
For the clinical-stage biotechnology company, the findings concern development of its lead candidate rather than an approved commercial product. Zentalis has no approved products or product revenue, making further clinical evidence central to the program’s progress.
Conclusion
The interim findings support continued evaluation of azenosertib in Cyclin E1-positive ovarian cancer, without establishing a comparative survival benefit. The next development to watch is evidence from DENALI Part 2, which Zentalis describes as an ongoing registration-intent trial.
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