Zentalis Pharmaceuticals Announces 2026 Milestones for Azenosertib Development
Zentalis Pharmaceuticals provided a corporate update and highlighted key milestones and expected momentum in the azenosertib development program for 2026. 2025 Accomplishments: Completed enrollment in DENALI Part 2a, supporting registration-intended development of azenosertib; Aligned with the FDA on confirmatory ASPENOVA Phase 3 trial design; Strong data across three trials in PROC established a solid foundation for the lead indication in Cyclin E1-positive platinum-resistant ovarian cancer; Maintained a strong cash position supporting an estimated runway into late 2027 following strategic restructuring to focus pipeline and resources. Anticipated 2026 Milestones: DENALI Part 2a dose confirmation expected in first half of 2026; Confirmatory ASPENOVA Phase 3 trial initiation expected in first half of 2026; DENALI Part 2 topline readout on track and expected by year end 2026
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Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer during the GOBLET Cohort 4, significantly exceeding the historical benchmark of 10%, indicating its crucial clinical value in a setting with no FDA-approved treatment options.
- Duration of Response: Among 14 evaluable patients, the median duration of response for pelareorep reached approximately 17 months, far surpassing the standard treatment's 9.5 months, showcasing the drug's durable efficacy in heavily pretreated patients and addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for potential accelerated approval if the data is validated.
- Strategic Investment and Expert Support: The company expanded its Scientific Advisory Board by adding three globally recognized experts from Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center, further strengthening its strategic positioning in the gastrointestinal oncology field.

Oncolytics Biotech Advances Pelareorep for Anal Cancer with 29% Response Rate
- Clinical Data Breakthrough: Oncolytics Biotech's pelareorep demonstrated a 29% objective response rate in anal cancer patients during the GOBLET Cohort 4 study, significantly surpassing the historical benchmark of 10%, indicating the therapy's substantial potential in a patient population with no FDA-approved options.
- Duration of Response: The study also revealed a median duration of response of approximately 17 months, far exceeding the standard treatment's 9.5 months, suggesting that pelareorep offers durable efficacy in heavily pretreated patients, addressing a critical unmet medical need.
- FDA Accelerated Approval Plans: Oncolytics plans to hold a Type C meeting with the FDA in Q1 2026 to discuss advancing pelareorep into a registration-directed clinical study, paving the way for accelerated approval if the observed data can be replicated.
- Strategic Investment and Expansion: The company is enhancing its strategic positioning in gastrointestinal oncology by expanding its Scientific Advisory Board, further solidifying its market presence in anal cancer and other indications.









