Phase 3 ovarian cancer trial starts for Zentalis (Nasdaq: ZNTL) drug azenosertib
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Zentalis Pharmaceuticals has dosed the first patient in ASPENOVA, its global Phase 3 trial of investigational WEE1 inhibitor azenosertib for Cyclin E1-positive platinum-resistant ovarian cancer. The randomized study plans to enroll about 420 patients, comparing oral azenosertib 400mg once daily on a 5-days-on, 2-days-off schedule to standard single-agent chemotherapy.
ASPENOVA is designed as a confirmatory trial to support potential full approval, alongside the Phase 2 DENALI study, which is intended to underpin an accelerated approval application with a topline readout targeted by year-end 2026. Azenosertib, which has U.S. FDA Fast Track Designation for this setting, is being developed with a biomarker-driven strategy in collaboration with major gynecologic oncology trial groups.
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Insights
First patient dosed in ASPENOVA advances Zentalis’ dual-track approval plan for azenosertib.
Zentalis has initiated dosing in ASPENOVA, a Phase 3 trial in Cyclin E1-positive platinum-resistant ovarian cancer. The study will compare oral azenosertib at 400mg QD 5:2 against standard single-agent chemotherapy across approximately 420 patients, with progression-free survival as the primary endpoint.
This program sits within a dual-track regulatory strategy: the Phase 2 DENALI trial is intended to support accelerated approval, while ASPENOVA is designed as the confirmatory study for full approval, subject to outcomes and FDA discussions. Both trials use the same dose, selected after an interim Part 2a analysis showed a differentiated response rate versus 300mg with comparable safety.
Azenosertib already has FDA Fast Track Designation for Cyclin E1-positive platinum-resistant ovarian cancer, a biomarker-defined subgroup estimated at about 50% of this population. The actual impact on Zentalis will depend on DENALI Part 2 data expected by year-end 2026 and whether ASPENOVA confirms durable benefit and safety acceptable for broad clinical use.
8-K Event Classification
3 items: 7.01, 8.01, 9.01
3 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
ASPENOVA planned enrollment: approximately 420 patients
Azenosertib dose: 400mg QD 5:2
DENALI Part 2a cohorts: ≈30 patients per dose group
+4 more
7 metrics
ASPENOVA planned enrollment
approximately 420 patients
Cyclin E1-positive platinum-resistant ovarian cancer Phase 3 trial
Azenosertib dose
400mg QD 5:2
once daily, 5-days-on, 2-days-off schedule in ASPENOVA and DENALI
DENALI Part 2a cohorts
≈30 patients per dose group
dose confirmation at 300mg and 400mg QD 5:2
DENALI Part 2b enrollment
up to ≈100 patients
expansion at selected 400mg QD 5:2 dose
DENALI Part 2c enrollment
approximately 40 patients
previously treated with taxane-containing regimen for PROC
Biomarker population share
approximately 50%
Cyclin E1-positive share of platinum-resistant ovarian cancer patients
DENALI topline timing
year-end 2026
expected completion of Part 2 enrollment and topline readout
Key Terms
platinum-resistant ovarian cancer, accelerated approval pathway, Fast Track Designation, companion diagnostic assay, +2 more
6 terms
platinum-resistant ovarian cancer medical
"evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC)"
A form of ovarian cancer that stops responding to standard platinum-based chemotherapy, typically when the disease returns within about six months after treatment; think of it like a pest becoming resistant to a once-effective pesticide. It matters to investors because this resistance creates a large unmet medical need, shaping demand for new drugs, clinical trial strategies, regulatory priority and potential pricing — all of which can materially affect company value and market opportunity.
accelerated approval pathway regulatory
"requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval"
The accelerated approval pathway is a process that allows new medicines to be approved more quickly based on early evidence that they may be effective, rather than waiting for full proof. This can help patients access promising treatments faster, but it also means ongoing studies are needed to confirm the benefits. For investors, it highlights potential faster market entry and earlier revenue opportunities, along with some uncertainty about long-term outcomes.
Fast Track Designation regulatory
"Azenosertib has been granted Fast Track Designation by the U.S. FDA"
A "fast track designation" is a process that speeds up the review and approval of a product or project, allowing it to reach the market or be completed more quickly than usual. For investors, it can signal that a product may become available sooner, potentially leading to earlier revenue or benefits, and indicating a priority status that might influence company performance and market opportunities.
companion diagnostic assay medical
"Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials"
progression-free survival (PFS) medical
"The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS)"
Progression-free survival (PFS) measures the length of time in a clinical trial or treatment period during which a patient’s disease does not get worse. Investors watch PFS because longer PFS in trials can signal a drug’s effectiveness, influence regulatory approval and reimbursement decisions, and affect commercial value—think of it as how long a product keeps a problem from returning, which helps estimate future sales and competitive advantage.
WEE1 inhibitor medical
"investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach"
A Wee1 inhibitor is a drug that blocks the Wee1 protein, which normally acts like a safety brake that pauses damaged cells before they divide. By removing that brake, cancer cells with DNA damage are forced into division and often die, making the approach useful for targeting tumors. Investors track Wee1 inhibitors because their clinical trial success, safety profile and use with other therapies can greatly affect a biotechnology company's value.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of report (Date of earliest event reported): May 5, 2026
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(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) | (Commission File Number) | (I.R.S. Employer Identification No.) | ||||||||||||
(Address of principal executive offices) (Zip Code)
(Registrant’s telephone number, include area code)
N/A
(Former name or former address, if changed since last report)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On May 5, 2026, Zentalis Pharmaceuticals, Inc. (“Zentalis” or the “Company”) issued the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Current Report”) and incorporated herein by reference.
The information contained in Item 7.01 of this Current Report (including Exhibit 99.1 attached hereto) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly provided by specific reference in such a filing.
Item 8.01 Other Events.
On May 5, 2026, the Company announced that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer ("PROC").
ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive PROC. The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 (single daily dose on an intermittent schedule of five days on and two days off) to the investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan). The trial design was based on feedback from the U.S. Food and Drug Administration regarding requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval, subject to data outcomes.
Cautionary Note Regarding Forward-Looking Statements
This Current Report contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this Current Report that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding: the continued development of azenosertib; the clinical and therapeutic potential of azenosertib; the potential benefits of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer or other indications; and the Company’s planned regulatory strategy for azenosertib and the timing thereof, including the potential for ASPENOVA to support converstion to full approval. The terms “design,” “develop,” “expect,” “intend,” “plan,” “potential,” “strategy,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s limited operating history, which may make it difficult to evaluate the Company’s current business and predict the Company’s future success and viability; the Company has incurred and expects to continue to incur significant losses; the Company’s need for additional funding, which may not be available; the Company’s substantial dependence on the success of azenosertib; the Company’s plans, including the costs thereof, of development of companion diagnostics; the outcome of early clinical trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; the Company’s product candidates may cause serious adverse side effects; our ability to establish effective sales or marketing capabilities; the interim and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; if our confirmatory trials do not verify clinical benefit, the FDA may seek to withdraw accelerated approval; our ability to establish effective sales or marketing capabilities; the Company’s reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; the Company’s ability to attract, retain and motivate qualified personnel; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in the Company’s most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and the Company’s other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this Current Report. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause the Company’s views to change.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The following Exhibit 99.1 relating to Item 7.01 shall be deemed to be furnished, and not filed:
Exhibit No. | Description | |||||||
| 99.1 | Press Release issued on May 5, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ZENTALIS PHARMACEUTICALS, INC. | ||||||||||||||
| Date: May 5, 2026 | By: | /s/ Julie Eastland | ||||||||||||
| Julie Eastland | ||||||||||||||
| President and Chief Executive Officer | ||||||||||||||
Exhibit 99.1
Zentalis Pharmaceuticals Announces First Patient Dosed in ASPENOVA Phase 3 Trial of Azenosertib in Patients with Cyclin E1-Positive Platinum-Resistant Ovarian Cancer
•Global Phase 3, randomized, controlled trial comparing azenosertib to standard-of-care chemotherapy now enrolling
•ASPENOVA designed as confirmatory study to support DENALI Phase 2 accelerated approval pathway, pending FDA feedback
SAN DIEGO — May 5, 2026 — Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced that the first patient has been dosed in the Phase 3 ASPENOVA clinical trial (NCT07546500, GOG-3147, ENGOT-ov109, APGOT-OV27) evaluating azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC).
"Dosing the first patient in the ASPENOVA Phase 3 clinical trial represents a significant milestone in our development of azenosertib for patients with platinum-resistant ovarian cancer," said Ingmar Bruns, M.D., Chief Medical Officer of Zentalis. "With DENALI Part 2 progressing toward a year-end readout that may support accelerated approval and ASPENOVA now enrolling to evaluate azenosertib versus standard-of-care chemotherapy to support full approval, we are executing on a comprehensive development and regulatory strategy designed to bring this therapy to patients as quickly as possible. We are deeply grateful to the patients participating in this important trial and to our collaborators at The GOG Foundation, Inc. (GOG-F), ENGOT, and APGOT for their partnership in advancing this research."
"Cyclin E1-overexpressing ovarian cancers are associated with platinum-resistance and poor outcomes, representing a clinical unmet need," said Fiona Simpkins, M.D., Professor at the University of Pennsylvania Perelman School of Medicine and Lead Investigator for the ASPENOVA trial and GOG-F. "This biomarker has yet to be exploited therapeutically and azenosertib, a WEE1 inhibitor, is an oral, targeted treatment that is showing exciting activity in Cyclin E1-overexpressing ovarian cancer (SGO Annual Meeting, 2025). The biomarker-driven approach now being studied in this Phase 3 randomized trial has the potential to identify patients most likely to benefit while sparing them from the inconvenience of intravenous regimens. On behalf of GOG Foundation, we are pleased to collaborate with Zentalis, ENGOT, and APGOT on this important trial for this underserved patient population."
ASPENOVA is a randomized, controlled Phase 3 trial designed to confirm the clinical benefit of azenosertib and support full approval as part of Zentalis' dual-track regulatory strategy. The company is pursuing accelerated approval based on the ongoing registration-intended DENALI Phase 2 trial, with a topline readout expected by year-end 2026, while simultaneously advancing ASPENOVA as the confirmatory study to satisfy FDA requirements for conversion to full approval. Both trials are evaluating azenosertib at 400mg once daily on a 5-days-on, 2-days-off schedule (400mg QD 5:2), the dose selected based on the DENALI Part 2a interim analysis announced in April 2026. The planned interim analysis showed a meaningful, clearly differentiated response rate at 400mg QD 5:2 over 300mg QD 5:2 and comparable safety profiles between the two dose groups.
The ASPENOVA trial is being conducted in collaboration with The GOG Foundation, Inc. (GOG-F), the European Network of Gynaecological Oncological Trial groups (ENGOT), and Asia-Pacific Gynecologic Oncology Trials Group (APGOT), reflecting the global clinical and scientific community's recognition of the significant unmet need in this patient population.
About ASPENOVA Clinical Trial
ASPENOVA (NCT07546500, GOG-3147, ENGOT-ov109) is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin [PLD], gemcitabine, or topotecan) in this biomarker-selected population. The primary endpoint is progression-free survival (PFS); key secondary endpoints include overall survival (OS) and overall response rate (ORR). The trial design was aligned with the U.S. Food and Drug Administration (FDA) to meet requirements for the accelerated approval pathway and potential conversion to full approval.
About DENALI Clinical Trial
DENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825) studying azenosertib in PROC patients.
Part 1b enrolled patients with PROC regardless of Cyclin E1 protein expression, all treated at 400mg QD 5:2. Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on Zentalis' proprietary immunohistochemistry cutoff.
Part 2, in total, is designed to support accelerated approval, pending study outcome and discussions with the FDA. The study design consists of the following parts:
•Part 2a: Dose confirmation evaluated two doses, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. 400mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
•Part 2b: Enrollment expansion at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. This cohort is currently enrolling.
•Part 2c: Broadening study population to include approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling.
Zentalis expects to complete enrollment in all cohorts of DENALI Part 2 (2a, 2b, 2c) and provide a topline readout by year-end 2026.
For physician and patient information about the DENALI trial, please visit www.denalitrial.com.
About Azenosertib
Azenosertib is an investigational, potentially first-in-class, selective, and orally bioavailable inhibitor of WEE1 currently being evaluated in clinical studies in ovarian cancer and additional tumor types. WEE1
acts as a master regulator of the G1-S and G2-M cell cycle checkpoints, through negative regulation of both CDK1 and CDK2, to prevent replication of cells with damaged DNA. By inhibiting WEE1, azenosertib enables cell cycle progression, despite high levels of DNA damage, thereby resulting in the accumulation of DNA damage and leading to mitotic catastrophe and cancer cell death.
Azenosertib is in late-stage development as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is currently no approved treatment option specifically for this biomarker-selected population which comprises approximately 50% of PROC patients. Cyclin E1 protein overexpression has been established as a sensitive and specific predictive biomarker for identifying patients who could potentially derive benefit from azenosertib treatment, based on retrospective analysis of azenosertib studies in PROC. Validation of the Cyclin E1 companion diagnostic assay is ongoing in the DENALI and ASPENOVA trials.
Azenosertib has been granted Fast Track Designation by the U.S. FDA for the treatment of patients with Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track Designation is intended to facilitate the development and expedite the review of therapies that have the potential to treat serious conditions and address unmet medical needs.
About Zentalis Pharmaceuticals
Zentalis is a clinical oncology innovator developing a treatment approach for ovarian cancer and multiple tumor types. Leveraging therapeutics development and biomarker expertise, Zentalis is advancing monotherapy and combination studies of its investigational first-in-class WEE1 inhibitor, azenosertib. Focused on translating WEE1 science into clinical practice, we aim to equip physicians with a targeted, non-chemo, orally available medicine that enhances treatment experience, choice, and outcomes. Our mission: to unburden cancer patients with more convenience and care.
For more information, please visit www.zentalis.com. Follow Zentalis on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential for azenosertib to be first-in-class; the continued development of azenosertib; the clinical and therapeutic potential of azenosertib, including the potential for azenosertib to be an important treatment option for patients with ovarian cancer or other indications; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib; the potential to advance research on additional areas of opportunity for azenosertib outside PROC; the Company’s anticipated milestones and the timing thereof, including the anticipated timing of the topline readout from DENALI Part 2; and the Company’s planned regulatory strategy for azenosertib and the timing thereof, including the potential for DENALI Part 2 to support an accelerated approval and the potential for ASPENOVA to support full approval. The terms “anticipate,” “advance,” “believe,” “could,” “design,” “develop,” “expect,” “intent,” “look forward,” “may,” “on track,” “pending,” “plan,” “position,” “potential,” “runway,” “strategy,” “support,” “target,” and “will” and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance
or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our limited operating history, which may make it difficult to evaluate our current business and predict our future success and viability; we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; our substantial dependence on the success of azenosertib; our plans, including the costs thereof, of development of companion diagnostics; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; our product candidates may cause serious adverse side effects; the interim, initial, “topline,” and preliminary data from our clinical trials may change as more patient data becomes available, and are subject to audit and verification procedures that could result in material changes in the final data; our reliance on third parties; effects of significant competition; the possibility of system failures or security breaches; risks relating to intellectual property; our ability to attract, retain and motivate qualified personnel, and risks relating to management transitions; significant costs as a result of operating as a public company; and the other important factors discussed under the caption “Risk Factors” in our most recently filed periodic report on Form 10-K or 10-Q and subsequent filings with the U.S. Securities and Exchange Commission (SEC) and our other filings with the SEC. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
ZENTALIS® and its associated logo are trademarks of Zentalis and/or its affiliates. All website addresses and other links in this press release are for information only and are not intended to be an active link or to incorporate any website or other information into this press release.
Contact:
Aron Feingold
VP, Investor Relations & Corporate Communications
ir@zentalis.com
VP, Investor Relations & Corporate Communications
ir@zentalis.com
FAQ
What did Zentalis Pharmaceuticals (ZNTL) announce in this 8-K filing?
Zentalis announced dosing of the first patient in ASPENOVA, a Phase 3 trial of investigational WEE1 inhibitor azenosertib for Cyclin E1-positive platinum-resistant ovarian cancer, marking the start of a pivotal, randomized comparison against standard single-agent chemotherapy in this high-need setting.
What is the ASPENOVA Phase 3 trial described by ZNTL?
ASPENOVA is a randomized, controlled Phase 3 trial enrolling about 420 Cyclin E1-positive platinum-resistant ovarian cancer patients. It compares azenosertib monotherapy at 400mg once daily on a 5-days-on, 2-days-off schedule with investigator’s choice of standard single-agent chemotherapy, using progression-free survival as the primary endpoint.
How does ASPENOVA fit into Zentalis (ZNTL) azenosertib regulatory strategy?
Zentalis is using a dual-track approach: the Phase 2 DENALI trial is intended to support an accelerated approval filing for azenosertib, while ASPENOVA is designed as the confirmatory Phase 3 study to support potential full approval, assuming favorable data and agreement with the U.S. Food and Drug Administration.
What is the DENALI trial and when is Zentalis expecting topline data?
DENALI is a multi-part Phase 2 registration-intended trial of azenosertib in platinum-resistant ovarian cancer, including biomarker-selected Cyclin E1-overexpressing patients. Parts 2a, 2b, and 2c explore dose confirmation and expanded cohorts, with Zentalis expecting a Part 2 topline readout by year-end 2026, subject to study progress.
What dosing regimen of azenosertib is used in ASPENOVA and DENALI?
Both ASPENOVA and the registration-intended DENALI trial use azenosertib 400mg once daily on a 5-days-on, 2-days-off schedule. This 400mg QD 5:2 monotherapy dose was selected after an interim Part 2a analysis showed a meaningfully better response rate than 300mg QD 5:2 with comparable safety profiles.
What regulatory designations has azenosertib received for ovarian cancer?
Azenosertib has received U.S. FDA Fast Track Designation for Cyclin E1-positive platinum-resistant ovarian cancer. Fast Track is intended to facilitate development and expedite review of therapies that may treat serious conditions and address unmet medical needs, potentially enabling more frequent FDA interactions and rolling review benefits.