Mirvetuximab soravtansine

Sofetabart mipitecan (Sofe-M) in combination with bevacizumab demonstrated a 79% confirmed objective response rate and 100% disease control rate, with similar activity observed across FRα expression levels Clinical activity with Sofe-M was maintained even in patients with prior PARP inhibitor exposure, patients who typically experience poor outcomes with platinum-based chemotherapy Sofe-M is currently being studied in both platinum-sensitive and platinum-resistant ovarian cancer in multiple Phase 3 studies as part of the FRAmework-01 master protocol INDIANAPOLIS, Oct. 24, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced new Phase 1 data showing that its investigational folate receptor alpha (FRα) antibody-drug conjugate (ADC) sofetabart mipitecan (Sofe-M) plus bevacizumab achieved a confirmed objective response rate (cORR) of 79% and a disease control rate (DCR) of 100% in patients with platinum-sensitive ovarian cancer (PSOC). A cORR of 79% or higher was seen in both poly (ADP-ribose) polymerase inhibitor (PARPi)-treated and PARPi-naïve patients. These data will be shared in an oral presentation at the European Society for Medical Oncology (ESMO) Annual Congress in Madrid, Spain. FRα is expressed in almost all ovarian cancers, at much higher levels than in healthy tissue, making it a target that can help direct treatment to tumor cells. Sofe-M is an FRα-targeting ADC composed of an Fc-silent, FRα-specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker. The antibody is designed to bind FRα on the surface of tumor cells, delivering exatecan directly into the tumor cell to disrupt DNA replication. Jacob Van Naarden, Executive Vice President and President of Lilly Oncology: "The standard of care for platinum-sensitive ovarian cancer has remained unchanged for a decade and demands new treatment options. Results for Sofe-M show a promising efficacy and tolerability profile across both platinum-resistant and platinum-sensitive ovarian cancer, regardless of FRα expression levels or prior treatment. These data give us confidence as we continue to study Sofe-M in our Phase 3 FRAmework-01 program to bring this potential new medicine to the women who need it." The Phase 1 study is evaluating Sofe-M plus bevacizumab in patients with advanced solid tumors, including a cohort of 33 women with PSOC who received Sofe-M (4 mg/kg) plus bevacizumab (15 mg/kg). Patients received a median of three prior systemic regimens (range 1–6), including prior PARPi (67%) and prior bevacizumab (70%). As of the July 6, 2026, data cutoff, the cORR among the 29 patients with measurable disease was 79.3% (23/29; 6 complete responses [CR, 20.7%] and 17 partial responses [PR, 58.6%]), and DCR was 100%. Responses were consistent across FRα expression levels and prior PARPi exposure. Median duration of response (DOR) and median progression-free survival (PFS) were not reached at median follow-ups of 6.2 and 10.2 months, respectively. Chrisann Kyi, MD, Gynecologic Medical Oncologist & Early Drug Development Specialist at Memorial Sloan Kettering Cancer Center: "The durable and robust responses we've seen in patients with platinum-sensitive ovarian cancer are important, particularly in a PARPi pretreated population, where the response rate seen with Sofe-M exceeds what has been reported in published platinum re-challenge studies. The observed safety profile and low discontinuation rates, combined with early efficacy results, support the continued investigation of Sofe-M as a potentially meaningful new option for patients." Sofe-M plus bevacizumab demonstrated a safety profile consistent with the known profiles of each medicine. No new safety signals were observed. The most common treatment-emergent adverse events (TEAEs) across all patients included epistaxis (73%), nausea (73%), anemia (58%), neutropenia (55%), and fatigue (52%). The most common Grade ≥3 TEAEs were neutropenia (42%) and anemia (24%); febrile neutropenia occurred in 3% of patients, and G-CSF prophylaxis was not mandated. Any-grade neuropathy occurred in 9% of patients, with no Grade ≥3 events. Dose reductions occurred in 42% of patients, and 6% discontinued treatment due to an adverse event. The FRAmework-01 program is evaluating Sofe-M in three global Phase 3 trials across both platinum-resistant and platinum-sensitive ovarian cancer: Part A tests Sofe-M as monotherapy in platinum-resistant disease; Part B tests Sofe-M plus bevacizumab in platinum-sensitive disease that progressed on or within six months of completing a PARPi; and Part C tests Sofe-M plus bevacizumab in PARPi-naïve platinum-sensitive disease. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). For more information on Lilly's oncology pipeline, click here. Frequently Asked Questions What is sofetabart mipitecan (Sofe-M)? Sofetabart mipitecan (Sofe-M) is an investigational folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC) being studied for the treatment of ovarian cancer and other solid tumors. It is designed to selectively bind to cancer cells expressing FRα and deliver a topoisomerase I inhibitor payload directly to those cells. What is an antibody-drug conjugate? An antibody-drug conjugate (ADC) is a type of medicine that pairs an antibody with a cell-killing payload. The antibody is designed to recognize and bind to a specific protein found on the surface of cancer cells, and the payload is released once the ADC reaches its target, allowing the medicine to attack cancer cells while limiting exposure to healthy tissue.1 How is Sofe-M different from other FRα-targeted ADCs? Sofe-M is designed to target FRα across a broad range of expression levels, including in tumors with lower FRα expression. In this Phase 1 study, Sofe-M plus bevacizumab showed a confirmed objective response rate of 79.3% in platinum-sensitive ovarian cancer (PSOC), with consistent activity across FRα expression levels and regardless of prior PARP inhibitor exposure. Earlier studies in platinum-resistant ovarian cancer (PROC) also demonstrated responses observed across all FRα expression levels and in patients previously treated with mirvetuximab soravtansine (MIRV).2 These results are being further evaluated in Lilly's ongoing Phase 3 FRAmework-01 program, which is studying Sofe-M across both platinum-resistant and platinum-sensitive ovarian cancer. What are the results with sofetabart mipitecan (Sofe-M) in the treatment of platinum-sensitive ovarian cancer (PSOC)? The Phase 1 study demonstrated encouraging clinical activity, including a confirmed objective response rate (cORR) of 79.3% and a disease control rate (DCR) of 100%, in heavily pretreated patients with platinum-sensitive ovarian cancer. Activity was observed across FRα expression levels and regardless of prior PARP inhibitor exposure. Median duration of response (DOR) and median progression-free survival (PFS) were not reached at median follow-ups of 6.2 and 10.2 months, respectively. Sofetabart mipitecan (Sofe-M) plus bevacizumab demonstrated a safety profile consistent with the known profiles of each medicine, with no new safety signals observed and a low rate of discontinuation due to adverse events (6%). These findings support continued investigation of Sofe-M in the ongoing Phase 3 FRAmework-01 trial. In this study Sofe-M was dosed at 4 mg/kg. Why is it dosed at 3mg/kg in the Phase 3 FRAmework-01 trial? The 3 mg/kg dose of Sofe-M was selected as the recommended phase 3 dose (RP3D), based on analysis of the safety, efficacy and PK data as monotherapy. The ORR was comparable between the two doses, with ORRs of 59.0% (95% CI 42.1, 74.4) and 58.8% (95% CI 32.9, 81.6), at 4 mg/kg and 3mg/kg doses, respectively. Safety signals were higher at 4 mg/kg versus 3 mg/kg, with Grade ≥3 TRAEs at 56.4% vs 35.3% and dose reductions of 41.0% vs 23.5%. What are historical clinical trial results for standard of care in platinum-sensitive ovarian cancer (PSOC)? For patients who recur after platinum-based chemotherapy and PARP inhibitor (PARPi) maintenance, published real world data on subsequent platinum re-challenge have shown modest response rates, with an objective response rate (ORR) of 41.9%.3 Other studies of platinum-based regimens, such as OCEANS, were conducted prior to the routine use of PARPi maintenance and did not include patients previously treated with a PARPi,4 a population that now represents a majority of patients with recurrent PSOC, including those enrolled in Sofe-M's Phase 1 study. What is platinum-sensitive ovarian cancer (PSOC)? Platinum-sensitive ovarian cancer (PSOC) is characterized as ovarian cancer that comes back more than six months after platinum-based chemotherapy. While people with PSOC can often be treated with platinum again, the disease tends to return, and each recurrence can leave fewer treatment options and shorter remissions.5 What is the current unmet need in platinum-sensitive ovarian cancer (PSOC)? The standard of care for PSOC has remained largely unchanged for more than a decade, even as understanding of which patients benefit from it has evolved. Approximately 50% of PSOC patients have HRD-positive tumors, meaning their tumors carry a specific DNA-repair deficiency.6 These patients tend to have longer progression-free survival with upfront platinum-based chemotherapy plus a PARP inhibitor (PARPi).6 However, when these patients do recur after PARPi maintenance, response rates to subsequent platinum-based treatment are modest.6 Patients with non-HRD-positive tumors see minimal benefit from PARPi to begin with and generally have a poorer prognosis overall.6 Despite these different outcomes between HRD-positive and HRD-negative patients, treatment approaches for PSOC have not meaningfully changed to reflect that distinction. What is the difference between platinum-resistant (PROC) and platinum-sensitive ovarian cancer (PSOC)? The difference comes down to timing. If ovarian cancer returns more than six months after platinum-based chemotherapy, it's considered platinum-sensitive, and patients often respond well to platinum treatment again. If the cancer returns within six months, or continues growing during treatment, it's considered platinum-resistant, and platinum-based chemotherapy is generally no longer effective. Because platinum resistance tends to develop gradually, each recurrence can bring a shorter remission, even while a patient's disease is still classified as platinum-sensitive.6 What is folate receptor alpha (FRα), and why is FRα expression level important in treating ovarian cancer? FRα is expressed in almost all ovarian cancers, at much higher levels than in healthy tissue, making it a target that can help direct treatment to tumor cells.7 FRα expression level refers to the amount of the protein present on a tumor and may influence eligibility for or response to certain FRα-targeted therapies.7 How is the FRAmework-01 clinical trial designed? FRAmework-01 is a global, three-part Phase 3 trial studying sofetabart mipitecan (Sofe-M) across both platinum-resistant and platinum-sensitive ovarian cancer in a single program: Part A tests Sofe-M as monotherapy in platinum-resistant disease; Part B tests Sofe-M plus bevacizumab in platinum-sensitive disease that progressed on or within six months of completing a PARPi; and Part C tests Sofe-M plus bevacizumab in PARPi-naïve platinum-sensitive disease. The trial's main measure of success across all three parts is how long patients go without their cancer progressing. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). Enrollment is ongoing globally with first registrational dose in Q4 2025 for PROC and in Q1 2026 for PSOC. About Ovarian Cancer Ovarian cancer is the sixth leading cause of cancer death among women in the United States.8 While most patients initially respond to platinum-based chemotherapy, approximately 70% will experience recurrence, leading to progressively shorter remission periods with each subsequent treatment.6 When cancer recurs during or within six months of platinum therapy, known as platinum-resistant disease, patients face limited treatment options.6,9 About Sofetabart Mipitecan Sofetabart mipitecan (Sofe-M; LY4170156) is composed of an Fc-silent, folate receptor alpha (FRα) specific humanized monoclonal antibody linked to exatecan, a topoisomerase I inhibitor, via a proprietary cleavable polysarcosine linker (PSARlink). Sofe-M was designed to target FRα across all expression levels with improved therapeutic index. FRα is a cell-surface glycoprotein encoded by the gene FOLR1 that binds to the essential nutrients folic acid and reduced folates, bringing them into cells to facilitate cell division and growth. FRα is overexpressed in many solid tumors such as ovarian and endometrial cancers. Sofe-M has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for platinum-resistant ovarian cancer (PROC) and is currently being evaluated in the Phase 3 FRAmework-01 program. The study is being conducted in partnership with the European Network for Gynaecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). About FRAmework-01 FRAmework-01 (NCT07213804) is a Phase 3, randomized, open-label, three-part study evaluating sofetabart mipitecan (Sofe-M; LY4170156) in patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer. Part A tests Sofe-M as monotherapy in platinum-resistant disease; Part B tests Sofe-M plus bevacizumab in platinum-sensitive disease that progressed on or within six months of completing a PARPi; and Part C tests Sofe-M plus bevacizumab in PARPi-naïve platinum-sensitive disease. The primary endpoint is progression-free survival (PFS), assessed by the investigator in Part A and by blinded independent central review (BICR) in Parts B and C. Key secondary endpoints are overall survival, objective response rate, duration of response, and safety. The FRAmework-01 study is in partnership with the European Network for Gynecological Oncological Trial groups (ENGOT - lead groups GINECO/NOGGO e.V.), the GOG Foundation (GOG), and the Asia-Pacific Gynecologic Oncology Trials Group (APGOT). More information on FRAmework-01 can be found on clinicaltrials.gov. References Drago JZ, Modi S, Chandarlapaty S. Unlocking the potential of antibody-drug conjugates for cancer therapy. Nat Rev Clin Oncol. 2021;18(6):327-344. doi:10.1038/s41571-021-00470-8 2. Ray-Coquard, et al. Sofetabart mipitecan, an antibody drug conjugate targeting folate receptor alpha, in high grade ovarian cancer: Results from the first-in-human phase 1 study, Annals of Oncology (2026), doi: . Romeo M, Gil-Martín M, Gaba L, et al. Multicenter real-world data of subsequent chemotherapy after progression to PARP inhibitors in a maintenance relapse setting. Cancers (Basel). 2022;14(18):4414. Aghajanian C, Blank SV, Goff BA, et al. OCEANS: a randomized, double-blind, placebo-controlled phase III trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer. J Clin Oncol. 2012;30(17):2039-2045. Lesnock JL, Temin S, Bouberhan S, et al. Systemic Treatment of Ovarian Cancer Recurrence: ASCO Living Guideline, Version 2026.1.0. J Clin Oncol. Published online July 13, 2026. doi:10.1200/JCO-26-01591. Lheureux S, Braunstein M, Oza AM. Epithelial ovarian cancer: evolution of management in the era of precision medicine. CA Cancer J Clin. 2019;69(4):280-304. doi:10.3322/caac.21559. Bax HJ, Chauhan J, Stavraka C, et al. Folate receptor alpha in ovarian cancer tissue and patient serum is associated with disease burden and treatment outcomes. Br J Cancer. 2023;128(2):342-353. doi:10.1038/s41416-022-02031-x. American Cancer Society. Cancer Facts for Women. Accessed September 9, 2026. . Colombo N, Sessa C, du Bois A, et al. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease. Ann Oncol. 2019;30(5):672-705. doi: 10.1093/annonc/mdz062. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY © Lilly USA, LLC 2026. ALL RIGHTS RESERVED. MSK Disclosure: Dr. Kyi has financial interests related to Eli Lilly and Company. Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are references in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about sofetabart mipitecan plus bevacizumab and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that any of these therapies will prove to be a safe and effective treatment or receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Median overall survival of 15.9 months in Cyclin E1-positive PROC, with 1–5 prior lines of therapy; safety profile in DENALI Part 1b was consistent with prior reportingMedian relative dose intensity was 84.6%, confirming high overall exposure to azenosertibDENALI Part 1b interim analysis adds to the body of evidence supporting Cyclin E1 protein expression as a predictive biomarker for azenosertib in platinum-resistant ovarian cancer SAN DIEGO, Oct. 23, 2026 (GLOBE NEWSWIRE) -- 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 presented results from an interim analysis of the DENALI Part 1b study (GOG-3066) as of a May 22, 2026 data cutoff, including the first overall survival analysis for azenosertib, at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain. "These data continue to build the body of evidence supporting azenosertib as a potential treatment in Cyclin E1-positive platinum-resistant ovarian cancer, underpinning our development approach through the ongoing registration-intended DENALI Part 2 and ASPENOVA Phase 3 confirmatory trials. For patients with Cyclin E1-positive PROC who have limited effective treatment options, we are working to deliver something that has not existed — a targeted, oral treatment that offers more convenience and choice," said Julie Eastland, Chief Executive Officer of Zentalis Pharmaceuticals. "The overall survival results from DENALI Part 1b are particularly meaningful given the poor prognosis associated with Cyclin E1-positive tumors and the heavily pretreated nature of this trial patient population," said Fiona Simpkins, M.D., Professor at the University of Pennsylvania Perelman School of Medicine and Lead Investigator for the DENALI study and The GOG Foundation, Inc. (GOG-F). "The separation in median overall survival between Cyclin E1-positive and Cyclin E1-negative patients — 15.9 months versus 7.5 months — strongly supports Cyclin E1 protein expression as a clinically relevant and predictive patient selection biomarker for azenosertib. Taken together with the response data and manageable adverse events, these findings provide important evidence supporting continued development of azenosertib in this biomarker-selected population with high unmet need." Updated DENALI Part 1b Efficacy ResultsAs of the May 22, 2026 data cutoff, DENALI Part 1b enrolled 102 patients with PROC regardless of Cyclin E1 protein expression who had received between one and five prior lines of therapy, with prior bevacizumab required. This was a heavily pretreated population: 97% had received a taxane, 91% bevacizumab, 55% a PARP inhibitor, and 15% mirvetuximab soravtansine, with a median of three prior lines of therapy. Cyclin E1 status was retrospectively determined by immunohistochemistry using a proprietary cutoff, with 94 patients evaluable (Cyclin E1 IHC-positive: n=48, 51%; Cyclin E1 IHC-negative: n=46). Overall Survival (OS): Cyclin E1 IHC-positive (n=48): median OS of 15.9 months (95% CI, 8.7–21.2); 31 events had occurred (65%)Cyclin E1 IHC-negative (n=46): median OS of 7.5 months (95% CI, 5.8–12.3); 34 events had occurred (74%) Objective Response Rate (ORR) and Duration of Response (DOR): ORR in response-evaluable Cyclin E1 IHC-positive patients (n=43): 37.2% (95% CI, 23.0–53.3)ORR in all Cyclin E1 IHC-positive patients (n=48): 33.3% (95% CI, 20.4–48.4)Median DOR: 5.5 months (95% CI, 4.5–15.9) The updated ORR includes a patient with a confirmed response after the prior cutoff. The current median DOR of 5.5 months reflects a more mature dataset with less censoring than the prior cutoff, including two patients with particularly durable responses exceeding 15 and 20 months. SafetyThe safety profile was consistent with prior reporting. The most common treatment-related adverse events (TRAEs) were nausea, fatigue, diarrhea, thrombocytopenia, decreased appetite, anemia, and neutropenia. The most common non-hematologic Grade ≥3 TRAE was fatigue (16%). Grade ≥3 hematologic TRAEs included thrombocytopenia (12%), anemia (11%), and neutropenia (11%). The median relative dose intensity was 84.6%, confirming that overall exposure to azenosertib remained high despite dose modifications. TRAEs led to dose interruption in 56.9% of patients, dose reduction in 43.1%, and discontinuation in 19.6%. Serious TRAEs occurred in 21.6% of patients. The ESMO slides inclusive of the full interim analysis dataset presented at the medical meeting are available on the Zentalis website under scientific publications at the following link: https://zentalis.com/science/scientific-publications/ About the DENALI Clinical TrialDENALI is a multi-part Phase 2 registration-intended clinical trial (NCT05128825, GOG-3066) studying azenosertib in patients with PROC, conducted in collaboration with The GOG Foundation, Inc. (GOG-F). Part 1b enrolled 102 patients with PROC regardless of Cyclin E1 protein expression, all treated at 400 mg QD 5:2 (five days of once-daily administration of azenosertib, followed by two days without azenosertib). The primary endpoint was objective response rate per RECIST v1.1; secondary endpoints included duration of response, progression-free survival, overall survival, and safety. 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 positive study outcomes and further discussions with the FDA. The study design consists of the following parts: Part 2a: Dose confirmation evaluated two doses, 300 mg QD 5:2 and 400 mg QD 5:2, with approximately 30 patients enrolled per dose group. 400 mg QD 5:2 was selected as the optimal monotherapy dose. Recruitment at the 300 mg 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 400 mg QD 5:2 dose up to approximately 100 patients, including patients at this dose in Part 2a. Enrollment in this cohort is complete.Part 2c: Expansion of the study population, expected to enroll approximately 40 patients previously treated with a taxane-containing regimen for PROC. This cohort is currently enrolling. For physician and patient information about the DENALI trial, please visit www.denalitrial.com. About ASPENOVA Clinical TrialASPENOVA 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 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 based on feedback from the U.S. FDA regarding requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval. About AzenosertibAzenosertib 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. About Zentalis PharmaceuticalsZentalis 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 continued development of azenosertib; the clinical and therapeutic potential of azenosertib; the potential for azenosertib to be first-in-class; the broad franchise potential of azenosertib; the Company’s biomarker-driven strategy for azenosertib, including the ability of Cyclin E1 to be a highly selective and predictive biomarker for response to azenosertib; and our participation in conference presentations. The terms “anticipate,” “advance,” “believe,” “design,” “develop,” “expect,” “intent,” “look forward,” “on track,” “plan,” “position,” “potential,” “runway,” “strategy,” “support,” “target,” “upcoming,” 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; inability to maintain our collaborations, or the failure of these collaborations; 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 FeingoldVP, Investor Relations & Corporate Communicationsir@zentalis.com