Fallopian Tube Carcinoma

Debiopharm aims to further characterize the safety, tolerability, and preliminary anti-tumor activity of its potent WEE1 inhibitor Debio 0123 as a monotherapy in three different expansion cohorts LAUSANNE, Switzerland--(BUSINESS WIRE)-- Debiopharm ( ), a privately-owned, Swiss-based biopharmaceutical company aiming to establish tomorrow’s standard-of-care to cure cancer and infectious diseases, today announced the first patient dosed in the expansion of its open-label, non-randomized, multicenter Phase 1 study evaluating Debio 0123, an oral, potent, highly selective and brain-penetrant WEE1 inhibitor, as a monotherapy in patients with recurrent or progressive solid tumors. The expansion of this Phase 1 study, NCT05109975, is to characterize the safety, tolerability, and initial signs of antitumor activity of Debio 0123 when administered as monotherapy. Two out of the three expansion arms of the study will be using biomarkers to pre-select patients with different solid tumors while the third arm will be treating patients with recurrent serous endometrial carcinoma. Currently, sites are open for enrollment in the United States, Spain, and Switzerland. “Part of our strategy of utilizing OMICs* approaches to identify specific biomarkers and identify patient populations that will respond to Debio 0123 due to synthetic lethality will allow us to enroll patients who are most likely to benefit from treatment, thereby taking a truly precision medicine approach” expressed Dr. Victor Rodriguez-Freixinos, Medical Director, Debiopharm. Uterine serous carcinoma (USC) is an uncommon, but aggressive subtype of endometrial cancer. It represents approximately 10% of all endometrial cases, which translates to more than 6,000 newly diagnosed patients each year in the United States 1-2. Despite representing a small proportion of endometrial cancer cases, uterine serous carcinoma accounts for an alarming 39% of endometrial cancer-related deaths. Features highlighting the gravity of USC include the high rates of deep myometrial invasion, as well as metastatic spread to lymph nodes and peritoneal surfaces 1. These features largely affect the 5-year overall survival but compared with more common endometrial cancer, the prognosis for USC is generally poor and the risk of relapse is high 3. Similar to USC, epithelial ovarian cancer (EOC) is known for its poor prognosis due to the aggressive clinical course and the tendency to metastasize. However, EOC accounts for about 90% of all ovarian cancers and affects more than 17,000 American women each year, of which about 30% survive for 5 years after diagnosis 4-5. “This study’s population is mainly female, burdened by fatal malignancies like Uterine Serous Carcinoma, Epithelial Ovarian Cancer and fallopian tube cancer which are well-known hard-to-treat cancers. These patients need new treatment options, as the current standard of care is insufficient in assuring long-term progression free survival.” Dr. Manish R. Sharma, Principal Investigator at the START Midwest, Michigan. The Debio 0123 program originates from a growing awareness of DDR inhibition in fighting life-threatening cancers. Maximizing efficacy, while preserving safety are key elements that Debiopharm is eager to assess throughout the clinical development of Debio 0123. With the successful realization of these requirements, Debio 0123 could become the first choice WEE1 inhibitor. About Debio 0123 Debio 0123 is a brain-penetrant, highly selective WEE1 kinase inhibitor. WEE1 is a key regulator of the G2/M and S phase checkpoints, activated in response to DNA damage, allowing cells to repair their DNA before resuming their cell cycle. WEE1 inhibition, particularly in combination with DNA damaging agents, induces an overload of DNA breaks. In conjunction with abrogation of other checkpoints such as G1, the compound pushes the cells through cycle without DNA repair, promoting mitotic catastrophe and inducing apoptosis of cancer cells. Currently in research for solid tumors in monotherapy and combination, Debio 0123 is being developed to respond to high unmet needs of patients living with the burden of difficult-to-treat cancers. About DNA-Damage Response (DDR) When cells have damaged DNA, they need to undergo a repair process called DDR to be able to survive. Cancer cells use their hyperactive DDR response to divide and grow uncontrollably, which promotes cancer expansion. Inhibition of DDR, particularly in combination with other anticancer agents, induces an overall arrest in the uncontrollable cancer cell cycle. This ultimately activates a self-destruction program in cancer cells. DDR inhibitors such as Debiopharm's WEE1 and USP1 inhibitors, are being tested in either clinical or preclinical studies. Debiopharm’s commitment to patients Debiopharm aims to develop innovative therapies that target high unmet medical needs in oncology and bacterial infections. Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds and technologies for in-licensing, clinically demonstrate their safety and efficacy, and then select large pharmaceutical commercialization partners to maximize patient access globally. For more information, please visit We are on Twitter. Follow us @DebiopharmNews at Sources 1 Hamilton CA, et al. Br J Cancer. 2006 Mar 13;94(5):642-6. doi: 10.1038/sj.bjc.6603012. PMID: 16495918; PMCID: PMC2361201. 2 Clement PB, Young RH. Adv Anat Pathol. 2004 May;11(3):117-42. doi: 10.1097/00125480-200405000-00001. PMID: 15096727. 3 Acharya S, et al. Lancet Oncol. 2005 Dec;6(12):961-71. doi: 10.1016/S1470-2045(05)70463-0. Erratum in: Lancet Oncol. 2006 Feb;7(2):105. PMID: 16321764. 4 American Cancer Society. Key Statistics for Ovarian Cancer. 5 Arter, Z.L., et al. Br J Cancer 130, 108–113 (2024). * OMICs = technologies that are primarily aimed at the universal detection of genes (genomics), mRNA (transcriptomics), proteins (proteomics) and metabolites (metabolomics) in a specific biological sample

Robust azenosertib clinical development plan ongoing and on track with multiple clinical catalysts anticipated, including monotherapy and combination data readouts in gynecological and other cancer types during 2024 Strengthened management team with appointments of Diana Hausman, M.D., as Chief Medical Officer and Kyle Rasbach, Ph.D., Pharm.D., as Chief Business Officer $483 million cash balance as of December 31, 2023, with projected cash runway into 2026 NEW YORK and SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers, today announced financial results for the year ended December 31, 2023, and highlighted recent corporate accomplishments. "Zentalis is making remarkable progress in advancing our clinical development program for azenosertib, our potentially groundbreaking WEE1 inhibitor, across various tumor types," stated Kimberly Blackwell, M.D., Chief Executive Officer of Zentalis. "In November 2023, we disclosed promising clinical data demonstrating the potential of azenosertib as an effective monotherapy in ovarian cancer and uterine serous carcinoma. Our team is diligently executing a clinical strategy, which is firmly on track, designed to rapidly bring this promising therapeutic option to patients with gynecological cancers that continue to have a poor prognosis based on currently available treatment options. We anticipate an exciting and data-rich period ahead during the remainder of 2024 and into 2025 where we plan to share multiple clinical datasets to help further demonstrate the potential of azenosertib in multiple cancer types as a monotherapy and in combination." Program Updates and Highlights Azenosertib development program updates. In November 2023, the Company announced an updated analysis of the ongoing Phase 1 clinical trial of azenosertib as a monotherapy in solid tumors (ZN-c3-001), which continued to show anti-tumor activity with intermittent dosing. In the same population of 19 platinum resistant or refractory ovarian cancer and uterine serous carcinoma (USC) patients that were included in the data reported on June 6, 2023, the objective response rate (ORR) was 37%. Median follow-up had increased and the median progression free survival (mPFS) had increased to 6.5 months. The Company also disclosed in November 2023, that, with additional safety-evaluable patients and follow-up, azenosertib continued to demonstrate a favorable safety and tolerability profile similar to or better than approved ovarian cancer products. (Link)Azenosertib development continues to progress across a broad array of tumor types. Azenosertib is being evaluated in more than 10 ongoing and planned clinical trials as a monotherapy and in combinations supported by compelling scientific rationales across a broad array of tumor types, including platinum resistant ovarian cancer (PROC), platinum sensitive ovarian cancer (PROC), BRAF mutant metastatic colorectal cancer, and other solid tumors. In addition, the Company is evaluating azenosertib and its BCL-2 inhibitor in patients with relapsed or refractory Acute Myeloid Leukemia (AML). On track to disclose multiple clinical data readouts during 2024 and 2025 (anticipated milestones noted below) and on track to submit its first New Drug Application (NDA) for azenosertib in a gynecologic malignancy in 2026. Corporate Updates Strengthened Leadership Team with the addition of Diana Hausman, M.D. as Chief Medical Officer, and Kyle Rasbach, Ph.D., Pharm.D. as Chief Business Officer. Dr. Hausman is an oncologist with extensive experience in all aspects of drug development and clinical strategy, including over a decade of experience as a Chief Medical Officer at various biopharma companies. During her career, she has contributed to the development of multiple cancer therapeutics, including small molecules, antibody drug conjugates, and immunotherapies. Dr. Rasbach joins from Eventide Asset Management, where he was a Portfolio Manager for Eventide’s healthcare and life sciences strategies, a Managing Director for Eventide Ventures, and a Senior Research Analyst for other Eventide investments. He previously held investment management and equity research roles at several other firms. (Link)Strengthened balance sheet with licensing of ROR1 antibody drug conjugate and proprietary technology platform to Immunome. Under the terms of the transaction, in January 2024 Zentalis received an up-front payment of $35 million in cash and Immunome common stock and remains eligible to receive up to $275 million of milestone payments and mid-to-high single-digit royalties. (Link)Hosted a webcast with gynecologic oncology academic expert highlighting the strength of the emerging clinical profile for azenosertib. On November 10, 2023, Zentalis participated in a webcast with Joyce F. Liu, M.D., MPH, to discuss azenosertib ovarian cancer clinical data. (Link) Anticipated Upcoming Milestones 1H 2024 Final results of Phase 1 azenosertib + chemotherapy (gemcitabine) trial in osteosarcoma (ZN-c3-003) 2H 2024 Final results of Phase 1b azenosertib monotherapy trial in solid tumors (ZN-c3-001)Topline data from Phase 1/2 azenosertib + PARP inhibitor (niraparib) and azenosertib monotherapy trial in platinum resistant ovarian cancer in partnership with GSK (MAMMOTH, ZN-c3-006)Initial data from Phase 1 azenosertib + BEACON regimen (encorafenib + cetuximab) trial in BRAF mutant metastatic colorectal cancer in partnership with Pfizer (ZN-c3-016)Initial data from Phase 1 of azenosertib + ZN-d5 trial in R/R AML (ZN-d5-004C)Additional details on planned clinical trial of azenosertib in PSOC in the 1L maintenance setting 1H 2025 Topline data from Phase 2 azenosertib monotherapy trial in platinum resistant high-grade serous ovarian cancer (DENALI, ZN-c3-005) 2H 2025 Topline data from Phase 2 azenosertib monotherapy trial in recurrent or persistent USC (TETON, ZN-c3-004) 2025 Initiate clinical trial of azenosertib in PSOC in the 1L maintenance setting 2026 First NDA for azenosertib in a gynecologic malignancy Full Year 2023 Financial Results Cash, Cash Equivalents and Marketable Securities Position: As of December 31, 2023, Zentalis had cash, cash equivalents and marketable securities of $482.9 million. The Company believes that its existing cash, cash equivalents and marketable securities as of December 31, 2023 will be sufficient to fund its operating expenses and capital expenditure requirements into 2026. The December 31, 2023 cash, cash equivalents and marketable securities balance does not reflect the up-front payment from Immunome of $35 million in cash and Immunome stock, which was received in January 2024, as the Company’s agreement was executed and announced in January 2024.Research and Development Expenses: Research and development (R&D) expenses for the year ended December 31, 2023 were $189.6 million, compared to $172.7 million for the year ended December 31, 2022. The increase of $16.9 million was primarily due to a $7.5 million increase in expense relating to our cost sharing relationship with Zentera that was terminated in June 2023, a $7.4 million increase related to personnel expenses, of which $5.8 million related to non-cash stock-based compensation expense, a $2.8 million increase in facilities and overhead expenses and a $2.8 million increase in consulting expense. These increases were partially offset by decreases of $2.8 million and $0.9 million in collaborations expense and supplies/other expenses, respectively.General and Administrative Expenses: General and administrative expenses for the year ended December 31, 2023 were $64.4 million, compared to $54.6 million during the year ended December 31, 2022. The increase of $9.8 million was primarily attributable to a $4.9 million non-cash operating lease impairment charge, a $5.1 million increase related to personnel expenses, of which $3.7 million related to non-cash stock-based compensation expense, and $1.4 million related to outside services. This was partially offset by a $1.6 million decrease in facilities and overhead and other expense. About AzenosertibAzenosertib is a potentially first-in-class and best-in-class small molecule WEE1 inhibitor in development for the treatment of cancer. Inhibition of WEE1, a DNA damage response kinase, drives cancer cells into mitosis without being able to repair damaged DNA, resulting in cell death. Currently, there are no FDA-approved WEE1 inhibitors, and azenosertib has been designed for superior selectivity and pharmacokinetic properties. Azenosertib is being developed in therapeutic areas of high unmet need and is being evaluated as a monotherapy, in combination with chemotherapy, and in combination with molecularly targeted agents. About Zentalis Pharmaceuticals Zentalis® Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company discovering and developing clinically differentiated small molecule therapeutics targeting fundamental biological pathways of cancers. The Company’s lead product candidate, azenosertib (ZN-c3), is a potentially first-in-class and best-in-class WEE1 inhibitor for advanced solid tumors and hematologic malignancies. Azenosertib is being evaluated as a monotherapy and in combination across multiple clinical trials and has broad franchise potential. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types and in combination with several chemotherapy backbones. As part of its azenosertib clinical development program, the Company is exploring enrichment strategies targeting tumors of high genomic instability, such as Cyclin E1 positive tumors, homologous recombination deficient tumors and tumors with oncogenic driver mutations. The Company is also leveraging its extensive experience and capabilities across cancer biology and medicinal chemistry to advance its research on protein degraders. Zentalis has operations in both New York and San Diego. For more information, please visit www.zentalis.com. Follow Zentalis on X/Twitter at @ZentalisP and on LinkedIn at www.linkedin.com/company/zentalis-pharmaceuticals. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the potential for azenosertib to be first-in-class and best-in-class; the potential for azenosertib to be groundbreaking across various tumor types; the broad franchise potential of azenosertib; our plans to share multiple clinical datasets to demonstrate the potential of azenosertib in multiple cancer types as a monotherapy and in combination, and the timing thereof; our plans to submit an NDA for azenosertib in a gynecologic malignancy and the timing thereof; the potential for us to receive milestone payments from the Immunome licensing agreement; our plans with respect to the development of our product candidates, including azenosertib and ZN-d5; our plans and timing for the initiation of and the release of data from our clinical trials and our ability to meet other key milestones; the potential benefits of azenosertib, including the potential benefits of the design thereof, the value potential of the asset, and the potential to improve outcomes for patients; and the Company’s cash runway. The terms “advancing,” “anticipate,” “believe,” “continue,” “designed,” “evaluating,” “milestone,” “on track,” “ongoing,” “plan,” “potential,” “projected,” “progress,” “promising,” “strategy,” 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 plans, including the costs thereof, of development of any diagnostic tools; our substantial dependence on the success of our lead product candidates; the outcome of preclinical testing and early trials may not be predictive of the success of later clinical trials; failure to identify additional product candidates and develop or commercialize marketable products; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the regulatory approval process or ongoing regulatory obligations; failure to obtain U.S. or international marketing approval; 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. Comparisons of our product candidates to other agents in this press release are not head-to-head. Contact:Carlo Tanzi, Ph.D.Kendall Investor Relationsctanzi@kendallir.com Zentalis Pharmaceuticals, Inc.Consolidated Statements of Operations(In thousands, except per share amounts) Year endedDecember 31, 2023 2022 2021 Operating Expenses Research and development$189,590 $172,734 $175,601 Zentera in-process research and development45,568 - - General and administrative64,351 54,553 40,941 Total operating expenses299,509 227,287 216,542 Loss from operations(299,509) (227,287) (216,542) Other Income (Expense) Investment and other income, net22,617 5,987 401 Gain on deconsolidation of Zentera— — 51,582 Net loss before income taxes(276,892) (221,300) (164,559) Income tax expense (benefit)(601) (469) (297) Loss on equity method investment16,014 16,282 1,831 Net loss(292,305) (237,113) (166,093) Net loss attributable to noncontrolling interests(114) (307) (7,368) Net loss attributable to Zentalis$(292,191) $(236,806) $(158,725) Net loss per common share outstanding, basic and diluted$(4.47) $(4.48) $(3.72) Common shares used in computing net loss per share, basic and diluted65,409 52,857 42,688 Zentalis Pharmaceuticals, Inc. Selected Condensed Consolidated Balance Sheet Data (In thousands) December 31, 2023 2022 Cash, cash equivalents and marketable securities$482,919 $437,371 Working capital (1)427,351 395,286 Total assets551,688 539,310 Total liabilities114,297 105,286 Total Zentalis equity$437,391 $434,024 (1) The Company defines working capital as current assets less current liabilities.

AUSTIN, Texas--( BUSINESS WIRE )--Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, today announced that its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, has met coverage requirements from the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostics Services Program (MolDX) in two new indications: ovarian cancer in the adjuvant and surveillance settings, and breast cancer in the neoadjuvant setting. These determinations add to a growing list of covered indications for Signatera, including adjuvant and recurrence monitoring coverage in colorectal cancer, muscle-invasive bladder cancer, and breast cancer; and pan-cancer immunotherapy response monitoring. Ovarian Cancer The MolDX coverage decision applies to patients with ovarian cancer, in both the adjuvant and surveillance settings. Ovarian cancer is the 5 th leading cause of cancer-related death among women, with an estimated 2022 incidence and mortality of 19,880 and 12,810, respectively, and a median age at diagnosis of 63 years. 1 While multiple new treatment options have been introduced in recent years, physicians have had to rely on imperfect biomarkers to determine who is likely to benefit from these more intensive regimens, and recurrence risk remains high 2 . Additionally, current guidelines for surveillance are limited and providers often rely on tools with low sensitivity and specificity, such that a significant unmet need remains for these patients. 3 Signatera performance in ovarian cancer was validated in a blinded, multi-site study published in Gynecologic Oncology . 4 The study analyzed 163 plasma samples from 69 patients with stage I-IV ovarian cancer. Test performance was evaluated at multiple time points: pre-surgery, post-surgery prior to adjuvant treatment, and longitudinally. With longitudinal testing, recurrence was detected with 100% sensitivity, 100% specificity, and an average lead time of 10 months ahead of imaging. Breast Cancer (neoadjuvant setting) This MolDx coverage decision applies to patients with breast cancer in the neoadjuvant setting across all subtypes of the disease, including hormone receptor (HR)-positive, HER2-positive, and triple negative breast cancers. Up to 50% of newly diagnosed breast cancer patients receive neoadjuvant therapy (NAT). 5 Guidelines recommend routine assessment of tumor response to neoadjuvant therapy but acknowledge that this is “difficult” using currently available diagnostic tools. 6 Signatera has been validated to address this unmet need. The coverage decision was based on clinical evidence published in Cancer Cell 7 from the I-SPY2 trial, which reported on 283 patients and 1,024 plasma samples, with a median of more than 3 years of clinical follow up and a maximum of more than 7.5 years. The study demonstrated that early ctDNA clearance during NAT was a significant predictor of therapy response (p=0.0002), and Signatera negativity after NAT was significantly associated with improved distant recurrence-free survival (DRFS), even in patients with residual cancer burden at surgery (p<0.0001). By contrast, persistent Signatera positivity during and after NAT was significantly associated with therapy non-response and inferior DRFS (p=0.02 to p<0.0001). “ These important Medicare decisions support our ability to personalize disease management for patients with ovarian cancer, the most lethal gynecologic malignancy worldwide, and extend existing coverage in breast cancer to the neoadjuvant setting,” said Minetta Liu, M.D., chief medical officer of oncology at Natera. “ Clinical evidence continues to demonstrate the value of Signatera across various settings of disease, which can help clinicians make timely decisions and may improve outcomes for patients. We are incredibly proud of this milestone, and look forward to continuing to work with Medicare to make Signatera more widely accessible for people affected by cancer.” About Signatera Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard of care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer and muscle invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 65 peer-reviewed papers. About Natera Natera™ is a global leader in cell-free DNA testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health, and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated in approximately 175 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. For more information, visit www.natera.com . Forward-Looking Statements All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy and performance of our tests, or of the benefits of our tests and product offerings to patients, providers and payers. Additional risks and uncertainties are discussed in greater detail in “Risk Factors” in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov . References American Cancer Society. Key Statistics for Ovarian Cancer. https://www.cancer.org/cancer/types/ovarian-cancer/about/key-statistics.html Ovarian Cancer Research Alliance. Recurrence. https://ocrahope.org/patients/diagnosis-and-treatment/recurrence/#:~:text=Data%20has%20shown%20that%20statistically,periods%20of%20time%20after%20recurrence . NCCN Ovarian Cancer/Fallopian Tube Cancer/Primary Peritoneal Cancer Treatment Guidelines. V1.2024 - Jan 17, 2024. Hou JY, Chapman JS, Kalashnikova E, et al. Circulating tumor DNA monitoring for early recurrence detection in epithelial ovarian cancer. Gynecol Oncol. 2022;167:334-341. (doi: 10.1016/j.ygyno.2022.09.004). Riedel F, Hoffmann AS, Moderow M, et al. Time trends of neoadjuvant chemotherapy for early breast cancer. Int J Cancer. 2020;147(11):3049–3058. National Comprehensive Cancer Network (NCCN). Version 1.2024, Jan 25, 2024. Magbanua MJM, Swigart LB, Ahmed Z, et al. Clinical significance and biology of circulating tumor DNA in high-risk early-stage HER2-negative breast cancer receiving neoadjuvant chemotherapy. Cancer Cell. 2023;41:1-12.