Neu Direction: A Single Center Phase II Randomized Clinical Trial to Assess the Efficacy of Adding HER Inhibition to Standard of Care in Patients With Metastatic MLH1-low Endocrine-resistant ER+/HER2- Breast Cancer

The goal of this clinical trial is to learn if neratinib, an FDA-approved oral pan-HER2/3/4 inhibitor, improves disease control for participants with metastatic endocrine-resistant ER+/HER2-negative breast cancer. Neratinib is already approved for the treatment of HER2-postive breast cancers. The study will also learn about the safety of adding this drug to standard of care treatments. The main questions it aims to answer are:
1. Does adding neratinib to standard of care systemic therapy improve disease control for patients with metastatic hormone-driven breast cancer that is resistant to endocrine therapy?
2. What side effects do participants have when adding neratinib to standard of care therapy? Researchers will compare standard of care endocrine therapy regimens with and without neratinib to see if neratinib improves control of treatment-resistant metastatic breast cancer that has continued to progress while eon first line endocrine therapy.
Participants will:
1. Take standard of care endocrine therapy for metastatic endocrine-resistant breast cancer as determined by their medical oncologist or standard of care therapy with neratinib daily
2. Visit the clinic every 3 months for checkups, tests and imaging studies

Start Date01 Jul 2027

Sponsor / Collaborator

University of California San Diego

NCT07706374

/ RecruitingPhase 1IIT

E.N.D.E.A.V.O.R.: An Exemestane Needed Dose Efficacy and Verification as an Ovulation Induction Regimen Study

The goal of this clinical trial is to learn if study drug exemestane will increase chances of ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS, formerly called polycystic ovary syndrome (PCOS)). It will also learn about side effects of study drug exemestane in this study population. The main questions it aims to answer are:
Does exemestane lead to ovulation for patients with polyendocrine metabolic ovarian syndrome (PMOS- formerly called PCOS)?
Researchers will compare exemestane to a placebo (a look-alike substance that contains no drug) to see if exemestane helps PMOS patients ovulate.
Participants will:
Take exemestane or a placebo every day for 5-10 days Visit the clinic three times for ultrasounds, labs, and to answer questions about side effects.
If they become pregnant during this study, they will tell us how their pregnancy went after the study via a registry online.

Start Date01 Oct 2026

Sponsor / Collaborator

The University of North Carolina at Chapel Hill

CTR20262981

/ Active, not recruitingNot Applicable

依西美坦片在健康绝经后女性中随机、开放、两制剂、四周期、完全重复交叉、餐后状态下的生物等效性试验

[Translation] A randomized, open-label, two-dose, four-cycle, fully replicated crossover bioequivalence trial of exemestane tablets in healthy postmenopausal women.

以上海朝晖药业有限公司生产的依西美坦片（规格：25 mg）为受试制剂，Pfizer Italia s.r.l.持证的依西美坦片（规格：25 mg，商品名：阿诺新®/AROMASIN®）为参比制剂，比较在餐后给药条件下，受试制剂和参比制剂的药代动力学差异，评估在餐后给药条件下受试制剂和参比制剂的生物等效性和在健康绝经后女性试验参与者体内的安全性。

[Translation]

Exemestane tablets (25 mg) manufactured by Shanghai Zhaohui Pharmaceutical Co., Ltd. were used as the test formulation, and exemestane tablets (25 mg, brand name: AROMASIN®) licensed by Pfizer Italia s.r.l. were used as the reference formulation. The pharmacokinetic differences between the test and reference formulations under postprandial dosing conditions were compared, and the bioequivalence and safety of the test and reference formulations under postprandial dosing conditions in healthy postmenopausal female participants were evaluated.

Start Date29 Aug 2026

Sponsor / Collaborator

Shanghai Zhaohui Pharmaceutical Co. Ltd.

100 Clinical Results associated with Exemestane

100 Translational Medicine associated with Exemestane

100 Patents (Medical) associated with Exemestane

2,030

Literatures (Medical) associated with Exemestane

01 Dec 2026·Journal of Cancer Policy

Availability and affordability of essential anticancer medicines in a resource-constrained province of Iran: A WHO/HAI-based public health assessment

Article

Author: Karami, Masoud Ali ; Hayati, Hadi ; Piramoon, Majid ; Mirali, Armin

BACKGROUND:

Access to essential anticancer medicines in low- and middle-income countries is shaped not only by physical availability but also by affordability. Evidence from subnational settings in Iran remains limited. This study assessed the point-in-time availability and wage-based affordability of selected essential anticancer medicines in Lorestan Province, western Iran.

METHODS:

In a cross-sectional survey 20 essential anticancer medicines were assessed in 13 public hospital pharmacies and 70 private community pharmacies using an adapted WHO/HAI approach. Availability was measured as stock on the survey day, and affordability as the number of daily minimum wages needed for a standard 30-day course.

RESULTS:

Public-sector generic availability was high overall (mean 81% ± 24%), while public-sector originator availability was lower (33% ± 28%). Private pharmacies showed almost no stock for either generics (0.3% ± 1.1%) or originators (0.5% ± 2.2%). Eighteen of 20 medicines were unavailable in private pharmacies. Only three generics-letrozole, bortezomib, and exemestane-were affordable (≤1 wage-day), along with two originators-letrozole and bortezomib. Most treatments required several to hundreds of wage-days, with the highest burdens seen for capecitabine, nilotinib, rituximab, and trastuzumab.

CONCLUSIONS:

Availability in public hospitals did not translate into affordability, and private-sector access was extremely poor. Policy responses should combine stronger supply monitoring, procurement reform, and targeted financial protection to improve equitable access to oncology medicines.

01 Nov 2026·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Exemestane chronic exposure induces cardiotoxicity by disrupting calcium homeostasis and endothelin pathway: Evidence from biochemical, radiological and histopathological analyses

Article

Author: Alotaibi, Reem Nasser ; Alzahrani, Khalid J ; Hassan, Hesham M ; Alzahrani, Fuad M ; Jamil, Salim ; Hayat, Muhammad Faisal ; Halawani, Ibrahim F

Exemestane (EMT) is a third-generation steroidal aromatase inhibitor extensively used in hormone receptor (HR)-positive breast cancer therapy and has been known to exert cardiovascular effects during prolonged treatment. The current study was planned to investigate the dose-dependent cardiotoxic effects of EMT. Thirty-two Sprague Dawley rats were randomly divided into four groups i.e., control group, EMT (5 mg/kg), EMT (15 mg/kg) and EMT (25 mg/kg) groups. Gene expression analysis showed downregulated expression of ATP2A2 (SERCA2a), CACNA1C, NOS3 (eNOS) and KLF2 coupled with marked upregulation in the expression of RYR2, PLN, CAMK2D, VEGFA, EDN1 and ICAM1, suggesting impaired calcium handling and endothelial dysfunction. The antioxidant enzymes (CAT, SOD, GPx, GST, GSR, HO-1 and GSH) were decreased significantly while the concentrations of ROS and MDA were increased in dose-dependent manner after EMT intoxication. Cardiac function assessment by echocardiography showed that EMT caused dose-dependent cardiac dysfunction as evidenced by reduced heart rate, wall thickness and cardiac chamber volumes of the ventricles thereby suggesting progressive ventricular remodeling, myocardial hypertrophy, and chamber enlargement particularly at 25 mg/kg EMT administration. Furthermore, EMT intoxication caused elevation in the levels of CK-MB, CPK, troponins, LDH, BNP, NT-proBNP and CRP. Significant upregulation observed in the levels of NF-κB, TNF-α, IL-1β, IL-6 and COX-2 after EMT administration. Moreover, EMT exposure promoted the levels of Bax, Caspase-3 and Caspase-9 while suppressing the levels of Bcl-2. Histopathological analysis demonstrated progressive myocardial degeneration, edema, inflammatory infiltration and peripheral necrosis. Overall, chronic EMT exposure leads to severe, dose-dependent cardiotoxicity, characterized by calcium dysregulation, oxidative stress, inflammatory responses, endothelial dysfunction and apoptosis, and thus warrants cardiac monitoring during prolonged EMT therapy.

01 Oct 2026·CHEMICO-BIOLOGICAL INTERACTIONS

Exemestane induces a reduction in hematopoietic stem cells and immunotoxicity in zebrafish larvae by downregulating Wnt signaling pathway

Article

Author: Wang, Ziang ; Xiao, Juhua ; Huang, Sizhou ; Li, Weirong ; Chen, Wanqing ; Tang, Jingrong ; Zhang, Shouhua ; Peng, Wenjia ; Zeng, Junquan ; Zhou, Xiying ; Xiao, Zhonghao ; Georgiev, Milen I ; Cao, Zigang

Exemestane is a third-generation aromatase inhibitor commonly prescribed for estrogen-dependent breast cancer. Given the widespread clinical use of exemestane, various adverse reactions have been reported. However, there are only a limited number of reports on the effects on the immune system. Therefore, it is essential to examine its potential toxicity and mechanism of action. In this research, zebrafish were employed as a model organism to examine the impact of exemestane on embryonic development and immune function. The larvae that were fertilized 8 hours post-fertilization (hpf) were respectively exposed to exemestane solutions of different concentrations (0.9, 1.8 and 2.7 mg/L).The results demonstrated that exemestane exposure induced a concentration-dependent reduction in larval body length and an increase in yolk sac area, indicative of developmental toxicity. Subsequently, exemestane was administered to the corresponding transgenic fish lines, and it was observed that the numbers of hematopoietic stem cells (HSCs), neutrophils, macrophages, and thymic T cells exhibited dose dependent decreases during exposure. Concurrently, exemestane-exposed zebrafish exhibited significantly elevated oxidative stress levels and an increased incidence of apoptotic cells. Gene expression analysis demonstrated that the immune-related gene NF-kB was downregulated, whereas tlr2 and tlr3 were upregulated in response to treatment. Notably, no significant alterations were observed in the expression levels of il-1b, prl, or lakros. . The use of astaxanthin (AS) and the wnt signaling pathway activator BML-284 can alleviate the embryonic immunotoxicity caused by exemestane. In conclusion, our study represents the first comprehensive evaluation of the immunomodulatory effects of exemestane on zebrafish larvae. These effects are likely associated with exemestane-induced elevation of oxidative stress and suppression of the Wnt signaling pathway.

News (Medical) associated with Exemestane

24 Sep 2026

·www.businesswire.com

New Data Shows Physicians Changed Extended Endocrine Therapy Recommendations for Over 40% of Patients Following Breast Cancer Index Testing

MARLBOROUGH, Mass.--(BUSINESS WIRE)--Hologic, Inc. and its subsidiary, Biotheranostics, Inc., today announced newly published data in JAMA Network Open showing that Breast Cancer Index® (BCI®) test results led physicians to change their extended endocrine therapy recommendations for 42% of patients. In two-thirds of those cases, physicians changed their recommendation against extending treatment.1 "[This study] reinforces the clinical utility of the Breast Cancer Index test to provide individualized insight into tumor biology that can meaningfully change how physicians and patients approach these decisions.” - Tara B. Sanft, M.D. The findings come from a large-scale BCI Registry Study conducted across multiple institutions at the Sarah Cannon Research Institute, involving nearly 3,000 patients with early-stage, hormone receptor-positive (HR+) breast cancer who received the BCI test. 1 Endocrine therapy is the standard of care for breast cancer survivors to help limit the effects of hormones that can fuel cancer growth — but it is also often the longest phase of a breast cancer patient’s treatment and can cause adverse health outcomes that impact quality of life.2-8 In this analysis, 83% of patients reported side effects ranging from muscle and joint pain to vaginal, sexual and psychological complaints.1 “Decisions about extended endocrine therapy can be challenging, and assumptions based on standard information, such as nodal involvement and tumor size and grade, may be misleading,” said Tara B. Sanft, M.D., of Hartford Healthcare and lead author of the study. “This final analysis of the BCI Registry Study reinforces the clinical utility of the Breast Cancer Index test to provide individualized insight into tumor biology that can meaningfully change how physicians and patients approach these decisions.” Approximately half of recurrences in HR+ breast cancer occur beyond five years post-diagnosis.9 Yet studies suggest that roughly 30–50% of women discontinue endocrine therapy before reaching the five-year mark, often due to side effects or uncertainty about whether continued treatment is necessary.10-13 Multiple trials have demonstrated that while extended endocrine therapy may be beneficial for some women in reducing their risk of late recurrence, not all benefit.14-17 As of July 2026, physicians can now access an updated report option from the same BCI test, providing additional clinical insights earlier — at the time of diagnosis — to support greater clarity as patients plan for treatment.18-20 The updated report offers additional context on 10-year recurrence risk, which can either reinforce the case for medication adherence or help identify whether a patient’s risk may be low enough to consider a less intensive approach to endocrine therapy. “The Breast Cancer Index test’s updated report supports a more informed plan for the years ahead, allowing physicians to further personalize patient care and provide them with a clear roadmap from the time of diagnosis,” said Lloyd Sanders, Vice President and General Manager, Oncology Services at Hologic. “That clarity can make a real difference as patients plan for treatment and life as a cancer survivor.” The BCI test is the only genomic assay recognized by both the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) and the ASCO® Clinical Practice Guideline to predict which patients with early-stage, HR+, HER2- breast cancer are likely to benefit from extended endocrine therapy.2-3 The test has been used by more than 10,000 healthcare providers and evaluated across multiple clinical studies involving more than 15,000 patients.14-27 The recently published results from the BCI Registry Study solidify the clinical impact and value of the Breast Cancer Index test beyond its extensive validation and exclusive guideline recognition. Additional clinical insights from the same established test now enable earlier treatment planning and greater Clarity from the Start™.18-20 About the Breast Cancer Index Test The Breast Cancer Index test is a molecular, gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncology care teams and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. The Breast Cancer Index test has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. The ASCO® Clinical Practice Guideline and the NCCN Guidelines® acknowledge the Breast Cancer Index test as a biomarker to help inform extended endocrine treatment decisions.2-3 The Breast Cancer Index test is intended for routine clinical use, and physician treatment decisions based on results are the responsibility of the physician. It is a sole-source laboratory-developed test (LDT) performed by Biotheranostics, Inc., a CLIA-certified and CAP-accredited diagnostic laboratory. For more information and the full intended use and limitations, visit www.breastcancerindex.com. About Hologic, Inc. Hologic, Inc. is a global leader in women’s health dedicated to developing innovative medical technologies that effectively detect, diagnose and treat health conditions and raise the standard of care around the world. To learn more, visit www.hologic.com and connect with us on LinkedIn, Facebook, X, Instagram and YouTube. Forward-Looking Statements This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic products. There can be no assurance these products will achieve the benefits described herein or that such benefits will be replicated in any particular manner with respect to an individual patient, as the actual effect of the use of the products can only be determined on a case-by-case basis. In addition, there can be no assurance that these products will be commercially successful or achieve any expected level of sales. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements presented herein to reflect any change in expectations or any change in events, conditions or circumstances on which any such data or statements are based. Hologic, Biotheranostics, Breast Cancer Index, BCI and Clarity from the Start are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries. All other trademarks are the property of their respective owners. References Sanft T, et al. JAMA Netw Open. 2026;9(9):e2634974. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed September 8, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Andre F, et al. J Clin Oncol. 2022;40(16):1816-1837. Referenced with permission from the American Society of Clinical Oncology (ASCO® Clinical Practice Guideline) Clinical Practice Guideline Biomarkers for Adjuvant Endocrine and Chemotherapy in Early-Stage Breast Cancer. © American Society of Clinical Oncology. 2026. All rights reserved. To view the most recent and complete version of the guideline, go online to https://ascopubs.org/jco/special/guidelines . ASCO makes no warranties of any kind whatsoever regarding their content, use of application and disclaims any responsibility for their application or use in any way. Breastcancer.org. Side Effects of Hormonal Therapy for Breast Cancer. Breastcancer.org. Last updated June 11, 2026. Accessed on September 8, 2026. https://www.breastcancer.org/treatment/hormonal-therapy/side-effects U.S. Food & Drug Administration. Armidex Full Prescribing Information. Last updated December 16, 2024. Accessed June 16, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020541s036lbl.pdf U.S. Food & Drug Administration. Aromasin Full Prescribing Information. Last updated December 16, 2024. Accessed September 8, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020753s025lbl.pdf U.S. Food & Drug Administration. Femara Full Prescribing Information. Last updated September 16, 2025. Accessed September 8, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209092Orig1s025,209935Orig1s031lbl.pdf U.S. Food & Drug Administration. Soltamox Full Prescribing Information. Last updated April 8, 2019. Accessed June 16, 2026. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021807s006lbl.pdf Pan H, et al. N Engl J Med. 2017;377:1836-1846. Hershman DL, et al. J Clin Oncol. 2010;20;28(27):4120-4128. Friese CR, et al. Breast Can Res Treat. 2013;138(3):931-39. Saha P, et al. J Clin Oncol. 2017;(35):3113-3122. Wei J, et al. Breast Cancer Res Treat. 2025;214(2):239-246. Sgroi DC, et al. J Natl Cancer Inst. 2013;105(14):1036-1042. Bartlett JMS, et al. Clin Cancer Res. 2022;28(9):1871-1880. Noordhoek I, et al. Clin Cancer Res. 2021;27(1):311-319. Mamounas EP, et al. Clin Cancer Res. 2024;30(9):1984-1991. Jilderda MF, et al. Clin Cancer Res. 2025;3;31(11):2222-2229. Jilderda MF, et al. npj Breast Cancer. 2026;12;21. O’Regan RM, et al. Breast. 2026;86:104714. Data on file. Zhang Y, et al. Clin Cancer Res. 2013;19(15):4196-4205. Sgroi DC, et al. Lancet Oncol. 2013;14(11):1067-1076. Zhang Y, et al. Clin Cancer Res. 2017;23(23):7217-7224. Bartlett JMS, et al. Clin Cancer Res. 2024;30(8):1509-1517. O’Regan RM, et al. JAMA Oncol. 2024;10;(10):1379-1389. O’Regan RM, et al. JAMA Netw Open. 2025;8(11):e2540931.

ASCOClinical Result

29 Jun 2026

·www.biospace.com

Oncotelic Announces Peer-Reviewed Validation of Deciparticle™ Platform Supporting Clinical Development of Sapu003

Publication Highlights Novel Intravenous Everolimus Formulation and Demonstrates Broad Potential of Deciparticle ™ Technology for Hydrophobic Therapeutics SAN DIEGO, Calif., June 29, 2026 (GLOBE NEWSWIRE) -- Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB: OTLC) and Sapu Nano today announced today announced the publication of a peer-reviewed scientific manuscript validating its proprietary Deciparticle ™ nanoparticle platform through the successful development of Sapu003 , the Company's investigational intravenous everolimus formulation currently being evaluated in an ongoing Phase 1b clinical trial. The publication, "Intravenous Everolimus Formulation (Sapu003) for Clinical Trials," has been published in the International Journal of Molecular Sciences and provides the first comprehensive description of the Deciparticle ™ platform, including formulation design, scalable cGMP manufacturing, product characterization, stability, and preclinical evaluation. Publication Citation Min SH, Forero K, Putnam W, Anderson J, Hoff R, Lopp J, Trieu V, Ho K, Lee C. Intravenous Everolimus Formulation (Sapu003) for Clinical Trials. International Journal of Molecular Sciences. 2026;27(13):5775. doi:10.3390/ijms27135775. Everolimus is a well-established inhibitor of the mammalian target of rapamycin (mTOR) approved for the treatment of multiple cancers. However, because of its poor aqueous solubility and limited oral bioavailability, clinical use has historically been restricted to oral administration. Sapu003 was developed using the Deciparticle ™ platform to enable intravenous delivery through a stable nanoparticle formulation. The publication reports several significant achievements, including: Development of a stable intravenous everolimus formulation with mean particle sizes below 20 nanometers. A robust, scalable cGMP manufacturing process capable of producing clinical-grade material with high batch-to-batch reproducibility. Favorable product stability following lyophilization and refrigerated storage. Successful formulation of multiple hydrophobic therapeutic compounds, demonstrating the broader applicability of the Deciparticle ™ platform beyond everolimus. Potent preclinical antitumor activity supporting continued clinical development of Sapu003. "The publication of this work represents an important milestone for Sapu Bioscience," said Vuong Trieu, Ph.D., CEO and Chairman of Oncotelic. "Independent peer review validates not only the scientific foundation supporting Sapu003, but also the broader Deciparticle ™ platform. We believe this technology has the potential to address one of the longstanding challenges in drug development—enabling intravenous delivery of poorly water-soluble therapeutic compounds through a scalable and reproducible manufacturing process." Unlike many formulation technologies developed for a single product, the published research demonstrates that the Deciparticle ™ platform is compatible with wide range of hydrophobic molecules, including rapalogs, macrocyclic compounds, immunosuppressants, and selected peptide therapeutics. The Company believes this broad formulation capability may support future pipeline expansion and collaborative development opportunities. Sapu003 is currently being evaluated in an ongoing Phase 1b open-label dose-escalation study in patients with advanced mTOR-sensitive solid tumors. The study is assessing the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of weekly intravenous Sapu003 administered in combination with exemestane. "The publication marks the successful translation of the Deciparticle ™ platform from laboratory research to clinical-stage manufacturing," added Dr. Trieu. "As our Phase 1b clinical study progresses, we look forward to further evaluating the potential of Sapu003 while continuing to expand the application of the Deciparticle ™ platform to additional therapeutic programs." About Sapu003 Sapu003 is an investigational intravenous formulation of everolimus developed using Sapu Bioscience's proprietary Deciparticle ™ nanoparticle platform. The program is designed to overcome the formulation limitations associated with oral everolimus while enabling predictable intravenous administration for the treatment of patients with advanced cancers. About Deciparticle ™ Deciparticle ™ is Sapu Bioscience's proprietary nanoparticle formulation platform designed to enable intravenous delivery of poorly water-soluble therapeutic compounds. The technology combines amphiphilic polymer design with scalable cGMP manufacturing to generate stable nanoparticle formulations suitable for clinical development. The platform has demonstrated compatibility across multiple classes of hydrophobic therapeutic agents and is being evaluated for broader pharmaceutical applications. About Sapu Nano Sapu Nano (US) LLC is a clinical-stage biotechnology company developing the proprietary Deciparticle ™ nanomedicine platform for intravenous delivery of poorly water-soluble therapeutics. The Company's lead product candidate, Sapu003 (intravenous everolimus), is currently in Phase 1b clinical development for advanced mTOR-sensitive solid tumors. In addition to Sapu003, the Deciparticle ™ platform is being developed to enable next-generation nanomedicine products across oncology and other serious diseases. For more information, please visit . About Oncotelic Therapeutics Oncotelic Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of oncology and immunotherapy products. The Company's mission is to address high-unmet-need cancers and rare pediatric indications with innovative, late-stage therapeutic candidates. In addition to its directly owned and developed drug pipeline, Oncotelic benefits from the robust portfolio of inventions created by its CEO, Dr. Vuong Trieu, who has filed over 500 patent applications and holds 75 issued U.S. patents. Beyond its internal programs, the Company also licenses and co-develops select drug candidates through joint ventures. Currently, Oncotelic owns 45% of GMP Bio, a joint venture under Dr. Trieu's leadership and guidance, which is advancing its own pipeline of drug candidates that further complement and strengthen Oncotelic's strategic position in oncology and rare disease therapeutics. Oncotelic also develops PDAOAI, its proprietary artificial intelligence platform for drug discovery, cleanroom automation, and AI-assisted GMP manufacturing. Through Oncotelic's relationship with SAPU Bio — an OEB-5 sterile injectable cGMP manufacturing facility — PDAOAI underpins the Company's joint development work with TechForce Robotics on intelligent automation for high-containment GMP biomanufacturing. For more information, please visit . Oncotelic Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this release other than statements of historical fact are forward-looking and are based on current expectations, estimates, and projections about our business and future plans. In some cases, you can identify forward-looking statements by terms such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "project," "forecast," "potential," "continue," and similar expressions (including the negative of such terms). Forward-looking statements in this release include, without limitation: the completion, scope, timing, capabilities, and commercialization of Phase 2 objectives under our joint manufacturing automation initiative with TechForce Robotics; the operational utility, performance, and customer adoption of the AI-Powered GMP Manufacturing Services Platform; the application of PDAOAI to sterile manufacturing operations, electronic batch records, GMP workflow execution, cleanroom monitoring, and autonomous materials movement; the potential for future software licensing, automation deployment, manufacturing partnerships, and technology-enabled contract development and manufacturing services; the size, growth, and addressability of the pharmaceutical manufacturing software and automation market; the demonstration of PDAOAI and the integrated robotics platform at BIO International Convention 2026; the role of SAPU Bio as commercial deployment site and proving ground; regulatory interactions and potential approvals; development or commercialization of any product candidates within the Oncotelic / GMP Bio / Sapu ecosystem; future financings, strategic transactions, and/or public offerings involving our joint ventures or affiliates; and other statements that are not historical facts. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to: the competitive market of AI-enabled GMP manufacturing software and AI-enabled robotics; the performance and continued cooperation of our robotics and automation partners, including TechForce Robotics; the inherent uncertainties of drug discovery and development; our ability to enroll patients and complete studies on expected timelines; whether preclinical or early clinical findings (including biomarker associations) will be replicated in larger, controlled trials; regulatory developments in the United States and other jurisdictions; competitive developments; our ability to obtain or maintain intellectual property protection; our liquidity and access to capital; the performance of collaborators, suppliers, and manufacturers; and other risks described in our filings with the Securities and Exchange Commission (SEC), including the "Risk Factors" section of our most recent Form 10-K and subsequent periodic reports. Forward-looking statements speak only as of the date of this press release, and we undertake no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by law. Investor & Media Contact Oncotelic Therapeutics, Inc. Investor Relations ir@oncotelic.com Corporate Communications IBN | Austin, Texas Editor@InvestorBrandNetwork.com 512.354.7000

Phase 1ImmunotherapyDrug Approval

24 Jun 2026

·www.fda.gov

FDA approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer

On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer following induction treatment.Full prescribing information for Ibrance will be posted on Drugs@FDA.Efficacy and SafetyEfficacy was evaluated in PATINA (NCT02947685), a randomized, open-label trial in 518 patients with HR-positive, HER2-positive locally advanced or metastatic breast cancer who had no evidence of disease progression after induction treatment with a taxane and trastuzumab, with or without pertuzumab, for their advanced disease. Patients were randomized (1:1) to receive either palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy (fulvestrant or an aromatase inhibitor [anastrozole, letrozole, or exemestane]) or trastuzumab, with or without pertuzumab, and endocrine therapy alone. Patients received treatment until disease progression or unacceptable toxicity.The major efficacy outcome measure was investigator-assessed progression-free survival (PFS) per RECIST version 1.1. Overall survival (OS) was an additional efficacy outcome measure. A statistically significant improvement in investigator-assessed PFS was observed for palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy compared to trastuzumab, with or without pertuzumab, and endocrine therapy alone (Hazard ratio 0.76 [95% CI: 0.59, 0.97], 1-sided p-value 0.0134). Median PFS could not be adequately described because of censoring. At the time of the PFS analysis, OS data were not mature.The palbociclib prescribing information includes warnings and precautions for neutropenia, interstitial lung disease/pneumonitis, and embryo-fetal toxicity.Recommended DosageThe recommended palbociclib dosage is 125 mg orally once daily for 21 consecutive days, followed by seven days off treatment to comprise a complete cycle of 28 days. Refer to the prescribing information for the recommended dosages for trastuzumab, pertuzumab, and endocrine therapy.This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.Palbociclib received breakthrough therapy designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov.Follow the Oncology Center of Excellence on X (formerly Twitter) @FDAOncology.

Clinical ResultDrug ApprovalPriority ReviewBreakthrough Therapy

100 Deals associated with Exemestane

External Link

KEGG	Wiki	ATC	Drug Bank
D00963	Exemestane	L02BG06	DB00990

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Estrogen receptor positive breast cancer	United States	Pfizer Inc.	21 Oct 1999
Breast Cancer	Switzerland	Pfizer Inc.	14 Oct 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Neoplasms	NDA/BLA	China	Benova(Tianjin)Innovation Pharmaceutical Research Co., Ltd.	13 May 2022
Neoplasms	NDA/BLA	China	Cipla Ltd.	13 May 2022
Premenopausal breast cancer	Phase 3	China	Pfizer Inc.	09 Aug 2018
Hormone receptor positive HER2 negative breast cancer	Phase 3	Austria	Pfizer Inc.	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Austria	AstraZeneca PLC	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Hungary	Pfizer Inc.	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Hungary	AstraZeneca PLC	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Israel	AstraZeneca PLC	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Israel	Pfizer Inc.	13 Mar 2014
Hormone receptor positive HER2 negative breast cancer	Phase 3	Spain	AstraZeneca PLC	13 Mar 2014

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00541086 (GIM3 FATA, ESMO2026)	Phase 3	Early Stage Breast Carcinoma Adjuvant HR-positive	3,697	Anastrozoletamoxifen (Upfront or after 2 years of tamoxifen)	ddxjqmhixi(tpryxbaayh) = grfketmxbf wliecoftpy (uaithngpoe, 76.1 - 81.7)	Negative	23 Oct 2026
NCT00541086 (GIM3 FATA, ESMO2026)	Phase 3	Early Stage Breast Carcinoma Adjuvant HR-positive	3,697	Exemestanetamoxifen (Upfront or after 2 years of tamoxifen)	ddxjqmhixi(tpryxbaayh) = xbwhhzccfe wliecoftpy (uaithngpoe, 70.9 - 77.2)	Negative	23 Oct 2026
NCT02188745 (POLLY, CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	20	letrozole+Exemestane+17B-estradiol+anastrozole	ruangpqfiy = pmanfbdnkj xdtbdkzplj (aolgjonzzu, znzxkgqmdf - sxbkvizsob) View more	-	25 Sep 2026
NCT06169124 (Pubmed \| Gynecol Oncol)	Phase 2	Granulosa Cell Tumor of the Ovary	17	Exemestane 25 mg once dailyDarolutamide 600 mg twice daily + Exemestane 25 mg once dailyDarolutamide 600 mg twice daily + Exemestane 25 mg once dailyDarolutamide 600 mg twice daily four weeks	gsxauoeljc(gmjzpntgta) = gllrcypbzd cuygadclvd (fcglohoppk ) View more	Negative	01 Sep 2026
ESMO_SRC2026	Not Applicable	Perivascular epithelioid cell tumour	3	sirolimus + exemestane + gemcitabine	ezqtlntqjo(xwruxnsvxw) = alubxlkmtp kbyfvmgevc (izswyyusjz ) View more	Positive	09 Mar 2026
NCT04272801 (POWER, CTgov)	Phase 2	Early Stage Breast Carcinoma	84	Patient reported outcomes+letrozole+tamoxifen+exemestane+anastrozole	pwncpgqhhx = helgripjxw ugudclyveh (acqqdxopra, dxvofqubas - obtotlqqiw) View more	-	22 Oct 2025
NCT00253422 (SoFEA, CTgov)	Phase 3	Metastatic breast cancer	698	fulvestrant+anastrozole (Faslodex + Placebo)	xqdqhreqte(pitockqcuu) = aehqcebcsy izodrmygky (pcacojqxnp, rvrrvmfwtw - uyaphyzxao) View more	-	04 Jun 2025
NCT00253422 (SoFEA, CTgov)	Phase 3	Metastatic breast cancer	698	fulvestrant+anastrozole (Faslodex + Arimidex)	xqdqhreqte(pitockqcuu) = hnfbggxcjn izodrmygky (pcacojqxnp, wcvjnyibma - kpgenjgpyv) View more	-	04 Jun 2025
NCT03300557 (CTgov)	Phase 2	Endometrioid intraepithelial neoplasia \| Endometrial Endometrioid Adenocarcinoma \| Endometrial Hyperplasia ... View more	40	Pharmacokinetic Study+Exemestane	oxrrqbnfue(ikvaeobyqe) = yojazpymoi fhktukyxku (ensvmbvgqx, 0.22) View more	-	03 Jun 2025
SOFT and TEXT (ASCO2025)	Not Applicable	Hormone receptor positive breast cancer Adjuvant hormone receptor-positive	-	Exemestane + Ovarian Function Suppression	axrtcoaron(ghwctwzqdq) = vpjbfewxyo kcngfhlsgn (tfbvjictme ) View more	Positive	30 May 2025
SOFT and TEXT (ASCO2025)	Not Applicable		-	Tamoxifen + Ovarian Function Suppression	axrtcoaron(ghwctwzqdq) = loyynpxlqs kcngfhlsgn (tfbvjictme ) View more	Positive	30 May 2025
NCT02990845 (Pubmed) Manual	Phase 1/2	ER-positive/HER2-negative Breast Cancer ER Positive \| HER2 Negative	15	Pembrolizumab + exemestane + leuprolide	lqzfyrmcoc(yqnpwswoxo) = bigzyrpqon eiezdwakmi (owyehbqnlr ) View more	Positive	18 Dec 2024
NCT02028507 (PEARL \| GEICAM/2013-02 PEARL \| PEARL study, CTgov)	Phase 3	Metastatic breast cancer \| Hormone receptor positive HER2 negative breast cancer	693	palbociclib+Exemestane (Cohort 1: Palbociclib Plus Exemestane)	zzvqzncylu(vdscpbngxq) = cluvtlrmip dhqdcwcjlt (kbccgegbny, zqehbjwhos - puwabmzjdb) View more	-	25 Sep 2024
	Phase 3		693	fulvestrant+palbociclib (Cohort 2: Palbociclib Plus Fulvestrant)	zzvqzncylu(vdscpbngxq) = jkxnltbjhg dhqdcwcjlt (kbccgegbny, tevlgtzafs - bkcxqovlqs) View more	-	25 Sep 2024

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