A Prospective Study Based on Spatial Multi-Omics for Predicting the Efficacy of Androgen Deprivation Therapy Combined With Second-Generation Novel Endocrine Therapeutic Agents in Metastatic Hormone-Sensitive Prostate Cancer.

This study plans to enroll patients with newly diagnosed metastatic hormone-sensitive prostate cancer (mHSPC) and conduct a prospective, single-center, observational study. By performing whole-exome sequencing (WES), Xenium spatial transcriptomics, and PhenoCycler-Fusion spatial single-cell proteomics (PCF analysis) on tumor tissue samples, we aim to comprehensively delineate the molecular landscape of patients with different spatial multi-omic profiles in the real-world setting. We will investigate the associations between these molecular features and differential treatment responses to various therapeutic regimens, and further construct predictive models of treatment response. Ultimately, this will enable precise evaluation of treatment outcomes across distinct molecular subtypes and provide evidence to support individualized precision diagnostics and therapeutics for patients with mHSPC.

Start Date01 Oct 2026

Sponsor / Collaborator

Anhui Medical University

NCT07783282

/ Not yet recruitingPhase 1

A Phase 1 Open-label Study to Evaluate the Effect of Enzalutamide, Apalutamide and Bicalutamide on the Pharmacokinetics of Fezolinetant in Male Participants With Prostate Cancer

Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of testosterone in the body. One of the side effects of hormone therapy is hot flashes. There is an unmet medical need to treat hot flashes in men undergoing hormone therapy for prostate cancer. This study will help researchers understand if hormone therapy (enzalutamide, apalutamide or bicalutamide) affects the way fezolinetant is processed by the body in men with prostate cancer.
The main aim of this study is checking levels of fezolinetant in the blood over time to learn how long it takes to get into the blood, spread through the body and be cleared from the body.
Men with prostate cancer or healthy men can take part. The men with prostate cancer will have already been taking standard hormone therapy (enzalutamide, apalutamide or bicalutamide) for a few months. Men cannot take part if they have recently had major surgery, have had an infection, have a heart condition, or have gut problems. Men with prostate cancer cannot take part if they have other cancers, have recently had certain treatments for prostate cancer, have certain ongoing medical conditions or any chronic disease. This includes any liver problems.
There will be 4 groups in this study:
Group 1 - men with prostate cancer who are taking enzalutamide will be given fezolinetant.
Group 2 - men with prostate cancer who are taking apalutamide will be given fezolinetant.
Group 3 - men with prostate cancer who are taking bicalutamide will be given fezolinetant.
Group 4 - healthy men will only be given fezolinetant.
The men taking part in the study will stay in the clinic for a few days and nights. The men will have nothing to eat or drink for several hours before taking 1 tablet of fezolinetant. Blood samples will be taken and health checks done. During their stay, the men with prostate cancer will continue to be given the standard dose of their hormone therapy. All the men in the study will continue to have regular health checks and will be asked if they have any medical problems. After the men leave the clinic, they will return to the clinic about a week later for a final health check.

Start Date31 Aug 2026

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT07751133

/ RecruitingPhase 3IIT

Evaluating Hormone Therapy to Achieve Optimal Doses in Metastatic Prostate Cancer

The goal of this phase 3 clinical trial is to determine the clinical effectiveness and cost effectiveness of using lower doses of Androgen Receptor Pathway Inhibitors (ARPI) to treat patients with prostate cancer that has spread (metastasized). The main questions it aims to answer are:
1. if overall survival for reduced dose ARPI is not worse than standard dose ARPI when treating patients with metastatic prostate cancer, and
2. that fatigue (extreme exhaustion) and not stopping ARPI permanently (due to adverse effects) are better than average with the reduced dose.
Participants will:
* Be randomised to take full dose (100%) of ARPI or half dose (50%) of ARPI.
* Receive standard of care ADT.
* Be on treatment for approximately 3 years according to standard of care.
* Have clinic assessments and visits in clinic or remotely, as per their treating hospital's standard routine local practice in line with standard of care. Additional visits are not expected.
* Complete quality of life questionnaires at week 0 (pre-treatment) and weeks 4, 16, 32, 48 and 64.
* Keep a diary of their symptoms.
Translational research samples will be collected as follows:
* Blood samples at week 0 (pre-treatment) and weeks 24, 32, 48 and at disease progression.
* Urine samples at week 0 (pre-treatment) and week 24 and at disease progression.
* FFPE Tumour: Routinely collected diagnostic blocks. The duration of follow-up is approximately 3 years after the last patient is recruited (minimum follow-up is 3 years; maximum follow-up is approximately 6 years for the the first patient recruited) and the trial is expected to complete August 2032 (Last Patient Last Visit).

Start Date28 Aug 2026

Sponsor / Collaborator

University College London

[+3]

100 Clinical Results associated with Apalutamide

100 Translational Medicine associated with Apalutamide

100 Patents (Medical) associated with Apalutamide

815

Literatures (Medical) associated with Apalutamide

05 Oct 2026·BRITISH JOURNAL OF CANCER

Functional and omics-based rationale for the induction of BRCAness by androgen receptor pathway inhibitors to sensitize prostate cancer to PARP inhibition, regardless of HRR status

Article

Author: Hu, Zifan ; Moustafa, Ayham ; Tilki, Derya ; Burdak-Rothkamm, Susanne ; Siebels, Bente ; Alawi, Malik ; Petersen, Cordula ; Hahn, Jan ; Mansour, Wael Y ; Maurer, Tobias ; Mair, Thomas ; von Amsberg, Gunhild ; Elsesy, Mohamed E ; Rothkamm, Kai ; Bokemeyer, Carsten ; Oh-Hohenhorst, Su-Jung ; Müller, Christian ; Schlüter, Hartmut

Abstract:

Background:

Two PARP inhibitors (PARPis), olaparib and talazoparib, have been approved in combination with androgen receptor pathway inhibitors (ARPIs) for metastatic castration-resistant prostate cancer (mCRPC) in Europe, regardless of homologous-recombination repair (HRR) status. However, the mechanism in HRR-negative patients remains unclear.

Methods:

We assessed PARP inhibitors (PARPis; olaparib, talazoparib) alone and with ARPIs (abiraterone, enzalutamide, apalutamide) in prostate cancer cell lines, metastatic patient-derived organoids (mPDOs), and LN-metastatic tissue slice cultures. HRDetect and multi-omics analyses were used to investigate response mechanisms.

Results:

PARPi-ARPI combinations significantly reduced survival in LNCaP, DU145, and 22RV1 cells and produced greater cytotoxicity than either agent alone in all models. In three metastatic mPDOs, olaparib alone had no effect, whereas talazoparib reduced survival in one mPDO and ARPIs reduced survival in two. In all tested models, PARPi-ARPI combinations produced greater cytotoxicity than either agent alone. None of the mPDOs showed BRCAness by HRDetect. ARPIs downregulated RAD51 and induced a BRCAness-like state, with reduced RAD51 foci formation at DNA double-strand break sites and impaired repair capacity, thereby sensitizing cells to PARPis. In LN-metastatic tissue slice cultures, combination therapy reduced double-strand break repair capacity in 67% of samples. Proteomic analysis showed that olaparib suppressed prometastatic pathways, including epithelial-mesenchymal transition and angiogenesis.

Conclusion:

ARPIs induce a BRCAness-like phenotype through RAD51 downregulation and enhance PARPi sensitivity in metastatic prostate cancer models, supporting combined ARPI-PARPi therapy.

01 Oct 2026·European Urology Open Science

Oncologic Outcomes in a Contemporary “PROTEUS-like” Cohort of High-risk Prostate Cancer Treated with Radical Prostatectomy Without Neoadjuvant Hormonal Therapy

Article

Author: Westhofen, Thilo ; Seizer, Clara ; Kolligs, Frederik ; Heck, Matthias ; Steinestel, Julie ; Buchner, Alexander ; Aydogdu, Can ; John, Benso ; Papadopoulos, Iason ; Berg, Elena K ; Stief, Christian G ; Casuscelli, Jozefina ; Mayr, Roman

Background and objective:

High-risk prostate cancer (PCa) carries substantial risks of recurrence, metastasis, and mortality. Neoadjuvant therapy before radical prostatectomy (RP) remains investigational. The PROTEUS (NCT03767244) trial evaluates perioperative apalutamide + androgen deprivation therapy (ADT) but lacks a surgery-only control cohort. The objective of this study is to characterize oncologic outcomes in patients with PROTEUS-like high-risk PCa undergoing RP without neoadjuvant therapy.

Methods:

We performed a retrospective, single-center cohort study of consecutive patients fulfilling PROTEUS high-risk criteria who underwent RP with lymphadenectomy without prior ADT or neoadjuvant treatment. The primary outcome was biochemical recurrence-free survival (BCR-FS). Secondary outcomes included metastasis-free survival (MFS), event-free survival (EFS), and cancer-specific survival (CSS).

Key findings and limitations:

Among 1392 patients, median follow-up was 60 mo (95% confidence interval [CI], 56-64); 67% received postoperative radiotherapy. BCR-FS at 36, 60, and 120 mo was 60% (95% CI, 57-64), 44% (95% CI, 40-49), and 22% (95% CI, 17-28), respectively. MFS was 79% (95% CI, 76-83), 71% (95% CI, 66-76), and 56% (95% CI, 47-65), respectively. EFS was 56% (95% CI, 52-60), 40% (95% CI, 36-45), and 18% (95% CI, 13-23), respectively. CSS remained high at 95.5% (95% CI, 94-97), 92% (95% CI, 90-94), and 86% (95% CI, 81-91), respectively. Limitations include the retrospective, single-center design, absence of centralized pathology review, and maturing follow-up.

Conclusions and clinical implications:

These findings demonstrate substantial rates of recurrence and metastatic progression despite contemporary management, underscoring the persistent unmet need in this population and providing a rationale for prospective evaluation of perioperative treatment intensification strategies such as PROTEUS.

01 Oct 2026·EUROPEAN JOURNAL OF CANCER

Evaluating safety: Number needed to harm analyses of androgen receptor inhibitors in advanced prostate cancer

Article

Author: George, Daniel J ; Yip, Yen Yen ; McManus, Hannah D ; Saad, Fred ; Fizazi, Karim ; Srinivasan, Shankar ; Upton, Alexander ; Duflot, Maxime ; Morgans, Alicia K

INTRODUCTION:

Androgen receptor inhibitors (ARIs) are standard of care in prostate cancer. Patient-centered treatment goals include optimizing efficacy, safety, tolerability, and quality of life, and prolonging time to treatment change. Number needed to harm (NNH) analyses can help contextualize adverse event (AE) risk and support treatment decisions. This exploratory study assessed NNH for AEs of interest with ARIs in nonmetastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC).

METHODS:

NNH was calculated using AE data from pivotal trials comparing ARIs plus androgen deprivation therapy (ADT) versus ADT and derived using the reciprocal of the absolute risk increase, then compared between ARIs.

RESULTS:

In nmCRPC, darolutamide had a higher NNH (lower risk) than apalutamide and enzalutamide for the all-grade AEs hot flash (100.0/not reported [NR])/20.0), fatigue (29.4/10.8/5.3), arthralgia (negative [NEG]/11.9/100.0), cognitive impairment (≥ 250/47.6/33.3), hypertension (71.4/20.0/14.3), and falls (NEG/15.2/14.3) in the primary analysis, a trend generally maintained in the final analysis. A similar trend was reported for most grade ≥ 3 AEs. In mHSPC, darolutamide also had a higher NNH for most all-grade/grade ≥ 3 AEs. Exceptions included all-grade constipation (higher NNH for apalutamide and enzalutamide) and anemia (higher NNH for apalutamide). NNH comparisons across trials should be interpreted cautiously because of heterogeneity in trial designs and study populations.

DISCUSSION:

Similar NNH trends observed in nmCRPC and mHSPC patient populations suggest a lower risk of incremental harm for most AEs with darolutamide versus apalutamide and enzalutamide. Understanding ARI risk profiles is key to optimizing treatment selection and improving tolerability in patients.

206

News (Medical) associated with Apalutamide

07 Oct 2026

·www.biospace.com

Astellas Highlights Data Advancing Cancer Care and Innovation for Patients with Hard-to-Treat Cancers at ESMO 2026

– PADCEV™ (enfortumab vedotin) plus pembrolizumab data highlight durable survival benefit in advanced bladder cancer – – VYLOY™ (zolbetuximab) research reinforces the role of CLDN18.2 in shaping gastric cancer treatment decisions – TOKYO , Oct. 6, 2026 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that 21 abstracts from its oncology portfolio will be presented at the European Society for Medical Oncology Congress 2026 (ESMO 2026), taking place October 23–27 in Madrid, Spain. The presentations span prostate, urothelial, gastric/gastroesophageal junction (GEJ), lung and pancreatic cancers, reflecting Astellas' commitment to advancing standards of care and pursuing new scientific approaches designed for cancers where significant unmet need remains. Moitreyee Chatterjee-Kishore, Ph.D., MBA, Executive Vice President and Head of Oncology Development, Astellas: "Standards of care do not change by accident. The data being presented at ESMO 2026 demonstrate how a deep understanding of disease biology and differentiated modalities is helping advance care for patients with bladder, gastric, and prostate cancers, including through approaches such as PADCEV ™ (enfortumab vedotin) plus pembrolizumab, VYLOY ™ (zolbetuximab), and XTANDI ™ (enzalutamide). We are building upon this knowledge to develop the next generation of therapeutic options for cancers where unmet needs remain and look forward to engaging in discussions about this work at the congress." Highlights from Astellas' ESMO 2026 presentations include: Enfortumab vedotin plus pembrolizumab presentations include the longest follow-up reported to date in locally advanced or metastatic urothelial cancer, along with analyses across patient subgroups and treatment settings. Additional presentations include trials in progress exploring bladder preservation in muscle-invasive bladder cancer. Zolbetuximab presentations examine CLDN18.2 assessment, patient identification and real-world use, reinforcing the growing body of evidence supporting CLDN18.2-guided treatment decisions in gastric and GEJ cancers. Pipeline presentations feature trials-in-progress across Astellas' investigational programs, including Phase 3 trials of setidegrasib in KRAS G12D-mutated pancreatic and non-small cell lung cancers, a Phase 1 trial of ASP5834 in KRAS-mutated or amplified solid tumors, and a Phase 1b/2 trial of ASP546C in CLDN18.2-expressing solid tumors. Together, these investigational studies illustrate Astellas' continued investment in advancing new approaches aimed at overcoming challenges that have limited progress in hard-to-treat cancers. Additional details on Astellas' presentations at ESMO 2026 are included below. Presentation Title Lead Author Presentation Details Enfortumab vedotin EV-103 DE/Cohort A and Cohort K Final Analysis: Enfortumab vedotin with or without pembrolizumab as first-line treatment for cisplatin (cis)-ineligible locally advanced or metastatic urothelial carcinoma: long-term follow-up analysis from EV-103 cohorts DE/A and K J. P. Maroto Rey Type: Rapid oral Abstract number: 4740RO Date/time: Saturday, October 24, 10:15-11:45 EV-302 Comorbidities (DCO3): Enfortumab vedotin plus pembrolizumab for previously untreated locally advanced or metastatic urothelial carcinoma: updated exploratory analysis of EV-302 in older patients and those with comorbidities S. S. Sridhar Type: Poster Abstract number: 4761P Date/time: Friday, October 23, 15:15-16:00 EV-302 Clinical Subgroups (DCO3): Enfortumab vedotin + pembrolizumab in previously untreated locally advanced or metastatic urothelial cancer: exploratory analyses based on disease-related characteristics from EV-302 J. Bedke Type: Poster Abstract number: 4760P Date/time: Friday, October 23, 15:15-16:00 EVOLVE 3: Real-world treatment patterns in patients with locally advanced and metastatic urothelial cancer in France F. Joly Type: ePoster EV-303/KN-905 ITT3: Perioperative pembrolizumab or enfortumab vedotin plus pembro in participants with muscle-invasive bladder cancer who are cisplatin-ineligible: ad hoc analysis from KEYNOTE-905 A. Ullén Type: Proffered paper session Abstract number: 4733O Date/time: Friday, October 23, 13:30-15:00 EV-304/KN-B15 ctDNA: ctDNA analysis of the phase 3 KEYNOTE-B15 trial: neoadjuvant and adjuvant enfortumab vedotin + pembrolizumab for participants with muscle-invasive bladder cancer who are eligible for cisplatin J. Chatzkel Type: Proffered paper session Abstract number: 4734O Date/time: Friday, October 23, 13:30-15:00 EV-304/KN-B15 ePRO: Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants (pts) with muscle-invasive bladder cancer eligible for cisplatin in the phase 3 KEYNOTE-B15 study A. Gómez De Liaño Type: Rapid oral Abstract number: 4738RO Date/time: Saturday, October 24, 10:15-11:45 EV-209 TiP: EV-209: an open-label, single-arm, phase 2 study of enfortumab vedotin plus pembrolizumab for bladder preservation in patients with muscle-invasive bladder cancer eligible for radical cystectomy Thomas Powles Type: Poster Abstract number: 4769TiP Date/time: Friday, October 23, 15:15-16:00 EV-309 TiP: EV-309: an open-label, randomized, phase 3 study of enfortumab vedotin plus pembrolizumab for bladder preservation in patients with muscle-invasive bladder cancer Matthew D. Galsky Type: Poster Abstract number: 4770TiP Date/time: Friday, October 23, 15:15-16:00 Enzalutamide Adelpi REALIZE: High-risk biochemically recurrent (hrBCR) hormone sensitive prostate cancer (PC): European real-world (RW) evidence on risk stratification, PSMA PET use, and physician practices A. Merseburger Type: ePoster Abstract number: 2063eP Date/time: N/A AMNOG NMA in mHSPC: Network meta-analysis (NMA) on the safety of androgen receptor pathway inhibitors (ARPIs) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from German AMNOG dossiers C. Ohlmann Type: Poster Abstract number: 2295P Date/time: Friday, October 23, 15:15-16:00 CASPER: Outcomes of enzalutamide (ENZ) and apalutamide (APA) in metastatic hormone-sensitive prostate cancer (mHSPC): a Canadian real-world (RW) study B. Shayegan Type: ePoster Abstract number: 2329eP Date/time: N/A ARCHES/ARANOTE indirect safety comparison : Indirect safety comparison of enzalutamide (ENZA) and darolutamide (DARO) with androgen-deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) S. Shariat Type: Poster Abstract number: 2294P Date/time: Friday, October 23, 15:15-16:00 EMBARK deep PSA response: Deep prostate-specific antigen (PSA) response by prior definitive treatment (tx) in patients (pts) with high-risk biochemically recurrent prostate cancer (hrBCR): EMBARK post hoc analysis S. Freedland Type: Poster Abstract number: 2293P Date/time: Friday, October 23, 15:15-16:00 Zolbetuximab SPOTLIGHT ctDNA: ctDNA Assessment in Patients with CLDN18.2+, HER2−, Locally Advanced Unresectable or Metastatic (la/m) Gastric or Gastroesophageal Junction Adenocarcinoma (G/GEJ a) in SPOTLIGHT K. Shitara Type: Poster Abstract number: 2882P Date/time: Sunday, October 25, 12:00-12:45 Canadian PSP: Real-World Use of Zolbetuximab Plus Chemotherapy (CTx) in Patients With CLDN18.2+, HER2−, Locally Advanced (LA) Unresectable or Metastatic Gastric or Gastroesophageal Junction Cancer (mGC/GEJC) in a Canadian Patient Support Program (PSP) H. Karachiwala Type: Poster Abstract number: 2941P Date/time: Sunday, October 25, 12:00-12:45 Pipeline Phase 3 PDAC TiP: A Phase 3, double-blind, randomized trial of setidegrasib + mFOLFIRINOX or NALIRIFOX as first-line treatment for patients with metastatic pancreatic ductal adenocarcinoma (PDAC) harboring KRAS G12D mutations: Trial in progress T. Macarulla Type: Poster Abstract number: 3190TiP Date/time: Sunday, October 25, 12:00-12:45 Phase 3 NSCLC TiP: Phase 3, randomized, open-label trial of setidegrasib vs docetaxel in patients with KRAS G12D-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) that progressed on or after platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy: Trial in progress F. Skoulidis Type: ePoster Abstract number: 2871eTiP Date/time: N/A Phase 1b/2 TiP: Phase 1b/2 study of ASP546C, a Claudin 18.2-targeting antibody-drug conjugate with a topoisomerase 1 inhibitor payload, in patients with Claudin 18.2-expressing unresectable locally advanced or metastatic solid tumors T. Macarulla Type: ePoster Abstract number: 1133eTiP Date/time: N/A FiH TiP: A phase 1 study of ASP5834 in patients with locally advanced or metastatic solid tumors with Kirsten rat sarcoma viral oncogene homologue (KRAS) mutations or amplifications S. Sen Type: ePoster Abstract number: 1145eTiP Date/time: N/A Combination clinical data for mss CRC: A phase 1/2 study of ASP1570 for locally advanced/metastatic microsatellite-stable (MSS) colorectal cancer (CRC) V. Boni Type: ePoster Abstract number: 1090eP Date/time: N/A About Astellas Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at . About PADCEV and the Pfizer, Astellas and MSD Collaboration Seagen and Astellas previously entered a clinical collaboration agreement with MSD to evaluate the combination of Seagen's and Astellas' PADCEV TM (enfortumab vedotin) and MSD's KEYTRUDA ® (pembrolizumab) in patients with urothelial cancer. Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada). About XTANDI and the Pfizer/Astellas Collaboration In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a commercial agreement to jointly develop and commercialize XTANDI ® (enzalutamide) in the United States, while Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing the product outside the United States. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S. Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions, and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. View original content to download multimedia: SOURCE Astellas Pharma Inc.

Phase 1Phase 3License out/inClinical ResultAcquisition

06 Oct 2026

·www.businesswire.com

Kairos Pharma Reports Positive, Statistically Significant Interim Efficacy Data from Phase 2 Trial of ENV-105 in Metastatic Prostate Cancer

LOS ANGELES--(BUSINESS WIRE)--Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing drug resistance in cancer, today announced positive interim efficacy data from its ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim analysis demonstrated a statistically significant difference in progression-free survival (PFS) between all patients in the trial treated with ENV-105 plus apalutamide and those treated with apalutamide alone. Median PFS was 17.7 months with the combination compared with 2 months with apalutamide alone (P=0.0008). With the interim efficacy signal, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in the course of disease progression. Rather than treating patients after one or two anti-androgen agents, the modified protocol will enroll patients who experience a PSA increase following upfront treatment with an androgen signaling inhibitor. Patients will be randomized to enzalutamide alone or enzalutamide in combination with ENV-105. The protocol modification is intended to expand the eligible patient population and facilitate enrollment, with Kairos Pharma targeting completion of the Phase 2 trial in or before the fourth quarter of 2027. "These interim results provide an important clinical signal for ENV-105 and support our strategy of targeting the mechanisms underlying drug resistance," said Kairos Pharma Chief Executive Officer Dr. John Yu. "The protocol modification will allow more patients to be eligible for the potential benefits of ENV-105 treatment while evaluating the therapy earlier in disease progression." The findings further support Kairos Pharma's strategy of targeting mechanisms associated with cancer drug resistance. ENV-105 targets CD105, a protein identified as a key driver of resistance and disease relapse in response to standard therapy, providing the rationale for evaluating ENV-105 in combination with standard cancer therapies. The Phase 2 trial is designed to evaluate ENV-105, a first-in-class CD105 antibody, in men with metastatic prostate cancer resistant to standard hormone therapy, in combination with standard of care, apalutamide. Patients have been enrolled at Cedars-Sinai Medical Center, City of Hope and Huntsman Cancer Institute at the University of Utah. About Kairos Pharma Ltd. Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Kairos Pharma's lead candidate, ENV-105 (carotuximab), is an antibody targeting CD105 — a protein identified as a key driver of resistance and disease relapse in response to standard cancer therapy. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. For more information, visit kairospharma.com. Cautionary Statement Concerning Forward-Looking Statements This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements are identified by terminology such as "may," "should," "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes," or the negative of these or similar terms. Actual results could vary materially from expectations and projections of Kairos Pharma if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties materialize. Risk factors include but are not limited to: success and/or completion of Phase 2 clinical trials (for prostate cancer) and Phase 1 clinical trials (for lung cancer); challenges inherent in product research and development; uncertainty regarding future regulatory approval and commercial success; and other factors described in Kairos Pharma's SEC filings, including its Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Kairos Pharma is not obligated to update any forward-looking statement except as required by applicable law.

Phase 2Clinical ResultPhase 1

08 Sep 2026

·www.biospace.com

Flare Therapeutics Appoints Peter Lebowitz, MD, PhD, to Board of Directors and Brian DeSchuytner as Chief Financial Officer and Chief Business Officer

- Addition of industry leader Dr. Peter Lebowitz strengthens the Board with deep oncology-focused drug development expertise - Brian DeSchuytner brings finance, business development, strategy, commercial and operations expertise to support company growth following prioritization of prostate cancer programs CAMBRIDGE, Mass., Sept. 08, 2026 (GLOBE NEWSWIRE) -- Flare Therapeutics Inc. (FlareTx), a clinical-stage biotechnology company targeting transcription factors to discover and develop transformative therapies for prostate cancer, today announced the appointments of Peter Lebowitz, MD, PhD, to its Board of Directors and Brian DeSchuytner as Chief Financial Officer and Chief Business Officer. “We're excited to welcome Peter to our Board. He is a highly accomplished, world-class oncology drug developer and industry leader, with a track record of identifying and delivering transformational medicines and building highly productive teams. His expertise will be invaluable as we work to advance our AR(ON) degrader, FX-111, and our AR(ON) RIPTAC program to address the needs of patients living with prostate cancer,” said Anna Protopapas, Chief Executive Officer. "We're also thrilled to have Brian join Flare Therapeutics at this pivotal moment in our growth. His broad executive leadership experience across finance, business development, strategy, commercial and operations is well-suited to advance our financial and business strategy toward key value-creating milestones.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Appointment of Peter Lebowitz, MD, PhD, to Board of Directors Peter Lebowitz, MD, PhD, is Chief Executive Officer and Chief Medical Officer at Third Arc Bio. Prior to Third Arc Bio, Peter served as the Global Head of Oncology R&D for Johnson & Johnson (J&J) overseeing an end-to-end research and development organization that delivered 13 new drugs to market with over 60 approvals. Over his career, Peter has delivered multiple first and best-in-class transformational medicines, including ZYTIGA ® , IMBRUVICA ® , DARZALEX ® , DARZALEX FASPRO ® , ERLEADA ® , RYBREVANT ® , LAZCLUZE ® , CARVYKTI ® , TECVAYLI ® , TALVEY ® , TAFINLAR ® , and MEKINIST ® . Peter’s innovative approach to drug development resulted in 12 FDA Breakthrough Therapy Designations and 38 New England Journal of Medicine publications for J&J medicines. These achievements underscore his ability to push the boundaries of science and deliver life-changing therapies to patients. Prior to J&J, Peter also held multiple leadership roles at GlaxoSmithKline (GSK) including Vice President, Global Head of Oncology Early Clinical Development and Vice President and Medical Development Leader in Late Development. In these roles, he successfully filed 10 Investigational New Drug applications and played a leading role in taking two medicines from early discovery through global registration trials by setting a new benchmark with a “novel-novel” drug combination approach. Peter now also serves as a CEO partner at Omega Funds, a leading life science investment firm, and as a board director at Neomorph and BridgeBio Oncology Therapeutics. After earning his BA in chemistry from Harvard University, Peter earned his MD and PhD in cell and molecular biology from the University of Pennsylvania and completed his training in internal medicine and oncology at Duke University and the National Cancer Institute. "FlareTx’s AR(ON)-targeting degrader, FX-111, and AR(ON) RIPTAC are highly differentiated and have the potential to address key limitations of current prostate cancer therapies," said Dr. Lebowitz. “I am greatly impressed with the rigor and strength of the scientific evidence, and I am excited to join the Board and support the team as they advance these programs.” Appointment of Brian DeSchuytner as Chief Financial Officer and Chief Business Officer ezstandalone.cmd.push(function () { ezstandalone.showAds(132); }); Most recently, Mr. DeSchuytner was the Chief Financial Officer and Chief Operating Officer at Mersana Therapeutics, where he raised significant capital and led impactful business development collaborations with J&J, GSK, and Merck KGaA, culminating in the sale of the company to Day One Biopharmaceuticals. Prior to Mersana, he was Vice President responsible for ZEJULA ® (niraparib) commercialization at TESARO. Previously, Mr. DeSchuytner held increasingly senior roles in corporate development and in commercial at Millennium: The Takeda Oncology Company including serving as a Vice President and Global Brand Head responsible for the global launch of NINLARO ® (ixazomib). He started his career in the life sciences practice of L.E.K. Consulting. He holds an MBA from the Wharton School at the University of Pennsylvania and a BA from Dartmouth College. "Despite the introduction of novel androgen receptor pathway inhibitors and new targeted therapies, prostate cancer is a devastating disease and metastatic prostate cancer remains incurable. Targeting AR(ON) offers the potential to overcome key vulnerabilities of conventional therapies that target AR(OFF) and has broad potential across prostate cancer at all stages,” said Mr. DeSchuytner. “I look forward to partnering with Anna and the rest of the Flare Therapeutics team to demonstrate the value of our molecules and improve outcomes for patients living with prostate cancer.” Daphne Karydas, who served as President and Chief Financial Officer since October 2021, has decided to pursue other opportunities. Ms. Karydas will serve as an advisor to the Company, to support a smooth transition. “On behalf of the Board of Directors, our leadership and the entire Flare Therapeutics team, I also want to thank Daphne for her many contributions,” continued Ms. Protopapas. “Daphne was instrumental in growing and scaling the company to where we are today, including securing significant financing and executing key strategic partnerships. We wish her all the best in her new role.” ezstandalone.cmd.push(function () { ezstandalone.showAds(133); }); About Flare Therapeutics Inc. Flare Therapeutics is a clinical-stage biotechnology company drugging transcription factors to fully unlock the therapeutic potential of this previously elusive target class. The company’s discovery platform has generated a rich development portfolio which is currently focused on advancing transformative AR(ON)-targeting therapies for prostate cancer. For more information, please visit and follow us on LinkedIn . Contacts: Investors Sarah McCabe investorrelations@flaretx.com Media media@flaretx.com ezstandalone.cmd.push(function () { ezstandalone.showAds(134); });

Executive ChangeBreakthrough Therapy

100 Deals associated with Apalutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11040	Apalutamide	L02BB05	DB11901

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Japan	Janssen Pharmaceutical KK	29 May 2020
Metastatic castration-resistant prostate cancer	United States	Janssen Biotech, Inc.	17 Sep 2019
Hormone-dependent prostate cancer	European Union	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Iceland	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Liechtenstein	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	Norway	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	United Kingdom	Janssen-Cilag Ltd.	14 Jan 2019
Prostatic Cancer	Canada	Janssen Research & Development LLC	27 Jul 2018
Castration-sensitive prostate cancer	Australia	Janssen-Cilag Pty Ltd.	05 Jul 2018
Castration-Resistant Prostatic Cancer	United States	Janssen Biotech, Inc.	14 Feb 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	United States	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	China	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Australia	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Brazil	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Canada	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	France	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Germany	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Mexico	Janssen Research & Development LLC	31 Aug 2023
Metastatic Castration-Sensitive Prostate Carcinoma	Phase 3	Poland	Janssen Research & Development LLC	31 Aug 2023
Adenocarcinoma of prostate	Phase 3	Hong Kong	Janssen LP	20 Jul 2020

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03767244 (PROTEUS, Pubmed \| N Engl J Med)	Phase 3	Localized Prostate Carcinoma	2,109	ADT plus Apalutamide	vzghjdyqst(nxrykoqvlf) = ibmdslknke avhmnpcver (nmvxcsqxyj ) View more	Positive	06 Aug 2026
				ADT plus Placebo	vzghjdyqst(nxrykoqvlf) = kinfhslhjf avhmnpcver (nmvxcsqxyj ) View more
NCT03371719 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Adenocarcinoma of prostate	298	Apalutamide (Arm 1 (Radiation Therapy, Apalutamide))	nuqarymolt = kdjscrkufo yhdfdkjffa (rukpzohzxb, nfaotiewiv - okoettxkwb) View more	-	10 Jul 2026
				Placebo (Arm 2 (Radiation Therapy, Placebo))	nuqarymolt = tdvewvphnd yhdfdkjffa (rukpzohzxb, izmxqpcgxy - ivethibsim) View more
NCT05717582 (CHAMPION, Pubmed \| Eur J Nucl Med Mol Imaging)	Phase 2	Hormone-dependent prostate cancer PSMA-avid	48	Apalutamide + Apalutamideprivation Therapy	pxggrweita(cqabxwdhuj) = oeivsdldpv llxbwdjely (luwadcvznr, 86.0 - 98.8) View more	Positive	08 Jun 2026
NCT03767244 (PROTEUS, ASCO2026)	Phase 3	Locally Advanced Prostate Carcinoma	2,109	apalutamide+ADT	rqnwfjkafj(kiapnhiatq) = lqffbmwfkx zicljwgthd (htzlgddqzc ) View more	Positive	29 May 2026
				placebo+ADT	rqnwfjkafj(kiapnhiatq) = jlvnsffsye zicljwgthd (htzlgddqzc ) View more
NCT05884398 (LIBERTAS, ASCO2026)	Phase 3	Metastatic Castration-Sensitive Prostate Carcinoma	118	Apalutamide + continuous androgen deprivation therapy (ADT)	krtfqescpe(jdlvqwrjby) = aomvefjyni tsjduvsqyq (zblbhndiwt ) View more	Positive	29 May 2026
NCT02489318 (TITAN, ASCO2026)	Phase 3	Advanced Prostate Carcinoma	2,211	Apalutamide+ADT	ewqkecpcmo(dvuntnwjtg) = nykmfophxz ahqtouxovj (rptvgqbioi ) View more	Positive	29 May 2026
				Placebo+ADT	ewqkecpcmo(dvuntnwjtg) = knxkuzcejt ahqtouxovj (rptvgqbioi ) View more
NCT02789878 (NeoPRO, ASCO2026)	Phase 2	Localized Prostate Carcinoma Neoadjuvant	62	goserelin+abiraterone acetate+prednisone	hfdfavvoet(jjvrvgitny) = wyqvuoynuq vojtpahsva (toamybbnjb ) View more	Negative	29 May 2026
				goserelin+abiraterone acetate+prednisone+apalutamide	hfdfavvoet(jjvrvgitny) = nzxaruksuq vojtpahsva (toamybbnjb ) View more
AUA2026	Not Applicable	Hormone-dependent prostate cancer First line	4,011	Enzalutamide	tbndougpwz(qsouehtykj): HR = 0.93 (95.0% CI, 0.82 - 1.06), P-Value = 0.27 View more	Positive	15 May 2026
				Apalutamide
AUA2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma	9,294	ADT + Docetaxel + ARPI	hxujymvinl(sqgdwmqdxs) = ynmgqmmiwf qmbakkitvl (atvjmganiw, 71 - 84) View more	Positive	15 May 2026
				ADT + ARPI	hxujymvinl(sqgdwmqdxs) = snstudfiom qmbakkitvl (atvjmganiw, 58 - 64)
NCT02772588 (CTgov)	Phase 2	Prostatic Cancer \| Adenocarcinoma of prostate	64	stereotactic, ultra-fractionated radiotherapy+ARN-509+Abiraterone+Leuprolide	pyowjqkpkz = xqkuzzfcph xwekgziuzn (syfklvvfvd, vbtgmsjalr - jycvpshnty) View more	-	13 Apr 2026

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