This phase III trial compares the effect of adding docetaxel to hormonal therapy and apalutamide versus hormonal therapy and apalutamide alone in treating patients with prostate cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Hormone therapy for prostate cancer, also called androgen deprivation therapy (ADT), uses surgery or drugs to lower the levels of male sex hormones in a man's body. This helps slow the growth of prostate cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Giving docetaxel in addition to the usual treatment of hormonal therapy and apalutamide may work better in treating patients with metastatic prostate cancer than the usual treatment alone.

Start Date08 Nov 2025

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

NCT05521698

/ Not yet recruitingPhase 1IIT

A Randomized Trial of Apalutamide in Non-Muscle Invasive Bladder Cancer

This phase I trial evaluates the effects of apalutamide, compared to placebo, on epidermal growth factor receptor (EGFR) protein expression in patients with non-muscle invasive bladder cancer. Apalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Previous studies have suggested that expression of a protein called EGFR on tumor cells is related to bladder cancer disease progression. This trial may help doctors evaluate if apalutamide has any effect on EGFR expression in patients with non-muscle invasive bladder cancer.

Start Date01 Nov 2025

Sponsor / Collaborator

National Cancer Institute

NCT07086651

/ RecruitingNot Applicable

Real-world Clinical Outcomes With Androgen Receptor Pathway Inhibitors (ARPIs) in Metastatic Castration-sensitive Prostate Cancer (mCSPC) in the Flatiron Health Electronic Health Records (EHR) Database

The purpose of this study is to learn about how long apalutamide and enzalutamide are taken by men to treat mCSPC.
Prostate cancer is one of the most common cancers in men. The prostate is a gland in the male body that helps make semen. Metastatic cancer is a cancer that has spread to other parts of the body. Castration-sensitive prostate cancer means the cancer is being controlled by keeping the testosterone levels as low as would be expected if the testicles were removed by surgery.
This is a real-world study, not a clinical study. This means that researchers will look at what happens when men receive the treatments prescribed by their own doctor as part of their usual healthcare treatment. In this study, researchers will use information from cancer clinics (Flatiron Health electronic health records).
The study will include patients' information from the database for men who:
* Were identified to have mCSPC.
* Started treatment with apalutamide or enzalutamide (index date) for mCSPC.
* Were 18 years of age or older on the index date. Men in this study will be taking apalutamide or enzalutamide for treatment of their mCSPC. The study will compare how long men take apalutamide or enzalutamide. This study will use patient information from cancer clinics. Information from start of apalutamide or enzalutamide treatment until information is available in the database will be used to describe how long patients receive treatment.

Start Date21 Jul 2025

Sponsor / Collaborator

Pfizer Inc.

[+1]

100 Clinical Results associated with Apalutamide

100 Translational Medicine associated with Apalutamide

100 Patents (Medical) associated with Apalutamide

794

Literatures (Medical) associated with Apalutamide

31 Dec 2025·JOURNAL OF MEDICAL ECONOMICS

Healthcare resource utilization and costs among patients with metastatic castration-sensitive prostate cancer initiated on apalutamide or enzalutamide in the United States (2019–2023)

Article

Author: Khilfeh, Ibrahim ; Bilen, Mehmet A. ; Joshi, Kruti ; Rossi, Carmine ; Du, Shawn ; Shore, Neal D. ; Lowentritt, Benjamin ; Pilon, Dominic ; Wong, Gordon ; Kinkead, Frederic ; Burbage, Sabree

AIMS:

This retrospective longitudinal cohort study compared healthcare resource utilization (HRU) and costs among patients with metastatic castration (hormone)-sensitive prostate cancer who initiated apalutamide or enzalutamide, two androgen receptor pathway inhibitors (ARPIs) that have demonstrated efficacy in the treatment of advanced prostate cancer in phase 3 clinical trials.

METHODS:

Linked patient-level data from a practice-related clinical urology database and an administrative claims database in the United States (1 January 2016-31 December 2023) were used. Per-patient-per-month (PPPM) HRU and cost outcomes were compared between the apalutamide and enzalutamide cohorts during the observation period (i.e. from ARPI initiation until continuous insurance eligibility end) after inverse probability treatment weighting to balance differences in baseline characteristics.

RESULTS:

Overall, 486 patients who initiated apalutamide (mean age 70.3 years, 53.5% white, 25.4% Black, 58.1% Medicare-insured) and 601 patients who initiated enzalutamide (mean age 70.5 years, 52.9% white, 25.5% Black, 58.8% Medicare-insured) were included. Duration of continuous treatment use was 9.6 months for apalutamide and 8.6 months for enzalutamide. Despite longer continuous ARPI use among patients treated with apalutamide relative to enzalutamide, the number of inpatient admissions (rate ratio [RR] = 0.58; 95% confidence interval [CI] = 0.37, 0.86; p = 0.012), number of admission days (RR = 0.58; 95% CI = 0.19, 0.70; p = 0.004), as well as all-cause medical costs (mean monthly cost difference = -$1,845; 95% CI = -$52, -$4,908; p = 0.044) were significantly lower in the apalutamide cohort than the enzalutamide cohort during the observation period. Mean monthly all-cause pharmacy costs between the cohorts was not significantly different ($2,121; 95% CI = -2,389, 5,703; p = 0.320).

LIMITATIONS:

This study relied on administrative claims and clinical data, which may contain coding inaccuracies or omissions. While linkages between the data sources are comprehensive, any mislinkages may have led to misclassification and information bias.

CONCLUSION:

The findings of this study suggest that apalutamide may result in better economic outcomes relative to enzalutamide.

15 Dec 2025·INTERNATIONAL JOURNAL OF CANCER

Severe cutaneous adverse reactions associated with novel antiandrogens: A disproportionality analysis of three databases

Article

Author: Huang, Zhaohui ; Jiang, Jie ; Yang, Ziwen ; Zhu, Jianhong ; Li, Xinyu ; Li, Sha ; Huo, Xiaotong ; Wu, Junyan

Abstract:

Severe cutaneous adverse reactions (SCARs) encompassing Stevens‐Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP) are increasingly reported among patients treated with novel antiandrogens, but the signals of disproportionate reporting and clinical features remain inadequately defined. This study was an observational retrospective pharmacovigilance study using the publicly available FAERS/EudraVigilance/JADER databases. To explore the signals of disproportionate reporting, disproportionality analysis was conducted using information component (IC) and reporting odds ratio (ROR) methodologies. Descriptive statistics were calculated for baseline and demographic information, onset time, and reaction outcomes. There was no disproportional signal for SCARs in patients using abiraterone, enzalutamide, and darolutamide. Significant over‐reporting signals for apalutamide were observed in SJS (FAERS, ROR 025 = 4.12, IC 025 = 1.70, N = 30; EudraVigilance, ROR 025 = 11.54, IC 025 = 2.84, N = 55; JADER, ROR 025 = 2.90, IC 025 = 1.33, N = 25), TEN (FAERS, ROR025 = 4.40, IC025 = 1.75, N = 29, EudraVigilance, ROR 025 = 30.96, IC 025 = 3.74, N = 58; JADER, ROR 025 = 5.34, IC 025 = 1.85, N = 25), DRESS (FAERS, ROR025 = 2.68, IC025 = 1.33, N = 38; EudraVigilance, ROR 025 = 25.06, IC 025 = 3.53, N = 55; JADER, ROR 025 = 0.62, IC 025 = 0.19, N = 6) and AGEP (FAERS, ROR025 = 1.16, IC025 = 0.55, N = 7; EudraVigilance, ROR 025 = 4.18, IC 025 = 1.02, N = 5; JADER, ROR 025 = 1.05, IC 025 = 0.45, N = 4). Incorporated data from 3 databases, the lethal rates of apalutamide‐related SCARs were 24.4% for SJS, 51.1% for TEN, and 10.5% for DRESS. The median time to onset was 41 days for SJS, 29 days for TEN, and 40 days for DRESS, respectively. The postmarketing pharmacovigilance study suggested an association between SCARs and apalutamide use, but not for other novel antiandrogens. As apalutamide gains greater clinical use, practitioners must be aware of apalutamide‐SCARs risk.

01 Nov 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Novel androgen receptor inhibitors in prostate cancer: What do we know so far?

Review

Author: Rifaldi, Francesca ; Sporeni, Silvio ; Secondino, Simona ; Montagna, Benedetta ; Naspro, Richard Lawrence John ; Pedrazzoli, Paolo ; Tortorella, Anna ; Figini, Simone ; Lanzetta, Irene ; Lancia, Andrea ; Chiellino, Silvia

Prostate cancer (PC) is the second most common cancer among males, following lung cancer, more frequently occurring at an advanced age. Even nowadays, early diagnosis represents a challenge and validated screening methods are still missing. To date, multiple therapeutic strategies are available and a tailored approach is possible. The backbone of PC therapy is represented by the inhibition of the androgen signaling pathway, which mediates tumor cells growth. In this current therapeutic scenario, androgen-receptors signaling inhibitors (ARSIs) play a role in improving cancer treatment. This paper provides an overview of the currently available treatment options, focusing on the new drugs (ARSIs), their actual implications and future developments. METHODS: We conducted a research from Pubmed and Embase database regarding the terms 'prostate cancer', 'ARSI', 'androgen receptor inhibitors', ''enzalutamide", "apalutamide", and "Darolutamide". Original full-text articles published in English were reviewed. Based on this research 185 potentially relevant articles were found, limiting our research to the period 2019-2025 of publication. 75 articles were excluded on the basis of abstract, title or the content.

152

News (Medical) associated with Apalutamide

27 Oct 2025

·investors.oricpharma.com

ORIC® Pharmaceuticals Presented Preclinical Data at the EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics Supporting Best-in-Class Potential of ORIC-944 to Treat Patients With Prostate Cancer and Other Solid Tumors

SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Oct. 27, 2025 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, presented posters at the 2025 EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics highlighting preclinical data that further illustrate the potential for ORIC-944, a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, to treat prostate cancer and various other solid tumors. “These preclinical data underscore the potential of ORIC-944 to overcome resistance not only in prostate cancer but in other solid tumors and highlight that the therapeutic potential of PRC2 inhibition may be maximized in combination with inhibitors of key tumor drivers, including AR inhibitors and KRAS inhibitors,” said Lori Friedman, PhD, chief scientific officer. “Based on these data and clinical findings to date, we continue to believe ORIC-944 is a potential best-in-class PRC2 inhibitor with potential in both castration-resistant and castration-sensitive prostate cancer, as well as multiple other tumor types.” Key findings of posters presented at the 2025 EORTC-NCI-AACR International Conference on Molecular Targets and Cancer Therapeutics: PRC2 inhibition enhances AR inhibitor response to delay treatment relapse in castration-sensitive prostate cancer by restricting adaptation of tumor cells in preclinical studies ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with androgen receptor (AR) inhibition, synergistically impaired tumor growth, significantly improved survival and extended the duration of response to AR inhibitors in vivo by restricting cellular plasticity and delaying prostate tumor adaptation in castration-sensitive prostate cancer (CSPC). Transcriptional effects induced by combining ORIC-944 and AR inhibitors were comparable across all AR inhibitors tested (i.e., darolutamide, apalutamide or enzalutamide), and consistent with transcriptional effects of mevrometostat and AR inhibitor combination. Mechanistically, ORIC-944 in combination with AR inhibition in CSPC was linked to increased luminal cell state, and the restriction of lineage adaptation through reduced chromatin accessibility at binding sites of transcription factors associated with lineage diversification and cell plasticity such as FOXA, HNF1A and ONECUT2. These results were reproduced with mevrometostat and AR inhibitor combination and are consistent with what was previously reported in preclinical studies of CRPC. PRC2 inhibition enhances KRAS inhibitor response to delay treatment relapse in KRAS-mutant preclinical lung and colorectal cancer models ORIC-944 is a potential best-in-class PRC2 inhibitor that, when combined with KRAS inhibition, significantly improved efficacy and progression-free survival in KRAS G12C mutant non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) models, demonstrating that PRC2 inhibition can deepen and extend responses by preventing or delaying resistance to KRAS inhibition. PRC2 activity is increased in tumors from KRAS-mutant NSCLC and CRC patients, and transcriptional analysis from in vivo studies of CRC demonstrated that PRC2 inhibition drives tumor cell differentiation. ORIC-944 combined with the KRAS inhibitor adagrasib, regressed 100% of tumors in KRAS-mutant adenocarcinoma and squamous NSCLC xenograft models in vivo. The combination also prevented adagrasib tumor relapse and extended progression-free survival in a KRAS G12C adenocarcinoma NSCLC xenograft model. About ORIC-944 ORIC-944 is a potent and selective allosteric PRC2 inhibitor via EED subunit that demonstrates best-in-class drug properties in preclinical studies, including potency, solubility, and pharmacokinetics, with half-life supporting once daily dosing. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement, and a favorable safety profile. ORIC-944 continues to further demonstrate a potential best-in-class profile with positive interim PSA response data generated in an ongoing Phase 1b trial in combination with ERLEADA® (apalutamide) and in combination with NUBEQA® (darolutamide) for prostate cancer (NCT05413421). About ORIC Pharmaceuticals, Inc. ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the continued clinical development of ORIC-944 and its best-in-class potential; the potential advantages of ORIC-944, including in combination with KRAS inhibitors in lung and colorectal cancers; the development plans and timelines for ORIC-944; plans underlying ORIC’s clinical trials and development; and statements by the company’s chief scientific officer . Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC’s product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements; the potential market for our product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on August 12, 2025, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Contact: Dominic Piscitelli, Chief Financial Officer dominic.piscitelli@oricpharma.com info@oricpharma.com

Phase 1AACRClinical Result

22 Oct 2025

·www.biospace.com

How J&J Kept Growing Amid the Erosion of Cornerstone Drug Stelara

iStock, Denis_prof The company cut back in areas while investing in internal and external opportunities to offset the loss of exclusivity on a product that, until recently, accounted for 20% of innovative medicine sales. Johnson & Johnson has made a molehill out of a mountain. Facing the loss of exclusivity on a drug that accounted for 20% of innovative medicine sales in 2023, J&J has reshaped its business around other products and programs to leave analysts predicting a new era of growth for the company. The anticipated arrival of biosimilar versions of Stelara, J&J’s blockbuster autoimmune disease drug, has occupied analysts for years. J&J executives have fielded questions about their preparations since at least 2021, reflecting how important the anti-IL-12 and IL-23 antibody became to the company after sales of chronic inflammatory disease drug Remicade began to erode in the face of off-patent rivals. Stelara sales peaked at $10.9 billion in 2023. Biosimilar competition, first overseas and later in the U.S., caused sales to slip in 2024 and tumble further in 2025. Yet while sales of the drug fell 40% over the first nine months of 2025, J&J still grew global innovative medicine revenue by 5%. BioSpace , Annalee Armstrong Cutting and Investing The growth reflects J&J’s multi-year effort to adapt its business for a post-Stelara future. Some parts of the business have been sacrificed to enable investment in the most promising programs. In 2023, J&J axed clinical-phase programs targeting hepatitis B, HIV and respiratory syncytial virus and ended R&D at an infectious disease and vaccine site in the Netherlands. J&J CFO Joseph Wolk framed the infectious disease and vaccine changes in the context of Stelara at a Bernstein event in May; The company “probably had to cut some investment” to prepare for the entry of Stelara biosimilars, he said. J&J’s medtech business provides sales to offset slowdowns at the medicines unit but the company nonetheless had to pull back from some areas. “We still make choices. You saw last year we exited infectious diseases and vaccines. We still prioritize, but it gives us a lot more flexibility to manage for that long term and have the robust pipeline and the growth outlook we have for the balance of this decade,” Wolk said. As J&J pulled back from infectious diseases and vaccines, it invested in other areas to ensure new growth drivers were in place to ease the Stelara transition. At J&J’s immunology unit, rising sales of Tremfya and Simponi are partly offsetting the decline of Stelara and the development of icotrokinra , JNJ-4804 and nipocalimab are laying the groundwork for a potential new-look portfolio. All three assets are in development for multiple indications, from plaque psoriasis to ulcerative colitis to psoriatic arthritis. The emergence of oncology as J&J’s tentpole business has allowed the company to weather a period of falling immunology sales. Five years ago, J&J reported nine-month oncology revenue of $8.9 billion. Oncology sales for the first nine months of 2025 were $18.5 billion. The growth reflects the blossoming of multiple myeloma drug Darzalex, plus product launches. Darzalex was a blockbuster in 2020, generating sales of $2.9 billion in just the first nine months of the year. It has grown significantly since then. The growth covers a period in which J&J launched a subcutaneous version of Darzalex and expanded the label. Sales hit $10.4 billion over the first nine months of 2025. J&J has also turned its prostate cancer drug Erleada, which was approved in 2019, into a multi-billion dollar a year product. The CAR T cell therapy Carvykti became J&J’s latest cancer blockbuster in the third quarter of 2025, when total sales for the year reached $1.3 billion. With sales of the bispecific antibodies Tecvayli, Talvey and Rybrevant still rising, and the bladder cancer drug Inlexzo new to the market, J&J is aiming to grow oncology revenues to $50 billion by 2030. The forecast was at least three times above the 2028 analyst consensus estimate when the company made the prediction in July, partly reflecting J&J’s belief that annual Inlexzo sales will exceed $5 billion. Guggenheim Securities analysts recently discussed Inlexzo’s prospects with a community urologist. J&J could face competition from CG Oncology’s oncolytic immunotherapy cretostimogene grenadenorepvec. The urologist told the analysts that the ability to keep Inlexzo at room temperature, the lack of biohazard requirements and the option to administer the drug at the office give J&J an advantage. “The speaker emphasized that in his community practice setting, practical convenience and logistical advantages would be the main determinants in choosing between the two products,” the analysts wrote in a note to investors. “As such, he envisions using Inlexzo in the large majority of his patients when both products are available in the future.” Deals Drive Growth Speaking on an earnings call in October, J&J CEO Joaquin Duato called Inlexzo an example of the company’s “outstanding business development model.” J&J acquired the asset through its 2019 takeover of Taris Biomedical. Wolk said on the earnings call that the company paid “a couple of hundred million dollars” for Taris, which was then in early clinical development. Duato said J&J has completed “more than 60 deals of this kind” in the past 18 months. J&J has struck the early-stage deals alongside bigger bets such as its $14.6 billion takeover of Intra-Cellular Therapies. The deal added the schizophrenia and bipolar depression drug Caplyta to J&J’s neuroscience portfolio. Caplyta generated $240 million in the third quarter, helping J&J grow neuroscience revenues despite sales of Concerta and Invega falling. Spravato is the other key product in J&J’s neuroscience portfolio. Sales grew more than 50% to near $1.2 billion over the first nine months of 2025. The drugs have established neuroscience as J&J’s third biggest innovative medicine unit after oncology and immunology. J&J’s pulmonary hypertension and cardiovascular units also have blockbuster drugs, giving the company a broad base to offset future challenges. The nature of the pharma industry means new challenges are inevitable. J&J is now receiving questions about potential price negotiations and patent expirations for Darzalex. Guggenheim analysts said they believe investors are “underappreciating Darzalex’s increased longevity and potentially improved economics,” but at some point J&J will need to adapt to pressure on its latest star drug. Having navigated the launches of Remicade and Stelara biosimilars over the past decade, the company has established a track record of managing such pressures and continuing to grow.

AcquisitionDrug ApprovalImmunotherapyBiosimilar

20 Oct 2025

·www.businesswire.com

Kairos Pharma Presents on Phase 2 Trial of ENV-105 in Advanced Prostate Cancer at European Society Medical Oncologists (ESMO) Meeting

LOS ANGELES--(BUSINESS WIRE)--Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today presents on the positive interim efficacy data from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC) at the annual European Society Medical Oncologists meeting in Berlin, Germany. An interim efficacy analysis from the ongoing trial with ENV-105, a first-in-class CD105 antagonist, is being tested for safety and early efficacy in men with metastatic prostate cancer resistant to standard hormone therapy. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with hormone therapy, apalutamide, in 86% of treated patients. All responders remained progression-free for at least four months and half remained progression-free beyond one year. Notably, seven of nine evaluable patients experienced a reduction in PSA levels from baseline. “The positive safety profile and initial clinical benefit we’ve seen through our extensive interim analysis validates the comprehensive mechanism of action studies that preceded this clinical study, demonstrating how ENV-105 restores a patient’s ability to respond to hormone therapy,” said Dr. Neil Bhowmick, CSO of Kairos Pharma. Edwin Posadas, Director of the Experimental Therapeutics Program and the Medical Director of the Center for Uro-Oncology Research Excellence at the Cedars-Sinai Cancer Institute, leads the randomized Phase 2 trial that is currently accruing up to 100 patients at Cedars-Sinai Medical Center, City of Hope Cancer Center, and the Huntsman Cancer Institute. The 13.7 median PFS (progression free survival) achieved by imaging with the ENV-105 and apalutamide combination reported would suggest an improvement over current alternatives of chemotherapy and radioligand therapy, in terms of disease control as well as tolerability. Kairos Pharma seeks to provide a safe and effective therapy with ENV-105 for the over 3 million men with hormone-resistant prostate cancer worldwide. About Kairos Pharma, Ltd. Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) aims to work at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV105, is an antibody that targets CD105 – a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. 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. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our expectations regarding the success and/or completion of our Phase 2 clinical trial; our success in completing newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us, including those described in Kairos Pharma’s Annual Report on Form 10-K, as amended, and our other filings made with the Securities and Exchange Commission. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments, except as required by U.S. federal securities laws.

Phase 2Clinical Result

100 Deals associated with Apalutamide

External Link

KEGG	Wiki	ATC	Drug Bank
D11040	Apalutamide	L02BB05	DB11901

R&D Status

Approved

10 top approved records.

to view more data

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
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.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	Hong Kong	Janssen LP	20 Jul 2020
Recurrent Prostate Carcinoma	Phase 3	Hong Kong	Janssen LP	20 Jul 2020
Non-metastatic prostate cancer	Phase 3	France	Janssen Pharmaceutica NV	09 Jan 2020
Alzheimer Disease	Phase 3	United States	Janssen Research & Development LLC	07 Dec 2015
Alzheimer Disease	Phase 3	United States	Xian-Janssen Pharmaceutical Ltd.	07 Dec 2015
Alzheimer Disease	Phase 3	United States	Aragon Pharmaceuticals, Inc.	07 Dec 2015
Alzheimer Disease	Phase 3	Japan	Aragon Pharmaceuticals, Inc.	07 Dec 2015
Alzheimer Disease	Phase 3	Japan	Janssen Research & Development LLC	07 Dec 2015
Alzheimer Disease	Phase 3	Japan	Xian-Janssen Pharmaceutical Ltd.	07 Dec 2015
Alzheimer Disease	Phase 3	Argentina	Xian-Janssen Pharmaceutical Ltd.	07 Dec 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05884398 (LIBERTAS, ESMO2025)	Phase 3	Hormone-dependent prostate cancer	420	Apalutamide + continuous androgen deprivation therapy (cADT)	ukxveumlge(ugosavllnb) = dqyiztxbla gsnzksbpry (bmjpunmxgb ) View more	Negative	17 Oct 2025
				Apalutamide + intermittent androgen deprivation therapy (iADT)	ukxveumlge(ugosavllnb) = bmagpzwjpe gsnzksbpry (bmjpunmxgb ) View more
NCT05534646 (ESMO2025)	Phase 2	Castration-Resistant Prostatic Cancer CD105	10	Apalutamide 160 mg daily + Carotuximab	iqwgjqkglk(rvbankyoou) = Adverse events were consistent with previous studies of carotuximab and included grade 1-2 headache (88%), epistaxis (50%), fatigue (50%), and nausea (50%). zgrnemkeua (iicsnghgkt ) View more	Positive	17 Oct 2025
ESMO2025	Not Applicable	Castration-sensitive prostate cancer	455	Darolutamide + Docetaxel	fdzstaqhwn(fpaigtnaza) = almhjueglw lwpwjiqflm (fnifacwbfr )	Positive	17 Oct 2025
				Apalutamide	fdzstaqhwn(fpaigtnaza) = xcojaoyhtw lwpwjiqflm (fnifacwbfr )
NCT03098836 (PANTHER, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	93	ARN-509+Prednisone+Abiraterone Acetate (Caucasian)	azmmmxkkqe = zbdeoefytw ggxelkvwks (rshutbbbif, ahhvbhugip - uueaibyxfs) View more	-	12 Sep 2025
				ARN-509+Prednisone+Abiraterone Acetate (African American)	azmmmxkkqe = bmolxgwley ggxelkvwks (rshutbbbif, jgwfhomevj - zzdhlfjlre) View more
NCT04530552 (CTgov)	Phase 2	Localized Prostate Carcinoma \| Adenocarcinoma of prostate	34	apalutamide (Cohort 1)	gweipxnjhj = nbsyhucagd mmasxltuyd (gjayidfych, iwllvxofzw - aiozmzyjtx) View more	-	29 Aug 2025
				apalutamide (Cohort 2)	gweipxnjhj = kvqioxkerc mmasxltuyd (gjayidfych, rcvvbqfdlv - ildbapigrr) View more
NCT03298087 (CTgov)	Phase 2	Oligometastatic Prostate Carcinoma	28	stereotactic body radiotherapy+apalutamide+Abiraterone+Leuprolide	vgkyfvvtkw = xzpyzupjej uqzjrqzlnu (rivlbpmscg, nsptdzrawb - gcxsloocce) View more	-	01 Aug 2025
ASCO2025	Not Applicable	Hormone-dependent prostate cancer PSA kinetics	129	Apalutamide plus ADT	njobsbrfwl(lgxgabhofn) = vjzhoejvno unrptmgfkw (pqnengovew ) View more	Positive	30 May 2025
PANTHER phase II study, Abi Race phase II study (ASCO2025)	Phase 2	CYP3A4 \| ACTH	-	Apalutamide + Abiraterone Acetate + Prednisone	smfhifbozm(vcgsdvypgk) = irpcotgflk gjcmebdqpd (jiisyixthb ) View more	Negative	30 May 2025
				Abiraterone Acetate + Prednisone	smfhifbozm(vcgsdvypgk) = ittwscedrv gjcmebdqpd (jiisyixthb ) View more
NCT04926181 (CTgov)	Phase 2	Prostate Neuroendocrine Carcinoma \| Small cell carcinoma of prostate	2	Apalutamide+Cetrelimab	dvbxvxygwc = ifeawctmwg auhigxebmd (faedesihhm, olypawfjjh - bpjlgvpjmj) View more	-	15 May 2025
NCT04108208 (CTgov)	Phase 4	Castration-Resistant Prostatic Cancer	75	Placebo (Placebo Plus Androgen-deprivation Therapy (ADT))	yywncrefqj(rccxwpickr) = ehyvbddamo tpphwepkyp (eomrqnpuly, xwazcgwvdf - negidkljqj) View more	-	28 Mar 2025
				Apalutamide (Apalutamide 240 mg Plus ADT)	yywncrefqj(rccxwpickr) = ngggeedfhg tpphwepkyp (eomrqnpuly, zqssglkyhq - slerssyvnn) View more

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