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 Date23 Apr 2025

Sponsor / Collaborator

National Cancer Institute

NCT06592924 / Not yet recruitingPhase 3IIT

A Randomized Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer Without Deep PSA Response

This study is being done to answer the following question: can the chance of prostate cancer growing or spreading be lowered by adding a drug to the usual combination of drugs?
This study would like to find out if this approach is better or worse than the usual approach for prostate cancer.
The usual approach for patients who are not in a study is hormone treatment with Androgen Deprivation Therapy (ADT) and Androgen-Receptor Pathway Inhibitor (ARPI).

Start Date15 Jan 2025

Sponsor / Collaborator

Canadian Cancer Trials Group

[+4]

NCT06274047 / RecruitingPhase 3IIT

PROSTATE-IQ: Parallel RandOmized STudy of Personalized Apalutamide Treatment and Evaluation to Improve Quality of Life in Post-Operative Radiation With Androgen Axis Suppression. A Phase III Multi-center Study for Men With Detectable PSA After Prostatectomy for Prostate Cancer.

1. Personalize treatment for prostate cancer based on how aggressive the disease is and
2. Learn if apalutamide-based treatment can help to reduce fatigue and other side effects of treatment in participants who are being treated with radiation therapy for prostate cancer, as compared to standard therapy.

Start Date10 Sep 2024

Sponsor / Collaborator

The University of Texas MD Anderson Cancer Center

[+1]

100 Clinical Results associated with Apalutamide

100 Translational Medicine associated with Apalutamide

100 Patents (Medical) associated with Apalutamide

553

Literatures (Medical) associated with Apalutamide

31 Dec 2024·Journal of Medical Economics

Adverse events and costs among non-metastatic castration-resistant prostate cancer patients

Article

Author: Partridge, Jamie ; Freedland, Stephen J ; Parkin, Jacqueline ; Yao, Jianying ; Kong, Sheldon X ; Appukkuttan, Sreevalsa

BACKGROUNDLimited real-world evidence exists on the economic burden of adverse events (AEs) to the healthcare system among patients with non-metastatic castration-resistant prostate cancer (nmCRPC) treated with second-generation androgen receptor antagonists (ARAs). Current data is needed to understand real-world clinical event rates among ARAs and the cost of these events.OBJECTIVESDescribe the incidence of non-central nervous system (CNS)-related AEs and CNS-related AEs among nmCRPC patients treated in the United States with second-generation ARAs (apalutamide and enzalutamide) and evaluate healthcare resource utilization (HCRU) and costs for these patients.METHODS AND STUDY DESIGNThis was a retrospective observational cohort study using claims data from Optum Clinformatics Data Mart to identify adult males with prostate cancer, castration, no metastases, and >1 claim for apalutamide or enzalutamide. The study was conducted from January 2017 to March 2020, with a patient index identification period from January 2018 to December 2019. AEs were classified as CNS-related or non-CNS-related.RESULTSOf 605 patients (156 apalutamide and 449 enzalutamide), most were ≥65 years (94%) and had ≥1 non-CNS-related AE (55%). Many had ≥1 CNS-related AE (32%). Pain (12%) and arthralgia (11%) were the most frequently reported non-CNS-related AEs. Fatigue/asthenia (14%) and dizziness (7%) were the most frequently reported CNS-related AEs. Among patients with versus without non-CNS-related AEs, 34% versus 8% had emergency room (ER) events, and 25% versus 2% had inpatient events. Among patients with versus without CNS-related AEs, 41% versus 14% had ER events, and 38% versus 4% had inpatient events. Adjusted per-patient per-year cost (in 2020 USD) differences were significant between patients with and without non-CNS-related AEs ($30,765, p = 0.0018) and between patients with and without CNS-related AEs ($40,689, p = 0.0017).CONCLUSIONThere is significant HCRU and cost burden among nmCRPC patients treated with ARAs developing AEs, highlighting the need for treatments with improved tolerability. Additional studies are warranted to include recently approved agents.

01 Dec 2024·Urologic Oncology: Seminars and Original Investigations

Treatment Intensification in Metastatic Hormone-Sensitive Prostate Cancer: An Analysis of Real-World Practice Patterns from the CancerLinQ Database

Article

Author: Kuna, Elizabeth Molina ; Eule, Corbin J ; Gershman, Boris ; Flaig, Thomas W ; Robin, Tyler P ; Kim, Simon P

BACKGROUNDIn metastatic hormone-sensitive prostate cancer (mHSPC), androgen deprivation therapy and standard of care treatment intensification with docetaxel and/or an androgen receptor signaling inhibitor (ARSI) are associated with improved survival outcomes for appropriate patients.METHODSThis retrospective study selected patients with de novo mHSPC diagnosed between 2014 and 2023 from CancerLinQ Discovery®, a United States (US)-based, de-identified clinical database. Patient-level data, including clinical characteristics, treatments, and demographics, were collected from CancerLinQ. Treatment intensification was defined as the use of docetaxel, abiraterone, apalutamide, enzalutamide, or docetaxel plus abiraterone or darolutamide. Patient characteristics and treatment intensification data were analyzed descriptively and using multivariable logistic regression.RESULTSOf the 3,684 patients with mHSPC, the overall rate of treatment intensification was 58.4% but increased from 32.5% in 2014 to 67.5% in 2023. A relative decline in docetaxel use was accompanied by an increase in ARSI use. Black patients with mHSPC were less likely to receive treatment identification (OR 0.78, 95% CI 0.64-0.95, P = 0.013). Treatment intensification was also less likely for patients of older age and increased ECOG performance status. Despite increasing treatment intensification for Black patients with mHSPC over time, rates of docetaxel use are disproportionately declining relative to White patients.CONCLUSIONSTreatment intensification rates are increasing to include the majority of patients with mHSPC. However, treatment disparities exist for Black patients, who are less likely to receive intensification. These findings illustrate the importance of promoting treatment intensification in appropriate patients and addressing racial treatment disparities.

01 Dec 2024·European Urology Open Science

Prostate-specific Antigen at 3 Months as a Predictor of Radiologic Progression-free Survival in Metastatic Hormone-sensitive Prostate Cancer Treated with Apalutamide: Analysis of 633 Patients in a Real-world Database

Article

Author: Rivas, Juan Gómez ; Hassi Roman, Mario ; Climent Durán, Miguel A. ; Picola, Natalia ; Expósito, Nagore García ; Vilaseca, Antoni ; Juan Fita, Maria J ; Juan Fita, Maria J. ; De Pablos-Rodriguez, Pedro ; Horcajada, Álvaro Zamora ; Esteban, Mario Domínguez ; Vázquez-Martul Pazos, Darío ; Sutil, Raquel Sopeña ; Rodríguez, Jesús Muñoz ; Climent Durán, Miguel A ; Espinós, Estefanía Linares ; Formisano, Luigi ; Cascales, Ana Guijarro ; Backhaus, Miguel Ramírez ; Planells, Marc Costa ; Sanz, Miguel García ; Bonet, Ángeles Sanchís ; Alemán, José Ramón ; Márquez, Meritxell Pérez ; Vives, Pol Servian ; Mate, Kinga ; de la Morena Gallego, José Manuel

Background and objectiveThe depth of the prostate-specific antigen (PSA) decline after androgen receptor pathway inhibitor (ARPI) treatment combined with androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC) may affect prognosis. The primary objective in our study was the correlation between the PSA response at 3 mo and radiologic progression-free survival (rPFS) at 24 mo. Three groups were defined according to the PSA decline: complete response (PSA ≤0.02 ng/ml), partial response (PSA >0.02 and ≤0.2 ng/ml), and incomplete response (PSA >0.2 ng/ml). Secondary objectives were correlation between the PSA response at 3 mo and overall survival, and the development of a model predicting complete PSA response.MethodsWe conducted a retrospective multicenter study of patients with mHSPC treated with apalutamide from May 2018 to September 2023 registered in the Real-World Evidence APA registry across 20 centers.Key findings and limitationsWe included 633 patients with mHSPC. The median age at diagnosis was 68 yr (interquartile range [IQR] 63-75) and median PSA was 16 ng/ml (IQR 7.5-64). Some 63% of the short had low-volume disease, 51% had de novo disease, 48% had recurrent disease. At 3 mo, 27% had a complete response, 42% a partial response, and 31% an incomplete response, with corresponding rRFS rates at 24 mo of 92%, 86%, and 63%. According to the predictive model, a complete PSA response at 3 mo was associated with the use of next-generation imaging and PSA <50 ng/ml at diagnosis. Study limitations include heterogeneity among the groups and variations in data quality and assessment methods.Conclusions and clinical implicationsPatients with a complete PSA response after 3 mo of apalutamide treatment face a very low risk of progression within 2 yr. Conversely, nearly 50% of patients with an incomplete PSA response will experience disease progression.Patient summaryFor patients with metastatic prostate cancer that is still responsive to hormone therapy, a complete response after treatment with a drug called apalutamide is associated with a very low risk of progression within 2 years. However, nearly half of patients with an incomplete response to apalutamide will experience progression of their cancer.

News (Medical) associated with Apalutamide

12 Nov 2024

·www.globenewswire.com

ORIC® Pharmaceuticals Reports Third Quarter 2024 Financial Results and Operational Updates

Presented preclinical data further supporting the potential best-in-class profile of ORIC-114 to treat EGFR exon 20 insertions and other atypical mutations at the EORTC-NCI-AACR Conference Announced clinical collaborations with multiple strategic partners to support ongoing trial evaluating ORIC-944 in combination with AR inhibitors for the treatment of prostate cancer Cash and investments of $282.4 million expected to fund operating plan into late 2026 SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Nov. 12, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today reported financial results and operational updates for the quarter ended September 30, 2024. “We are encouraged by the growing evidence supporting the potential best-in-class profiles of ORIC-114 and ORIC-944, and we continue to steadily advance both programs towards the initiation of registrational studies next year,” said Jacob M. Chacko, M.D., president and chief executive officer. “Preclinical data presented at the ENA conference highlighted ORIC-114's potential for superior potency and selectivity in targeting EGFR exon 20 insertions and other atypical mutations, building on previously reported clinical data in NSCLC patients. For ORIC-944, the clinical trial collaboration and supply agreements we secured with Bayer and Johnson and Johnson have helped us further advance our combination studies in prostate cancer. We remain laser-focused on execution across our clinical and preclinical pipeline and look forward to reporting updated data in 2025.” Third Quarter 2024 and Other Recent Highlights: ORIC-114: a brain penetrant, orally bioavailable, irreversible EGFR/HER2 inhibitor Presented preclinical data demonstrating potential best-in-class properties, including potency and selectivity, of ORIC-114 to treat NSCLC harboring EGFR exon 20 insertions and other atypical mutations at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics.Expect to report updated Phase 1b data in the first half of 2025. ORIC-944: a potent and selective allosteric inhibitor of PRC2 Initiated dosing of ORIC-944 in combination with NUBEQA® (darolutamide) and in combination with ERLEADA® (apalutamide) in the ongoing Phase 1b trial for prostate cancer in first half of 2024.Entered into clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson to support the ongoing Phase 1b trial of ORIC-944 in combinations with AR inhibitors for the treatment of prostate cancer. Corporate Highlights: Expanded the leadership team with the appointment of industry veteran Keith Lui as Senior Vice President of Commercial and Medical Affairs. Third Quarter 2024 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $282.4 million as of September 30, 2024, which the company expects will be sufficient to fund its operating plan into late 2026.R&D Expenses: Research and development (R&D) expenses were $31.2 million for the three months ended September 30, 2024, compared to $22.4 million for the three months ended September 30, 2023, an increase of $8.8 million. For the nine months ended September 30, 2024, R&D expenses were $82.1 million, compared to $60.7 million for the nine months ended September 30, 2023, an increase of $21.4 million. The increases were due to a net increase in external expenses related to the advancement of product candidates and discovery programs, as well as higher personnel costs, including additional non-cash-stock-based compensation.G&A Expenses: General and administrative (G&A) expenses were $7.1 million for the three months ended September 30, 2024, compared to $6.3 million for the three months ended September 30, 2023, an increase of $0.8 million. For the nine months ended September 30, 2024, G&A expenses were $21.2 million, compared to $18.7 million for the nine months ended September 30, 2023, an increase of $2.6 million. The increases were primarily due to higher personnel costs, including additional non-cash stock-based compensation. 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-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, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, being developed for multiple myeloma. Beyond these three product candidates, ORIC® is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. 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 StatementsThis 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, statements regarding the continued clinical development of ORIC-114 and ORIC-944; statements regarding the potential best-in-class properties of ORIC-114; ORIC-114 clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; the development plans and timelines for ORIC-114, ORIC-944 and ORIC’s other product candidates; the potential advantages of ORIC-114, ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of registrational studies; the period over which ORIC estimates its existing cash, cash equivalents and investments will be sufficient to fund its current operating plan; and statements by the company’s chief executive 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 or its clinical trial collaboration and supply agreements; the potential market for ORIC’s 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 titled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on November 12, 2024, 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 Officerdominic.piscitelli@oricpharma.cominfo@oricpharma.com ORIC PHARMACEUTICALS, INC.CONDENSED BALANCE SHEETS(in thousands, except share and per share amounts) September 30, 2024 December 31, 2023 (unaudited) Assets Current assets: Cash, cash equivalents and short-term investments$272,369 $208,187 Prepaid expenses and other current assets 7,059 4,410 Total current assets 279,428 212,597 Long-term investments 9,998 26,852 Property and equipment, net 3,091 2,862 Other assets 9,553 9,696 Total assets$302,070 $252,007 Liabilities and Stockholders' Equity Current liabilities: Accounts payable$4,249 $944 Accrued liabilities 16,999 19,514 Total current liabilities 21,248 20,458 Other long-term liabilities 6,828 7,461 Total liabilities 28,076 27,919 Total stockholders' equity 273,994 224,088 Total liabilities and stockholders' equity$302,070 $252,007 ORIC PHARMACEUTICALS, INC.STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS(Unaudited)(in thousands, except share and per share amounts) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2024 2023 2024 2023 Operating expenses: Research and development$31,202 $22,388 $82,102 $60,691 General and administrative 7,116 6,294 21,223 18,661 Total operating expenses 38,318 28,682 103,325 79,352 Loss from operations (38,318) (28,682) (103,325) (79,352) Other income, net 3,752 3,204 11,785 6,985 Net loss$(34,566) $(25,478) $(91,540) $(72,367)Other comprehensive income: Unrealized gain on investments 978 198 464 922 Comprehensive loss$(33,588) $(25,280) $(91,076) $(71,445)Net loss per share, basic and diluted$(0.49) $(0.44) $(1.32) $(1.46)Weighted-average shares outstanding, basic and diluted 70,542,684 57,402,226 69,417,672 49,424,418

Phase 1Financial StatementExecutive ChangeAACR

01 Nov 2024

·endpts.com

Essa’s shares tank as it looks for options after abandoning prostate cancer drug

Essa Pharma is exploring “strategic options” as it ends work on its prostate cancer drug that failed a mid-stage test. The company’s shares $EPIX nosedived by as much as 65% premarket Friday. In a planned Phase 2 interim analysis of 52 metastatic castration-resistant prostate cancer patients, Essa’s masofaniten plus Astellas and Pfizer’s Xtandi delivered a response rate of 64% in the primary endpoint of PSA90. But participants given Xtandi alone had a higher rate of 73%. The trial recruited patients who are naive to second-generation antiandrogens. A futility analysis suggested a low likelihood of the trial meeting its primary endpoint, the company said. Single-agent Xtandi showed a “much higher rate of PSA90 response … than were expected based upon historical data,” it added in a Thursday release . Astellas was supplying Xtandi for the Phase 2 under the terms of a 2021 clinical collaboration and supply agreement . Also, the South San Francisco-based biotech is ending a separate, early-stage test of masofaniten plus Johnson & Johnson’s Zytiga and Erleada in prostate cancer. Any investigator-sponsored trials will also be wrapped up, with Essa pulling all INDs and clinical trial applications for the drug. Essa said it is now focused on reviewing its “strategic options.” The company had $126.8 million in cash reserves and short-term investments as of the end of September. Prostate cancer is a notoriously challenging indication, with several drugmakers such as MacroGenics and Exelixis struggling to clear clinical hurdles this year.

Phase 2License out/inClinical ResultPhase 3

01 Nov 2024

·www.prnewswire.com

ESSA Pharma Announces Termination of Phase 2 Study Evaluating Masofaniten Combined with Enzalutamide in Patients with Metastatic Castration-Resistant Prostate Cancer

Efficacy signals observed will not achieve ESSA's target product profile in patients with metastatic castration-resistant prostate cancer naïve to second-generation antiandrogens A futility analysis conducted as part of a protocol-specified interim review of the safety, PK and efficacy data showed the single-agent enzalutamide control arm performing better than historical controls and similar to the combination of masofaniten and enzalutamide and therefore, unlikely to achieve the primary endpoint of the study Additional clinical studies with masofaniten including the combination study with abiraterone acetate and apalutamide as well as the remaining investigator sponsored trials will also be terminated and the IND and CTAs in different geographies will be withdrawn Company will initiate a process to explore and review strategic options focused on maximizing shareholder value SOUTH SAN FRANCISCO, California and VANCOUVER, Canada, Oct. 31, 2024 /PRNewswire/ - ESSA Pharma Inc. ("ESSA", or the "Company") (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced that it has made the decision to terminate the Phase 2 clinical trial evaluating in a 2:1 randomization masofaniten combined with enzalutamide versus enzalutamide single agent in patients with metastatic castration-resistant prostate cancer ("mCRPC") naïve to second-generation antiandrogens. This decision, mutually agreed upon by both senior management and the board of directors, was based on a protocol-specified interim review of the safety, PK and efficacy data, which showed a much higher rate of PSA90 response in patients treated with enzalutamide monotherapy (which is standard of care for this patient population) than were expected based upon historical data. In addition, there was no clear efficacy benefit seen with the combination of masofaniten plus enzalutamide compared to enzalutamide single agent. A futility analysis determined a low likelihood of meeting the prespecified primary endpoint of the study. The combination of masofaniten plus enzalutamide was well-tolerated with no new safety signals and a safety profile similar to that seen in Phase 1 studies. "Providing a meaningful clinical benefit to patients in our clinical trials, along with a robust safety profile, is of utmost importance to us at ESSA," said David Parkinson, MD, President and CEO. "We designed this randomized study to rigorously evaluate the clinical benefit of adding masofaniten to enzalutamide. We made the difficult decision to terminate this Phase 2 study following the interim analysis because we concluded that the emerging efficacy profile of masofaniten combined with enzalutamide would not likely meet the primary endpoint of the study, nor our internal requirements for a prostate cancer therapy candidate. We would like to thank our partners, investigators, employees, and most importantly, the patients and their families involved in our clinical trials." Richard Glickman, LLD, Chairman of the Board of Directors of ESSA, commented, "Senior management, together with the board of directors, are actively focused on preserving capital and will initiate a strategic process to explore and review a range of strategic options focused on maximizing shareholder value." The Phase 2 study (NCT05075577) was designed as an open label, two-arm randomized (2:1) trial and was planned to enroll a total of 120 patients (80 in the combination arm and 40 in the enzalutamide single agent arm). The efficacy interim analysis included 52 enrolled patients (48% of the total planned patients) who had at least one PSA measurement after baseline and 41 patients (34% of total planned patients) who completed at least three months follow up. Enrolled patients were from clinical sites located in the United States, Canada, Australia and France. The primary study endpoint is the proportion of patients reaching PSA90. Additional PSA-based secondary endpoints included PSA50 response as well as PSA50 and PSA90 response rates at 12 weeks as well as time to event parameters (which were not mature at the time of the interim analysis). Primary and PSA-related Secondary Endpoints of the Study As part of the effort to focus its resources, ESSA is also planning to terminate the other remaining company-sponsored and investigator-sponsored clinical studies evaluating masofaniten either as a monotherapy or in combination with other agents. Liquidity and Outstanding Share Capital As of September 30, 2024, the Company had available cash reserves and short-term investments of $126.8 million and net working capital of $124.3 million (unaudited figures). The Company has no long-term debt facilities. As of September 30, 2024, the Company had 44,388,551 common shares issued and outstanding, and there were 2,920,000 common shares issuable upon the exercise of prefunded warrants at an exercise price of $0.0001. About the Phase 2 Study The Phase 2 dose expansion portion of this Phase 1/2 study is a two-arm, randomized, open-label study (NCT05075577) that evaluated the safety, tolerability and preliminary efficacy of masofaniten, and was expected to enroll approximately 120 patients. Criteria for entry into the Phase 2 dose expansion were similar to those in the Phase 1 dose escalation. Patients continued to receive androgen deprivation therapy and were randomized 2:1 to receive either the combination of masofaniten (600mg twice-daily ("BID")) and enzalutamide (160mg once daily ("QD")) or enzalutamide (160mg QD) as a single agent. Patients were eligible to remain on study treatment as long as they tolerated treatment without disease progression based on RECIST v1.1 and/or Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria. About Masofaniten Masofaniten (formerly known as EPI-7386) is a first-in-class investigational oral, small molecule inhibitor of the androgen receptor ("AR"). Masofaniten's unique mechanism of action disrupts the AR signaling pathway, the primary pathway that drives prostate cancer growth. The U.S. Food and Drug Administration has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment. ESSA retains all rights to masofaniten worldwide. About ESSA Pharma Inc. ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit , and follow us on X and LinkedIn. Forward-Looking Statement Disclaimer This release contains certain information which, as presented, constitutes "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and "forward-looking information" within the meaning of applicable Canadian securities laws (collectively, "forward-looking statements"). Forward-looking statements include, but are not limited to, statements that relate to future events and often addresses expected future business and financial performance, containing words such as "anticipate", "believe", "plan", "estimate", "expect", and "intend", statements that an action or event "may", "might", "could", "should", or "will" be taken or occur, or other similar expressions and includes, but is not limited to, statements regarding the termination of the Company's clinical studies of masofaniten, the Company's financial resources, the evaluation of the Company's strategic alternatives, the primary and PSA-related endpoints of the Phase 2 study and other statements surrounding the Company's evaluation of masofaniten. Forward-looking statements are subject to various known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which may cause ESSA's actual results, performance or achievements to be materially different from those expressed or implied thereby. Such statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by ESSA as of the date of such statements, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. In making forward looking statements, ESSA may make various material assumptions, including but not limited to (i) the accuracy of ESSA's financial projections; (ii) obtaining positive results of clinical trials; (iii) obtaining necessary regulatory approvals; and (iv) general business, market and economic conditions. Forward-looking statements are developed based on assumptions about such risks, uncertainties and other factors set out herein and in ESSA's Annual Report on Form 10-K dated December 12, 2023, under the heading "Risk Factors", a copy of which is available on ESSA's profile on EDGAR at and on SEDAR+ at , and as otherwise disclosed from time to time on ESSA's EDGAR and SEDAR+ profiles. Forward-looking statements are made based on management's beliefs, estimates and opinions on the date that statements are made and ESSA undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as may be required by applicable United States and Canadian securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements. Contacts ESSA Pharma, Inc. Peter Virsik, Chief Operating Officer 778.331.0962 [email protected] Investors and Media: Argot Partners 212.600.1902 [email protected] SOURCE ESSA Pharma Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Clinical ResultPhase 1Fast Track

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 castration-resistant prostate cancer	US	Janssen Biotech, Inc.	17 Sep 2019
Metastatic Prostate Carcinoma	JP	Janssen Pharmaceutical KK	26 Mar 2019
Hormone-dependent prostate cancer	IS	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	LI	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	EU	Janssen-Cilag International NV	14 Jan 2019
Hormone-dependent prostate cancer	NO	Janssen-Cilag International NV	14 Jan 2019
Prostatic Cancer	CA	Janssen Research & Development LLC	27 Jul 2018
Castration-sensitive prostate cancer	AU	Janssen-Cilag Pty Ltd.	05 Jul 2018
Castration-Resistant Prostatic Cancer	US	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-resistant prostate cancer	Phase 3	BR	Aragon Pharmaceuticals, Inc.	01 Nov 2014
Metastatic castration-resistant prostate cancer	Phase 3	CA	Aragon Pharmaceuticals, Inc.	01 Nov 2014
Metastatic castration-resistant prostate cancer	Phase 3	GB	Aragon Pharmaceuticals, Inc.	01 Nov 2014
Metastatic castration-resistant prostate cancer	Phase 3	KR	Aragon Pharmaceuticals, Inc.	01 Nov 2014
Metastatic castration-resistant prostate cancer	Phase 3	NL	Aragon Pharmaceuticals, Inc.	01 Nov 2014
Metastatic castration-resistant prostate cancer	Phase 3	MX	Aragon Pharmaceuticals, Inc.	01 Nov 2014
Castration-Resistant Prostatic Cancer	Phase 3	RU	Aragon Pharmaceuticals, Inc.	01 Oct 2013
Castration-Resistant Prostatic Cancer	Phase 3	IL	Aragon Pharmaceuticals, Inc.	01 Oct 2013
Castration-Resistant Prostatic Cancer	Phase 3	TW	Aragon Pharmaceuticals, Inc.	01 Oct 2013
Castration-Resistant Prostatic Cancer	Phase 3	NZ	Aragon Pharmaceuticals, Inc.	01 Oct 2013

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECOP Manual	Not Applicable	Castration-sensitive prostate cancer	3,719	Apalutamide	wegctbqmph(hxyukombrl): HR = 0.77 (95% CI, 0.62 - 0.96), P-Value = 0.019 View more	Positive	02 Oct 2024
				Enzalutamide
NCT03777982 (CTgov)	Phase 3	Prostatic Cancer	12	LHRH Agonist or Antagonist+Apalutamide+Prednisone+Abiraterone Acetate (Prednisone+Apalutamide+Abiraterone Acetate +LHRH Agonist)	jetfcuiqxt(vdekzupvqv) = sxpndfcauv dtgnjkpevb (bowhjgfhwd, gajkpvtcyx - jgbzhhtzgg) View more	-	19 Sep 2024
				LHRH Agonist or Antagonist (LHRH Agonist or Antagonist)	jetfcuiqxt(vdekzupvqv) = siokdjybxz dtgnjkpevb (bowhjgfhwd, lpghdqwgpy - ciypbxghvp) View more
NCT04523207 (Apa-RP, Pubmed \| Carcinogenesis) Manual	Phase 2	Localized Prostate Carcinoma Adjuvant preoperative PSA \| baseline testosterone	108	Apalutamide + ADT	(cgyzugfymu) = toirmdtxyn dymdwndicj (hulmumaqmj, 93 - 100) View more	Positive	01 Aug 2024
NCT02489318 (TITAN, Pubmed)	Phase 3	prostate-specific antigen	-	Apalutamide 240 mg/day	rrfajsxpno(jtoixgbtnf): HR = 0.24 (95% CI, 0.13 - 0.43), P-Value = <0.001 View more	Positive	28 Jun 2024
				Placebo
NCT04523207 (Apa-RP, ASCO2024) Manual	Phase 2	Localized Prostate Carcinoma Adjuvant	108	Apa + ADT	mzffvxwyul(tptqyfozzj) = dfcpgngqct htxqrgpmxk (jsxakgqtfp, 93.4 - 100.0) View more	Positive	24 May 2024
				Apa + ADT (Black Patients)	mzffvxwyul(tptqyfozzj) = ogkqcxioyc htxqrgpmxk (jsxakgqtfp, 57.9 - 100.0) View more
NCT03098836 (PANTHER, ASCO2024)	Phase 3	Metastatic castration-resistant prostate cancer Gleason score 8-10 \| visceral metastases \| prior docetaxel	-	Apalutamide plus abiraterone acetate and prednisone (AAP)	(jhxpnrjmuk) = nbwtevpbqd bwfonduwfm (nbkbdolwtx, 55 - 83) View more	Positive	24 May 2024
OASIS Project (ASCO2024)	Not Applicable	Castration-sensitive prostate cancer PSA	183	Apalutamide+ADT	(hrdbzgkzmj) = fwsbattnzy iwkgutralp (cnnmtzqgiz )	Positive	24 May 2024
NCT04523207 (Apa-RP, PRNewswire) Manual	Phase 2	Localized Prostate Carcinoma	108	ERLEADA® plus androgen deprivation therapy	(hlrcdrexne) = deludhvknz sifdsiqkti (nejfajgqgg ) Met View more	Positive	03 May 2024
MP60-09 (AUA2024) Manual	Not Applicable	Castration-sensitive prostate cancer First line Neutrophil-to-lymphocyte ratio (NLR) \| PSA	581	Apa	uglmdnaldv(ujzvvvvwpq): P-Value = 0.490 View more	Positive	01 May 2024
				Enza
NCT03311555 (STARTAR, CTgov)	Phase 2	Recurrent Prostate Carcinoma	39	Androgen deprivation+Apalutamide+Docetaxel	rhwsdlfmay(vebuqqzomv) = wcycgegdtv jpftwdbesd (lgjmxxheoq, dhbwuctsrz - rlapcycaja) View more	-	19 Mar 2024

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