TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

The purpose of the study is to evaluate the safety, tolerability, and efficacy of the two different treatment combinations of tulmimetostat in participants with de novo or recurrent Metastatic Hormone-Sensitive Prostate Cancer (mHSPC).

Start Date13 Jan 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

100 Clinical Results associated with Abiraterone acetate

100 Translational Medicine associated with Abiraterone acetate

100 Patents (Medical) associated with Abiraterone acetate

3,594

Literatures (Medical) associated with Abiraterone acetate

26 Sep 2026·ENDOCRINE-RELATED CANCER

Body composition in recurrent prostate cancer and the role of steroidogenic genotype

Article

Author: Pilie, Patrick G ; Mukhida, Sagar S ; Koutroumpakis, Efstratios ; Corn, Paul G ; McQuade, Jennifer L ; Tidwell, Rebecca S ; Gregg, Justin R ; Zurita, Amado J ; Hahn, Andrew W ; Aparicio, Ana ; Frigo, Daniel E ; Huff, Chad ; Logothetis, Christopher J ; Subudhi, Sumit K ; Siddiqui, Bilal A ; Venkatesh, Neha ; Yu, Yao

Hormone therapy (HT) to treat prostate cancer is reported to cause adverse changes in body composition. Clinically, interpatient body composition changes are heterogeneous, but the biological and clinical determinants of body composition toxicity are unknown. Herein, we test the hypothesis that inherited polymorphisms in steroidogenic genes are associated with differential changes in body composition after HT. Men with biochemically recurrent prostate cancer (BCR) who received 8 months of LHRH analog (LHRHa) +/− abiraterone acetate (AAP) were eligible if they had: i) CT imaging of L3 prior to and after treatment; and ii) nucleated cells collected. Cardiometabolic co-morbidities were retrospectively extracted. Body composition was measured using an AI-based segmentation tool. Germline DNA whole exome or genome sequencing was performed. In 162 men treated with 8 months of HT, median skeletal muscle mass (SMMi) loss was 6.6% and subcutaneous adipose gain was 12.3%. Men with type 2 diabetes had higher losses of SMMi after treatment (−11.1% vs −6.3%, P = 0.003). For the 150 men with germline NGS, SRD5A2 rs523349 genotype was associated with differential loss in skeletal muscle density after HT, (−1.3% vs −7.1%, P = 0.04). In addition, the HSD3B1 rs104703 genotype was associated with decreased baseline visceral adipose tissue (63.0 cm2/m2 vs 77.9, P = 0.05). In men with BCR, HT induced notable loss of skeletal muscle and increased subcutaneous adipose tissue. An inherited polymorphism in SRD5A2 and T2DM was associated with differential skeletal muscle toxicity. These findings suggest that inherited polymorphisms may contribute to the body composition toxicity observed with HT.

01 Jun 2026·Health policy OPEN

Price transparency & out-of-pocket payments for medications: Implications of associated delivery fees in the United States

Article

Author: Kaye, Deborah R ; Scales, Charles D ; George, Daniel J ; Lee, Hui-Jie ; Bundorf, M Kate

Background:

Price transparency has been cited as a tool to reduce out-of-pocket (OOP) payments to patients. These tools for prescription drugs often focus on the price to patients for the drug alone. However, costs associated with drug delivery (i.e. infusion center fees, labs, etc) are often unknown and could impact the effectiveness of price transparency tools. Objective: To examine total OOP payments on day of drug receipt ("full day", i.e. drug + drug administration fees) out-of-pocket (OOP) payments associated with six first-line treatments for metastatic castrate resistant prostate cancer and compare these with payments for drug alone and by insurance type.

Methods:

Using the IBM Marketscan databases, we identify male patients who initiated treatment with one of six focus drugs (docetaxel, abiraterone, enzalutamide, sipuleucel-T, cabazitaxel, and radium-223) used to treat mCRPC from 07/01/2013-06/30/2019. We calculated total OOP payments on day of drug receipt (full day OOP payments) by drug type for six first line treatments. We then used a two-part model to assess the association of first-line therapy with OOP payments for the four most frequently prescribed during the study time period.

Results:

We find that there is variation in the proportion of payments for drug alone relative to full day payments across first-line treatments. However, regression-adjusted mean full day OOP payments are not statistically different across first-line treatments for mCRPC for the four most frequently prescribed drugs. There are differences in the likelihood that an individual will incur any OOP payment by first-line treatment type and by health plan type.

Conclusion:

These analyses suggest that when accounting for additional services required on the day of drug receipt, the amount a patient pays to receive a medication for mCRPC can be very different from the OOP payment for the drug alone; these payments also vary by drug and health plan type. Therefore, price transparency for drug alone may not lead to reduced OOP payments for patients.

01 Jun 2026·JOURNAL OF STEROID BIOCHEMISTRY AND MOLECULAR BIOLOGY

Serendipity, steroids and science

Review

Author: Sharifi, Nima

The androgen signaling pathway is probably the most important pathway in enabling prostate cancer progression but it also plays essential roles in numerous processes in normal physiology. Both testosterone and dihydrotestosterone are potent androgens that activate the androgen receptor (AR). The essentiality of the androgen pathway in prostate cancer is evidenced in part by the reactivation of AR in prostate cancer that becomes resistant to treatment by gonadal testosterone deprivation. Furthermore, steroid metabolic processes that allow the regeneration of potent androgens in prostate cancer tissues drive this treatment-resistant state, as is made clear by the survival benefit of blocking the synthesis of non-gonadal androgens, e.g., with abiraterone. Here, I narrate and review the process that led to a series of discoveries in androgen metabolism from our group. In this perspective and mechanistic narrative review, I give an honest description of the accidental nature of some of our initial findings, followed by data-driven hypothesis refinement and subsequent studies that illuminate elements of androgen metabolism, with a focus on metabolism of carbon 3, carbon 5 and carbon 17 of the steroid backbone.

474

News (Medical) associated with Abiraterone acetate

07 Apr 2026

·www.biospace.com

Q1 2026: Strong Revenue Growth and Therapeutics Pipeline Advancement

MELBOURNE, Australia and INDIANAPOLIS, April 07, 2026 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) provides a market update on its commercial and operational performance for the quarter ended March 31, 2026 (Q1 2026). Q1 2026 Highlights Q1 2026 unaudited Group revenue of US$230 million, up 11% quarter-over-quarter. FY 2026 revenue guidance of US$950 million to US$970 million is reaffirmed. Precision Medicine Q1 2026 unaudited revenue of US$186 million, up 16% quarter-over-quarter. Strong revenue growth in both Illuccix® and Gozellix® segments. ProstACT® Global Phase 3 study of TLX591-Tx prostate cancer therapy candidate: Part 1 lead-in met safety and dosimetry objectives, with no new safety signals observed 1 . TLX101-Px (brain cancer imaging candidate): New Drug Application (NDA) resubmitted to the United States (U.S.) Food and Drug Administration (FDA) 2 for Pixclara® 3 . Marketing Authorization Application (MAA) filed in Europe 4 for Pixlumi® 3 . TLX591-Px 5 : NDA accepted in China by the National Medical Products Administration (NMPA) 6 . Q1 2026 Revenue (Unaudited) Revenue (US$M) Q1 2026 Q1 2025 Variation Q4 2025 Variation Group revenue 230 186 24% 208 11% Precision Medicine revenue 7 186 151 23% 161 16% TMS third-party revenue 8 44 34 29% 44 —% Executive Commentary Dr. Christian Behrenbruch, Managing Director and Group CEO, stated, “Growth accelerated across our Precision Medicine business in the first quarter, with U.S. dose volumes increasing 5% quarter-over-quarter. This performance reflects the growing uptake of Gozellix alongside Illuccix, contributing to market share gains underpinned by disciplined sales execution and pricing, and high-quality service delivery despite extreme North American weather conditions, an advantage of the pharmacy distribution model. With our two‑product PSMA 9 imaging strategy, differentiated clinical positioning and expanding commercial presence globally, we are seeing a solid foundation for continued growth through 2026. Importantly, we are delivering on our strategic priorities to advance our high-value clinical programs, demonstrated by the momentum in our therapeutics pipeline this quarter.” Therapeutics Business Unit Telix continues to progress its industry-leading Therapeutics pipeline, which spans multiple product candidates and disease areas. Q1 2026 highlights include: TLX591-Tx (lutetium ( 177 Lu) rosopatamab tetraxetan): Part 1 of ProstACT Global, the Phase 3 trial of its lead prostate cancer therapy candidate, achieved its study objectives, demonstrating an acceptable safety and tolerability pro no new safety signals observed 1 . No adverse drug-drug interactions were observed in TLX591-Tx combinations, demonstrating the feasibility of integrating TLX591-Tx with current standard of care therapies for mCRPC 10 , including ARPIs 11 (enzalutamide or abiraterone) and docetaxel. Telix has commenced engagement with the FDA to present data from Part 1 and ascertain eligibility for U.S. patients to participate in Part 2 (randomized treatment expansion). Part 2 is open for enrollment in Australia, New Zealand and Canada, with site activation underway in preparation to open enrollment in China, Singapore, South Korea, Türkiye, the United Kingdom and Japan, where regulatory approvals have already been granted. TLX250-Tx (lutetium ( 177 Lu) girentuximab tetraxetan): Telix has opened its first clinical site and is recruiting patients for Part 1 of LUTEON 12 , a pivotal trial of TLX250-Tx as a monotherapy in advanced ccRCC 13 . Trial recruitment will initially focus ex-U.S. TLX101-Tx ( 131 I-iodofalan): Telix has enrolled the first patient in IPAX-BrIGHT, an international, multi-center pivotal trial of TLX101-Tx in patients with recurrent glioblastoma 14 . The trial is now open for enrollment in Australia, Austria and the Netherlands and has received regulatory approval to commence in Belgium. TLX090-Tx ( 153 Sm-DOTMP): Telix continues to dose patients in SOLACE 15 , a Phase 1 study of a drug candidate for treating pain in patients with osteoblastic bone metastases from prostate and breast cancers. The study was expanded this quarter to include additional U.S. sites to accelerate recruitment. TLX597-Tx ( 177 Lu-DOTA-HYNIC-panPSMA): TLX597-Tx is a "next generation" PSMA-targeting prostate cancer therapy candidate being developed to facilitate patient access in select geographies, where routine clinical availability to approved therapies is limited or not available. Early clinical data suggests a favorable asset biodistribution with limited uptake in healthy organs of concern (e.g., salivary glands, kidneys) relative to available 177 Lu-PSMA therapies. Interim data from OPTIMAL-PSMA 16 , an investigator-led, randomized, dose intensification study of TLX597-Tx in mCRPC, will be presented at the International Prostate Cancer Symposium in April 2026. Precision Medicine Business Unit PSMA imaging portfolio: Telix continues to expand its commercial footprint with Illuccix now launched in 21 countries globally, which includes 16 countries in Europe. This growing international presence enhances access to PSMA-PET/CT imaging 17 while establishing a scalable commercial and operational platform to support future product launches, including follow-on therapeutic products. Telix's broad proposed label for TLX591-Px (Illuccix) is under review by the NMPA Centre for Drug Evaluation as part of the NDA submission 18 . TLX101-Px, (Floretyrosine F 18 or 18 F-FET): Telix has resubmitted its NDA in the U.S. with the additional clinical data and analysis as agreed with the FDA. Telix has submitted a MAA in Europe covering commercially significant markets, seeking to expand patient access to advanced brain imaging. Zircaix® 3 (TLX250-Px, 89 Zr-DFO-girentuximab): Based on two successful Type A meetings with the FDA, Telix believes it has aligned on key outstanding issues for the Biologics License Application (BLA) resubmission, including demonstration of drug product comparability between clinical trial material and scale-up commercial production. The Company is now completing the agreed deliverables and documentation required, targeting a H1 2026 submission. Corporate Updates Telix has announced the appointment of David Gill as Non-Executive Director (NED), effective May 11, 2026, as part of its Board renewal process 19 . Mr. Gill is expected to be appointed as Chair in due course, succeeding Dr. Mark Nelson who will remain on the Board as NED. The Board believes Mr. Gill's appointment will enhance the Board’s capability, with extensive experience in U.S. public company governance, financial oversight and senior leadership across commercial and clinical-stage biopharmaceutical companies. FY 2026 guidance Telix reaffirms FY 2026 revenue guidance of US$950 million to US$970 million 20 . Guidance reflects revenue from product sales in jurisdictions with a marketing authorization, and a full year of revenue contribution from RLS. Telix reaffirms research and development (R&D) expenditure guidance of US$200 million to US$240 million, subject to achieving ongoing global commercial milestones. About Telix Pharmaceuticals Limited Telix is a global biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals with the goal of addressing significant unmet medical need in oncology and rare diseases. Telix is headquartered in Melbourne (Australia) with international operations in the United States, United Kingdom, Brazil, Canada, Europe (Belgium and Switzerland), and Japan. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (NASDAQ: TLX). Illuccix (kit for the preparation of gallium-68 ( 68 Ga) gozetotide injection) has been approved by the FDA 21 , and in multiple markets globally. Gozellix (kit for the preparation of gallium-68 ( 68 Ga) gozetotide injection) has been approved by the FDA 22 . No other Telix product mentioned in this announcement has received a marketing authorization in any jurisdiction. Visit for further information about Telix, including details of the latest share price, ASX and U.S. Securities and Exchange Commission (SEC) filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on LinkedIn , X and Facebook . Telix Investor Relations (Global) Ms. Kyahn Williamson SVP Investor Relations and Corporate Communications kyahn.williamson@telixpharma.com Telix Investor Relations (U.S.) Ms. Annie Kasparian Director Investor Relations and Corporate Communications annie.kasparian@telixpharma.com Telix Investor Relations (Australia) Ms. Charlene Jaw Associate Director Investor Relations charlene.jaw@telixpharma.com This announcement has been authorized for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. Guidance Disclaimer The stated revenue guidance is based on expected global and domestic economic conditions and is subject to known and unknown risks, uncertainties and other factors that may cause our actual results to differ materially. As such, investors are cautioned not to place undue reliance on this guidance and in particular Telix cannot guarantee a particular result. In compiling financial forecasts, a number of key variables that may have a significant impact on guidance have been identified and are listed below. Key variables that could cause actual results to differ materially include: the success and timing of research and development activities; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; competitive developments affecting our products; the ability to successfully market new and existing products; difficulties or delays in manufacturing; trade buying patterns and fluctuations in interest and currency exchange rates; legislation, regulation, or policy that affects product production, distribution, pricing, reimbursement, access or tax; acquisitions and divestitures; research collaborations; litigation or government investigations; and Telix’s ability to protect its patents and other intellectual property. See the Legal Notices section below for additional information, risks and assumptions. Legal Notices Cautionary Statement Regarding Forward-Looking Statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement. This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as “may”, “expect”, “intend”, “plan”, “estimate”, “anticipate”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’s business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix’s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress, completion and results of Telix’s preclinical and clinical trials, and Telix’s research and development programs; Telix’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals for Telix’s product candidates, including TLX101-Px and TLX250-Px, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialization of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix’s expenses, future revenues and capital requirements; Telix’s financial performance; developments relating to Telix’s competitors and industry; the anticipated impact of U.S. and foreign tariffs and other macroeconomic conditions on Telix’s business, including as a result of war or other geopolitical conflicts; and the pricing and reimbursement of Telix’s product candidates, if and after they have been approved. Telix’s actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. Trademarks and Trade Names. All trademarks and trade names referenced in this press release are the property of Telix Pharmaceuticals Limited (Telix) or, where applicable, the property of their respective owners. For convenience, trademarks and trade names may appear without the ® or ™ symbols. Such omissions are not intended to indicate any waiver of rights by Telix or the respective owners. Trademark registration status may vary from country to country. Telix does not intend the use or display of any third-party trademarks or trade names to imply any affiliation with, endorsement by, or sponsorship from those third parties. ©2026 Telix Pharmaceuticals Limited. All rights reserved. 1 Telix media release March 9, 2026. ClinicalTrials.gov ID: NCT06520345 . 2 Telix ASX disclosure March 16, 2026. 3 Brand name subject to final regulatory approval. 4 Telix ASX disclosure February 18, 2026. 5 Branded as Illuccix in commercial jurisdictions outside of China. 6 Telix ASX disclosure January 20, 2026. 7 Primarily sales of Illuccix and Gozellix in our Precision Medicine business. 8 Telix Manufacturing Solutions (TMS) third-party revenue predominantly driven by RLS Radiopharmacies (RLS), excludes Illuccix and Gozellix sales and TMS inter-segment revenue. Q1 2025 includes RLS revenue contribution since acquisition close on January 28, 2025. 9 Prostate-specific membrane antigen. 10 Metastatic castration-resistant prostate cancer. 11 Androgen receptor pathway inhibitor. 12 ClinicalTrials.gov ID: NCT07197580 . 13 Clear cell renal cell carcinoma. 14 ClinicalTrials.gov ID: NCT07100730 . 15 ClinicalTrials.gov ID: NCT07197645 . 16 ANZCTR.org.au ID: ACTRN12625000971437. 17 Imaging of prostate-specific membrane antigen with positron emission tomography/computed tomography. 18 Telix media release January 20, 2026. 19 Telix ASX disclosure April 2, 2026. Appointment subject to grant of Australian Director Identification number. 20 Refer to Telix ASX disclosures February 20, 2026. 21 Telix ASX disclosure December 20, 2021. 22 Telix ASX disclosure March 21, 2025.

Phase 3Phase 1Drug ApprovalExecutive Change

02 Apr 2026

·www.biopharmadive.com

Immunovant eye drug flunks Phase 3 studies; Beam sickle cell data published in NEJM

Today, a brief rundown of news from Immunovant and Alto Neuroscience, as well as updates from Oric Pharmaceuticals, Korsana Biosciences and a couple genetic medicine developers you may have missed.Shares for Immunovant, a Roivant spinout, fell Thursday after the company announced its experimental therapy for thyroid eye disease failed two late-stage trials. The company said batoclimab, its drug in development with partner HanAllBiopharma,did not meet the Phase 3 trials key goals, which centered on a reduction in eye swelling for adults with active thyroid disease. Immunovant said safety data was consistent with previous findings, and no new safety signals were identified. The company did not share detailed results. The partners said they will review plans for their candidate and provide updates at a later date. Delilah AlvaradoAn experimental drug from Alto Neuroscience has failed a so-called proof-of-concept study evaluating it as a treatment for the cognitive impairment associated with schizophrenia. The drug, known as ALTO-101, is meant to inhibit the PDE4 enzyme. Altos study found ALTO-101 was not significantly better than a placebo when looking effects on brain activity and cognitive function. The company said has developed a modified-release, once-daily oral formulation of ALTO-101 and plans to explore partnering opportunities for it. Alto shares were subsequently down more than 7% in late morning trading Thursday. Andrew Tsai, an analyst at Jefferies, wrote that Wall Street had low expectations for this trial and is more focused on two Alto drugs for depression that have upcoming readouts. Jacob BellUpdated data published in the New England Journal of Medicine from Beam Therapeutics show that risto-cel, a gene editing treatment that it's studying for sickle cell disease, eliminated severe pain crises among 31 patients enrolled in the trial.The gene therapy company said Wednesday its treatment, which relies on a technology called base editing to change the individual letters in DNA, also helped restore the shape of red blood cells, resolve anemia and reduce the breakdown of red blood cells. Patients were followed anywhere from a little under two weeks to more than 20 months. Beam previously reported a patient death in its study of risto-cel, then known as BEAM-101, that investigators found to be related to busulfan, a chemotherapy drug used to condition patients for stem cell transplants. Late last month, the company also reported positive data from its study of a gene editing treatment for alpha-1 antitrypsin deficiency. Gwendolyn WuCell therapy developer Orca Bio said Wednesday that the Food and Drug Administration has delayed the review of its blood cancer drug Orca-T. Originally slated for this month, federal regulators now have until July 6 to return a decision on its allogeneic T cell therapy. In a Phase 3 study last year, the California biotechnology firm said that its treatment helped three-quarters of trial participants with a variety of hematological cancers avoid a serious side effect called graft-versus-host disease, compared to just 38% of patients given an ordinary stem cell transplant. Orca recently submitted additional information on its manufacturing processes, but has not been asked for additional clinical data, according to the company. The FDA has extended, or missed, deadlines for numerous other drugs over the past year. Gwendolyn WuShares of Oric Pharmaceuticals fell more than 40% Wednesday after the California-based drug developer provided updates on its most advanced research program. Oric has been testing rinzimetostat an experimental medicine meant to block a cancer-linked enzyme called EZH2 in an early-stage clinical trial of patients with metastatic castration-resistant prostate cancer who were previously treated with a median of two prior lines of therapy, including Johnson & Johnsons Zytiga. Oric said based on data from the trial, it has decided to run a larger Phase 3 study to evaluate a 400 milligram dose of its drug in combination with Bayers Nubeqa. Jefferies analyst Maury Raycroft wrote in a client note that some investors believe J&Js Erleada would have been a strategically better combination choice. Raycroft, though, argues that the evidence Oric has gathered so far shows it has a competitive drug. The stock sell off is therefore an overreaction, the analyst wrote. Oric shares rebounded around 10%, to $8.30 apiece, by mid-morning Thursday. Jacob BellKorsana Biosciences on Wednesday announced a reverse merger with Cyclerion Therapeutics. The combined company will trade on Nasdaq under the ticker KRSA and focus on advancing Korsanas potential treatments for neurodegenerative diseases. The most advanced of those treatments, codenamed KRSA-028, is a shuttled monoclonal antibody for Alzheimers disease that targets the protein amyloid beta. Alongside the merger, Korsana secured commitments for an oversubscribed private investment thats expected to total $380 million in gross proceeds. Fairmount and Venrock Healthcare Capital Partners led the investment. Jacob Bell '

Phase 3AcquisitionClinical ResultGene TherapyCell Therapy

02 Apr 2026

·allsci.com

Oric’s PRC2 inhibitor rinzimetostat combo regimen advances to Phase III trial in mCRPC

ORIC Pharmaceuticals (Nasdaq: ORIC) reported Phase Ib dose optimization data for rinzimetostat in combination with darolutamide in post-abiraterone metastatic castration-resistant prostate cancer (mCRPC), selecting 400 mg once daily as the recommended Phase 3 dose and announcing plans to initiate the Himalayas-1 global Phase III registrational trial in the first half of 2026. At a median follow-up of approximately five months, a five-month landmark rPFS rate of 84% appears numerically favorable relative to historical benchmarks for approved therapies in this setting, though the dataset remains small and cross-trial comparisons are limited. Trial specifics The Phase Ib dose optimization trial enrolled patients with mCRPC who had received prior androgen receptor pathway inhibitor (ARPI) therapy and up to one prior line of chemotherapy. The post-abiraterone cohort included 18 patients treated at 400 mg once daily and 15 at 600 mg once daily, both in combination with darolutamide (Nubeqa) at 600 mg twice daily. In 18 efficacy-evaluable patients at the 400 mg dose, landmark rPFS rates were 93%, 84%, and 84% at 3, 4, and 5 months respectively, with a median follow-up of 4.9 months. Among 15 patients with at least one post-baseline PSA assessment, 47% achieved a PSA50 response, with 33% confirmed. In 14 patients with detectable ctDNA at baseline, 71% achieved greater than 50% ctDNA reduction. For context, ORIC cited 5-month landmark rPFS rates of approximately 60% to 75% for approved therapies including enzalutamide (Xtandi), cabazitaxel (Jevtana), docetaxel (Taxotere), and lutetium-177 vipivotide tetraxetan (Pluvicto) in comparable populations, though these figures derive from separate trials with different patient characteristics. Treatment-related adverse events at the 400 mg dose were predominantly Grade 1. The most common were fatigue (39%), diarrhea (22%), and nausea (22%). A single Grade 3 TRAE was observed; no Grade 4 or 5 events were attributed to either drug. Dose modifications were rare, with one interruption and one discontinuation and no dose reductions required across the cohort. The dose selection followed an exposure-response analysis conducted across more than 100 patients in both single-agent and combination settings, in alignment with the FDA’s Project Optimus initiative. That analysis found comparable efficacy at 400 mg and 600 mg, but identified statistically significant associations between higher drug exposure and increased toxicity and treatment modifications, favoring the lower dose on safety grounds. Rinzimetostat and PRC2 inhibition Rinzimetostat is an allosteric inhibitor of polycomb repressive complex 2 (PRC2) acting through the EED subunit. PRC2 mediates histone H3 lysine 27 trimethylation (H3K27me3), an epigenetic modification associated with transcriptional silencing of differentiation programs. In prostate cancer, PRC2 activity has been implicated in the transition toward AR-indifferent or neuroendocrine phenotypes following ARPI exposure — a resistance mechanism not addressed by sequential AR-directed therapy. Pairing rinzimetostat with darolutamide, an AR antagonist with a distinct binding conformation and low CNS penetration, is designed to simultaneously block AR signaling and suppress epigenetic resistance pathways. The most direct competitive reference point is mevrometostat (PF-06821497), Pfizer’s EZH2-targeting PRC2 inhibitor, which is currently in Phase III in mCRPC in combination with enzalutamide. ORIC has positioned rinzimetostat’s safety profile as a potential differentiator, citing lower rates of Grade 3 or higher events and fewer dose modifications relative to competitor regimens, though cross-trial comparisons are limited by differences in patient populations, prior therapy, and data maturity. An earlier EZH2 inhibitor combination effort in prostate cancer, the CELLO-1 trial evaluating tazemetostat with an ARPI, was terminated, leaving the field without a validated precedent for this mechanism in registrational testing. The post-abiraterone mCRPC population represents a setting with limited oral, biomarker-agnostic options. Approved PARP inhibitors — olaparib, rucaparib, and the combination regimens talazoparib plus enzalutamide and niraparib plus abiraterone — are restricted to patients with homologous recombination repair mutations, estimated at roughly 25%-30% of mCRPC cases. Pluvicto gained a label expansion in early 2025 covering pre-taxane, post-ARSI mCRPC, but requires PSMA-PET imaging, specialized nuclear medicine infrastructure, and intravenous administration. Chemotherapy with docetaxel or cabazitaxel carries a toxicity burden that limits use in patients with compromised performance status. The unselected post-abiraterone population — approximately 17,000 new patients annually in the US by ORIC’s estimate — lacks a well-tolerated oral targeted option with a novel mechanism. The planned Himalayas-1 trial will enroll approximately 600 patients across more than 250 sites in over 20 countries, randomized 1:1 to rinzimetostat 400 mg once daily plus darolutamide versus physician’s choice of an AR inhibitor or chemotherapy. The primary endpoint is rPFS; overall survival is the key secondary endpoint. ORIC also reported early data from 19 patients with mCRPC previously treated with AR inhibitors other than abiraterone, showing 5-month landmark rPFS of 85%, suggesting potential applicability beyond the post-abiraterone cohort, though sample sizes remain too small to draw firm conclusions. Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

Phase 3Clinical ResultPhase 1Phase 2

100 Deals associated with Abiraterone acetate

External Link

KEGG	Wiki	ATC	Drug Bank
D09701	Abiraterone acetate	L02BX03	DB05812

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Prostate Carcinoma	Brazil	Libbs Farmacêutica Ltda.	24 Dec 2018
Prostate Neuroendocrine Carcinoma	Japan	Janssen Pharmaceutical KK	16 Feb 2018
Castration-Resistant Prostatic Cancer	Australia	Janssen-Cilag Pty Ltd.	01 Mar 2012
Hormone-dependent prostate cancer	Australia	Janssen-Cilag Pty Ltd.	01 Mar 2012
Metastatic castration-resistant prostate cancer	United States	Janssen Biotech, Inc.	28 Apr 2011

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	United States	Tavanta Therapeutics, Inc.	05 May 2021
Adenocarcinoma of prostate	Phase 3	France	Tavanta Therapeutics, Inc.	05 May 2021
Adenocarcinoma of prostate	Phase 3	Hungary	Tavanta Therapeutics, Inc.	05 May 2021
Adenocarcinoma of prostate	Phase 3	Poland	Tavanta Therapeutics, Inc.	05 May 2021
Adenocarcinoma of prostate	Phase 3	Spain	Tavanta Therapeutics, Inc.	05 May 2021
Adenocarcinoma of prostate	Phase 3	Sweden	Tavanta Therapeutics, Inc.	05 May 2021
Adenocarcinoma of prostate	Phase 3	United Kingdom	Tavanta Therapeutics, Inc.	05 May 2021
Castration-sensitive prostate cancer	Phase 3	United States	Tavanta Therapeutics, Inc.	05 May 2021
Castration-sensitive prostate cancer	Phase 3	France	Tavanta Therapeutics, Inc.	05 May 2021
Castration-sensitive prostate cancer	Phase 3	Hungary	Tavanta Therapeutics, Inc.	05 May 2021

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03012321 (BRCAAway, ASCO_GU2026) Manual	Phase 2	Metastatic castration-resistant prostate cancer First line DNA repair defects	61	Abiraterone 1000 mg QD + prednisone 5 mg BID	zneqbggiqj(jbpkfqouxs) = yqtirlqbgu wdofrcssxe (kszhgfrgke, 13 - NR) View more	Positive	26 Feb 2026
				Olaparib 300 mg BID	zneqbggiqj(jbpkfqouxs) = vrepihszwd wdofrcssxe (kszhgfrgke, 26 - NR) View more
NCT06991556 (ASCO_GU2026)	Phase 2	Hormone-dependent prostate cancer	150	Luxdegalutamide 100 mg QD + abiraterone 1000 mg QD	jindpagxqo(silykcrydd) = zjqmzadjgr daerqbzeeu (ymdbanbhdc ) View more	Positive	26 Feb 2026
				Luxdegalutamide 300 mg QD + abiraterone 1000 mg QD	jindpagxqo(silykcrydd) = wjbfffeydb daerqbzeeu (ymdbanbhdc ) View more
NCT03449719 (ARTO, ASCO_GU2026)	Phase 2	Castration-Resistant Prostatic Cancer First line	157	abiraterone acetate +ADT + SBRT	rblpvxhgpc(gsvykwprog) = ajirrgcavt gjedjedyvt (nshrkgieum ) View more	Positive	26 Feb 2026
				abiraterone acetate + ADT	rblpvxhgpc(gsvykwprog) = zhbhcntmar gjedjedyvt (nshrkgieum ) View more
ASCO_GU2026	Not Applicable	Metastatic Prostate Carcinoma	344	Enzalutamide (Charlson Comorbidity Index ≥3)	rlnizinjvi(xpgkvotdcl) = opraedkkzd jmveypukub (pzkyydvaeo, 25.9 - 55.1) View more	Positive	26 Feb 2026
				Abiraterone (Charlson Comorbidity Index ≥3)	rlnizinjvi(upfrwsbzio) = oqnacthasy oslyhbtwlw (chrymmzfad )
NCT04812366 (GUNS, ASCO_GU2026)	Phase 2	Localized Prostate Carcinoma Neoadjuvant ETS fusions \| FOXA1 \| TP53 ... View more	48	ARPI doublet + docetaxel	cwqolmntdn(pccqdjrlng) = azxtsrluyz jnaiqgqeli (jyxyckopoe )	Positive	26 Feb 2026
				ARPI doublet	-
ASCO_GU2026	Not Applicable	Metastatic Castration-Sensitive Prostate Carcinoma	4,806	Abiraterone acetate (mCSPC)	fupasoqisq(zobmcpvgik) = Fatigue (31% ABI vs 34% ENZ) and falls (7% vs 8%) were slightly more common with ENZ, while hypertension was marginally higher in the ABI group (2% vs 1.8%). wujjdimpjh (clikpgtjat ) View more	Positive	26 Feb 2026
				Enzalutamide (mCSPC)
ASCO_GU2026	Not Applicable	Prostatic Cancer	195	Abiraterone acetate	wylpwktufs(cdokdkwtur) = eqbfskeqbo hqkdmialad (qwiwlzmhhl ) View more	Negative	26 Feb 2026
				Apalutamide	wylpwktufs(cdokdkwtur) = dopsrunutp hqkdmialad (qwiwlzmhhl ) View more
NCT03565835 (CTgov)	Phase 2	Metastatic Prostate Carcinoma \| Metastatic castration-resistant prostate cancer	31	prednisone+Abiraterone Acetate	qoozxtezxv = qjlwkkknog czupnwifdj (vezystouzf, yxpdjhqgoj - otaxrxkers) View more	-	26 Jan 2026
NCT03419234 (CHAARTED2, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	223	Androgen deprivation therapy+Cabazitaxel+prednisone+Abiraterone Acetate (Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel))	deriuwgeah(gutcdanxef) = eujjratdji ymfchjdqdm (jrrvhmpatg, pieaihjonq - uayiolndpd) View more	-	08 Jan 2026
				Androgen deprivation therapy+prednisone+Abiraterone Acetate (Arm B (Abiraterone Acetate, Prednisone))	deriuwgeah(gutcdanxef) = nvhhpjyhzb ymfchjdqdm (jrrvhmpatg, taaggzojzo - duwzvdiitt) View more
NCT02574910 (CTgov)	Phase 1	Congenital Adrenal Hyperplasia Due to 21 Hydroxylase Deficiency	4	Abiraterone Acetate (Abiraterone acetate 1 mg/kg/d)	hmmaeytlji = tggxvujieo ibuxfweekc (jehpqppvxb, vphwkdrvhm - pzttdjpcmp) View more	-	04 Nov 2025
				Abiraterone Acetate (Abiraterone acetate 2 mg/kg/d)	hmmaeytlji = tjzznazurk ibuxfweekc (jehpqppvxb, dywbtecvsw - plsgwjlgbb) View more

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