The purpose of this study is to find out what treatment works best for participants with metastatic prostate cancer that are not responding to hormone treatment and docetaxel and are also Prostate-specific membrane antigen(PSMA) positive.

Start Date14 Jul 2025

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT06890832

/ Not yet recruitingPhase 2

A Phase-2, Open-label, Randomized, Parallel-Group, Three-Arm Study to Assess Efficacy and Safety of Cabazitaxel Lipid Tablet in Combination with Prednisone for the Treatment of Adult Men with Metastatic Castration-Resistant Prostate Cancer Previously Treated with a Docetaxel-containing Treatment Regimen

A total of 75 participants will be enrolled in the study, with 25 participants allocated per intervention group. In Group 1, participant will take 50 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 2, participant will take 100 mg cabazitaxel every week for 6 cycles (3 doses per cycle), 10 mg prednisone daily till the end of cycle 6. In Group 3, participant will take 200 mg cabazitaxel every 3 weeks for 6 cycles (1 doses per cycle), 10 mg prednisone daily till the end of cycle 6.
The study comprises three phases: a 21-day screening phase, an 18-week intervention phase starting on Day 1 (baseline), and a post-intervention follow-up phase lasting up to 12 months from Day 1. The total duration of participation for each individual will be approximately one year.
Key efficacy assessments include CT scans/MRI, bone scans, PSA, ALP, LDH, symptomatic skeletal events, and pain evaluations. Key safety assessments encompass the monitoring of adverse events (AEs), ECOG performance status, physical examinations, vital sign measurements, clinical laboratory tests, peripheral neuropathy evaluation, 12-lead ECG, and echocardiogram (ECHO) assessments.
Pharmacokinetic parameters will also be evaluated.

Start Date01 May 2025

Sponsor / Collaborator

Jina Pharmaceuticals, Inc.

NCT06632977

/ RecruitingPhase 2IIT

PREcision DIagnostics in Prostate Cancer Treatment (PREDICT)

This phase II trial evaluates whether genetic testing in prostate cancer is helpful in deciding which study treatment patients are assigned. Patient cancer tissue samples are obtained from a previous surgery or biopsy procedure and tested for deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) abnormalities or mutations in their cancer. Valemetostat tosylate is in a class of medications called EZH1/EZH2 inhibitors. It blocks proteins called EZH1 and EZH2, which may help slow or stop the spread of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Cabazitaxel injection is in a class of medications called microtubule inhibitors. It works by slowing or stopping the growth of tumor cells. Abiraterone acetate blocks tissues from making androgens (male hormones), such as testosterone. This may cause the death of tumor cells that need androgens to grow. It is a type of anti-androgen. Enzalutamide 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. Lutetium Lu 177 vipivotide tetraxetan is in a class of medications called radiopharmaceuticals. It works by targeting and delivering radiation directly to tumor cells which damages and kills these cells. Assigning patients to targeted treatment based on genetic testing may help shrink or slow the cancer from growing

Start Date06 Feb 2025

Sponsor / Collaborator

Alliance for Clinical Trials in Oncology

[+1]

100 Clinical Results associated with Cabazitaxel Acetone

100 Translational Medicine associated with Cabazitaxel Acetone

100 Patents (Medical) associated with Cabazitaxel Acetone

1,686

Literatures (Medical) associated with Cabazitaxel Acetone

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 ; George, Daniel J ; Scales, Charles D ; 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 Feb 2026·BJU INTERNATIONAL

Long‐term outcomes of a cascading salvage strategy for high‐risk non‐muscle‐invasive bladder cancer

Article

Author: McElree, Ian M. ; Hougen, Helen Y. ; Mott, Sarah L. ; Steinberg, Ryan L. ; Packiam, Vignesh T. ; O'Donnell, Michael A.

Objective:

To report long‐term oncological outcomes of patients with high‐risk non‐muscle‐invasive bladder cancer (HR‐NMIBC) undergoing bladder‐sparing therapy (BST) after bacillus Calmette–Guérin (BCG) failure.

Patients and Methods:

We retrospectively reviewed patients with HR‐NMIBC treated from 2000 to 2025 with intravesical therapies after BCG failure, all of whom received salvage gemcitabine/docetaxel (Gem/Doce). Subsequent BST included valrubicin/docetaxel, sequential doxorubicin/gemcitabine alternating with mitomycin‐C/docetaxel, and gemcitabine/cabazitaxel with pembrolizumab. Kaplan–Meier analysis estimated recurrence‐free survival (RFS), progression‐free survival (PFS), cystectomy‐free survival (CFS), and cancer‐specific survival (CSS).

Results:

A total of 85 patients with HR‐NMIBC were included of whom 38 (45%) were BCG‐unresponsive. The median (interquartile range) follow‐up was 86 (43–108) months from induction Gem/Doce. Following Gem/Doce initiation, RFS did not significantly decline with each successive line of salvage therapy: among patients treated with first (Gem/Doce), second, and third line salvage therapy, the 2‐year RFS was 47%, 43%, and 39%, respectively ( P = 0.68). Overall, the PFS at 5 years was 81% (95% confidence interval [CI] 69–88%). PFS did not significantly decline with each successive salvage line of therapy: among patients treated with first (Gem/Doce), second, and third line salvage therapy, the 2‐year PFS was 91%, 88%, and 93%, respectively ( P = 0.98). CFS and CSS were 74% (95% CI 62–83%) and 88% (95% CI 79–94%) at 5 years, respectively.

Conclusions:

Multi‐line BST is feasible and can yield durable bladder preservation and oncological control in select patients with HR‐NMIBC following BCG failure. Progression‐free outcomes remained favourable across successive lines of salvage therapy. These findings support the role of longitudinal BST as an alternative to radical cystectomy in carefully and appropriately selected patients.

01 Feb 2026·PROSTATE

Efficacy of Early Switching From Docetaxel to Cabazitaxel in Castration‐Resistant Prostate Cancer

Article

Author: Fujii, Yoichi ; Maki, Kazuki ; Kakutani, Shigenori ; Taguchi, Satoru ; Yamada, Daisuke ; Niimi, Aya ; Takada, Tappei ; Nakagawa, Tohru ; Tanaka, Takehiro ; Miyakawa, Jimpei ; Kume, Haruki ; Kawai, Taketo ; Kamei, Jun ; Yamada, Yuta

ABSTRACT:

Background:

Cabazitaxel is a taxane agent associated with fewer symptomatic adverse events than docetaxel in treating castration‐resistant prostate cancer (CRPC), yet it is typically reserved for post‐docetaxel failure. This study assessed whether early switching from docetaxel to cabazitaxel could improve clinical outcomes.

Methods:

Beginning in 2019, a treatment approach was adopted wherein patients with CRPC were switched to cabazitaxel after three cycles of docetaxel, regardless of response. Patients who initiated docetaxel between February 2019 and March 2022 were classified as the switch group, while those who started between September 2014 and February 2019 were designated as the historical non‐switch group. Chemotherapy duration, number of chemotherapy cycles, and adverse events were compared. Progression‐free survival (PFS), time to failure of both taxanes, and overall survival (OS) were analyzed using propensity score matching.

Results:

The switch and non‐switch groups included 36 and 37 patients, respectively. The switch group received significantly more chemotherapy cycles ( p = 0.043) and had a longer cumulative chemotherapy duration ( p = 0.035), even when including chemotherapy administered in subsequent lines. The cumulative incidence of peripheral neuropathy was significantly lower in the switch group ( p = 0.037). Within the switch group, symptomatic adverse events, including fatigue, anorexia, and alopecia, were significantly reduced after switching to cabazitaxel. PFS was significantly prolonged in the switch group ( p = 0.002), although time to failure of both taxanes and OS did not differ significantly between groups.

Conclusions:

Early switching to cabazitaxel after three cycles of docetaxel may reduce symptomatic adverse events, including peripheral neuropathy, while enabling longer chemotherapy exposure and improved PFS in patients with CRPC.

News (Medical) associated with Cabazitaxel Acetone

04 May 2026

·investors.oricpharma.com

ORIC® Pharmaceuticals Reports First Quarter 2026 Financial Results and Operational Updates

Announced selection of rinzimetostat RP3D in combination with darolutamide for Himalayas-1 Phase 3 global registrational trial in post-abiraterone mCRPC, expected to initiate in 1H 2026 Reported rinzimetostat data in post-abiraterone mCRPC supporting potential best-in-disease profile, including a highly differentiated safety profile and landmark rPFS consistent with competitor PRC2 inhibitor and substantially better than standard of care therapies in mCRPC Reported early rinzimetostat data in post-AR inhibitor mCRPC, demonstrating promising durability and reinforcing rinzimetostat’s potential to restore and sustain the benefit derived from AR inhibitors Anticipate rinzimetostat program update in 2H 2026 and several enozertinib clinical updates in 2H 2026 ahead of potential initiation of a registrational trial Cash and investments of approximately $420 million expected to provide runway into 2H 2028 and beyond anticipated primary endpoint readout from first Phase 3 trial for rinzimetostat SOUTH SAN FRANCISCO and SAN DIEGO, May 04, 2026 (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 provided operational updates for the quarter ended March 31, 2026. “The first quarter marked a pivotal step for ORIC as we selected our Phase 3 dose for rinzimetostat, reported data supporting a potential best-in-disease profile, and moved toward the initiation of Himalayas-1, our first registrational trial,” said Jacob M. Chacko, M.D., president and chief executive officer. “With a strong cash position and multiple enozertinib clinical updates expected later this year, we see a clear path to building ORIC into a multi-asset, late-stage oncology company.” First Quarter 2026 and Other Recent Highlights Rinzimetostat: a potent and selective allosteric inhibitor of PRC2 Announced the selection of rinzimetostat 400 mg once daily as the Recommended Phase 3 Dose (RP3D) in combination with darolutamide for the Himalayas-1 Phase 3 global trial in post-abiraterone mCRPC. Reported rinzimetostat dose optimization data in post-abiraterone mCRPC supporting potential best-in-disease profile. As of the March 2026 presentation cutoff dates, rinzimetostat 400 mg once daily in combination with darolutamide demonstrated compelling safety and efficacy across multiple endpoints: The vast majority of treatment-related adverse events (TRAEs) were Grade 1 in severity and consistent with PRC2 and androgen receptor (AR) inhibition. A single Grade 3 TRAE was observed, and no Grade 4 or 5 AEs were attributed to rinzimetostat or darolutamide. Dose modifications were rare (one interruption and one discontinuation), with no dose reductions required. With a median follow up of 4.9 months, landmark rPFS rates of 93%, 84%, and 84% at 3, 4, and 5 months, respectively, are consistent with the competitor PRC2 inhibitor currently in Phase 3 in post-abiraterone mCRPC patients and superior to available standard-of-care therapies, including Xtandi®, Jevtana®, Taxotere®, and Pluvicto®. For reference, the 5-month landmark rPFS for these approved therapies ranges from approximately 60% to 75%. 47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed. Impressive ctDNA reductions observed across a range of AR mutations, with 71% of patients (10/14) achieving >50% ctDNA reduction. Reported early rinzimetostat dose optimization data in patients with mCRPC previously treated with AR inhibitors. Rinzimetostat 400 mg once daily in combination with the AR inhibitor darolutamide demonstrated compelling landmark rPFS rates of 93%, 85%, and 85% at 3, 4, and 5 months, respectively, with a median follow-up of 4.8 months. For reference, the clinical benefit of androgen receptor pathway inhibitors in this setting is limited; for example, Zytiga® has demonstrated a median rPFS of 3.4 months. Presented preclinical data at AACR showing PRC2 inhibition reduces tumor adaptability and sustains the benefit derived from AR inhibition, with potential advantages of EED over EZH2 inhibition. The vast majority of treatment-related adverse events (TRAEs) were Grade 1 in severity and consistent with PRC2 and androgen receptor (AR) inhibition. A single Grade 3 TRAE was observed, and no Grade 4 or 5 AEs were attributed to rinzimetostat or darolutamide. Dose modifications were rare (one interruption and one discontinuation), with no dose reductions required. With a median follow up of 4.9 months, landmark rPFS rates of 93%, 84%, and 84% at 3, 4, and 5 months, respectively, are consistent with the competitor PRC2 inhibitor currently in Phase 3 in post-abiraterone mCRPC patients and superior to available standard-of-care therapies, including Xtandi®, Jevtana®, Taxotere®, and Pluvicto®. For reference, the 5-month landmark rPFS for these approved therapies ranges from approximately 60% to 75%. 47% of patients (7/15) achieved a PSA50 response, with 33% (5/15) confirmed. Impressive ctDNA reductions observed across a range of AR mutations, with 71% of patients (10/14) achieving >50% ctDNA reduction. Enozertinib: a brain-penetrant, selective inhibitor targeting EGFR exon 20 insertion mutations and EGFR atypical mutations Completed enrollment in the Phase 1b trial of enozertinib as a single-agent in first-line patients with advanced NSCLC harboring EGFR exon 20 insertion mutations. Continue to enroll Phase 1b trial of enozertinib as a single-agent in first-line patients with advanced NSCLC harboring EGFR atypical mutations. Continue to enroll Phase 1b trial of enozertinib in combination with subcutaneous (SC) amivantamab in first-line patients with advanced NSCLC harboring EGFR exon 20 insertion mutations. Anticipated Program Milestones: ORIC anticipates the following upcoming milestones: Rinzimetostat in mCRPC: 1H 2026: Initiate Himalayas-1 global Phase 3 registrational trial in post-abiraterone mCRPC 2H 2026: Program update Enozertinib in NSCLC: 2H 2026: 1L EGFR atypical monotherapy data 2H 2026: 1L EGFR exon 20 insertion monotherapy data and combination data with SC amivantamab 1H 2026: Initiate Himalayas-1 global Phase 3 registrational trial in post-abiraterone mCRPC 2H 2026: Program update 2H 2026: 1L EGFR atypical monotherapy data 2H 2026: 1L EGFR exon 20 insertion monotherapy data and combination data with SC amivantamab First Quarter 2026 Financial Results Cash, Cash Equivalents and Investments: Cash, cash equivalents and investments totaled $419.7 million as of March 31, 2026, which includes $59.9 million in net proceeds raised from healthcare specialist funds during the quarter under the ATM (at-the-market) program. The company expects its cash and investments to fund the operating plan into 2H 2028. R&D Expenses: Research and development (R&D) expenses were $31.4 million for the three months ended March 31, 2026, compared to $24.6 million for the three months ended March 31, 2025, an increase of $6.8 million. The increase was primarily due to an increase in external expenses related to the advancement of rinzimetostat and enozertinib, offset primarily by lower preclinical costs. G&A Expenses: General and administrative (G&A) expenses were $8.2 million for the three months ended March 31, 2026, relatively consistent with $8.1 million for the three months ended March 31, 2025. 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) rinzimetostat, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 insertion and EGFR atypical mutations, being developed for NSCLC. 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 rinzimetostat and enozertinib; the potential advantages of rinzimetostat and enozertinib; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-disease profile of rinzimetostat; the development plans and timelines for rinzimetostat and enozertinib; plans underlying ORIC’s clinical trials and development; anticipated program milestones, including timing of program and data updates and the initiation of a registrational trial; 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 rinzimetostat, enozertinib or any other 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 entitled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 4, 2026, 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 All registered trademarks are the property of their respective owners.

Clinical ResultPhase 1Phase 3Financial StatementAACR

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

05 Jan 2026

·www.taiho.co.jp

Sanofi and Taiho Announce Sales Transfer of Anticancer Agent JEVTANA® Intravenous Infusion 60 mg

Sanofi K.K. (hereinafter “Sanofi”) and Taiho Pharmaceutical Co., Ltd. (hereinafter “Taiho”) announced today that the sales of the anticancer agent Jevtana® I.V. Infusion 60 mg (generic name: cabazitaxel; hereinafter “Jevtana”) will be transferred from Sanofi to Taiho in Japan effective April 1, 2026. Jevtana is an anticancer agent which was approved and launched in Japan in 2014, indicated for patients with castration-resistant prostate cancer previously treated with a docetaxel-containing regimen. The agent inhibits cell division by promoting tubulin polymerization and stabilizing microtubules, thereby suppressing the proliferation of cancer cells. On April 1, 2026, Taiho will assume responsibility for the sales and marketing, and medical information activities for Jevtana in Japan, while Sanofi will continue to be the marketing authorization holder and will also continue to manufacture the product. Sanofi and Taiho remain committed to ensuring a smooth transition and continued supply of Jevtana to patients in need of this treatment. Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people’s lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. For more information about Sanofi K.K., please visit https://www.sanofi.co.jp. Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/　), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in Japan for developing innovative medicines for the treatment of cancer, a reputation that is rapidly expanding through their extensive global R&D efforts. In areas other than oncology, as well, the company creates and markets quality products that effectively treat medical conditions and can help improve people’s quality of life. Always putting customers first, Taiho Pharmaceutical also aims to offer consumer healthcare products that support people’s efforts to lead fulfilling and rewarding lives. For more information about Taiho Pharmaceutical, please visit https://www.taiho.co.jp/en/.

Drug ApprovalVaccine

100 Deals associated with Cabazitaxel Acetone

External Link

KEGG	Wiki	ATC	Drug Bank
D09755 D10452	Cabazitaxel Acetone	L01CD04	DB06772

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Prostatic Cancer	Japan	Sanofi KK	04 Jul 2014
Metastatic castration-resistant prostate cancer	United States	Sanofi-Aventis U.S. LLC	17 Jun 2010

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	France	Sanofi	01 Dec 2013
Localized Prostate Carcinoma	Phase 3	France	Sanofi	01 Dec 2013
Transitional Cell Carcinoma	Phase 3	United Kingdom	Sanofi	01 Jan 2013
Castration-Resistant Prostatic Cancer	Phase 3	United States	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Japan	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Denmark	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Finland	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Peru	Aventis Pharma	05 May 2011
Castration-Resistant Prostatic Cancer	Phase 3	Sweden	Aventis Pharma	05 May 2011
Bone Diseases	Phase 2	Italy	Sanofi Srl	12 Mar 2018

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01616875 (The Bristol Bladder trial, CTgov)	Phase 2	Urothelial Carcinoma of the Urinary Bladder	28	Cabazitaxel+Cisplatin chemotherapy	czjdepowsb = upvbmipbvi pxoyfzwfmw (nlmpmhygzm, csipoelmrw - jejkaikaec) View more	-	06 Mar 2026
NCT01952223 (PEACE-2, ASCO_GU2026)	Phase 3	Localized Prostate Carcinoma	761	ADT + Radiotherapy + Cabazitaxel ± Pelvic Radiotherapy	ttsblnhzdv(hioduhvyjt) = zaxyaadwll yubygrczzn (kymepctijf ) View more	Negative	26 Feb 2026
				ADT + Radiotherapy ± Pelvic Radiotherapy	ttsblnhzdv(hioduhvyjt) = zjzywclslx yubygrczzn (kymepctijf ) View more
ASCO_GU2026	Not Applicable	Metastatic castration-resistant prostate cancer	28	cabazitaxel	lsqmkaxmck(lceumdwdaz) = qhajhqsfft kfkhskmpfn (dxhmpginun, 3.0 - 13.4) View more	Positive	26 Feb 2026
				cabazitaxel (PSA 50 responders to LuPSMA)	lsqmkaxmck(lceumdwdaz) = cjhqlukmmg kfkhskmpfn (dxhmpginun, 4.0 - NR) View more
NCT03419234 (CHAARTED2, CTgov)	Phase 2	Metastatic castration-resistant prostate cancer	223	Androgen deprivation therapy+Cabazitaxel+prednisone+Abiraterone Acetate (Arm A (Abiraterone Acetate, Prednisone, Cabazitaxel))	xyhrksmctk(gmtjfybskc) = kadsszdkov xecmtdvuek (lhdestrzes, hnxrsqfjmb - ayfszqxaww) View more	-	08 Jan 2026
				Androgen deprivation therapy+prednisone+Abiraterone Acetate (Arm B (Abiraterone Acetate, Prednisone))	xyhrksmctk(gmtjfybskc) = rtdwphdfgx xecmtdvuek (lhdestrzes, pkcifoegsd - hrodvcvkuv) View more
NCT02485691 (CARD, Pubmed \| JCI Insight)	Phase 3	Metastatic castration-resistant prostate cancer chromosomal instability in circulating tumor cells	600	cabazitaxel	ofhuccktmq(grolisdqic) = cxhbchejtc sjrvovykmd (uktpeinizg )	Positive	22 Dec 2025
				alternative ARPI	ofhuccktmq(grolisdqic) = zmjqcoukxf sjrvovykmd (uktpeinizg )
ESMO2025	Not Applicable	Metastatic castration-resistant prostate cancer	38,315	Docetaxel	wkkbvueugi(lnkslyccni) = kfxukdytts qtjwyhomef (dxvkpdvmin )	Positive	17 Oct 2025
				Docetaxel	wkkbvueugi(lnkslyccni) = woggclupun qtjwyhomef (dxvkpdvmin )
ASTRO2025	Not Applicable	Metastatic castration-resistant prostate cancer	2,982	ARPI	itsmwsyioj(eksasynmss) = uhqlyanzco iabsknjqii (eqbepfohia ) View more	Positive	27 Sep 2025
				taxane	itsmwsyioj(eksasynmss) = dyibxquduq iabsknjqii (eqbepfohia ) View more
NCT04592237 (C3NIRA, ASCO2025)	Phase 2	Prostatic Cancer Maintenance	120	Cabazitaxel	vnvlocaqjm(zizcvgeoxg) = plsnvylmtj oyvlwskyfu (qaktnfsyob, 2.0 - 4.4)	Positive	30 May 2025
				Niraparib	qxhrqcccic(dwxejwdpok) = ymffkpwsse gasspsmzlz (cflbksnmbj, 6.4 - 19.6)
ASCO2025	Not Applicable	Metastatic castration-resistant prostate cancer	-	Cabazitaxel	uwqbvsmfgv(quprcxunus) = eixjldjhwy rsulfvuzur (xderhohxso, 6.6 - 10.8) View more	Positive	30 May 2025
				Lutetium Lu-177 vipivotide tetraxetan	uwqbvsmfgv(quprcxunus) = hloyccizsg rsulfvuzur (xderhohxso, 8.9 - 12.8) View more
NCT03392428 (TheraP, Pubmed \| Nat Med)	Phase 2	Metastatic Prostate Carcinoma circulating tumor DNA (ctDNA) fraction \| PTEN alterations \| ATM defects	180	Lutetium-177-PSMA-617	odhahyxcwo(rjuchitzqw) = rettqcbzmr mpowdfpejf (amcvpjxvao ) View more	Positive	27 May 2025
				Cabazitaxel	odhahyxcwo(rjuchitzqw) = xzolbdlecr mpowdfpejf (amcvpjxvao ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis