cabazitaxel / Generic mfg. - LARVOL DELTA

Long-term safety of radium-223 (Ra-223) in metastatic castration-resistant prostate cancer (mCRPC): 7-year follow-up from the largest global prospective study. (ASCO 2025) - P | "Prior treatments included abiraterone (48% of pts), enzalutamide (39%), docetaxel (39%), and cabazitaxel (9%). This real-world safety analysis of pts with mCRPC is the longest follow-up of a radiopharmaceutical reported to date and supports the well-established favorable safety profile of Ra-223. The incidence of SPMs was low. The rate of fracture was low, especially in the presence of BHAs."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Musculoskeletal Diseases • Oncology • Orthopedics • Prostate Cancer • Solid Tumor

Androgen deprivation therapy and radiotherapy with or without cabazitaxel in very-high risk localized prostate cancer: First results of the PEACE-2 randomized phase III trial. (ASCO-GU 2026) - P3 | "Clinical Trial Registry Number: NCT01952223. The full, final text of this abstract will be available on Feb 26 at 10:00 AM EST."

Clinical • Late-breaking abstract • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

THE β-BLOCKER CARVEDILOL INCREASES THE ANTITUMOR EFFICACY OF TAXANES IN DRUG-RESISTANT CANCER CELLS (WRMC 2026) - "The prostate cancer cell line, DU145-TxR, is resistant to taxanes including paclitaxel, docetaxel, and cabazitaxel...We also tested the effects of carvedilol combined with other chemotherapy drugs and found that carvedilol failed to sensitize cisplatin-resistant ovarian cancer cells to cisplatin... Based on our data, carvedilol increases the efficacy of taxanes and doxorubicin in taxane-resistant cancer cell lines independent of its β-AR and α1-AR blocking activity."

Clinical • Colon Cancer • Colorectal Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

Treatment patterns in patients with castration-resistant prostate cancer who received darolutamide in the ARAMIS trial in Spain: PARASEC study. (PubMed, Clin Transl Oncol) - "These real-world practice patterns suggest a lack of consensus in Spanish clinical practice for the management of patients with mCRPC, indicating that there is a need for more standardized strategies and unification of the criteria to make decisions in accordance with the recommendations of international clinical practice guidelines."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology

CYP11A1 INHIBITOR OPEVESOSTAT ALONE OR IN COMBINATION WITH OTHER THERAPIES FOR PARTICIPANTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER: THE PHASE 1/2 OMAHA-01A SUBSTUDY (SUO 2025) - P1/2 | "In the efficacy phase, participants will be randomized 1:1:1:1 to receive opevesostat alone (5 mg PO BID; N≤100), or in combination with olaparib, docetaxel or cabazitaxel at the RP2D (~40 participants each). Secondary end points include ORR, DOR and radiographic PFS per PCWG-modified RECIST v1.1, and OS. "

Combination therapy • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Addition of darolutamide to first line treatment of metastatic castration-resistant prostate cancer (mCRPC): A randomized open label phase II trial (SAKK 08/23). (ASCO-GU 2025) - P2 | "Funded by State secretariat for education, research and information (SERI) Switzerland Clinical Trial Registration Number: NCT06401980 Background: The implementation of androgen-receptor pathway inhibitors (ARPI) +/- docetaxel (doce) in addition to androgen deprivation therapy (ADT) in metastatic hormone sensitive prostate cancer (mHSPC) has limited the therapeutic options in the mCRPC setting...Continuing enzalutamide in addition to doce versus a switch to doce alone after progression on enzalutamide in later line mCRPC has been demonstrated to prolong PFS in a phase 3 trial...Patients will be randomized 1:1 to receive physician's choice standard of care (SOC: doce, cabazitaxel, 177lutetium-PSMA, radium-223 or olaparib) or SOC with daro...The trial will enroll pts in Switzerland and Spain. Accrual to the study is currently ongoing."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Clonal hematopoiesis (CH) in participants with metastatic castration-resistant prostate cancer (mCRPC) receiving 177Lu-PSMA-617 or cabazitaxel: An exploratory post-hoc analysis of a randomized phase II trial (TheraP; ANZUP 1603). (ASCO 2025) - P2 | "Here, we explored CH in the TheraP trial randomizing participants (pts) with docetaxel-refractory mCRPC to cabazitaxel or 177Lu-PSMA-617 (NCT03392428). 177Lu-PSMA-617 was associated with a greater number of new CH mutations, especially in DNA damage repair genes, compared to cabazitaxel. Whilst the clinical relevance of this finding in a population of patients with heavily-treated mCRPC is unclear, CH emergence and expansion may have implications as radioligand therapy is used as an earlier line of therapy."

Clinical • Metastases • P2 data • Retrospective data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ASXL1 • CHEK2 • DNMT3A • PPM1D • TET2

Lutetium-177-PSMA-617 or cabazitaxel in metastatic prostate cancer: circulating tumor DNA analysis of the randomized phase 2 TheraP trial. (PubMed, Nat Med) - P2 | "We anticipate our ctDNA fraction-aware analytical framework will aid future precision management strategies for [¹⁷⁷Lu]Lu-PSMA-617 and other PSMA-targeted therapeutics. ClinicalTrials.gov identifier: NCT03392428 ."

Circulating tumor DNA • Journal • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • ATM • FOLH1 • PTEN

Nivolumab plus ipilimumab for the treatment of post-chemotherapy metastatic castration-resistant prostate cancer (mCRPC): Additional results from the randomized phase 2 CheckMate 650 trial. (ASCO-GU 2023) - P2 | "Here, we report results from pts with post-CT mCRPC receiving alternative NIVO+IPI dosing regimens vs IPI alone vs cabazitaxel (CABA) in CheckMate 650. Newly enrolled pts previously treated with docetaxel for mCRPC were randomized 2:2:1:2 to cohorts D1 (NIVO 3 mg/kg [N3] + IPI 1 mg/kg [I1] Q3W × 4 doses then NIVO 480 mg Q4W), D2 (N1 Q3W × 8 doses + I3 Q6W × 4 doses then NIVO 480 mg Q4W), D3 (I3 Q3W × 4 doses), or D4 (CABA 20 or 25 mg/m2 Q3W + prednisone 10 mg × 10 doses)... These results further support the clinical activity of NIVO+IPI in select pts with post-CT mCRPC. Detailed evaluations of the characteristics of responders to NIVO+IPI, including more expansive biomarker analyses, are warranted. Clinical trial information: NCT02985957."

Clinical • Metastases • P2 data • Tumor mutational burden • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • TMB

C3NIRA: Randomized phase II study of carboplatin-cabazitaxel-cetrelimab (anti-PD-1) induction followed by niraparib +/- cetrelimab maintenance in men with aggressive variant prostate cancers (AVPC). (ASCO 2025) - P2 | "Most were White/non-Hispanic (78%) and had not received prior docetaxel (58%). A subset of men with AVPC derive meaningful benefit from the addition of anti-PD-1 to PARP inhibitor maintenance following platinum-taxane-anti-PD-1 induction. Ongoing correlates aim to identify biomarkers to select patients for this treatment strategy and reveal candidate mechanisms of resistance to guide future therapeutic combinations."

Clinical • IO biomarker • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD8 • FOXP3

Lu-177 PSMA vs Comparator Treatments and Survival in Metastatic Castration-Resistant Prostate Cancer. (PubMed, JAMA Netw Open) - "Observed treatment effects on overall survival (OS) differed substantially in the first 2 randomized clinical trials of lutetium Lu 177 vipivotide tetraxetan (Lu-177) prostate-specific membrane antigen (PSMA) in metastatic castration-resistant prostate cancer...VISION randomized participants to receive treatment with or without Lu-177 PSMA in addition to physicians' choice of protocol-permitted treatments (PPT; approved hormonal treatments [such as abiraterone and enzalutamide], bisphosphonates, radiotherapy, denosumab, or glucocorticoids), excluding cabazitaxel...Findings of this secondary analysis of the TheraP and VISION randomized clinical trials suggest that the choice of comparator treatments (ie, cabazitaxel vs PPT) may explain the difference in the observed effect of Lu-177 PSMA on OS between the 2 trials. Causal inference methods such as RPSFTM and IPCW may help rule out crossover as a plausible explanation."

Clinical • Journal • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

AcTFirst: Study Comparing AAA817+ARPI Versus Standard of Care in Adult Participants With PSMA-positive mCRPC (clinicaltrials.gov) - P3 | N=940 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial primary completion date: Feb 2028 ➔ Sep 2028

Trial primary completion date • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • HRD

Clonal hematopoiesis after 177Lu-PSMA-617 radioligand therapy in prostate cancer. (PubMed, Clin Cancer Res) - "177Lu-PSMA-617 strongly promotes CH, supporting integration of longitudinal monitoring for long-term hematologic sequelae as radioligand therapy is implemented earlier in prostate cancer care."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Hematological Malignancies • Oncology • Prostate Cancer • Solid Tumor • PPM1D

Price transparency & out-of-pocket payments for medications: Implications of associated delivery fees in the United States. (PubMed, Health Policy Open) - "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. 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."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Chromosomal instability in circulating tumor cells and cabazitaxel resistance in metastatic castration-resistant prostate cancer. (PubMed, JCI Insight) - P4 | "This preplanned biomarker analysis of CARD confirms that CTC-CIN counts are a clinically useful prognostic and predictive biomarker of taxane resistance in mCRPC. Detectable CTC-CIN at baseline defines a patient subpopulation with unmet clinical needs in which alternative therapeutics should be tested."

Circulating tumor cells • Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CTCs

Opevesostat (MK-5684/ODM-208), an oral CYP11A1 inhibitor, in metastatic castration-resistant prostate cancer (mCRPC): Updated CYPIDES phase II results (ESMO 2024) - P1/2 | "53.0% and 36.8% had previously received both abiraterone and enzalutamide, and 69.7% and 64.7% had received cabazitaxel in patients with and without AR-LBD mutation respectively. Administration of Opevesostat to heavily pre-treated mCRPC patients shows promising antitumor activity. PSA50 responses were most frequent among patients harbouring activating AR-LBD mutations."

Metastases • P2 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Preliminary phase II results of the CYPIDES study of ODM-208 in metastatic castration-resistant prostate (mCRPC) cancer patients (ESMO 2022) - P1/2 | "51% patients had previously received both abiraterone and enzalutamide, and 65% patients both docetaxel and cabazitaxel. Conclusions Administration of ODM-208 to heavily pre-treated mCRPC patients with AR LBD mutation was highly effective in blocking the production of steroid hormones and showed promising antitumor activity. NCT03436485."

Clinical • P2 data • Oncology • Prostate Cancer

[Lu]Lu-PSMA-617 versus cabazitaxel in patients with metastatic castration-resistant prostate cancer (TheraP): a randomised, open-label, phase 2 trial. (PubMed, Lancet) - P2 | "[Lu]Lu-PSMA-617 compared with cabazitaxel in men with metastatic castration-resistant prostate cancer led to a higher PSA response and fewer grade 3 or 4 adverse events. [Lu]Lu-PSMA-617 is a new effective class of therapy and a potential alternative to cabazitaxel."

Clinical • Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Clinical and cost impact of cabazitaxel versus lutetium-177 vipivotide tetraxetan (Lu-PSMA) for patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2026) - "Research Funding Sanofi . The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Outcomes of cabazitaxel following 177Lu-PSMA-617 (LuPSMA) in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2026) - "Research Funding Conquer Cancer, the ASCO Foundation, Prostate Cancer Foundation. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

TheraP: 177Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel—Overall survival after median follow-up of 3 years (ANZUP 1603). (ASCO 2022) - P2 | "LuPSMA is a suitable option for men with mCRPC progressing after docetaxel, with lower adverse events, higher response rates, improved patient-reported outcomes, and similar OS compared with cabazitaxel. Median survival was considerably shorter for patients excluded on PSMA/FDG-PET due to either low PSMA expression or FDG-discordant disease who would otherwise be eligible for LuPSMA."

Clinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

PSMA and FDG-PET as predictive and prognostic biomarkers in patients given [Lu]Lu-PSMA-617 versus cabazitaxel for metastatic castration-resistant prostate cancer (TheraP): a biomarker analysis from a randomised, open-label, phase 2 trial. (PubMed, Lancet Oncol) - P2 | "In men with metastatic castration-resistant prostate cancer, PSMA-PET SUVmean was predictive of higher likelihood of favourable response to [Lu]Lu-PSMA-617 than cabazitaxel, which provides guidance for optimal [Lu]Lu-PSMA-617 use. High FDG-PET MTV was associated with lower responses regardless of randomly assigned treatment, warranting further research for treatment intensification. A strength of this analysis is the validation of pre-specified cutpoints within a multicentre, randomised, controlled trial. Quantitative PET parameters used, however, require specialised software and are not yet routinely available in most clinics."

Biomarker • FDG PET • Journal • P2 data • Genito-urinary Cancer • Hematological Disorders • Oncology • Prostate Cancer • Solid Tumor

PCPro as a prognostic plasma lipidomic biomarker in TheraP (ANZUP 1603): A randomised trial of [177Lu]Lu-PSMA-617 (LuPSMA) vs cabazitaxel in metastatic castration resistant prostate cancer (mCRPC) (ESMO 2025) - P2 | "Background TheraP showed that LuPSMA improves PSA response rate (RR), objective tumour RR, and radiographic progression free survival (rPFS), compared with cabazitaxel in participants (pts) with PSMA-positive, non-FDG-discordant mCRPC progressing after docetaxel. Table: 2392P Multivariable analysis for OS Variable Hazard ratio [95% Confidence interval] p-value PCPro, positive 1.78 [1.05 – 3.03] 0.032 PSMA PET SUV mean 30% 4.07 [1.55 – 10.7] 8.91 [3.17 – 25.1] 0.004 <0.001 Conclusions PCPro positive status was an independently significant prognostic factor for shorter OS in pts treated with either LuPSMA or cabazitaxel in TheraP. These data support further research of PCPro as a prognostic biomarker in mCRPC being treated with LuPSMA or a taxane."

Biomarker • Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Circulating tumour DNA fraction as a predictor of treatment efficacy in a randomized phase 2 trial of [ 177 Lu]Lu-PSMA-617 (LuPSMA) versus cabazitaxel in metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel (TheraP ANZUP 1603). (ASCO 2024) - P2 | "ctDNA% is a candidate predictive and prognostic biomarker for differential response to LuPSMA versus taxane chemotherapy in patients with molecular imaging-selected mCRPC progressing after docetaxel."

Circulating tumor DNA • Clinical • Metastases • P2 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Clinical Trial Protocol for LuCAB: A Phase I-II Trial Evaluating Cabazitaxel in Combination with [177Lu]Lu-PSMA-617 in Patients with Metastatic Castration-Resistant Prostate Cancer. (PubMed, J Nucl Med) - "[177Lu]Lu-prostate-specific membrane antigen (PSMA)-617 is a standard treatment for patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel and an androgen receptor pathway inhibitor. Plasma will be collected at baseline, during treatment, and at disease progression for circulating tumor DNA analysis, which will be correlated with clinical outcomes to identify potential biomarkers of treatment response or resistance. Enrollment commenced in August 2022, with anticipated completion in 2025."

Journal • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Pain • Prostate Cancer • Solid Tumor • FOLH1