cabazitaxel / Generic mfg. - LARVOL DELTA

Attrition After Cabazitaxel (Caba) or 177Lutetium prostate-specific membrane antigen-617 (177 Lu-PSMA) and Its Determinants in Metastatic Prostate Cancer (mPCa) (CABALUTE study) (ESMO 2026) - No abstract available

Metastases • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase I/II trial of combined Cabazitaxel and Lutetium-177 PSMA-617 (LuPSMA) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Results of the LuCAB trial (ESMO 2026) - No abstract available

Clinical • Metastases • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

5-year update for the Concept Trial 3-weekly cabazitaxel (CAB) chemotherapy (CCT) vs weekly paclitaxel (Taxol) CCT in the first line treatment of HER2 negative metastatic breast cancer (MBC) (ESMO 2026) - No abstract available

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Comparative Pharmacovigilance Analysis of Safety Signals Among Advanced Prostate Cancer Therapies Using FAERS (FDA Adverse Event Reporting System). (PubMed, Curr Oncol) - "A retrospective pharmacovigilance study of FAERS reports evaluated enzalutamide, darolutamide, apalutamide, abiraterone acetate, relugolix, niraparib/abiraterone, talazoparib, rucaparib, cabazitaxel, sipuleucel-T, and lutetium-177 vipivotide. The absence of a detected signal should not be interpreted as evidence of safety or equivalence, as reporting volume, detection bias, and statistical power varied across therapies. Overall, the therapies demonstrated distinct toxicity profiles, which may inform treatment selection, toxicity monitoring, and patient counseling."

Adverse events • Clinical • Journal • Retrospective data • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Hematological Disorders • 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

Safety and efficacy of pasritamig (PAS) + docetaxel (DOCE) in participants with metastatic castration-resistant prostate cancer (mcrPc): Initial results of a phase 1b study. (ASCO-GU 2026) - P1 | "Pts were heavily pretreated with a median of 3 (range 1–9) prior therapies, including ARPI (100%), DOCE (43.1%), cabazitaxel (21.6%), Lutetium-177 vipivotide tetraxetan (19.6%). PAS was readily combinable with DOCE, demonstrating a safety profile consistent with DOCE alone, no CRS, and promising anti-tumor activity in heavily pretreated patients post-ARPI/taxanes. A confirmatory phase 3 trial is planned."

Clinical • First-in-human • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • KLK2

Prognostic Value of the Modeled Prostate-Specific Antigen KELIM Confirmation in Metastatic Castration-Resistant Prostate Cancer Treated With Taxanes in FIRSTANA. (PubMed, JCO Clin Cancer Inform) - P3 | "This external validation study confirmed previous results about modeled PSA longitudinal kinetics prognostic value regarding PFS/OS in patients with mCRPC treated with taxanes. PSA.KELIM could be used to identify a subpopulation with poor prognosis, who may benefit from treatment intensification."

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

Early chemo-induced TME alterations as a predictor of response to PD-1 blockade in AVPC: Single-cell data from C3NIRA. (ASCO 2026) - P2 | "The C-COLA study (NCT03263650) showed that Cabazitaxel/Carboplatin (CabCarb) elicited inflammatory signaling in responsive patients with AVPC...Sixty patients completed induction and were subsequently randomized to Niraparib maintenance with or without Cetrelimab... One cycle of CabCarb induction altered the TME in a subset of AVPC tumors, with reduction of suppressive myeloid and T cell populations and expansion of anti-tumor effector cells associated with clinical responses. These early TME changes may predict benefit from the addition of PD-1 blockade and help refine patient selection for immune checkpoint inhibition. Ongoing analyses are identifying additional therapeutic vulnerabilities in the TME that can be targeted to further improve outcomes in men with AVPC."

Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD4 • CD8 • FOXP3 • GZMK • LAG3 • SPP1 • TIGIT

Phase 2 multicenter trial of chemoimmunotherapy for patients with neuroendocrine or aggressive variant metastatic prostate cancer (CHAMP). (ASCO 2026) - P2 | " We conducted a multicenter, phase II trial evaluating cabazitaxel, carboplatin, ipilimumab, and nivolumab (NCT04709276) in patients with metastatic NEPC/AVPC defined by histologic, clinical, or molecular features. Dual PD-1/CTLA4 immune checkpoint blockade with platinum doublet chemotherapy is effective in patients with AVPC/NEPC, resulting in greater efficacy than expected with historic platinum chemotherapy alone, and with acceptable toxicity given disease risk. These results support randomized controlled clinical trials of chemoimmunotherapy in patients with NEPC/AVPC."

Clinical • Metastases • P2 data • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Genito-urinary Cancer • Immunology • Infectious Disease • Lung Cancer • Neutropenia • Oncology • Prostate Cancer • Septic Shock • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • CTLA4

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

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

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

Neutropenia in Patients With Castration-Resistant Prostate Cancer Treated Using Cabazitaxel and Prophylactic Administration of Pegfilgrastim. (PubMed, Adv Urol) - "Cabazitaxel was administered every 3-4 weeks at doses determined by the treating physicians, generally 20-25 mg/m2, with daily oral prednisolone...A longer interval from CRPC diagnosis to cabazitaxel initiation showed a consistent trend toward association with FN risk in Japanese patients across analyses. These findings provide real-world safety data and highlight the importance of careful hematologic monitoring, particularly in patients treated later in the CRPC disease course."

Journal • Castration-Resistant Prostate Cancer • Febrile Neutropenia • Genito-urinary Cancer • Hematological Disorders • Neutropenia • Oncology • Prostate Cancer • Solid Tumor

Biomimetic PD-1-MSCs membrane-engineered nanoparticles for enhanced blood-brain barrier penetration and anti- glioma therapy. (PubMed, Front Immunol) - "This study aimed to construct PD-1-functionalized mesenchymal stem cell (MSC) membrane biomimetic nanoparticles co-loaded with elemene and cabazitaxel (PD-1-MSCs-ELE/CTX@BLIP) and investigate their capacity to penetrate the BBB, target gliomas, and their combined chemoimmunotherapeutic efficacy and related mechanisms...It efficiently crosses the BBB, specifically accumulates in glioma tissues, exerts potent antitumor effects, and improves the tumor immune microenvironment with favorable biosafety. This study provides a novel, promising biomimetic chemoimmunotherapeutic approach for precise glioma treatment."

Journal • Brain Cancer • Glioma • Oncology • Solid Tumor • CD8 • IFNG • IL1B • PD-1

Early results from CASCARA: A phase 2 study of cabazitaxel/carboplatin plus abiraterone in high-volume metastatic castrate-sensitive prostate cancer (mCSPC). (ASCO 2023) - P2 | " This phase 2 study enrolled 61 mCSPC patients with high-volume disease who received ADT plus cabazitaxel (20 mg/m2 q21d x 6) and carboplatin (AUC=4 q21d x 6) followed by abiraterone (1000 mg, plus prednisone 5 mg). Quadruplet therapy with ADT + cabazitaxel/carboplatin + abiraterone was well tolerated. At 1 year, 77% of pts were progression-free. PSA ≤0.2 ng/mL at month-7 was 61%, exceeding the historical month-7 PSA ≤0.2 ng/mL rate of 45% in CHAARTED–docetaxel arm."

Metastases • P2 data • Fatigue • Gastrointestinal Disorder • Genito-urinary Cancer • Infectious Disease • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • BRIP1 • CDK12 • CHEK2 • ERG • HRD • RAD51B • SPOP • TP53

Preliminary phase 2 results of PT-112 monotherapy in late-line metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2025) - P2 | "In the more mature Arm 2, OS in pts without prior cabazitaxel (22 pts) was 16.4m and without cabazitaxel or PSMA-Lu-177 (17 pts) was 20.5m. PT-112 treatment resulted in a manageable and reasonably low rate of G3-4 TRAEs and was active in pts with very late-line mCRPC. The better balance of safety and efficacy in Arms 2 and 3 is indicative of an optimized RP3D. Biomarker responses (ALP, CTC and T cell) may reflect broad activity of PT-112."

IO biomarker • Metastases • Monotherapy • P2 data • Anemia • Castration-Resistant Prostate Cancer • Fatigue • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Cost-Effectiveness of 177Lu-PSMA-617 Versus Cabazitaxel: Accounting for Real-World and Health Equity Considerations. (PubMed, J Nucl Med) - No abstract available

HEOR • Journal • Real-world evidence

BrUOG360: A phase Ib/II study of copanlisib combined with rucaparib in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2022) - P1/2 | " Enrollment criteria included progressive mCRPC, prior androgen inhibitors (abiraterone, enzalutamide, and/or apalutamide); prior taxane chemotherapy was allowed...Seven pts (63%) received prior chemotherapy (docetaxel [7], cabazitaxel [3])... The combination of rucaparib and copanlisib is well tolerated. The RP2D was rucaparib 400mg BID with copanlisib 45mg (D1, D15; 28-day cycle) with signal of efficacy. Enrollment in a phase 2 expansion cohort in HR-mutated mCRPC is ongoing."

Clinical • P1/2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • CDK12 • FANCA • PALB2

Enfortumab vedotin (EV) as monotherapy in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Results of stage I of a phase 2 trial. (ASCO-GU 2024) - P2 | "Key eligibility criteria: ≥18 years age, mCRPC with histologically/cytologically confirmed adenocarcinoma without small cell histology, performance status ≤ 1, adequate organ function, prior treatment (Rx) with ≥3 cycles of docetaxel and at least one androgen-receptor pathway inhibitor, received/refused all therapies shown to improve overall survival except cabazitaxel which is exclusionary. EV showed promising efficacy and an acceptable safety profile in pts with heavily treated refractory mCRPC. Further enrollment in stage 2 of the trial is ongoing. Clinical trial information: NCT04754191."

Clinical • Metastases • Monotherapy • P2 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • NECTIN4

Cabazitaxel with abiraterone versus abiraterone alone randomized trial for extensive disease following docetaxel: The CHAARTED2 trial of the ECOG-ACRIN Cancer Research Group (EA8153). (ASCO 2024) - P2 | "The addition of cabazitaxel to abiraterone/prednisone significantly prolonged PFS in patients with metastatic CRPC who previously received ADT + docetaxel for HSPC compared to abiraterone/prednisone alone. No significant OS difference was noted between the two arms, but the study was not powered for this endpoint. Clinical trial: NCT03419234."

Clinical • Late-breaking abstract • 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

A Phase III Study of Cabazitaxel with or without Carboplatin in Patients with Metastatic Castrate Resistant Prostate Cancer (MCRPC), Stratified by Aggressive Variant Signature (SWOG-Fall 2024) - "Participants must have received therapy containing docetaxel in the castrate-sensitive and/or castrateresistant disease state prior to Step 1 registration. Accrual Goals The accrual goal is 528 participants to achieve 450 eligible randomized participants. Interim analyses are planned for when one-third and two-thirds of the expected events have occurred"

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hematological Disorders • Human Immunodeficiency Virus • Infectious Disease • Musculoskeletal Diseases • Oncology • 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 | "Cabazitaxel does not improve cPFS in very-high risk localized prostate cancer. With very few prostate cancer-related deaths observed during the first decade, data from PEACE-2 challenge our current definition of very-high risk localized prostate cancer, especially when defined using modern imaging."

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

Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16). (PubMed, J Clin Oncol) - "SAKK 08/16 met its primary end point, showing that switch maintenance with darolutamide after prior taxane chemotherapy and at least one ARPI resulted in a statistically significant but clinically modest rPFS prolongation with good tolerability. The median OS with darolutamide maintenance appears promising. Should these findings be confirmed in a larger trial, maintenance treatment could be a novel strategy in managing patients with mCRPC, especially those who responded well to prior ARPI."

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