docetaxel / Generic mfg. - LARVOL DELTA

Final results of a randomized phase II trial of second-line treatment for advanced soft tissue sarcoma comparing trabectedin, eribulin, and pazopanib: 2ND-STEP study, JCOG1802. (ASCO 2026) - "Funded by Japan Agency for Medical Research and Development (AMED) Clinical Trial Registration Number: jRCTs031190152 Background: The optimal second-line treatment for advanced soft tissue sarcomas (STS) after doxorubicin therapy remains unclear. This trial aimed to identify the most promising agent among trabectedin, eribulin, and pazopanib for subsequent phase III comparison against gemcitabine plus docetaxel (GD), which has traditionally been considered a standard treatment... Consistent with the primary analysis, pazopanib generally showed favorable PFS, OS, and DCR among the three agents. Based on these results, pazopanib was identified as the most appropriate candidate to be compared with GD in a phase III trial, which is currently being planned."

Clinical • Metastases • P2 data • Leiomyosarcoma • Liposarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Phase II study of izalontamab (SI-B001) in combination with paclitaxel or docetaxel in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). (ASCO 2026) - P2 | "Izalontamab in combination with paclitaxel showed encouraging antitumor activity and a manageable safety profile in patients with R/M HNSCC who were previously treated with anti-PD-(L)1 therapy."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Hematological Disorders • Leukopenia • Neutropenia • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • ERBB3

Adagrasib versus docetaxel in KRASG12C-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial. (PubMed, Lancet) - P3 | "Adagrasib demonstrated a statistically significant improvement in progression-free survival over docetaxel in patients with previously treated KRASG12C-mutated NSCLC, without new safety signals."

Clinical • IO biomarker • Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

IDeate-Prostate01: A PHASE 3, RANDOMIZED, OPEN-LABEL STUDY OF IFINATAMAB DERUXTECAN VERSUS DOCETAXEL IN PARTICIPANTS WITH PREVIOUSLY TREATED METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (SUO 2025) - P3 | "Recruitment is ongoing. "

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • CD276

Systemic Therapies in Docetaxel (DTX)-Naïve, Biomarker-Unselected Metastatic Castration-Resistant Prostate Cancer (mCRPC) post Androgen Receptor Pathway Inhibitor (ARPI)/Androgen Deprivation Therapy (ADT): A Systematic Literature Review (SLR) & Indirect Treatment Comparison (ITC) (ESMO 2026) - No abstract available

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

Pathological response guides adjuvant 5-fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy in surgically resected gastro-oesophageal cancer (SPACE-FLOT): international cohort study. (PubMed, Br J Surg) - "Pathological response to neoadjuvant FLOT may guide the use of adjuvant FLOT, enabling personalized approaches to treatment."

Journal • Retrospective data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Oncology • Solid Tumor

Efficacy and safety of perioperative durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma in Asia: A subgroup analysis of the MATTERHORN trial (ESMO Asia 2025) - P3 | "Consistent with global MATTERHORN results, D + FLOT improved efficacy vs P + FLOT with a manageable safety profile in Asian pts with resectable G/GEJ adenocarcinoma."

Clinical • Gastroesophageal Junction Adenocarcinoma • Oncology

Pembrolizumab (pembro) plus enzalutamide (enza) and androgen deprivation therapy (ADT) for patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC): Randomized double-blind phase III KEYNOTE-991 study (ESMO 2023) - P3 | "Methods Eligible pts (aged ≥18 yrs, ECOG PS ≤1) had confirmed mHSPC (≥2 bone lesions and/or visceral disease, verified centrally), no prior NHA, and had completed any prior docetaxel (≤6 cycles) ≤2 mo from randomization. Conclusions The study was stopped for futility. The addition of pembro to enza plus ADT did not improve rPFS or OS in pts with NHA-naïve mHSPC and was associated with more serious and treatment-related AEs vs enza plus ADT."

Clinical • Metastases • P3 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Decipher mRNA score for prediction of survival benefit from docetaxel at start of androgen deprivation therapy (ADT) for advanced prostate cancer (PC): An ancillary study of the STAMPEDE docetaxel trials (ESMO 2024) - P2/3 | "We hypothesised that the Decipher 22-gene mRNA score (DS) predicts Doce benefit. DS were generated from whole transcriptome profiling with a clinical test (Veracyte) on tumor index cores from patients (pts) randomised 1:1 to ADT or ADT + Doce +/- zoledronic acid (ZA) in the STAMPEDE protocol (Oct 2005 - Mar 2013). High DS identifies synchronous M1 PC pts who benefit from Doce. DS is the 1st molecular classifier independent of metastatic volume to show a statistically significant interaction with Doce in directly randomised M1 PC pts."

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

A model of cellular proliferation and mitochondrial biogenesis predicts prognosis and immunotherapy response in lung adenocarcinoma. (PubMed, Transl Cancer Res) - "Drug sensitivity analysis indicated that the risk model could guide personalized treatment strategies; for instance, high-risk patients showed increased susceptibility to agents such as docetaxel and 5-fluorouracil. The established MBGs/CPGs prognostic model provides a novel tool for stratified treatment planning in LUAD, underscoring the crucial roles of cellular proliferation and mitochondrial biogenesis in tumor progression. Functional validation of CIDEC offers experimental support for the development of potential therapeutic strategies."

IO biomarker • Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CYP27A1 • KRT17 • LDHA • NPAS2 • PLK1

Combined treatment with radium-223 (RAD) and enzalutamide (ENZ) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Insights from the global REASSURE study (ESMO 2025) - P, P3 | "Incidence of fractures was slightly higher in ALL pts (10%) with fewer pts receiving concomitant BPAs (denosumab 28% and zoledronic acid 13%)...Table: 2401P ENZ/RAD (N=45) ALL Pts (N=1,472) Median time since initial diagnosis of bone metastases to study entry, months 14 23 Median time since castration resistant cancer to study entry, months 7 13 Extent of disease, % Bone only metastases 80 81 Bone metastases + lymph node only 9 13 Disease burden, % 20 metastases but not Superscan 18 20 Superscan 4 6 Laboratory values, median ALP (U/L) 131 133 PSA (ng/mL) 33 59 Prior abiraterone, % 40 48 Prior docetaxel, % 16 39 Prior Sipuleucel-T, % 18 9 Conclusions In this subgroup of pts treated with combined ENZ/RAD in a real-world setting, there was no new safety signal...Pts received ENZ/RAD earlier in the disease course based on time from mCRPC, time from initial diagnosis of bone metastases and prior docetaxel. Fracture incidence was low in ENZ/RAD, and the majority of pts..."

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

Pembrolizumab and trastuzumab in combination with FLOT in the perioperative treatment of HER2-positive localized esophagogastric adenocarcinoma: Interim analysis of the phase II PHERFLOT/IKF-053 trial of the AIO study group (AIO STO 0321) (ESMO 2025) - P2 | "Perioperatively, FLOT (5-FU, leucovorin, oxaliplatin, docetaxel) is preferred in resectable HER2-positive disease...All pts experienced adverse events (AEs); 48.4% had at least one grade 3 treatment-related (TR) serious AE, predominantly chemotherapy-related; grade 4 neutropenia was the only ≥ grade 4 TRAE. Table: 2095MO Pathological response n (%) Missing value due to withdrawal from surgery 1 (3.2%) Complete Response (pCR) - no tumor cells visible, but signs of regression 15 (48.4%) Subtotal Response (pSR) - morphologically intact neoplastic cells in 50% of tumor bed 6 (19.4%) Conclusions Perioperative FLOT plus P and T is feasible, with an expected safety profile and strong antitumor activity, suggesting superiority over current standards."

Combination therapy • IO biomarker • P2 data • Esophageal Cancer • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

Gleam Study Long Time Follow-up: Glumetinib + albumin-bound docetaxel (HB1801) in patients (pts) with MET overexpression (OE) non-small cell lung cancer (NSCLC) (ESMO 2026) - No abstract available

Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ProstACT Global: A phase 3 study of Lutetium (Lu177) rosopatamab tetraxetan plus SoC vs SoC alone in patients with metastatic castration-resistant prostate cancer (SUO 2025) - P3 | "In Part 1, patients are divided into 3 groups (n=10 each) to receive 2 single intravenous injections of 76 mCi each, 14d apart, of 177 Lu-rosopatamab with standard of care (SoC) combinations with abiraterone, enzalutamide, or docetaxel to characterize biodistribution & safety profiles of 177 Lu-rosopatamab + SoC combinations...Eligible patients must have PSMA-expressing mCRPC and have experienced disease progression on a minimum 12w prior therapy on their 1 st ARPI (abiraterone, apalutamide, darolutamide, or enzalutamide) in metastatic castration-sensitive PC, non-metastatic CRPC, or mCRPC settings...This study is sponsored by Telix Pharmaceuticals and is currently enrolling in Part 1. ClinicalTrials.gov ID: NCT06520345 "

Clinical • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Prospective randomized multicenter phase III trial comparing perioperative chemotherapy (FLOT protocol) to neoadjuvant chemoradiation (CROSS protocol) in patients with adenocarcinoma of the esophagus (ESOPEC trial). (ASCO 2024) - P3 | "ESOPEC (NCT02509286) is a multicenter prospective randomized trial comparing neoadjuvant CROSS (41.4Gy plus carboplatin/paclitaxel) followed by surgery versus perioperative FLOT (5-FU/ leucovorin/oxaliplatin/docetaxel) and surgery for the curative treatment of EAC... Perioperative FLOT improves survival in resectable EAC compared to neoadjuvant CROSS. Funding: The trial was funded by the Deutsche Forschungsgemeinschaft (DFG, German Research Foundation), project number 264590883."

Clinical • Late-breaking abstract • P3 data • Esophageal Adenocarcinoma • Esophageal Cancer • Gastrointestinal Cancer • Oncology

Treatment patterns and clinical outcomes among patients with metastatic castration-resistant prostate cancer: a multinational retrospective medical record review. (PubMed, Cancer Treat Res Commun) - "In a population where few had received treatment intensification for metastatic hormone-sensitive prostate cancer, real-world outcomes were aligned with those observed previously and in clinical trials. However, there remains significant need to broaden access to effective systemic therapy in mCRPC and to find new treatments to improve outcomes."

Clinical data • Journal • Retrospective data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Effect of type and location of BRCA2 deleterious variant on prognosis and survival in metastatic prostate cancer: A longitudinal, international, cohort study from hormone-sensitive to castration-resistant settings. (ASCO 2026) - "Contrary to previous reports, BRCA2-mutated mHSPC pts had superior ToT from ADT+ARPi vs. ADT+docetaxel (55 vs 15 mos; HR 3.5, p < 0.001)...Among 201 pts treated with olaparib, those with RAD51-BD PVs achieved significantly longer ToT (20.0 vs 7.0 mos; p = 0.01) and longer OS... This is the largest longitudinal study to demonstrate that BRCA2 PV type and location are critical determinants of survival and treatment response in mPC. Our findings identify a "high-risk" molecular subgroup (PCCR and RAD51-BD/DBD-outside and frameshift deletions) with significantly poorer outcomes. These results provide a rationale for refined risk-stratification and personalized treatment selection, including early PARPi integration, in BRCA2-mutated patients."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA • BRCA2 • HRD • RAD51

Analysis of quality-adjusted time without symptoms or toxicity (Q-TWiST) in patients with metastatic hormone-sensitive prostate cancer: From the ARASENS trial. (ASCO-GU 2026) - P3 | "Background: Triplet combination of darolutamide (DARO; an androgen receptor inhibitor) with androgen deprivation therapy (ADT), and docetaxel significantly improved overall survival (OS; HR 0.68; 95% CI 0.57–0.80; P<0.001) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the ARASENS trial (NCT02799602). In ARASENS, DARO triplet therapy provided an additional 6.3 months of OS without symptoms or toxicity and a Q-TWiST relative gain of 16.0% corresponding to higher overall quality-adjusted survival vs doublet therapy at 53 months. This highlights the benefit of the standard of care ARASENS regimen for patients with mHSPC."

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

Efficacy and safety of abiraterone acetate plus prednisone and androgen deprivation therapy +/- docetaxel in older patients (≥70 years), with de novo metastatic-castration sensitive prostate cancer, compared to younger patients (<70 years): The PEACE-1 trial. (ASCO-GU 2023) - P3 | "This post-hoc analysis of PEACE-1 suggests that, in the overall population, OM derive a lower benefit, both in terms of rPFS and OS, from adding AAP to SOC versus YM. This decreased benefit is likely due to more toxicity leading to more frequent and earlier drug discontinuation. Importantly, in OM fit enough to receive ADT+D, the benefit of adding AAP to SOC was comparable to YM."

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

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

PROSPECTIVE OPEN LABEL STUDY TO EVALUATE THE SAFETY AND EFFICACY OF INTRAVESICAL SUSTAINED RELEASE GEMCITABINE DOCETAXEL COMBINATION (NDV-01) IN HIGH RISK NMIBC (AUA 2025) - P2 | "The proportion of patients achieving primary and secondary endpoints will be reported with an exact 95% CI for the proportion. Kaplan-Meier methods will be used to provide estimates of median duration and of the probability of duration at 3 months intervals."

Clinical • Bladder Cancer

A new prognostic model of overall survival (OS) in patients (pts) with metastatic hormone sensitive prostate cancer (mHSPC) (ESMO 2024) - P2/3, P3 | "We validated the fitted model using two comparisons from the STAMPEDE trial (SOC vs. SOC + docetaxel (A vs C) and SOC vs. SOC + zoledronic acid+ docetaxel (A vs E)). The model identified novel prognostic factors of OS in men with mHSPC. It offers the potential for classifying pts into risk groups useful in selecting men in future mHSPC trials. Further validation of this prognostic model of OS is warranted."

Clinical • Metastases • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

SI-B001 plus chemotherapy in patients with locally advanced or metastatic EGFR/ALK wild-type non-small cell lung cancer: A phase II, multicenter, open-label study. (ASCO 2023) - P2 | "SI-B001 plus docetaxel demonstrated antitumor activity in locally advanced or metastatic NSCLC EGFR/ALK wild-type pts who failed on prior first-line anti-PD-1/L1 antibody plus PBC, especially without AGA. The toxicity of SI-B001 + docetaxel was manageable. These findings support the continued investigation of SI-B001 and docetaxel as a treatment option in NSCLC."

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

Perioperative immunochemotherapy (mDCF + avelumab) in locally advanced gastro-esophageal adenocarcinoma: A phase II trial. (ASCO 2023) - P2 | " Single-arm phase II study (NCT03288350) of avelumab + chemotherapy (modified docetaxel/cisplatin/5-FU or mDCF) given every 2 weeks x 4 cycles before and after surgery...Exclusion criteria: other histology, metastatic stage, use of immunosuppressants, serious autoimmune disease, intake >10 mg prednisone/d... The neoadjuvant combination of avelumab with chemotherapy (mDCF) shows promising safety and efficacy in gastroesophageal adenocarcinoma, without obvious correlation to known biomarkers. Clinical trial information: NCT03288350."

IO biomarker • Metastases • P2 data • Dermatology • Endocrine Disorders • Esophageal Adenocarcinoma • Esophageal Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Immune Modulation • Immunology • Infectious Disease • Nephrology • Oncology • Pneumonia • Pruritus • Renal Disease • Respiratory Diseases • Solid Tumor

Mevrometostat (PF-06821497) in combination with enzalutamide for androgen receptor pathway inhibitor (ARPI)-naïve patients with metastatic castration-resistant prostate cancer (mCRPC): The phase 3, randomized MEVPRO-2 trial. (ASCO-GU 2025) - P1, P3 | "In a nonrandomized, phase 1 dose-escalation study, objective responses to mevrometostat with enzalutamide were observed in patients with CRPC and prior abiraterone or enzalutamide treatment (NCT03460977; Schweizer MT, et al...Hazard ratios and 95% confidence intervals will be estimated using a Cox proportional hazard model, stratified by prior docetaxel and presence of hepatic metastases. P-values will be provided using a stratified log-rank test. Safety and tolerability will also be assessed."

Clinical • Combination therapy • Metastases • P3 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Hormone Sensitive Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • EZH2