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DRUG:

Padcev (enfortumab vedotin-ejfv)

i
Other names: ASG-22ME, AGS-22C3, AGS-22CE, AGS-22M6E, AGS-M6, ASG-22CE, ASG-22M6E, ASG-22ME, AGS 22C3, AGS 22ME, AGS 22CE, AGS22M6E, AGS 22M6E, AGSM6, AGS M6, ASG 22CE, ASG22M6E, ASG 22M6E, ASG22ME, ASG 22ME, AGS22C3, AGS22ME, AGS22CE
Company:
Astellas, Pfizer
Drug class:
Microtubule inhibitor, Nectin-4-targeted antibody-drug conjugate
Related drugs:
3d
Genomic Biomarkers Associated with Enfortumab Vedotin Outcomes for Patients with Advanced Urothelial Carcinoma: Analysis of UNITE Study Data. (PubMed, Eur Urol Oncol)
Enfortumab vedotin (EV) is used as monotherapy or combined with pembrolizumab in advanced urothelial carcinoma (aUC), but biomarker data associated with EV outcomes are limited. However, mutations in two genes (CDKN2A and CDKN2B) were associated with worse outcomes after EV treatment. These findings will not affect current clinical practice, but should be investigated further in future studies.
Journal • Tumor mutational burden • PD(L)-1 Biomarker • Metastases
|
TMB (Tumor Mutational Burden) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • CDKN2B (Cyclin Dependent Kinase Inhibitor 2B) • TSC1 (TSC complex subunit 1)
|
TMB-H • CDKN2A mutation • TSC1 mutation
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
7d
Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy (clinicaltrials.gov)
P1, N=30, Recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2024 --> Sep 2025 | Trial primary completion date: Oct 2024 --> Sep 2025
Trial completion date • Trial primary completion date • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1) • FGFR2 (Fibroblast growth factor receptor 2) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
PD-L1 expression • NECTIN4 expression
|
Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv)
7d
The Role of Antibody-Drug Conjugates in Urothelial Cancer: A Review of Recent Advances in the Treatment of Locally Advanced and Metastatic Urothelial Cancer. (PubMed, Clin Med Insights Oncol)
Today, novel agents called antibody drug conjugates (ADCs), including enfortumab vedotin (EV) and sacituzumab govitecan (SG), have been approved for la/mUC offering patients treatment options following or instead of traditional chemotherapy...In 2023, EV in combination with pembrolizumab almost doubled progression-free and overall survival versus platinum-based chemotherapy, which led to accelerated FDA approval as first-line treatment for all patients with la/mUC...Finally, a recent cancer agnostic accelerated approval for trastuzumab deruxtecan (T-DXd) in HER2-positive (IHC3+) solid tumors provides another active ADC option for biomarker-selected patients with treatment refractory la/mUC. Several new ADCs are being investigated in urothelial cancer (UC) clinical trials. This review summarizes the clinical studies and real-world data regarding the use of ADCs in UC.
Review • Journal • PD(L)-1 Biomarker • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
HER-2 positive
|
Keytruda (pembrolizumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv)
14d
Renal Retention in High Grade Upper Tract Urothelial Cancer (clinicaltrials.gov)
P2, N=20, Recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Not yet recruiting --> Recruiting
Enrollment open
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
21d
NEPTUNE: Study of Neoadjuvant Enfortumab Vedotin and Pembrolizumab in Cisplatin-eligible Upper Tract Urothelial Cancer (clinicaltrials.gov)
P2, N=32, Not yet recruiting, University of Michigan Rogel Cancer Center | Trial completion date: Jul 2027 --> Nov 2027 | Initiation date: Oct 2024 --> Feb 2025 | Trial primary completion date: Jul 2027 --> Nov 2027
Trial completion date • Trial initiation date • Trial primary completion date • Tumor mutational burden
|
TMB (Tumor Mutational Burden)
|
PD-L1 IHC 22C3 pharmDx
|
Keytruda (pembrolizumab) • cisplatin • Padcev (enfortumab vedotin-ejfv)
1m
Targeted therapeutic strategies for Nectin-4 in breast cancer: Recent advances and future prospects. (PubMed, Breast)
Enfortumab vedotin(EV)is an antibody-drug conjugate (ADC) targeting Nectin-4, which has been approved by FDA for the treatment of urothelial carcinoma...These therapies offer novel strategies for delivering targeted treatments to Nectin-4-expressing cancer cells, enhancing treatment efficacy and minimizing off-target effects. In conclusion, this review aims to provide an overview of the latest advances in understanding the role of Nectin-4 in breast cancer and discuss the future development prospects of Nectin-4 targeted agents.
Review • Journal • IO biomarker
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
NECTIN4 expression
|
Padcev (enfortumab vedotin-ejfv)
1m
FGFR Inhibitors in Urothelial Cancer: From Scientific Rationale to Clinical Development. (PubMed, J Korean Med Sci)
Among these therapies, erdafitinib, a pan-fibroblast growth factor receptor (FGFR) inhibitor for specific FGFR2 and FGFR3 alterations, is the only targeted therapy approved till now...Ongoing investigations exist on its use in non-muscle-invasive BC and in combination with drugs such as enfortumab vedotin in mUC...This review emphasizes the importance of FGFR inhibition in UC and the optimization of its use in clinical practice. Moreover, it underscores the ongoing efforts to evaluate combination strategies and early treatment testing to enhance the effectiveness of targeted therapies for UC.
Review • Journal • IO biomarker
|
TP53 (Tumor protein P53) • FGFR2 (Fibroblast growth factor receptor 2) • FGFR3 (Fibroblast growth factor receptor 3) • RB1 (RB Transcriptional Corepressor 1)
|
TP53 mutation • FGFR2 mutation • FGFR3 mutation
|
Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv)
1m
Phase 2 Trial of Enfortumab Vedotin in Patients With Previously Treated Locally Advanced or Metastatic Urothelial Carcinoma in China. (PubMed, Cancer Med)
Enfortumab vedotin demonstrated meaningful clinical activity with a manageable safety profile in Chinese patients with previously treated locally advanced or mUC.
P2 data • Journal • Metastases
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Padcev (enfortumab vedotin-ejfv)
2ms
Risk Classification of Patients With Advanced Urothelial Carcinoma Treated With Enfortumab Vedotin. (PubMed, Cancer Diagn Progn)
Significant differences were observed in PFS and OS among the three groups (p<0.001 and p<0.001, respectively) and c-indices were 0.766 for PFS and 0.800 for OS. The risk classification using CRP and hypercalcemia is useful for predicting the outcomes of patients with advanced UC treated with EV.
Journal • Metastases
|
CRP (C-reactive protein)
|
Padcev (enfortumab vedotin-ejfv)
2ms
Pre-treatment metastatic biopsy: a step towards precision oncology for urothelial cancer. (PubMed, Nat Rev Urol)
The characterization of metastatic tumour samples can improve response prediction to immunotherapy, the anti-NECTIN4 antibody-drug conjugate enfortumab vedotin and the FGFR inhibitor erdafitinib. Routine metastatic biopsy can thus improve the precision of identifying driver druggable alterations, thus improving treatment selection for patients with mUC.
Review • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases • Biopsy
|
FGFR3 (Fibroblast growth factor receptor 3)
|
FGFR3 mutation • PD-L1 mutation
|
Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv)
2ms
New trial
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
2ms
ETx-22: a novel nectin-4-directed antibody drug conjugate, demonstrates safety and potent antitumor activity in low nectin-4 expressing tumors. (PubMed, Cancer Res Commun)
ETx-22 has a highest non severely toxic dose of over 20 mg/kg in non-human primates without signs of important skin toxicity. ETx-22 represents a valuable therapy, for the treatment of patients with nectin-4 expressing tumors including those that have become resistant to enfortumab vedotin treatment.
Journal
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
NECTIN4 expression • NECTIN4 underexpression
|
Padcev (enfortumab vedotin-ejfv)
2ms
Renal Retention in High Grade Upper Tract Urothelial Cancer (clinicaltrials.gov)
P2, N=20, Not yet recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Trial completion date: Jun 2028 --> Jun 2029 | Trial primary completion date: Jun 2027 --> Jun 2028
Trial completion date • Trial primary completion date
|
FGFR (Fibroblast Growth Factor Receptor)
|
FGFR mutation • FGFR fusion
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
2ms
Immunohistochemical Expression of p53 and FGFR3 Predicts Response to Enfortumab Vedotin in Metastatic Urothelial Carcinoma. (PubMed, Int J Mol Sci)
Immunohistochemically abnormal p53 tumors were found to respond well to EV, while high FGFR3 tumors had a poorer response. Thus, p53 and FGFR3 are potential biomarkers for predicting response to EV treatment in patients with urothelial carcinoma.
Journal • Metastases
|
TP53 (Tumor protein P53) • FGFR3 (Fibroblast growth factor receptor 3)
|
TP53 wild-type • TP53 expression • FGFR3 expression
|
Padcev (enfortumab vedotin-ejfv)
2ms
A Clinical Study of V940 Treatment and Pembrolizumab in People With Bladder Cancer (V940-005/INTerpath-005) (clinicaltrials.gov)
P1/2, N=230, Recruiting, Merck Sharp & Dohme LLC | Phase classification: P2 --> P1/2
Phase classification
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv) • intismeran autogene (mRNA-4157)
2ms
Enfortumab Vedotin With Radiation for Locally Advanced Bladder Cancer (CONSOLIDATE) (clinicaltrials.gov)
P1/2, N=41, Suspended, M.D. Anderson Cancer Center | Not yet recruiting --> Suspended
Trial suspension • Metastases
|
Padcev (enfortumab vedotin-ejfv)
3ms
Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer (clinicaltrials.gov)
P1/2, N=47, Not yet recruiting, University of California, San Francisco | Trial completion date: Jun 2027 --> Sep 2027 | Initiation date: Aug 2024 --> Nov 2024 | Trial primary completion date: Jun 2027 --> Sep 2027
Trial completion date • Trial initiation date • Trial primary completion date
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
3ms
MORPHEUS mUC: Study Evaluating the Efficacy and Safety of Multiple Immunotherapy-Based Treatments and Combinations in Patients With Urothelial Carcinoma (MORPHEUS-UC) (clinicaltrials.gov)
P1/2, N=645, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting | Trial completion date: Nov 2027 --> May 2026
Enrollment closed • Trial completion date
|
PD-L1 (Programmed death ligand 1)
|
cisplatin • Tecentriq (atezolizumab) • gemcitabine • Zejula (niraparib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • magrolimab (ONO-7913) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • RG7827
3ms
Enrollment change
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
3ms
Real-world evaluation of nivolumab utilization in adjuvant treatment of localized muscle-invasive urothelial carcinoma. (PubMed, Fr J Urol)
Our real-world data align with existing literature regarding adjuvant nivolumab in localized invasive muscle urothelial carcinoma.
Journal • HEOR • Real-world evidence • PD(L)-1 Biomarker • IO biomarker • Real-world
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Opdivo (nivolumab) • cisplatin • carboplatin • gemcitabine • Padcev (enfortumab vedotin-ejfv)
3ms
A Study to Evaluate Enfortumab Vedotin Versus (vs) Chemotherapy in Subjects With Previously Treated Locally Advanced or Metastatic Urothelial Cancer (EV-301) (clinicaltrials.gov)
P3, N=608, Active, not recruiting, Astellas Pharma Global Development, Inc. | Trial completion date: Aug 2024 --> Feb 2025
Trial completion date • Metastases
|
paclitaxel • docetaxel • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
3ms
STAR-EV: Enfortumab Vedotin and Stereotactic Radiation for Localized, Cisplatin Ineligible Muscle Invasive Bladder Cancer (clinicaltrials.gov)
P1/2, N=19, Recruiting, University of Texas Southwestern Medical Center | Not yet recruiting --> Recruiting
Enrollment open
|
Padcev (enfortumab vedotin-ejfv)
3ms
KEYNOTE-F21: A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202) (clinicaltrials.gov)
P2, N=329, Active, not recruiting, Astellas Pharma Global Development, Inc. | Recruiting --> Active, not recruiting
Enrollment closed • Metastases
|
BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor)
|
PD-L1 expression • HER-2 positive • ER positive • EGFR mutation • BRAF mutation • HER-2 negative • ER negative • PGR negative • HER-2 negative + ER positive
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
3ms
Case series of advanced cancer patients harboring FGFR3-TACC3 fusions detected by comprehensive genomic profiling (ESMO Asia 2024)
Received 3 cycles of pembrolizumab and enfortumab vedotin...Treatment with Erdafitinib, gemcitabine and cisplatin resulted in a partial response...Pembrolizumab with gemcitabine and cisplatin was administered for 4 cycles, but the disease progressed with liver metastasis...Over one year he received many lines of treatment, including sorafenib, gemcitabine and cisplatin, , ramucirumab, nivolumab, and liposomal doxorubicin, lenvatinib durvalumab, and ramucirumab... In clinical practice, ctDNA or tumor NGS can detect rare and actionable FGFR3-TACC fusions in patients with advanced solid tumors that have progressed on standard therapy. Targeted therapy for such fusions can result in clinical benefit.
Clinical • PD(L)-1 Biomarker • Metastases
|
FGFR3 (Fibroblast growth factor receptor 3) • TACC3 (Transforming acidic coiled-coil containing protein 3)
|
FGFR3-TACC3 fusion
|
Guardant360® CDx • ACTOnco
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • Imfinzi (durvalumab) • gemcitabine • sorafenib • Lenvima (lenvatinib) • Balversa (erdafitinib) • Cyramza (ramucirumab) • Padcev (enfortumab vedotin-ejfv)
3ms
Pharmacovigilance study of the association between peripheral neuropathy and antibody-drug conjugates using the FDA adverse event reporting system. (PubMed, Sci Rep)
Signals for peripheral sensory neuropathy were 4.83, 2.44, 2.74, and 2.21 (calculated based on IC025) for brentuximab vedotin, trastuzumab emtansine, enfortumab vedotin, and polatuzumab vedotin, while signals for peripheral motor neuropathy were 5.31, 0.34, 2.27, and 0.03, respectively...Tisotumab vedotin had the highest hospitalization rate at 26.67%, followed by brentuximab vedotin at 25.5%...Brentuximab vedotin and enfortumab vedotin showed similar profiles for peripheral sensory neuropathy and motor neuropathy. Given the delayed time to onset and potentially poor outcomes, ADC-related peripheral neuropathy warrants significant attention.
Journal • Adverse events
|
ROR1 (Receptor Tyrosine Kinase Like Orphan Receptor 1)
|
Kadcyla (ado-trastuzumab emtansine) • Adcetris (brentuximab vedotin) • Padcev (enfortumab vedotin-ejfv) • Polivy (polatuzumab vedotin-piiq) • Tivdak (tisotumab vedotin-tftv)
3ms
Matching-Adjusted Indirect Comparison of the Efficacy and Safety of Erdafitinib vs Enfortumab Vedotin in Patients with Locally Advanced Metastatic Urothelial Carcinoma. (PubMed, J Health Econ Outcomes Res)
An anchored MAIC was conducted according to the National Institute for Health and Care Excellence Decision Support Unit guidance, with physician's choice of chemotherapy (docetaxel/paclitaxel and vinflunine) as the common comparator. The MAIC indicates comparable efficacy of erdafitinib vs EV for overall survival and progression-free survival, with erdafitinib showing a higher probability of achieving deep responses. While erdafitinib is associated with slightly more adverse events compared with EV, these events seem to be less severe.
Journal • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
paclitaxel • docetaxel • Balversa (erdafitinib) • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
4ms
Paradigm shift in systemic therapy for metastatic urothelial carcinoma-antibody-drug conjugates (ADCs) and fibroblast growth factor receptor (FGFR) inhibitors (PubMed, Urologie)
These novel combinations are revolutionizing the treatment standard for metastatic urothelial carcinoma and necessitate a new approach to managing side effects.
Review • Journal • PD(L)-1 Biomarker • Metastases
|
FGFR (Fibroblast Growth Factor Receptor)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • gemcitabine • Bavencio (avelumab) • Balversa (erdafitinib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • Javlor (vinflunine)
4ms
TROPHY-U-01: Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread (clinicaltrials.gov)
P2, N=827, Recruiting, Gilead Sciences | Trial completion date: Jul 2026 --> Jun 2030 | Trial primary completion date: Jul 2024 --> Jun 2030
Trial completion date • Trial primary completion date • Metastases
|
Keytruda (pembrolizumab) • cisplatin • carboplatin • gemcitabine • Bavencio (avelumab) • Yutuo (zimberelimab) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv) • domvanalimab (AB154)
4ms
Ph II Study of Enfortumab Vedotin in Patients With Advanced or Metastatic CRC or HCC (clinicaltrials.gov)
P2, N=40, Not yet recruiting, H. Lee Moffitt Cancer Center and Research Institute
New P2 trial • Metastases
|
Padcev (enfortumab vedotin-ejfv)
4ms
Cabozantinib in Combination With Enfortumab Vedotin for Locally Advanced or Metastatic Urothelial Cancer (clinicaltrials.gov)
P1, N=32, Recruiting, Emory University | Trial completion date: Jan 2025 --> Jan 2026
Trial completion date • Combination therapy • Metastases
|
PD-L1 (Programmed death ligand 1) • PD-1 (Programmed cell death 1) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Cabometyx (cabozantinib tablet) • Cometriq (cabozantinib capsule) • Padcev (enfortumab vedotin-ejfv)
5ms
EV-104: A Study of Intravesical Enfortumab Vedotin For Treatment of Patients With Non-muscle Invasive Bladder Cancer (NMIBC) (clinicaltrials.gov)
P1, N=58, Recruiting, Astellas Pharma Global Development, Inc. | Trial primary completion date: Jun 2024 --> Jun 2026
Trial primary completion date
|
Padcev (enfortumab vedotin-ejfv)
5ms
Oncologic Outcomes of Patients with Immune Checkpoint Inhibitor Resistant Urothelial Carcinoma Treated with Enfortumab Vedotin and the Impact of Neutrophil-to-Lymphocyte Ratio and Dysgeusia on Overall Survival: A Retrospective Multicenter Cohort Study in Japan. (PubMed, Cancers (Basel))
Patients without these factors had a significantly prolonged OS compared to those with both factors. In real-world practice, EV therapy is an effective treatment for patients with la/mUC after ICI treatment.
Retrospective data • Journal • Checkpoint inhibition
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Padcev (enfortumab vedotin-ejfv)
5ms
Novel therapeutic regimens in previously untreated metastatic urothelial carcinoma: A systematic review and bayesian network meta-analysis. (PubMed, Urol Oncol)
Median overall survival (OS) ranged from 12.1 to 31.5 months across the studies, with the combination of enfortumab vedotin and pembrolizumab demonstrating the most substantial reduction in the risk of death (HR 0.47 [95% CrI: 0.38, 0.58]), followed by avelumab monotherapy (HR 0.69 [95% CrI: 0.56, 0.86]). Avelumab showed notable single-agent activity. These findings provide a valuable framework to guide clinical decision-making and highlight priority areas for future research, including biomarker refinement and novel combination strategies to enhance antitumor immunity in this challenging malignancy.
Retrospective data • Review • Journal • PD(L)-1 Biomarker • IO biomarker • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Keytruda (pembrolizumab) • Bavencio (avelumab) • Padcev (enfortumab vedotin-ejfv)
5ms
Exploring membranous NECTIN-4 expression patterns and enfortumab vedotin response in prostate cancer. (PubMed, J Cell Mol Med)
In summary, EV may be effective in NECTIN-4-positive PCa. However, our findings demonstrate that the tumoural NECTIN-4 expression is predominantly low in metastatic PCa, which suggests that EV may only be effective in a biomarker-stratified subgroup.
Journal
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Padcev (enfortumab vedotin-ejfv)
5ms
Population Pharmacokinetic Modeling and Exposure-Response Analysis for the Antibody-Drug Conjugate Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Carcinoma. (PubMed, Clin Pharmacol Ther)
Enfortumab vedotin and free MMAE exposures were statistically significant predictors of grade ≥ 3 treatment-related adverse events (both P < 0.0001). This analysis supports enfortumab vedotin 1.25 mg/kg on days 1, 8, and 15 of a 28-day cycle.
PK/PD data • Journal • Metastases
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Padcev (enfortumab vedotin-ejfv)
5ms
Enfortumab vedotin-induced cutaneous eruption: Ring mitotic figures as a distinctive histopathologic feature. (PubMed, J Cutan Pathol)
The agent, now given in combination with pembrolizumab, frequently induces cutaneous reactions. An emerging literature of small series and case reports, largely from oncologic literature, presents the histopathology of EV-induced cutaneous eruption as a vacuolar interface dermatitis with the inconsistently reported feature of arrested mitotic figures. This case study demonstrates distinctive clinical and histopathologic features of EV-induced eruption, which may inform dermatologic and oncologic management.
Journal
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Keytruda (pembrolizumab) • Padcev (enfortumab vedotin-ejfv)
5ms
Nectin-4-directed antibody-drug conjugates (ADCs): Spotlight on preclinical and clinical evidence. (PubMed, Life Sci)
Of great note, the US Food and Drug Administration (FDA)-approval of the first Nectin-4-directed ADC, enfortumab vedotin (EV), in urothelial cancer (UC) not only introduced Nectin-4 as a clinically validated and reliable target antigen but also confirmed the evolving role of Nectin-4-directed ADCs as novel and promising cancer therapeutics. In addition to EV, there have been or are currently being seven and eleven Nectin-4-directed ADCs, respectively, in various stages of clinical trials and preclinical development, offering a promising future for the treatment of Nectin-4-positive cancer patients. This study reviewed clinical- and preclinical-stage Nectin-4-directed ADCs.
Preclinical • Review • Journal
|
NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Padcev (enfortumab vedotin-ejfv)
5ms
Antibody-Drug Conjugates in Urothelial Cancer: From Scientific Rationale to Clinical Development. (PubMed, Cancers (Basel))
Targeted therapies that have been developed include the anti-nectin 4 ADC enfortumab vedotin and the fibroblast growth factor receptor inhibitor erdafitinib. Enfortumab vedotin has shown efficacy in prospective studies in patients with advanced UC, alone and in combination with pembrolizumab. The anti-Trop-2 ADC sacituzumab govitecan has also demonstrated effectiveness in single-armed studies. This review highlights the mechanism of action of ADCs, their application in mono- and combination therapies, primary mechanisms of resistance, and future perspectives for their clinical use in UC treatment. ADCs have proven to be an increasingly vital component of the therapeutic landscape for urothelial carcinoma, filling a gap in the treatment of this progressive disease.
Review • Journal • PD(L)-1 Biomarker • IO biomarker
|
FGFR (Fibroblast Growth Factor Receptor) • NECTIN4 (Nectin Cell Adhesion Molecule 4)
|
Keytruda (pembrolizumab) • Balversa (erdafitinib) • Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv)
5ms
Advancements in First-Line Treatment of Metastatic Bladder Cancer: EV-302 and Checkmate-901 Insights and Future Directions. (PubMed, Cancers (Basel))
The approval of nivolumab in combination with gemcitabine and cisplatin and pembrolizumab with antibody-drug conjugate enfortumab vedotin has revolutionized the first-line treatment of advanced bladder cancer in many countries. We further discuss newer novel treatment options in the second and subsequent lines of treatment on progression, like immunotherapy in combination with other agents, including fibroblast growth factors receptor inhibitors, human epidermal growth factor inhibitors, antibody-drug conjugates, tyrosine kinase inhibitors, and novel antibodies. Finally, we discuss the integration of these novel therapies into current clinical practice amidst the rapidly evolving landscape of advanced bladder cancer treatment, aiming to enhance patient outcomes.
Review • Journal • Metastases
|
HER-2 (Human epidermal growth factor receptor 2)
|
Keytruda (pembrolizumab) • Opdivo (nivolumab) • cisplatin • gemcitabine • Padcev (enfortumab vedotin-ejfv)
6ms
Efficacy of Antibody Drug Conjugates Alone and in Combination with other Agents in Metastatic Urothelial Carcinoma: A Scoping Review. (PubMed, Bladder Cancer)
In addition to enfortumab vedotin and sacituzumab govitecan, various HER2-targeted antibody drug conjugates and ADC-anti-PD-1 combination regimens have demonstrated efficacy in clinical trials and are poised for clinical advancement.
Review • Journal • Combination therapy • Metastases
|
NECTIN4 (Nectin Cell Adhesion Molecule 4) • SLITRK6 (SLIT And NTRK Like Family Member 6)
|
Trodelvy (sacituzumab govitecan-hziy) • Padcev (enfortumab vedotin-ejfv)