Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as • Padcev, • ASG-22CE, • ASG-22Me, ASP7465
enfortumab vedotin · 4 trials · 5 indications
BI-EFS is defined as the time from randomization to any of the following events: histologically confirmed persistent or residual MIBC post-treatment confirmed by BICR, histologically confirmed recurrent MIBC by BICR, disease progression by BICR, cystectomy, or death from any cause.
Time from randomization to death due to any cause.
cCR rate is defined as the proportion of participants having cCR after treatment with enfortumab vedotin in combination with pembrolizumab. cCR is defined as no visible tumor detected on cystoscopy or no residual tumor on transurethral resection of bladder tumor (TURBT); no evidence of malignancy, except for the presence of Ta (low grade), and no radiographic evidence of residual or metastatic disease on imaging (magnetic resonance urogram \[MRU\] or computed tomography urogram \[CTU\] if contraindicated). Bladder wall thickening on imaging is acceptable if not associated with malignancy, except for the presence of Ta (low grade), and negative urine cytology.
BI-EFS rate is defined as the proportion of participants who have not had an observed BI-EFS event 2 years after the first dose. BI-EFS is defined as the time from first dose to either histologically confirmed recurrent muscle-invasive bladder cancer (MIBC), disease progression, cystectomy, or death from any cause.
ORR was defined as the percentage of participants with best overall response (BOR) as complete response (CR) or partial response (PR) based on the RECIST v1.1. CR was defined as disappearance of all target and nontarget lesions. Any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \< 10 mm from baseline measurement. PR was defined as at least a 30% decrease in the sum of diameters (longest for nonnodal lesions, short axis for nodal lesions) of target lesions taking as reference to the baseline sum of diameters.
Cmax was derived from the PK blood samples collected.
Cmax was derived from the PK blood samples collected.
Cmax was derived from the PK blood samples collected.
Cmax was derived from the PK blood samples collected.
As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.
As per planned analysis, if more than 50% of PK concentrations were below the limit of quantification (i.e 0) at a given time point, standard deviation was not reported.
Ctrough was derived from the PK blood samples collected.
Ctrough was derived from the PK blood samples collected.
Tmax was derived from the PK blood samples collected.
Tmax was derived from the PK blood samples collected.
AUC0-28d was derived from the PK blood samples collected.
AUC0-28d was derived from the PK blood samples collected.
AUC0-7d was derived from the PK blood samples collected.
AUC0-7d was derived from the PK blood samples collected.
AUC0-7d was derived from the PK blood samples collected.
AUC0-7d was derived from the PK blood samples collected.
Accumulation ratio is the ratio of Cmax after the dosing interval (Cycle 1 Day 15) divided by Cmax after the first dosing interval (Cycle 1 Day 1).
RacAUC0-7d was calculated using AUC0-7d and derived from the PK blood samples collected.
t1/2 was derived from the PK blood samples collected.
CL was derived from the PK blood samples collected.
Vss was derived from the PK blood samples collected.
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | Enfortumab vedotin + pembrolizumab (EV + P) |
| Arm B | ACTIVE_COMPARATOR | Concurrent Chemoradiotherapy (cCRT) |
| Enfortumab Vedotin with Pembrolizumab | EXPERIMENTAL | Participants will receive enfortumab vedotin on days 1 and 8 of every 21-day cycle and pembrolizumab on day 1 of every 21-day cycle. |
| Enfortumab Vedotin 1.25 mg/kg | EXPERIMENTAL | Participants received 1.25 milligrams per kilogram (mg/kg) of body weight enfortumab vedotin by intravenous (IV) infusion over approximately 30 minutes on days 1, 8 and 15 of every 28-day cycle. Participants received study treatment until radiological disease progression as determined per investigator assessment or other discontinuation criteria were met or upon study termination, or study completion, whichever occurred first. Participants who had intense PK Sampling were enrolled in PK Cohort. |
| Part A enfortumab vedotin Dose Escalation (Dose Levels 1-4) | EXPERIMENTAL | All subjects will receive a single 30 minute intravenous (IV) infusion of enfortumab vedotin once weekly for the first 3 weeks of every 4 week cycle (i.e., on Days 1, 8 and 15). |
| Part B enfortumab vedotin Renal Insufficiency Expansion | EXPERIMENTAL | Subjects will receive a single 30 minute IV infusion of enfortumab vedotin at a dose level below and escalated up to the preliminary RP2D once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8 and 15) until disease progression, intolerability of the investigational product or consent withdrawal. A cycle is 4 weeks. |
| Part B enfortumab vedotin NSCLC Expansion | EXPERIMENTAL | Subjects will receive a single 30 minute IV infusion of enfortumab vedotin at the preliminary RP2D once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8 and 15) until disease progression, intolerability of the investigational product or consent withdrawal. A cycle is 4 weeks. |
| Part B enfortumab vedotin Ovarian Cancer Expansion | EXPERIMENTAL | Subjects will receive a single 30 minute IV infusion of enfortumab vedotin at the preliminary RP2D once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8 and 15) until disease progression, intolerability of the investigational product or consent withdrawal. A cycle is 4 weeks. |
| Part C enfortumab vedotin CPI Treated Expansion | EXPERIMENTAL | Subjects will receive a single 30 minute IV infusion of enfortumab vedotin at the preliminary RP2D once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8 and 15). A cycle is 4 weeks. Subjects will continue treatment until disease progression, intolerability of enfortumab vedotin, Investigator decision or consent withdrawal. |
| Name | Type | Description |
|---|---|---|
| Enfortumab vedotin | DRUG | Enfortumab vedotin administered as an IV infusion on Days 1 and 8 of every 3-week cycle up to cycle 9. |
| Conventional Radiotherapy | RADIATION | 64 Gy in 32 fractions over 6.5 weeks administered to the participant's bladder only or the bladder and prophylactically to pelvic nodes. |
| Hypofractionated Radiotherapy | RADIATION | 55 Gy in 20 fractions over 4 weeks administered to the participant's bladder only. |
| Cisplatin | DRUG | 40 mg of cisplatin per meter squared of body surface area, administered once weekly via IV infusion during radiation OR 20 mg of cisplatin per meter squared of body surface area per day on Days 1 and 2 weekly via IV infusion during radiation. |
| Fluorouracil | DRUG | 500 mg per meter squared of body surface area per day on Days 1-5 (week 1) and Days 22 26 (week 3) administered as continuous IV infusion during radiation in combination with mitomycin C. |
| Mitomycin C | DRUG | 12 mg per meter squared of body surface area administered as an IV bolus on Day 1 during radiation in combination with fluorouracil. |
| Gemcitabine | DRUG | 100 mg per meter squared of body surface area administered once weekly via IV infusion during radiation OR 27 mg per meter squared of body surface area administered twice weekly via IV infusion during radiation |
| Pembrolizumab | DRUG | IV infusion on Day 1 of every 3-week cycle up to cycle 17. |
Inclusion Criteria: * Has histologically confirmed initial diagnosis of muscle-invasive bladder cancer (MIBC) with predominant urothelial histology staged cT2-T4aN0M0 * Tissue comprising muscle-invasive urothelial cancer must be submitted for clinical staging at baseline * Eligible for and agree to...
Enfortumab vedotin is an investigational antibody-drug conjugate being studied in urothelial cancer, including metastatic urothelial cancer, muscle-invasive bladder cancer, and other malignant solid tumors. Clinical development includes use both as a single agent and in combination with pembrolizumab in patients with bladder cancer.
Enfortumab vedotin is an antibody-drug conjugate that targets Nectin-4, a protein expressed on urothelial cancer cells. The antibody component binds Nectin-4 and delivers a cytotoxic payload into the tumor cell. It is also known by the research name ASG-22CE.
Enfortumab vedotin is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor of the clinical trials evaluating the drug in urothelial cancer and muscle-invasive bladder cancer.
Enfortumab vedotin is in clinical development across multiple phases. A Phase 3 trial, EV-309, is currently recruiting, and a Phase 2 trial in muscle-invasive bladder cancer is also recruiting. Earlier Phase 1 and Phase 2 studies in metastatic urothelial cancer have been completed.
Enfortumab vedotin is being evaluated in several trials, including NCT07566156 (EV-309), a Phase 3 study combining it with pembrolizumab versus concurrent chemoradiotherapy in muscle-invasive bladder cancer, and NCT07475806, a Phase 2 study in the same setting. Completed trials include NCT04995419 and NCT02091999.
Yes, enfortumab vedotin is also known as ASG-22CE. The name ASG-22CE appears in earlier clinical trial records, including a Phase 1 study of escalating doses in metastatic urothelial cancer and other solid tumors expressing Nectin-4.