Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Enfortumab vedotin · 3 trials · 4 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.
| 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. |
| 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 for the treatment of urothelial cancer, muscle-invasive bladder cancer, metastatic urothelial cancer, and other malignant solid tumors. It is currently in Phase 2 clinical development for these oncology indications.
Enfortumab Vedotin is an antibody-drug conjugate that targets Nectin-4, a protein expressed on the surface of cancer cells. By binding to Nectin-4, the drug delivers a cytotoxic agent directly to tumor cells, which is the basis of its mechanism of action in treating Nectin-4-expressing cancers.
Enfortumab Vedotin is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various bladder cancer and solid tumor indications.
Enfortumab Vedotin is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is studying the drug in combination with pembrolizumab for muscle-invasive bladder cancer.
Enfortumab Vedotin is being evaluated in multiple clinical trials, including NCT02091999, a completed Phase 1 study in metastatic urothelial cancer; NCT07475806, a recruiting Phase 2 trial in muscle-invasive bladder cancer; and NCT07566156, a recruiting Phase 3 trial in urothelial cancer.