Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Vepugratinib · 2 trials · 4 indications
ORR by Investigator Assessment.
PFS by blinded independent committee review (BICR).
| Arm | Type | Description |
|---|---|---|
| Vepugratinib + EV + Pembrolizumab (Safety Lead In) | EXPERIMENTAL | Vepugratinib administered orally with EV + pembrolizumab administered IV |
| Vepugratinib + Enfortumab Vedotin (EV) + Pembrolizumab | EXPERIMENTAL | Vepugratinib administered orally, and EV + pembrolizumab administered by intravenous (IV) infusion. |
| Placebo + EV + Pembrolizumab | PLACEBO_COMPARATOR | Placebo administered orally, and EV + pembrolizumab administered by IV infusion. |
| Phase 1a: Cohort A1 Vepugratinib Monotherapy Dose Escalation | EXPERIMENTAL | Vepugratinib administered orally |
| Phase 1a: Cohort A2 Vepugratinib Monotherapy Dose Optimization | EXPERIMENTAL | Vepugratinib administered orally |
| Phase 1b: Cohort B1, B2, B4, C1, and D1 Vepugratinib Monotherapy Dose Expansion | EXPERIMENTAL | Vepugratinib administered orally |
| Phase 1b: Cohort B5 Vepugratinib Plus Pembrolizumab Plus Enfortumab Vedotin | EXPERIMENTAL | Vepugratinib administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV |
| Phase 1b: MIBC Cohort B6 Vepugratinib Plus Pembrolizumab Plus Enfortumab Vedotin | EXPERIMENTAL | Vepugratinib administered orally in combination with pembrolizumab administered IV and enfortumab vedotin administered IV |
| Experimental: Phase 1b: Cohort B7 Vepugratinib Plus Trastuzumab Deruxtecan | EXPERIMENTAL | Vepugratinib administered orally in combination with trastuzumab deruxtecan administered IV |
| Phase 1b: NMIBC Cohort B8 Vepugratinib Monotherapy Dose Expansion | EXPERIMENTAL | Vepugratinib administered orally |
| Phase 1b: Cohort D2 (Drug to Drug Interaction) | EXPERIMENTAL | Vepugratinib Plus Midazolam Plus Digoxin Plus Rosuvastatin (Lead-In Only) followed by Vepugratinib Monotherapy Vepugratinib administered orally Midazolam with digoxin with rosuvastatin administered orally once per cycle for 2 cycles. |
| Name | Type | Description |
|---|---|---|
| Vepugratinib | DRUG | Administered orally |
| Placebo | OTHER | Administered orally |
| EV | DRUG | Administered by IV infusion |
| Pembrolizumab | DRUG | Administered by IV infusion |
| enfortumab vedotin | DRUG | IV |
| Trastuzumab Deruxtecan | DRUG | IV |
| Midazolam | DRUG | Oral |
| Digoxin | DRUG | Oral |
| Rosuvastatin | DRUG | Oral |
Inclusion Criteria: * Have histologically confirmed, unresectable locally advanced or metastatic urothelial cancer (mUC). Individuals with mixed histology other than small cell or neuroendocrine carcinoma are eligible if a urothelial component is present. * Have a qualifying fibroblast growth facto...
Vepugratinib is an investigational small molecule being studied for the treatment of transitional cell carcinoma, urinary bladder neoplasms, and other cancers of the urinary tract, including cases with metastasis. It is currently in Phase 3 clinical development for these oncology indications.
Vepugratinib is a kinase inhibitor, a type of targeted therapy that blocks specific enzymes involved in cancer cell growth. It is being studied in patients whose tumors have alterations in the FGFR3 gene, as part of the FORAGER-1 clinical trial.
Vepugratinib is being developed by Eli Lilly and Company, a biopharmaceutical company traded on the stock exchange under the ticker symbol LLY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with urinary tract cancers.
Vepugratinib is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial is actively recruiting participants to study its effects in patients with transitional cell carcinoma and related urinary tract cancers.
Vepugratinib is being studied in two active clinical trials. The first is NCT05614739, a Phase 1 study called FORAGER-1, which is recruiting patients with FGFR3 gene alterations. The second is NCT07218380, a Phase 3 study in patients with urinary tract cancers. Both trials are currently recruiting participants.
Yes, Vepugratinib is also known by the alternative names LY3866288 and LOXO-435. These names refer to the same investigational drug being developed by Eli Lilly and Company for the treatment of urinary tract cancers, including transitional cell carcinoma and bladder neoplasms.