Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OMP-59R5 · 2 trials · 2 indications
Number of participants with dose-limiting toxicities when administered OMP-59R5 every of other week (Days 1 and 15) in combination with nab-paclitaxel (Nab-P) 125 mg/m2 and gemcitabine (Gem) 1000 mg/m2 on Days 1, 8, and 15 of every 28-day cycle in subjects with previously untreated stage IV pancreatic cancer. In the event that no DLTs are observed, maximum tested dose would be considered the Maximum Tolerated Dose (MTD).
To determine the clinical benefit, as measured by overall survival (OS) ofthe addition of OMP-59R5 to nab-paclitaxel and gemcitabine in all subjects who are receiving first-line therapy for stage IV pancreatic cancer.
To determine the clinical benefit, as measured by OS of the addition of OMP-59R5 to Nab-P+Gem across the 4 subject subsets: subjects with Notch3 ≥ 25th percentile, subjects with Notch3 ≥ 50th percentile, subjects with Notch3 ≥ 75th percentile and all subjects receiving first-line therapy for stage IV pancreatic cancer with Notch3 high expression level.
The number of patients experiencing Adverse Events will be reported.
| Arm | Type | Description |
|---|---|---|
| OMP-59R5 plus Gemcitabine and Nab-Paclitaxel | EXPERIMENTAL | OMP-59R5 plus Gemcitabine and Nab-Paclitaxel |
| Gemcitabine and Nab-Paclitaxel plus Placebo | EXPERIMENTAL | Gemcitabine and Nab-Paclitaxel plus Placebo |
| OMP-59R5 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| OMP-59R5 | DRUG | OMP-59R5 administered intravenously |
| Gemcitabine | DRUG | administered intravenously |
| Placebo | DRUG | administered IV |
| Nab-Paclitaxel | DRUG | administered intravenously |
Inclusion Criteria: Subjects must meet all of the following major inclusion criteria to be eligible for the study: 1. 18 years of age or older 2. Histologically or cytologically documented stage IV ductal adenocarcinoma of the pancreas. 3. Performance Status (ECOG) 0 or 1 4. FFPE tumor tissue from...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
OMP-59R5, also known as tarextumab, is an investigational small molecule developed by Mereo BioPharma Group plc (ticker MREO) for oncology. It has been studied in solid tumors and Stage IV pancreatic cancer. It is not approved and remains in clinical development.
OMP-59R5 has been studied in solid tumors and in previously untreated Stage IV pancreatic cancer. It is an investigational agent and is not approved for any indication. All clinical development to date has been in oncology.
OMP-59R5 is developed by Mereo BioPharma Group plc, which trades under the ticker MREO. The company is responsible for the clinical development of tarextumab in oncology.
OMP-59R5 is in Phase 1 development. Two Phase 1 trials have been completed: a dose escalation study in solid tumors and a Phase 1b/2 study in Stage IV pancreatic cancer. No active trials are ongoing, and the drug is not approved.
OMP-59R5 has been evaluated in two completed Phase 1 trials. NCT01277146 was a dose escalation study in solid tumors with 42 participants. NCT01647828 was a Phase 1b/2 study in previously untreated Stage IV pancreatic cancer with 217 participants in the United States.
Yes, OMP-59R5 is also known as tarextumab. Both names refer to the same investigational small molecule developed by Mereo BioPharma Group plc for oncology indications including solid tumors and Stage IV pancreatic cancer.