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 | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
OMP-59R5 is an investigational small molecule being studied for the treatment of solid tumors and stage IV pancreatic cancer. It is developed by Mereo BioPharma Group plc (MREO) and is currently in Phase 1 clinical development.
OMP-59R5 is developed by Mereo BioPharma Group plc, a biopharmaceutical company listed on the stock exchange under the ticker MREO. The drug is being investigated for oncology indications, including solid tumors and stage IV pancreatic cancer.
OMP-59R5 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials have been completed, but the drug remains under investigation for solid tumors and stage IV pancreatic cancer.
OMP-59R5 has been studied in two completed clinical trials. NCT01277146 was a dose escalation study in subjects with solid tumors, enrolling 42 participants. NCT01647828 was a Phase 1b/2 study combining OMP-59R5 with nab-paclitaxel and gemcitabine in previously untreated stage IV pancreatic cancer, enrolling 217 participants.
Yes, OMP-59R5 is also known as Tarextumab. In clinical trial NCT01647828, the drug is referred to as OMP-59R5 (Tarextumab), confirming that both names refer to the same investigational agent.