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Demcizumab · 5 trials · 4 indications
Investigator assessed Kaplan-Meier estimates of progression-free survival for placebo/placebo arm and pooled demcizumab arm.
Investigator-assessed Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 response rate (unconfirmed) in placebo/placebo arm to demcizumab/placebo arm and demcizumab/demcizumab arm combined in subjects with first-line stage IV non-small cell lung cancer (NSCLC). Response rate was based on Investigator-assessed best-overall-response (BOR) and was defined as the best unconfirmed response determined by RECIST version 1.1 recorded from the start of the treatment until disease progression in the following order of importance: CR, PR , SD, progressive disease (PD), not evaluable, or missing.
The maximum tolerated dose (MTD) or maximum administered dose (MAD) will be determined in patients treated with demcizumab in combination with pembrolizumab
| Arm | Type | Description |
|---|---|---|
| Abraxane® and gemcitabine plus placebo | EXPERIMENTAL | Abraxane® and gemcitabine plus placebo (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression |
| Abraxane® and gemcitabine plus demcizumab plus placebo | EXPERIMENTAL | Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus placebo (3 cycles) and then Abraxane® and gemcitabine until disease progression |
| Abraxane® and gemcitabine plus demcizumab | EXPERIMENTAL | Abraxane® and gemcitabine plus demcizumab (3 cycles), Abraxane® and gemcitabine (3 cycles), Abraxane® and gemcitabine plus demcizumab (3 cycles) and then Abraxane® and gemcitabine until disease progression |
| Arm 1 Pem, carbo, placebo x 4 cycles | PLACEBO_COMPARATOR | Pemetrexed (500 mg/m2),carboplatin (area under the concentration-time curve of 6 mg/mL x min) once every 21 days X 4 cycles, pemetrexed maintenance and placebo starting at Day 84 |
| Arm 2 Pem, carbo x 4 cycles, one course of dem | ACTIVE_COMPARATOR | Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, one course of demcizumab 5mg/kg, maintenance pemetrexed + placebo starting on Day 84 |
| Arm 3 pem, carbo, dem x 4 cycles, dem retreatment | ACTIVE_COMPARATOR | Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, maintenance pemetrexed starting on Day 84. 2 courses of demcizumab 5 mg/kg |
| Demcizumab and Pembrolizumab | EXPERIMENTAL | Demcizumab will be administered prior to pembrolizumab |
| Carboplatin and Pemetrexed plus demcizumab | EXPERIMENTAL | Carboplatin and Pemetrexed plus demcizumab |
| Pemetrexed plus demcizumab | EXPERIMENTAL | Pemetrexed plus demcizumab |
| Gemcitabine and demcizumab With or Without Abraxane® | EXPERIMENTAL | Gemcitabine and demcizumab With or Without Abraxane® |
| Name | Type | Description |
|---|---|---|
| Demcizumab | DRUG | administered intravenously |
| Abraxane® | DRUG | administered intravenously |
| gemcitabine | DRUG | administered intravenously |
| Placebo | DRUG | - |
| Pemetrexed | DRUG | - |
| Carboplatin | DRUG | - |
| Pembrolizumab | DRUG | Drug: Pembrolizumab administered 2mg/kg IV every 3 weeks |
Inclusion Criteria: 1. Subjects must have histologically confirmed metastatic pancreatic ductal adenocarcinoma.. Prior chemotherapy and/or radiotherapy either in the adjuvant or neoadjuvant setting or for metastatic disease is not allowed. 2. Availability of formalin-fixed paraffin-embedded (FFPE) ...
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Demcizumab is an investigational oncology drug being studied for nonsquamous non-small cell lung cancer, pancreatic cancer, locally advanced or metastatic solid tumors, and non-small cell lung cancer. It is a small molecule in Phase 1 clinical development, and it is not yet approved by the FDA.
Demcizumab is being developed by Mereo BioPharma Group plc, a biopharmaceutical company traded on the stock exchange under the ticker MREO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various cancer indications.
Demcizumab is currently in Phase 1 clinical development. It has completed two Phase 1 trials and one Phase 2 trial, but it remains investigational and has not received regulatory approval. The drug is still being studied for safety and efficacy in oncology indications.
Demcizumab has been studied in several completed clinical trials, including NCT01189929 for pancreatic cancer, NCT01189968 for non-small cell lung cancer, NCT02259582 for nonsquamous non-small cell lung cancer, and NCT02722954 for locally advanced or metastatic solid tumors. These trials enrolled a total of 264 participants.
Yes, Demcizumab is also known as OMP-21M18. Clinical trial titles reference Demcizumab (OMP-21M18), confirming that these names refer to the same investigational drug being developed by Mereo BioPharma Group plc.