Approval Probability
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Adjusted LOA
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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 small molecule being developed for oncology indications, including locally advanced or metastatic solid tumors, pancreatic cancer, non-small cell lung cancer, and nonsquamous nonsmall cell neoplasm of the lung. It has been studied in clinical trials for these conditions, though it remains in clinical development and is not approved.
Demcizumab is being developed by Mereo BioPharma Group plc, a biopharmaceutical company traded under the ticker MREO. The company has sponsored clinical trials evaluating Demcizumab in various oncology settings, including pancreatic cancer and non-small cell lung cancer.
Demcizumab has completed Phase 1 and Phase 2 clinical trials. It is an investigational drug that has not received regulatory approval. The completed trials include Phase 1 studies in solid tumors and pancreatic cancer, and Phase 2 studies in non-small cell lung cancer and pancreatic ductal adenocarcinoma.
Demcizumab has been studied in four completed clinical trials: NCT01189929 (Phase 1, pancreatic cancer), NCT02259582 (Phase 2, non-small cell lung cancer), NCT02289898 (Phase 2, pancreatic ductal adenocarcinoma), and NCT02722954 (Phase 1b, solid tumors). All trials are completed with no active trials ongoing.
Yes, Demcizumab is also known as OMP-21M18. In clinical trial NCT01189929, the study title refers to Demcizumab (OMP-21M18), confirming that these names refer to the same investigational drug being developed by Mereo BioPharma.