Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pelareorep · 3 trials · 8 indications
Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1
Overall response rate at week 16 according to RECIST V1.1
Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1
DCR (complete response \[CR\], partial response \[PR\], and stable disease \[SD\]) assessed by the investigators according to RECIST v 1.1.
OS is defined as the time from date of first treatment to death from any cause
| Arm | Type | Description |
|---|---|---|
| Arm A | EXPERIMENTAL | - |
| Arm B | EXPERIMENTAL | - |
| Cohort 1 | ACTIVE_COMPARATOR | Patients receive paclitaxel alone. |
| Cohort 2 | EXPERIMENTAL | Patients receive pelareorep + paclitaxel. |
| Cohort 3 | EXPERIMENTAL | Patients receive pelareorep + paclitaxel + avelumab. |
| Cohort 1: Metastatic Pancreatic Cancer 1L | EXPERIMENTAL | Patients with first-line (1L) locally advanced/metastatic unresectable pancreatic ductal adenocarcinoma (PDAC): Pelareorep and atezolizumab added to gemcitabine and nab-paclitaxel |
| Cohort 2: Metastatic Colorectal Cancer 1L (MSI-H/dMMR) | EXPERIMENTAL | Patients with 1L metastatic colorectal cancer (mCRC), limited to microsatellite instability-high (MSIH) or mismatch repair deficient (dMMR) tumors: Pelareorep and atezolizumab |
| Cohort 3: Metastatic Colorectal Cancer 3L | EXPERIMENTAL | Patients with third-line (3L) mCRC independent of microsatellite instability (MSI)/dMMR status: Pelareorep and atezolizumab added to trifluridine/tipiracil |
| Cohort 4: Metastatic Unresectable Anal Cancer >/=2L | EXPERIMENTAL | Patients with \>/= 2L locally advanced/metastatic unresectable squamous cell carcinoma of the anal canal (SCCA) of viral or non-viral origin after prior systemic chemotherapy: Pelareorep and atezolizumab |
| Cohort 5: Metastatic PDAC 1L | EXPERIMENTAL | Patients with 1L metastatic PDAC: Pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab |
| Name | Type | Description |
|---|---|---|
| Bevacizumab | DRUG | Bevacizumab (5 mg/kg) IV infusion |
| FOLFIRI | DRUG | irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion |
| Pelareorep | DRUG | pelareorep 4.5 x 10\^10 TCID50 IV infusion |
| Paclitaxel | DRUG | Paclitaxel 80 mg/m\^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle. |
| Avelumab | DRUG | Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle. |
| Atezolizumab | DRUG | Atezolizumab 840 mg IV infusion |
| Gemcitabine and nab-paclitaxel | DRUG | Gemcitabine (1,000 mg/m2) and nab-paclitaxel (125 mg/m2) |
| Trifluridine Tipiracil | DRUG | Trifluridine/tipiracil administered at a 35 mg/m2 dose orally twice daily |
| mFOLFIRINOX Treatment Regimen | DRUG | mFOLFIRINOX- IV oxaliplatin 85 mg/m2; IV leucovorin 400 mg/m2; IV irinotecan 150 mg/m2; 5-FU 2400 mg/m2 by 46-hour infusion, per local standard of care |
Inclusion Criteria: * Histologically confirmed cancer of the colon or rectum with documented metastasis * Measurable disease per RECIST v. 1.1 * Not candidates for curative surgery or curative radiation * Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in ...
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