Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Encorafenib Oral Capsule
Encorafenib · 2 trials · 3 indications
The confirmed overall response rate (cORR) is the percentage of confirmed responses, defined as complete response (CR) or partial response (PR), as assessed by local radiologist/investigator review based on the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR): Disappearance of all target lesions; Partiel response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Overall Response (OR) = CR + PR.
DLT rate was estimated based on data from DLT-evaluable participants during the DLT-evaluation period (which is the first 28 days after the first dose of study intervention in the SLI) to assess the safety and tolerability of the doublet arm.
PFS was defined as the time from the date of randomization to the earliest documented disease progression (PD) as determined by BICR assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause.
PFS was defined as the time from the date of randomization to the earliest documented disease progression as determined by BICR assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, or death due to any cause.
| Arm | Type | Description |
|---|---|---|
| 1 Arm | EXPERIMENTAL | encorafenib plus binimetinib plus cetuximab |
| Encorafenib and cetuximab | EXPERIMENTAL | Safety Lead-in (SLI) phase: 28 day cycles of encorafenib once daily (QD) 300 mg (4 x 75 mg oral capsule) and cetuximab 400 mg/m² initial dose (120-minute infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly Randomized (Phase II) phase: 28 day cycles of encorafenib once daily (QD) 300 mg (4 x 75 mg oral capsule) and cetuximab 400 mg/m² initial dose (120-minute infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly |
| Irinotecan and cetuximab or FOLFIRI and cetuximab | EXPERIMENTAL | Randomized (Phase II) phase: Either irinotecan and cetuximab or FOLFIRI and cetuximab in 28 day cycles. Irinotecan and cetuximab: * irinotecan 180 mg/m² (90-minute intravenous infusion or to study site standards) every 2 weeks and * cetuximab 400 mg/m² initial dose (120-minute intravenous infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly OR FOLFIRI and cetuximab: * irinotecan 180 mg/m² (90-minute intravenous infusion or to study site standards) every 2 weeks * Folinic acid 400 mg/m² (120-minute infusion or to study site standards) or maximal dose tolerated in a prior regimen every 2 weeks * 5-FU 400 mg/m² initial dose bolus (not to exceed 15 minutes), then 1200 mg/m²/day × 2 days (total 2400 mg/m² over 46 to 48 hours) continuous infusion or maximal dose tolerated in a prior regimen every 2 weeks and * cetuximab 400 mg/m² initial dose (120-minute intravenous infusion), then 250 mg/m² (60-minute infusion) thereafter once weekly |
| Name | Type | Description |
|---|---|---|
| encorafenib | DRUG | 300 mg administered orally once daily (QD) |
| Binimetinib | DRUG | Binimetinib 45 mg administered orally twice daily (BID) |
| Cetuximab | DRUG | Standard of care for the 28 first weeks(\*) and then every 2 weeks (\*\*) : (\*) 400 mg/m2 administered as a 120-min infusion on Cycle 1 Day 1, followed by 250 mg/m2 administered as a 60-min infusion once weekly (QW) for the first 28 weeks. (\*\*) 500 mg/m2 administered as a 120-min infusion twice weekly (Q2W) from Week 29 (Cycle 8 Day 1) onward. Following implementation of an Urgent Safety Measure on 26 Mar 2020 due to the outbreak of COVID-19 pandemic, cetuximab infusions could be administered Q2W regardless of the cycle number, after investigator's evaluation of the benefit/risk ratio for the subject, with regards to COVID-19 pandemic. |
| FOLFIRI | DRUG | Combination of: irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion |
Inclusion Criteria: * Male or female ≥ 18 years of age * Histologically or cytologically confirmed CRC that is metastatic * Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening * Evidence of measurable disease as per RECIST, v1.1 * Subject able to receive ...
Encorafenib is an investigational small molecule being studied for the treatment of BRAF V600E-mutant metastatic colorectal cancer and BRAF V600E colorectal cancer. It is being evaluated in combination with other agents such as cetuximab and binimetinib in clinical trials.
Encorafenib targets kinases, as it belongs to the -nib class of kinase inhibitors. It is specifically being studied in patients with BRAF V600E mutations, indicating its role in targeting the BRAF V600E-mutant pathway in colorectal cancer.
Encorafenib is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with BRAF V600E-mutant colorectal cancer.
Encorafenib is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Multiple Phase 2 trials are ongoing or completed to assess its effectiveness in treating BRAF V600E-mutant colorectal cancer.
Encorafenib is being studied in several Phase 2 trials, including NCT03693170, NCT05004350, and NCT05706779. These trials evaluate combinations with cetuximab and binimetinib in patients with BRAF V600E-mutant colorectal cancer, with some trials completed and one currently recruiting.
Yes, Encorafenib is also known as Encorafenib Oral Capsule, Encorafenib Oral Capsule + Cetuximab, and Encorafenib + Cetuximab. These names refer to the same drug, often described in the context of its combination therapy with cetuximab for treating colorectal cancer.