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Mapatumumab · 2 trials · 2 indications
Time to progression is defined as the time from randomization to radiologic disease progression based on blinded independent review (BICR) of imaging scans using modified Response Evaluation Criteria in Solid Tumors assessment (mRECIST) for hepatocellular carcinoma. The primary analysis was performed using Kaplan Meier methods. The median time to progression is reported with one-sided 90% confidence interval. Analysis was performed on the modified Intent to Treat (mITT) Population which comprised of all randomized participants who received at least part of 1 dose of study agent (mapatumumab/placebo and/or sorafenib) with participants analyzed according to the groups to which they were randomized. NA indicates upper limit was not measurable as one-sided confidence interval is presented.
| Arm | Type | Description |
|---|---|---|
| Sorafenib plus mapatumumab | EXPERIMENTAL | Mapatumumab 30 milligrams (mg)/kilogram (kg) intravenously on Day 1 of each cycle (i.e. every 21 days) plus sorafenib 400 mg orally twice daily continuously in each cycle until radiologic disease progression or unacceptable toxicity |
| Sorafenib plus Placebo | PLACEBO_COMPARATOR | Placebo intravenously on Day 1 of each cycle (i.e. every 21 days) plus sorafenib 400 mg orally twice daily continuously in each cycle until radiologic disease progression or unacceptable toxicity |
| A | EXPERIMENTAL | mapatumumab and sorafenib |
| Name | Type | Description |
|---|---|---|
| Mapatumumab | DRUG | Mapatumumab will be supplied as a lyophilized formulation in 10 mL vials containing 100 mg mapatumumab for intravenous infusion at the dose of 30 mg/kg. |
| Placebo | DRUG | Normal saline solution for intravenous infusion will be administered as placebo for mapatumumab |
| Sorafenib | DRUG | Sorafenib will be supplied as tablets, each containing 274 mg sorafenib tosylate, equivalent to 200 mg of sorafenib, to be administered 400 mg (2 x 200 mg tablets) orally twice daily. |
Inclusion Criteria: * Child-Pugh Class A. * Barcelona Clinic Liver Cancer (BCLC) advanced stage (C) hepatocellular carcinoma, or BCLC intermediate stage (B) hepatocellular carcinoma if treatment with transarterial chemoembolization is not considered appropriate * Measurable disease demonstrating in...
Mapatumumab is an investigational drug being studied for the treatment of advanced hepatocellular carcinoma, a type of liver cancer. It is being evaluated in combination with sorafenib in clinical trials. The drug is still in clinical development and has not been approved for this use.
Mapatumumab is being developed by GSK plc, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced hepatocellular carcinoma.
Mapatumumab is in Phase 1 clinical development. Two Phase 1 trials have been completed, both studying the drug in combination with sorafenib in patients with advanced hepatocellular carcinoma. The drug is investigational and has not yet received regulatory approval.
Mapatumumab has been studied in two completed Phase 1 clinical trials. The first trial, NCT00712855, enrolled 23 participants in the United States. The second trial, NCT01258608, enrolled 101 participants across multiple countries including the United States, Germany, Poland, Puerto Rico, Romania, Russia, and Ukraine. Both trials evaluated Mapatumumab in combination with sorafenib for advanced hepatocellular carcinoma.
Mapatumumab is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for advanced hepatocellular carcinoma. The completed trials have not led to regulatory approval, and the drug remains under investigation for safety and efficacy.