Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Emibetuzumab · 2 trials · 7 indications
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, CR was defined as the disappearance of all target and non-target lesions; PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD. Percentage of participants was calculated as: (total number of participants with CR or PR from start of the treatment until disease progression or recurrence)/total number of participants treated) \* 100.
DLT is defined as an adverse event during Cycle1 that is possibly, probably, or definitely related to treatment with Emibetuzumab in combination with fixed regimen of Ramucirumab \& fulfills any 1 of the following criterion using NCI CTCAE Version 4.03: Grade 3 non-hematological toxicity. Exceptions will be made for:Nausea, vomiting, diarrhea, constipation, or skin rash that persists for ≤3 days following appropriate supportive care intervention. Grade 3 hypertension in which systolic BP ≥160 mmHg and/or diastolic BP ≥100 mmHg persist \<7 days after intensified antihypertensive therapy is initiated. Grade 4 hematological toxicity of ≥7 days duration. ≥Grade 3 thrombocytopenia with ≥Grade 2 bleeding. Any febrile neutropenia. Any other significant toxicity deemed by the primary investigator \& Lilly clinical research personnel to be dose-limiting (eg, any toxicity that is possibly related to the study medication that requires the withdrawal of participant from study Cycle1).
ORR is the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR is defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
| Arm | Type | Description |
|---|---|---|
| Arm A: Emibetuzumab plus Erlotinib | EXPERIMENTAL | 750 milligram (mg) Emibetuzumab flat dose given as a 1.5 hour intravenous (IV) infusion on Days 1 and 15 of a 28-day cycle and Erlotinib 150 mg given orally once daily on a 28-day cycle. |
| Arm B: Emibetuzumab | EXPERIMENTAL | 750 mg Emibetuzumab flat dose given as a 1.5-hour IV infusion on Days 1 and 15 of a 28-day cycle. |
| Emibetuzumab + Ramucirumab (Part A) | EXPERIMENTAL | Part A: Dose escalation (750mg, 2000mg) of Emibetuzumab administered intravenously (IV), on days 1 and 15 every 28 day cycle in combination with a fixed dose of 8mg/kg ramucirumab administered IV on Days 1 and 15 every 28 day cycle. |
| Emibetuzumab + Ramucirumab (Part B) | EXPERIMENTAL | Part B: Recommended 750mg Emibetuzumab dose from Part A to be administered IV, on days 1 and 15 every 28 day cycle in combination with a fixed dose of 8mg/kg ramucirumab administered IV on Days 1 and 15 every 28 day cycle. |
| Name | Type | Description |
|---|---|---|
| Emibetuzumab | DRUG | Administered IV |
| Erlotinib | DRUG | Administered Orally |
| Ramucirumab | DRUG | Administered Intravenously (IV) |
Inclusion Criteria: * Diagnosis of metastatic Stage IV NSCLC * At least 1 measurable extra-central nervous system (CNS) lesion * Documented radiographic progression while on continuous treatment with erlotinib monotherapy * Objective clinical benefit from erlotinib treatment as defined by either do...
Emibetuzumab is an investigational oncology drug being studied for the treatment of non-small-cell lung cancer and advanced cancer. It has been evaluated in clinical trials for conditions including carcinoma, non-small-cell lung, advanced cancer, gastric adenocarcinoma, gastroesophageal junction adenocarcinoma, hepatocellular cancer, and renal cell carcinoma.
Emibetuzumab is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY.
Emibetuzumab is an investigational drug that has completed clinical trials. One trial was a Phase 2 study in non-small-cell lung cancer, and another was a Phase 1 study in advanced cancer. Both trials are completed, and the drug is not approved and remains in clinical development.
Emibetuzumab has been studied in two completed clinical trials. NCT01900652 was a Phase 2 study in non-small-cell lung cancer with 111 participants. NCT02082210 was a Phase 1 study combining emibetuzumab with ramucirumab in advanced cancer with 97 participants.
Emibetuzumab is not FDA approved. It is an investigational drug that has completed clinical trials, including a Phase 2 study in non-small-cell lung cancer and a Phase 1 study in advanced cancer, but it remains in clinical development and has not been approved for any use.