Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IMC-1121B · 7 trials · 6 indications
PFS was the time from randomization to the first objective progression as defined by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v 1.1) or death from any cause, whichever occurred first. Progressive disease (PD) was defined as ≥20% increase in sum of diameter (SOD) of target lesions and short axes of target lymph nodes, taking as reference the smallest sum of the longest diameters recorded since treatment started and an absolute increase in sum diameter of ≥5 millimeters (mm); appearance of ≥1 new lesions and/or unequivocal progression of existing non-target lesions. Participants alive and without disease progression were censored at the time of the last objective tumor assessment. Participants who did not progress and were lost to follow-up were censored at their last radiographic assessment. If no baseline or post baseline radiologic assessments were available, participants were censored at date of randomization.
All electrocardiogram (ECG) tests were performed in triplicate prior to ramucirumab treatment. QT is the interval between the Q and T waves and QTc is the QT corrected for heart rate using Fridericia's formula: QTc = QT/RR\^0.33 where RR is the interval between 2 R waves. Each participant's mean QT/QTc value was calculated for each ECG test during Cycle 3 and compared to his/her mean pretreatment QT/QTc value. The greatest change from baseline during Cycle 3 was reported. QTc prolongation is defined as a QTc exceeding 10 milliseconds (msec) with a lower 90% confidence interval (CI) exceeding 5 msec at any postdose time points per the International Conference on Harmonization (ICH) E14 guidelines for non-thorough QT studies (ICH 2005; ICH 2008). Least squares (LS) mean was calculated using a linear mixed model for repeated measures (MMRM) and adjusted for serum concentration.
PFS was defined as the time from the first day of therapy to the first evidence of disease progression as defined by Response Evaluation Criteria in Solid Tumors (RECIST v1.0) or death from any cause. Progressive disease (PD) was defined as at least a 20% increase in the sum of the longest diameter (LD) of the target lesions, taking as reference the smallest sum LD recorded since the treatment started in comparison with the measurement of the nadir or the appearance of 1 or more new lesions. In addition, unequivocal progression of existing non-target lesions was considered PD. New or existing pleural effusion/ascites required cytological confirmation for PD according to the protocol. Participants who did not progress and who were alive or did not have documented progression or missed ≥2 visits, or had no post baseline assessment were censored at the day of their last tumor assessment.
Data presented are the number of participants who experienced adverse events (AE) of any grade, AE of Grade ≥3 based on National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3.0 (NCI-CTCAE v 3.0), serious adverse events (SAE) and AE resulting in death that was considered to be related to IMC-1121B (ramucirumab). A summary of SAEs and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Event module.
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.
AUC for Cycle 1 is AUC from time zero to infinity \[AUC(0-∞)\] and for Cycle 2 is AUC over a dosing interval (AUCτ).
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Cmax could not be calculated.
AUC for Cycle 1 is AUC from time zero to infinity \[AUC(0-∞)\] and for Cycle 2 is AUC over a dosing interval (AUCτ).
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, AUC could not be calculated.
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, t1/2 could not be calculated.
Due to the sparse pharmacokinetic sampling employed in Cycles 3 to 5, Vss could not be calculated.
| Arm | Type | Description |
|---|---|---|
| IMC-1121B + Pemetrexed + Carboplatin (AUC 6) or Cisplatin | EXPERIMENTAL | IMC-1121B + Pemetrexed + Carboplatin \[Area Under the Concentration Time Curve 6 (AUC 6)\] or Cisplatin |
| Pemetrexed + Carboplatin (AUC 6) or Cisplatin | ACTIVE_COMPARATOR | Pemetrexed + Carboplatin (AUC 6) or Cisplatin |
| IMC-1121B + Gemcitabine + Carboplatin (AUC 5) or Cisplatin | EXPERIMENTAL | IMC-1121B + Gemcitabine + Carboplatin \[Area Under the Concentration Time Curve 5 (AUC 5)\] or Cisplatin |
| Gemcitabine + Carboplatin (AUC 5) or Cisplatin | ACTIVE_COMPARATOR | Gemcitabine + Carboplatin (AUC 5) or Cisplatin |
| IMC-1121B | EXPERIMENTAL | Active-control participants (first 16 participants) will receive one dose of moxifloxacin orally 7 days before the first treatment with ramucirumab. All participants will undergo triplicate electrocardiogram (ECG) tests (consisting of three individual ECGs performed consecutively within a period of 4 minutes) and vital signs at various times over the trial period. For Cycle 1, all participants will also receive 2 infusions of diphenhydramine before ramucirumab therapy (the first infusion is 1 day before therapy and the second infusion is 15 minutes before therapy). For Cycles 2, 3, and 4, all participants will receive diphenhydramine 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, diphenhydramine infusions before ramucirumab therapy are at the investigator's discretion. Ramucirumab \[10 milligrams per kilogram (mg/kg)\] intravenously over 60 minutes, once every 3 weeks for minimum of 9 weeks without a break in between. |
| IMC-1121B (ramucirumab) + mFOLFOX-6 | EXPERIMENTAL | This regimen will be repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal. |
| IMC-1121B (ramucirumab) | EXPERIMENTAL | IMC-1121B (ramucirumab) |
| IMC-1121B (ramucirumab) + dacarbazine | ACTIVE_COMPARATOR | IMC-1121B (ramucirumab) + dacarbazine |
| Name | Type | Description |
|---|---|---|
| IMC-1121B (ramucirumab) | BIOLOGICAL | 10 milligrams/kilogram (mg/kg) once every 3 weeks beginning Day 1, Cycle 1 |
| Pemetrexed | DRUG | 500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle |
| Carboplatin (AUC 6) | DRUG | Day 1 of every 21-day cycle |
| Cisplatin | DRUG | 75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle |
| Gemcitabine | DRUG | 1000 mg/m² on Days 1 and 8 of every 21-day cycle |
| Carboplatin (AUC 5) | DRUG | Day 1 of every 21-day cycle |
| IMC-1121B | BIOLOGICAL | IMC-1121B (Ramucirumab) 10 mg/kg intravenously (IV) over 60 minutes, once every 3 weeks for minimum of 9 weeks. |
| Moxifloxacin | DRUG | Administered orally |
| Diphenhydramine | DRUG | Administered IV |
| Oxaliplatin | DRUG | 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1 |
| Folinic acid | DRUG | 400 mg/m² intravenous infusion over 2 hours on Day 1 |
| 5-FU | DRUG | 400 mg/m² intravenous bolus injection over 2-4 minutes, immediately following folinic acid infusion |
| Dacarbazine | DRUG | 1000 milligrams/square meter (mg/m2) intravenously every 3 weeks in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria. |
| 1121B | BIOLOGICAL | Cohort 2 8mg/kg I.V., once every other week for 4 weeks |
Inclusion Criteria: * Confirmed NSCLC * Stage IV disease at the time of study entry * Measurable disease at the time of study entry * Resolution to Grade ≤ 1 Adverse Events, of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy (except alopeci...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/ GEH200521- Part A |
| Zimmer Biomet Holdings, Inc. | ZBH | 1 | - | Undisclosed |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
IMC-1121B is an investigational monoclonal antibody being studied for the treatment of advanced solid tumors, metastatic malignant melanoma, colorectal carcinoma, and non-small-cell lung cancer. It is an oncology therapeutic developed by Eli Lilly and Company. The drug is currently in clinical development and has not been approved by the FDA.
IMC-1121B is a monoclonal antibody that targets a specific molecular pathway involved in tumor growth. It is being studied in oncology for its potential to treat various cancers, including advanced solid tumors and metastatic malignant melanoma. The drug is designed to interfere with cancer cell signaling to inhibit tumor progression.
IMC-1121B is developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker symbol LLY. The drug is an investigational monoclonal antibody in Phase 1 of clinical development for oncology indications, including advanced solid tumors and colorectal carcinoma.
IMC-1121B is in Phase 1 of clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is being studied for the treatment of advanced solid tumors and other cancers, with clinical trials conducted in the United States, Canada, Spain, and Japan.
IMC-1121B has been studied in several clinical trials, including NCT00533702 for metastatic malignant melanoma, NCT00793975 for advanced solid tumors, NCT00862784 for colorectal carcinoma, and NCT01005355 for advanced solid tumors. All trials are completed, with a total enrollment of 280 participants across the studies.
IMC-1121B is also known as ramucirumab. It is a monoclonal antibody being developed by Eli Lilly and Company for the treatment of various cancers, including advanced solid tumors and colorectal carcinoma. The drug is in Phase 1 of clinical development and remains investigational.