Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Necitumumab · 10 trials · 10 indications
Overall survival is defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. OS was estimated by the Kaplan-Meier method.
ORR was the percentage of participants achieving a best overall response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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 nontarget lesions, and no appearance of new lesions. Progressive disease (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 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, 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; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.
The denominator of ORR (Objective Response Rate) includes each participant enrolled who received any amount of study drug (necitumumab, gemcitabine, and/or cisplatin), and who had a complete radiographic assessment at baseline and at least one complete radiographic assessment post-baseline. The numerator includes those participants counted in the denominator with a confirmed best overall tumor response of partial or complete response (Complete Response (CR): disappearance of all non-nodal target lesions, with the short axes of any target lymph nodes reduced to \<10 millimeters (mm). Partial Response (PR): at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph nodes), taking as reference the baseline sum diameter.) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
The corrected QT interval was calculated using Fridericia's correction (QTcF) from electrocardiogram (ECG) data. Each participant had triplicate QT intervals measured at each timepoint and the average was calculated for each participant at each timepoint. For each timepoint, a participant's corresponding baseline (Day -1, pretreatment) QTcF interval was subtracted from the average QTcF intervals to create the change from time-matched baseline in the QTcF interval
A dose limiting toxicity (DLT) was defined as an adverse event (AE) during the first 21 days that was possibly related to the study drug and fulfilled any of the following criteria using the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0: Grade 3 or 4 nonhematologic toxicity, Grade 4 nausea, vomiting, or diarrhea that persists more than 3 days despite maximal supportive intervention, Grade 3 thrombocytopenia with bleeding requiring transfusion, Grade 4 thrombocytopenia with or without bleeding, Grade 4 neutropenia that persists more than 5 days, Grade 3 or 4 neutropenia with fever, Grade ≥3 skin toxicity despite best supportive care with some exceptions, if a total at least 75% of the planned dose for both agents cannot be administered in the first cycle due to toxicity, prolonged delay (\>2 weeks) in initiating cycle 2 due to treatment-related toxicity and Grade 5 toxicity.
ORR was 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 defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR 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. Progressive disease (PD) is defined as 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 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
A DLT was defined as one of the following adverse events (AEs), occurring in Cycle 1 if considered to be definitely, probably, or possibly related to necitumumab and abemaciclib: Grade 3 or 4 nonhematologic toxicity according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (NCI-CTCAE v4.0), except for nausea, vomiting, diarrhea, or electrolyte disturbance. Grade 3 or 4 nausea, vomiting, or diarrhea that persists more than 2 days despite maximal supportive intervention. Grade 3 thrombocytopenia with bleeding requiring transfusion. Grade 4 thrombocytopenia with or without bleeding. Grade 4 neutropenia that persists more than 5 days.
PFS is defined as the time from baseline until first observation of progressive disease(PD) defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause.PD was at least 20% increase in sum of diameters of target lesions with reference being smallest sum on study and an absolute increase of at least 5 millimeter (mm) or unequivocal progression of non-target lesions,or 1 or more new lesions.If participant does not have complete baseline disease assessment,PFS time censored at date of randomization, regardless of whether or not objectively determined disease progression or death observed for participant.If participant was not known to have died or have objective progression as of data inclusion cutoff date for analysis, the PFS time censored at last adequate tumor assessment date.The use of new anticancer therapy prior to occurrence of PD resulted in censoring at the date of last radiographic assessment prior to initiation of new therapy.
DLT was defined as any of the following events graded according to the National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, when the event occurred within 21 days from Day 1 in Cycle 1 and was considered to be definitely or probably related to necitumumab and/or gemcitabine-cisplatin chemotherapy: Grade 4 neutropenia ≥ 7 days, Grade ≥ 3 febrile neutropenia except for transient febrile neutropenia (Grade 3 neutropenia with fever ≥ 38.5 degrees Celsius (°C) for ≤ 24 hours), Grade 3 thrombocytopenia requiring platelet substitution, Grade 4 thrombocytopenia, ≥Grade 3 nonhematologic toxicity (excluding nausea, vomiting, arthralgia, myalgia, asthenia, fatigue, diarrhea, constipation, anorexia), any toxicity leading to the omission of necitumumab on Day 8 or 15 (for participants for whom necitumumab was delayed from Days 8 to 15) during the Cycle 1.
OS defined as the time from the date of randomization to the date of death due to any cause. Participants who are alive at the time of study completion or are lost to follow-up will be censored at the time they were last known to be alive.
| Arm | Type | Description |
|---|---|---|
| Necitumumab + Gemcitabine + Cisplatin | EXPERIMENTAL | Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle. Continues until progressive disease, toxicity, noncompliance, or withdrawal. Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles. |
| Gemcitabine + Cisplatin | ACTIVE_COMPARATOR | Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle. Continues for a maximum of six cycles. Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle. Continues for a maximum of six cycles. |
| Necitumumab + Pemetrexed + Cisplatin | EXPERIMENTAL | Necitumumab + Pemetrexed + Cisplatin |
| Pemetrexed + Cisplatin | ACTIVE_COMPARATOR | Pemetrexed + Cisplatin |
| Necitumumab + Nab-Paclitaxel + Carboplatin | EXPERIMENTAL | Induction: Necitumumab administered intravenously (IV) at 800 milligram (mg) on day 1 and 8 of each cycle (3 week cycles); nab-paclitaxel administered IV at 100 milligram per square meter (mg/m²) on day 1, 8 and 15 of each cycle; carboplatin administered IV at a concentration of AUC (area under curve) 6 milligram per milliliter over time (mg\*min/mL) on day 1 of each cycle, for a maximum of 4 cycles. Maintenance: Necitumumab administered IV at 800 mg on day 1 and 8 of each cycle; nab-paclitaxel administered IV at 100mg/m² on day 1 and 8 of each cycle (3 week cycles). Participants may continue to receive treatment until discontinuation criteria are met. |
| Gemcitabine + Cisplatin + Necitumumab | EXPERIMENTAL | Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle. Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles. Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles. |
| Necitumumab +Paclitaxel+Carboplatin | EXPERIMENTAL | Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent. |
| Paclitaxel + Carboplatin | ACTIVE_COMPARATOR | Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD. |
| Necitumumab, Gemcitabine and Cisplatin | EXPERIMENTAL | The study will be conducted in two sequential periods: a 3-week PK run-in participants will be treated sequentially with single doses of cisplatin, gemcitabine, and necitumumab. Cycle 1 will begin immediately following the PK run-in period. |
| Necitumumab | EXPERIMENTAL | 800 mg necitumumab, administered once per week as an intravenous infusion (IV) |
| Necitumumab + Pembrolizumab | EXPERIMENTAL | Part A Cohort 1: 600 mg Necitumumab + 200 mg Pembrolizumab: Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 600 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in participants with Stage IV NSCLC (all histologies). Part A Cohort 2, Part B and Part C: 800mg Necitumumab + 200mg Pembrolizumab: Participants received 200 mg pembrolizumab absolute dose by intravenous (IV) infusion on Day 1 of 21 days cycles followed by 800 mg necitumumab absolute dose by IV infusion on Days 1 and 8 of 21 days cycles in Part A cohort 2 participants with any histology, Part B and C participants with Stage IV NSCLC of squamous and nonsquamous histology. Part C were Japan participants. Part C were Japan participants. |
| Necitumumab + Abemaciclib | EXPERIMENTAL | Cohort 1 Part A: Necitumumab 800 mg administered intravenously (IV) on Days 1 and 8, followed by abemaciclib 100 mg given orally every 12 hours on Days 1 to 21. (21 day cycles.) Treatment may continue until discontinuation criterion is met. Cohort 2 Part A: Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. Treatment may continue until discontinuation criterion is met. Cohort 3 Part A: Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 200 mg given orally every 12 hours on Days 1 to 21. Treatment may continue until discontinuation criterion is met. Part B (expansion cohort): Necitumumab 800 mg administered IV on Days 1 and 8, followed by abemaciclib 150 mg given orally every 12 hours on Days 1 to 21. Treatment may continue until discontinuation criterion is met. |
| Necitumumab + Gem and Cis | EXPERIMENTAL | Phase 1b Dose Escalation: Necitumumab 800 milligram (mg) on Days 1 and 8 of every 21 day cycle, administered as an intravenous (IV) infusion. Gemcitabine (Gem) dose escalation of 1000 or 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin (Cis) 75 mg/m\^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Phase 2 Randomized: Necitumumab 800 mg on Days 1 and 8 of every 21 day cycle, administered as an IV infusion. Gemcitabine at fixed dose determined in Phase 1b (1000 or 1250 mg/m\^2) on Days 1 and 8 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. Cisplatin 75 mg/m\^2 on Day 1 of every 21 day cycle, administered as an IV infusion for a maximum of 4 cycles. |
| Name | Type | Description |
|---|---|---|
| Necitumumab | BIOLOGICAL | Administered intravenously. Continues until progressive disease, toxicity, noncompliance, or withdrawal. |
| Gemcitabine | DRUG | Administered intravenously. Continues for a maximum of six cycles. |
| Cisplatin | DRUG | Administered intravenously. Continues for a maximum of six cycles. |
| Pemetrexed | DRUG | 500 milligram per square meter (mg/m2) administered Intravenously (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles |
| Nab-Paclitaxel | DRUG | Administered IV |
| Carboplatin | DRUG | Administered IV |
| Paclitaxel | DRUG | Administered IV |
| Pembrolizumab | DRUG | Administered IV |
| Abemaciclib | DRUG | Administered orally. |
Inclusion Criteria: * Has histologically or cytologically confirmed squamous NSCLC * Has Stage IV disease at the time of study entry * Measurable or nonmeasurable disease at the time of study entry as defined by the Response Evaluation Criteria in Solid Tumors (RECIST 1.0) (participants with only t...
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Necitumumab is an investigational oncology drug being studied for the treatment of carcinoma, non-small cell lung cancer (NSCLC), solid tumors, and squamous non-small cell lung cancer. It is being developed by Eli Lilly and Company for these cancer indications.
Necitumumab is a small molecule drug being developed by Eli Lilly and Company for oncology indications. The specific molecular target of Necitumumab has not been disclosed in the available information.
Necitumumab is being developed by Eli Lilly and Company, a pharmaceutical company traded on the stock exchange under the ticker symbol LLY. The drug is currently in Phase 2 clinical development for various oncology indications.
Necitumumab is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All four clinical trials listed for Necitumumab are Phase 2 studies that have been completed.
Necitumumab has been studied in four completed Phase 2 clinical trials. These include NCT01606748, a drug-interaction study with gemcitabine-cisplatin in malignant solid tumors; NCT01624467, a monotherapy QT/QTc study in advanced solid tumors; NCT01769391, a study with chemotherapy in squamous non-small cell lung cancer; and NCT01788566, a study of gemcitabine-cisplatin plus necitumumab in squamous lung cancer.
Yes, Necitumumab is also known as IMC-11F8. The clinical trial NCT01606748, a drug-interaction study of necitumumab in combination with gemcitabine-cisplatin, explicitly refers to Necitumumab as IMC-11F8 in its title.