Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as eftilagimod alfa, eftilagimod alpha, Eftilagimod Alfa (Efti), Eftilagimod Alfa
eftilagimod alfa (efti / IMP321) · 4 trials · 7 indications
The number of pathological complete responses determined in surgical pathology report. The primary endpoint is pCR to NAC + efti. Simon's 2-stage design will be used. The null hypothesis that the true pCR rate is 0.08 (8%) will be tested against a one-sided alternative. In the first stage, 30 patients will be accrued. If there are 2 or fewer responses in these 30 patients, the study will be stopped. Otherwise, 20 additional patients will be accrued for a total of 50. The null hypothesis will be rejected if 8 or more responses are observed in 50 patients. This design yields a type I error rate of 0.0426 and power of 0.80 when the true pCR rate is 0.20 (20%).
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
ORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per immune Response Evaluation Criteria In Solid Tumors (iRECIST) for target lesions and assessed by CT or MRI. iCR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.
| Arm | Type | Description |
|---|---|---|
| efti + Standard of Care arm | EXPERIMENTAL | Combination of efti, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy |
| Placebo + Standard of Care arm | PLACEBO_COMPARATOR | Combination of efti-matching placebo, pembrolizumab (KEYTRUDA®) and histology-based platinum doublet chemotherapy |
| Efti + NAC Regimens | EXPERIMENTAL | Eftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC. NAC regimens: * Docetaxel-cyclophosphamide (TC) intravenous (i.v) every 3 weeks (q3w) x 4, or * Dose dense Adriamycin-cyclophosphamide (AC) i.v q2w x 4 followed by weekly paclitaxel IV X12 weeks (alternatively weekly nab-paclitaxel can be used per physician's preference if patient unable to tolerate paclitaxel due to infusion reaction). The NAC regimen will be determined by the treating physician prior to starting on this trial. |
| (CPS ≥1): pembrolizumab (KEYTRUDA®) + efti | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles (1 cycle = 6 weeks). pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks). |
| (CPS ≥1): pembrolizumab (KEYTRUDA®) | ACTIVE_COMPARATOR | pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks). |
| (CPS <1): pembrolizumab (KEYTRUDA®) + efti | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 4 cycles;thereafter every 3 weeks for up to 18 cycles (1 cycle = 6 weeks). pembrolizumab (KEYTRUDA®): 400 mg every 6 weeks for up to 18 cycles (1 cycle = 6 weeks). |
| 1st line NSCLC | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). pembrolizumab (KEYTRUDA®): 200 mg every 3 weeks. |
| 2nd line NSCLC | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). pembrolizumab (KEYTRUDA®): 200 mg every 3 weeks. |
| HNSCC | EXPERIMENTAL | eftilagimod alpha: 30 mg every 2 weeks for the first 8 cycles (1 cycle = 3 weeks) and every 3 weeks thereafter (starting cycle 9). pembrolizumab (KEYTRUDA®): 200 mg every 3 weeks. |
| Name | Type | Description |
|---|---|---|
| eftilagimod alfa | BIOLOGICAL | 30 mg of efti every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total |
| carboplatin plus paclitaxel | DRUG | For participants with squamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: carboplatin area under the curve (AUC) 5 or 6 in combination with paclitaxel 175 mg/m2 or 200 mg/m2 |
| cisplatin or carboplatin + pemetrexed | DRUG | For participants with nonsquamous histology for 4 cycles (1 cycle = 3 weeks) as follows: every 3 weeks: cisplatin 75 mg/m2 or carboplatin AUC 5 or 6 in combination with pemetrexed 500 mg/m2. After the initial 4 cycles, pemetrexed 500 mg/m2 maintenance therapy will be administered every 3 weeks |
| pembrolizumab (KEYTRUDA®) | BIOLOGICAL | 200 mg pembrolizumab (KEYTRUDA®) every 3 weeks i.v. for up to approximately 24 months |
| Placebo | OTHER | efti-matching placebo every 2 weeks subcutaneously for the first 6 months, thereafter every 3 weeks for up to 24 months in total |
| Eftilagimod Alfa (Efti) | DRUG | Eftilagimod Alfa (Efti) will be administered subcutaneously at a dose of 30 mg beginning of week 1 of the trial for a total of 3 doses (week 1, 2 and 3). After 3 weeks, efti will be administered starting with week 4, every 2 weeks and combined with either TC or AC |
| Docetaxel-cyclophosphamide (TC) intravenous (i.v) | DRUG | TC will be administered at docetaxel 75mg/m2 IV and cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 4 administrations starting on week 4 of the trial (weeks 4, 7,10, and 13). Docetaxel is administered over 60min (dilute in 250 mL NS or D5W to a final concentration of 0.3 to 0.74 mg/mL and administer over 60 minutes). Cyclophosphamide is administered over 30-60min (dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes after docetaxel). G-CSF support for TC is per institutional SOC guidelines. Efti is to be given always ≥ 30 minutes after TC is finished if both regimens are administered the same day. |
| Dose dense Adriamycin-cyclophosphamide (AC) i.v | DRUG | AC will be administered at doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 IV every 2 weeks for a total of 4 administrations starting week 4 of the trial (weeks 4, 6, 8 and 10): Doxorubicin is administered over 5 min (Dilute with NS to a final concentration of 2 mg/mL and administered as an IV bolus over three to five minutes into a free flowing IV infusion of NS or D5W). Cyclophosphamide is administered over 30-60min (Dilute in 250 to 500 mL NS or D5W and administer over 30 to 60 minutes). G-CSF support is per SOC/institutional guidelines. Paclitaxel is given weekly for a period of 12 weeks (weeks 12 to 23) at 80mg/m2 (Dilute with 250 to 500 mL NS or D5W (final concentration of 0.3 to 1.2 mg/mL) and administered per institutional guidelines). Alternatively nab-paclitaxel weekly can be used (if paclitaxel cannot be used due to allergic reaction). Efti is to be given always ≥ 30 minutes after AC or paclitaxel is finished if both regimens are administered the same day. |
| eftilagimod alpha | DRUG | APC activator, MHC II agonist, LAG-3 fusion protein |
Inclusion Criteria Participants may be enrolled if they meet all of the following criteria at screening: 1. Willing to give written informed consent and to comply with the protocol. 2. Histologically- or cytologically-confirmed diagnosis of advanced or metastatic (stage IIIB/C or stage IV) non-sma...
Eftilagimod alfa is an investigational immunotherapy being studied in advanced or metastatic non-small cell lung cancer, breast cancer, and head and neck squamous cell carcinoma. It is given in combination with pembrolizumab, with or without chemotherapy, in these solid tumor settings. It is not approved for any indication and remains in clinical development.
Eftilagimod alfa targets LAG3, also known as lymphocyte activation gene 3. It is a soluble LAG-3 fusion protein designed to bind MHC class II molecules and activate antigen presenting cells, which in turn stimulate T cell responses against tumors. It is classified as a monoclonal antibody modality in oncology.
Eftilagimod alfa is developed by Immutep Limited, which trades under the ticker IMMP. Immutep is the sponsor of the clinical program evaluating the agent across non-small cell lung cancer, breast cancer, and head and neck squamous cell carcinoma.
Eftilagimod alfa is in Phase 3 development. The Phase 3 trial is TACTI-004 in metastatic non-small cell lung cancer. The drug is investigational and has not been approved by the FDA. It has received FDA Fast Track and Orphan Drug designations.
Eftilagimod alfa has been studied in several trials. NCT06726265 (TACTI-004) is the Phase 3 study in metastatic NSCLC. NCT07102940 is a Phase 2 trial in HR positive, HER2 negative breast cancer. NCT04811027 and NCT03625323 are completed Phase 2 studies in HNSCC and NSCLC.
Yes. Eftilagimod alfa is also known as eftilagimod alpha, efti, and IMP321. These names refer to the same soluble LAG-3 fusion protein developed by Immutep Limited. The short form efti is commonly used in trial titles such as TACTI-004.