Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Eftilagimod Alfa (Efti)
eftilagimod alfa · 2 trials · 5 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%).
| 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. |
| 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. |
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, also known as Efti, is an investigational drug being studied for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) and hormone receptor positive, HER2-negative breast cancer. It is currently in Phase 2 clinical development for these indications.
Eftilagimod Alfa is a small molecule being developed by Immutep Limited. It is being studied in combination with pembrolizumab and chemotherapy for metastatic NSCLC, and in patients with HR-positive, HER2-negative breast cancer. The specific molecular target has not been disclosed.
Eftilagimod Alfa is being developed by Immutep Limited, a biopharmaceutical company traded under the ticker IMMP. The drug is currently in Phase 2 clinical trials for advanced or metastatic non-small cell lung cancer and breast cancer.
Eftilagimod Alfa is in Phase 2 clinical development. It has received Fast Track and Orphan Drug designations from the FDA. The drug is investigational and has not been approved for any use.
Eftilagimod Alfa is being studied in two clinical trials. NCT06726265 is a Phase 3 trial in metastatic NSCLC with 756 participants, and NCT07102940 is a Phase 2 trial in HR-positive, HER2-negative breast cancer with 50 participants. Both trials are active or planned.
Yes, Eftilagimod Alfa is also known as Efti. The drug is being developed by Immutep Limited under the brand name Efti, and it is currently in clinical trials for non-small cell lung cancer and breast cancer.