Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
eftilagimod alpha · 2 trials · 2 indications
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 |
|---|---|---|
| (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 alpha | DRUG | APC activator, MHC II agonist, LAG-3 fusion protein |
| pembrolizumab (KEYTRUDA®) | DRUG | anti-PD-1 antibody |
Main Inclusion Criteria: 1. Histologically- or cytologically-confirmed recurrent disease not amenable to curative treatment with local or systemic therapy, or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx that is considered incurable by local therapies and t...
Eftilagimod alpha is an investigational drug being studied for use in oncology, specifically in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC). It is being evaluated in combination with pembrolizumab for patients with these cancers.
Eftilagimod alpha is a soluble LAG-3 fusion protein, meaning it targets the LAG-3 pathway. It is designed to modulate immune responses by engaging LAG-3, which plays a role in regulating T-cell activity.
Eftilagimod alpha is being developed by Immutep Limited, a biopharmaceutical company. The company's stock is listed under the ticker symbol IMMP.
Eftilagimod alpha is in Phase 2 clinical development. It has received Fast Track designation from the FDA, but it is not yet approved and remains investigational.
Eftilagimod alpha has been studied in two completed Phase 2 trials. NCT03625323 enrolled 187 patients with NSCLC or HNSCC in the United States. NCT04811027 enrolled 171 patients with HNSCC across multiple countries including the US, Australia, and several European nations.
Yes, eftilagimod alpha is also known as IMP321. The clinical trial NCT03625323 refers to it as a soluble LAG-3 fusion protein IMP321, confirming that both names refer to the same drug.