Immutep Expands Patient Population For LAG-3 Candidate After FDA Meeting

Following a meeting with the U.S. FDA, Sydney, Australia-based biotech Immutep will update its trial design for its Lymphocyte Activating Gene-3 (LAG-3) candidate, eftilagimod alpha (efti). The changes include expanding the patient population to triple-negative breast cancer (TNBC) patients, after positive results from the AIPAC Phase 2b trial in metastatic breast cancer patients were observed. 

Late-stage clinical development efforts on efti remain focused on frontline non-small cell lung cancer (NSCLC) in combination with anti-PD-1 therapy, said the company. 

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Assessed For Multiple Solid Tumors

Efti is a soluble LAG-3 protein and potentially first-in-class antigen presenting cell (APC) activator for the treatment of cancer. LAG-3 stimulates innate and adaptive immunity, binding to APCs via MHC II molecules leading to the expansion of cytotoxic T-cells and helper T-cells as well as dendritic cells, NK cells, and monocytes. LAG-3 also upregulates the expression of CXCL10, a molecule that boosts the immune response against cancer. 

The candidate is being assessed for solid tumors, including NSCLC, head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. In the latter, efti has shown statistically significant improvements in overall survival in several subgroups. And due to its favorable safety profile, it can be combined with anti-PD-1 immunotherapy or chemotherapy. Efti has received FDA Fast Track Designation in first-line HNSCC and NSCLC. 

In AIPAC, efti is combined with standard-of-care chemotherapy to treat metastatic breast cancer. Initially, efti and chemotherapy were administered on different days, while chemotherapy treatment was stopped at six months. Under the new plan, efti will be administered with paclitaxel on the same day while treatment will continue until disease progression. Besides the original 30 mg dosing for efti, Immutep is adding a 90 mg dosage cohort in combination with paclitaxel thanks to a favorable safety profile for the LAG-3 candidate. 

Immutep and the FDA have agreed on a Phase 2/3 trial design that would prove pivotal for a Biologics License Application for efti. The Phase 2 portion of the metastatic breast cancer trial is slated for the first quarter of 2023. 

Meanwhile, Immutep is expecting the initiation of the registrational trial in first-line NSCLC. According to the company, both the lung cancer trial and the Phase 2 portion of the metastatic breast cancer trial do not affect the company’s expected cash runway of $80 million (as of June 2022) to the end of the first half of 2024. 

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Joy Lin

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