Positive Phase 2 clinical results for LAG-3 therapy

On March 31, Immutep announced that its LAG-3 fusion protein eftilagimod alpha (Efti, also known as IMP321), in combination with MSD's heavyweight PD-1 inhibitor Keytruda, has yielded positive interim data in a Phase 2 clinical trial for the second-line treatment of patients with metastatic non-small cell lung cancer. In refractory patients with disease progression after previous treatment with a prior PD-1 or PD-L1 inhibitor, the combination therapy achieved a 36.1% disease control rate and a progression-free survival rate of 26% at 6 months.

LAG-3 protein regulates the signaling pathways of T lymphocytes and antigen presenting cells (APCs) and is important in the adaptive immune response. Soluble LAG-3 activates APCs by binding to major histocompatibility complex II (MHC II) on their surface, resulting in an increase in the number and activation of cytotoxic CD8-positive T cells. Soluble LAG-3 protein can boost the immune response to cancer antigens via this mechanism.

Eftilagimod alpha is a soluble LAG-3 fusion protein. It was combined with the PD-1 inhibitor Keytruda in a phase 2 clinical trial called TACTI-002 to treat patients with different types of NSCLC, as well as patients with squamous cell carcinoma of the head and neck.

36 patients with advanced disease were treated in this section of the clinical trial. After receiving anti-PD-1/PD-L1 therapy, 28% of these patients had disease progression, and 72% had disease progression after getting a combination of chemotherapy and anti-PD-1/PD-L1 therapy. The majority of patients (69%) had a tumor PD-L1 TPS score of less than 50%, indicating that they had a poor response to anti-PD-1/PD-L1 therapy.

Trial results showed that:

l 73.7% of evaluable patients showed a reduction in tumor size or a decrease in tumor growth rate

l 73% of patients were still alive after 6 months of treatment

l Disease control rate of 36.1% and progression-free survival rate of 26% at 6 months

l The objective remission rate was 5.6%, with two patients achieving confirmed and durable partial remission, at 9 months and 23+ months respectively in this study

l Median overall survival has not yet reached

Dr. Frederic Triebel, Immutep's Chief Scientific Officer and Chief Medical Officer, said, "Efti, in combination with pembrolizumab, demonstrated an overall survival rate of 73% at 6 months, as well as promising disease control and tumor growth kinetics. These findings are encouraging, and these early signs support the possibility that Efti may enhance patients' immune systems and allow pembrolizumab to work more effectively in patients with advanced lung cancer while maintaining a favorable safety profile and tolerability."

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