Immutep Reports Positive Phase 2 Clinical Results for LAG-3 Fusion Protein Eftilagimod Alpha in Combination with Keytruda for Second-Line Metastatic NSCLC

Today, Immutep announced that its LAG-3 fusion protein eftilagimod alpha (efti, also known as IMP321), in combination with MSD's重磅 PD-1 inhibitor Keytruda, has obtained positive interim data in a Phase 2 clinical trial for second-line treatment of patients with metastatic non-small cell lung cancer. In refractory patients who had previously progressed after receiving prior PD-1 or PD-L1 inhibitor treatments, the combination therapy achieved a disease control rate of 36.1%, with a progression-free survival rate of 26% at six months.

LAG-3 Protein Can Regulate the Signaling Pathways of T Lymphocytes and Antigen-Presenting Cells (APCs), Playing a Key Role in Adaptive Immune Responses. Soluble LAG-3 Activates APCs by Binding to Major Histocompatibility Complex II (MHC II) on the Surface of APCs, Leading to an Increase and Activation of Cytotoxic CD8-Positive T Cells. Through This Mechanism, Soluble LAG-3 Protein Enhances Immune Responses Against Cancer Antigens.

Image Source: Immutep Official Website

Eftilagimod Alpha is a soluble LAG-3 fusion protein. In the phase 2 clinical trial named TACTI-002, it was combined with the PD-1 inhibitor Keytruda to treat patients with different types of NSCLC and squamous cell carcinoma of the head and neck.

In this part of the clinical trial, 36 patients with advanced disease received treatment. Among these patients, 28% experienced disease progression after receiving anti-PD-1 (PD-L1) therapy, and 72% experienced disease progression after receiving a combination of chemotherapy and anti-PD-1 (PD-L1) therapy. The majority (69%) of the patients had a tumor PD-L1 TPS score of less than 50%, indicating that they typically respond poorly to anti-PD-1 (PD-L1) therapies.

Test results show:

73.7% of evaluable patients experienced tumor shrinkage or a reduction in tumor growth rate.

73% of patients were still alive 6 months after receiving treatment.

The disease control rate was 36.1%, and the progression-free survival rate at 6 months was 26%.

The objective response rate was 5.6%, with two patients achieving confirmed and durable partial responses, participating in the study for more than 9 months and 23 months, respectively.

Median overall survival has not been reached

Image source: Reference [1]

Immutep Chief Scientific Officer and Chief Medical Officer Dr. Frederic Triebel stated: "The combination of Efti and pembrolizumab demonstrated a 73% overall survival rate at six months, along with encouraging disease control and tumor growth kinetics. These findings are promising, and these early signs suggest that Efti may enhance the patient's immune system, allowing pembrolizumab to work more effectively in patients with advanced lung cancer, while maintaining good safety and tolerability."

References:

[1] Immutep’s efti in combination with MSD’s pembrolizumab shows encouraging antitumor activity in difficult to treat 2nd line metastatic lung cancer patients. Retrieved March 30, 2022, from https://www.immutep.com/files/content/investor/press-release/2022/Immutep's%20Efti%20with%20Keytruda%20Shows%20Encouraging%20Activity%20in%20Lung%20Cancer%20-%2030Mar2022.pdf

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