Immutep Stock Soars on Breakthrough Head and Neck Cancer Data

Immutep Limited (ASX: IMM; NASDAQ: IMMP) is skyrocketing in premarket trading, surging 21.89% to $2.4500, after unveiling compelling results from Cohort B of its TACTI-003 Phase IIb trial. The clinical-stage biotech company, focused on developing novel LAG-3 immunotherapies, showcased the impressive efficacy and safety profile of its lead candidate, eftilagimod alfa (efti), in combination with Merck's anti-PD-1 therapy, KEYTRUDA®, for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) patients with negative PD-L1 expression.

A Breakthrough for PD-L1 Negative HNSCC Patients

The data, presented at the ESMO Virtual Plenary session, is nothing short of groundbreaking. The efti and KEYTRUDA combination demonstrated a remarkable objective response rate (ORR) of 35.5% and a disease control rate (DCR) of 58.1% in patients with PD-L1 negative tumors. These figures are significantly higher than historical control data for anti-PD-1 monotherapy and rank among the best outcomes achieved without chemotherapy in this patient population.

Moreover, the combination led to a complete response rate of 9.7%, a feat previously unattained with anti-PD-1 monotherapy. The durability of responses is also promising, with over 50% of patients treated for at least six months and no new safety signals observed.

Eftilagimod Alfa: A Game-Changer in Immuno-Oncology

These results underscore eftilagimod alfa's potential as a potent immune system enhancer when combined with immune checkpoint inhibitors like KEYTRUDA. By activating antigen-presenting cells, efti generates a broad anti-cancer immune response, addressing a significant unmet medical need for patients with PD-L1 negative HNSCC.

Path Forward

Given the compelling data and the substantial unmet medical need, Immutep will engage with regulatory agencies to determine the next steps. The company has already secured FDA Fast Track designation for efti in first-line HNSCC, regardless of PD-L1 expression. With approximately 20% of HNSCC patients exhibiting PD-L1 negative tumors, the market opportunity for this combination therapy is substantial.

Immutep's stock price surge reflects investor enthusiasm for these promising results. The company is now poised to become a key player in the immuno-oncology landscape, offering hope to patients with limited treatment options.