Investing.com -- Shares of Immutep Ltd ADR (NASDAQ: IMMP ) surged 37.4% following the announcement of favorable median Overall Survival (OS) data from its TACTI-003 Phase IIb trial. The trial evaluated eftilagimod alfa (efti) in combination with MSD’s KEYTRUDA® as a first-line therapy for patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) expressing low levels of PD-L1.

The company reported a median OS of 17.6 months in evaluable patients, a significant improvement over historical results from current standard-of-care approaches, which ranged from 7.9 to 11.3 months. This outcome positions efti, in combination with pembrolizumab, as a potential new treatment option for a patient population with limited current therapies.

The positive response to the news is attributed to the trial’s demonstration of a more than doubling in median OS compared to anti-PD-1 monotherapy, a standard treatment for this condition. The data, with a cut-off of March 31, 2025, also indicated that the combination therapy was well-tolerated, with no new safety concerns.

Marc Voigt, CEO of Immutep, emphasized the significant survival benefit for patients with ’cold tumors,’ which are less likely to respond to immunotherapies. He noted the potential of the combination therapy to provide more tolerable and effective treatments for patients with high unmet medical needs.

Looking ahead, Immutep has Fast Track designation for eftilagimod alfa in this indication and plans to consult with the U.S. Food and Drug Administration (FDA) to discuss approval pathways. The company will continue patient follow-up and data analysis, with further updates expected later in the year.

Investors reacted positively to the news, driving the stock up significantly during the trading session. The market’s response underscores the potential commercial and clinical impact of the therapy, as well as the company’s strategic position in addressing a challenging treatment landscape.

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