Immutep Receives FDA Support for Eftilagimod Alfa in Cancer Treatment, Boosting Its Market Position and Treatment Options for Underserved Patients.

Immutep receives FDA support for its cancer treatment drug, eftilagimod alfa, in combination with KEYTRUDA. The FDA's positive feedback highlights the drug's potential to address unmet medical needs in patients with low PD-L1 expression. This positions Immutep to explore collaborative development paths and offers new treatment options for underserved patients. The company's stock score reflects its high-risk, high-reward nature as a biotech firm in its developmental stage.

Immutep Limited, a late-stage immunotherapy company, has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding the future clinical development of its lead product candidate, eftilagimod alfa (efti), in combination with KEYTRUDA (pembrolizumab) for first-line treatment of recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 expression below 1.1. The FDA's support underscores the potential of efti in addressing the high unmet need in this patient population, which currently lacks effective non-chemotherapy treatment options.

The FDA's feedback follows the successful phase 2b TACTI-003/KEYNOTE-C34 trial, which evaluated eftilagimod alfa in combination with pembrolizumab in patients with PD-L1 combined positive score (CPS) of less than 1.1. The trial demonstrated an overall response rate (ORR) of 35.5% and a median overall survival (OS) of 17.6 months, indicating promising efficacy [1].

The FDA has outlined two potential clinical pathways for Immutep to pursue. The first is a randomized registrational trial evaluating the combination therapy against standard-of-care options. Alternatively, Immutep can lead a single-arm study of about 70 to 90 patients with key endpoints regarding safety, response rate, and duration of response, followed by a confirmatory randomized trial, potentially leading to accelerated approval.

Immutep's CEO, Marc Voigt, expressed satisfaction with the FDA's feedback and guidance, stating, "The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved patient population" [2].

The stock price of Immutep reflects its high-risk, high-reward nature as a biotech firm in its developmental stage. The company's stock score reflects its potential for significant growth if the clinical trials are successful and the drug gains regulatory approval.

References:
[1] https://www.onclive.com/view/fda-outlines-next-steps-for-development-of-eftilagimod-alfa-in-pd-l1-negative-hnscc
[2] https://www.nasdaq.com/articles/immutep-gets-positive-feedback-fda-late-stage-clinical-development-eftilagimod-alfa