Immutep Receives FDA Support for Cancer Drug Development, Boosts Pipeline Opportunities

Immutep's cancer drug, eftilagimod alfa, has received FDA support for development in first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma. The FDA highlighted potential for efti-KEYTRUDA combination to meet unmet needs of patients with PD-L1 expression below 1. Immutep focuses on immunotherapy and has a pipeline including IMP321, IMP701, and CVac. The company has strong liquidity and a conservative capital structure, but lacks revenue and profitability.

Immutep Limited (ASX: IMM; NASDAQ: IMMP), a late-stage immunotherapy company, has received positive feedback from the US Food and Drug Administration (FDA) regarding the clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa (efti), for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) patients with PD-L1 expression below 1 (CPS 1). The FDA's feedback underscores the high unmet medical need in this patient segment and supports the potential of efti in combination with Merck & Co., Inc.'s (MSD) anti-PD-1 KEYTRUDA® (pembrolizumab) to address this need [1].

The FDA's Project FrontRunner initiative, which aims to advance promising therapies to earlier treatment settings, has identified two potential development paths for efti-KEYTRUDA combination. These include a randomized registrational trial against standard-of-care therapy or a smaller single-arm study (70-90 patients) focusing on safety, response rate, and duration of response, followed by a confirmatory randomized study [2].

Immutep's CEO, Marc Voigt, expressed satisfaction with the FDA's feedback and guidance, highlighting the high unmet need among head and neck cancer patients with low PD-L1 expression. He noted that the FDA's 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 [1].

While Immutep's primary focus remains on its pivotal Phase III lung cancer trial (TACTI-004), the FDA's feedback creates valuable optionality for the company's clinical development strategy and potential partnerships. This development aligns with Immutep's broader focus on immunotherapy, with a pipeline that includes IMP321, IMP701, and CVac [1].

References:

[1] https://www.immutep.com/immutep-receives-positive-feedback-from-fda-on-late-stage-clinical-development-of-eftilagimod-alfa-in-head-and-neck-cancer-with-cps/
[2] https://www.stocktitan.net/news/IMMP/immutep-receives-positive-feedback-from-fda-on-late-stage-clinical-qk17pahwvxqx.html