Immutep reports positive Phase IIb results for Eftilagimod Alfa in head and neck cancer treatment

Immutep Limited (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company, has announced encouraging results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial. The study evaluates the effectiveness of eftilagimod alfa (efti) combined with Merck & Co., Inc.’s KEYTRUDA (pembrolizumab) in treating patients with recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC) with negative PD-L1 expression.

The trial demonstrated an objective response rate (ORR) of 35.5% and a disease control rate (DCR) of 58.1% among patients whose tumors do not express PD-L1 (Combined Positive Score [CPS] <1). These figures significantly surpass those of historical controls from anti-PD-1 monotherapy, which showed only a 5.4% ORR and 32.4% DCR, positioning efti and KEYTRUDA as a potent chemotherapy-free treatment option.

Dr. Robert Metcalf from The Christie NHS Foundation Trust highlighted the importance of these results during his presentation at the ESMO Virtual Plenary. “The high response rate from this novel immunotherapy combination far exceeds other treatment approaches and matches historical response rates from chemotherapy-based treatments, but without the associated toxicities,” Dr. Metcalf stated.

The combination therapy not only demonstrated high efficacy but also showed promising durability of responses, with over 50% of patients in Cohort B treated for at least six months. The safety profile remained favorable, with no new safety signals observed, underscoring the treatment’s suitability for ongoing use.

With these positive outcomes, Immutep plans to engage with regulatory authorities to discuss the next steps. Eftilagimod alfa has already received FDA Fast Track designation for use in 1L HNSCC, regardless of PD-L1 expression, highlighting its potential critical role in cancer treatment.

Efti, acting as both an MHC Class II agonist and a unique antigen-presenting cell activator, is proving to be a game-changer in the field of immuno-oncology. It enhances the body’s immune response against cancer, making it an invaluable tool in the fight against various solid tumors, including non-small cell lung cancer (NSCLC) and metastatic breast cancer.