• Efti in combination with KEYTRUDA® drives strong 17.6-month median Overall Survival in head and neck cancer patients with PD-L1 CPS <1
• Mature data builds on encouraging high response rates with multiple complete responses
• Patients with CPS <1 represent a high unmet medical need with no approved immunotherapy-only treatment options

Immutep Limited has announced an excellent median Overall Survival (OS) of 17.6 months in Cohort B of the TACTI-003 (KEYNOTE-C34) Phase IIb trial. This part of the study evaluates eftilagimod alfa (efti) in combination with KEYTRUDA® (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients with PD-L1 expression below 1 (Combined Positive Score [CPS] <1). The mature 17.6-month median OS in evaluable patients compares favorably to historical results from the two current standard-of-care approaches for 1L HNSCC patients with CPS <1, including 10.7-months from cetuximab + chemotherapy and 11.3-months from anti-PD-1 therapy + chemotherapy, as well as 7.9-months from anti-PD-1 monotherapy. Patients with CPS <1 in 1L HNSCC represent a treatment population with high unmet medical need, as up to 20% of 1L HNSCC patients have CPS <1 and despite immunotherapy's progress, anti-PD-1 therapy alone (without chemotherapy) is only approved for patients who express PD-L1 (CPS >1). Importantly, efti in combination with pembrolizumab continues to be well-tolerated with no new safety signals. Immutep has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss next steps, including potential paths to approval for 1L HNSCC with PD-L1 CPS <1.

Immutep has not provided any high-importance, price-sensitive forward-looking financial metrics or other company-specific metrics in the announcement.

Immutep plans to provide a further update on the TACTI-003 trial later this year. The company will meet with regulators to discuss next steps and potential paths to approval for 1L HNSCC with PD-L1 CPS <1.