Will Eftilagimod Improve the Anti-tumor Response of Pembrolizumab in Head and Neck Cancer?

TACTI-002 Part C Study

The HNSCC cohort included 39 patients with metastatic head and neck squamous cell carcinoma, with disease progression on or after first-line platinum-based therapy (± cetuximab), irrespective of PD-L1 expression. Eftilagimod alpha was subcutaneously dosed at 30 mg every two weeks, for eight 3-week cycles, and then dosed once every three weeks for up to one year. The 200 mg pembrolizumab was dosed intravenously, once every three weeks, for up to two years.

According to the results presented at the ASCO 2023 conference, an ORR of ~30%,  median PFS of 2.1 months, and a median OS of 8.7 months were achieved in patients responding to combination therapy of Eftilagimod and pembrolizumab. 

In patients with CPS ≥20, ORR of 60%, median PFS of 13.6 months, and a median OS of 15.5 months were achieved.

As far as the safety profile is concerned, 5% of patients discontinued treatment due to adverse events. The most common AEs were hypothyroidism (20.5%), fatigue (10.3%), and pruritus (10.3%).

KOL insights

“The results achieved from this study are quite exciting, the drug has the potential to become a promising therapeutic option for patients. The therapy showed positive results in this cohort, so further moving it into an earlier space would also be interesting to see”. -Expert Opinion.


The drug and pembrolizumab combination showed improved antitumor activity in platinum and partially cetuximab-pretreated second line HNSCC patients. Currently, TACTI-003 (NCT04811027) is recruiting patients for a randomized study of this combination therapy in first-line HNSCC patients