Dr. Bernard Doger of START Madrid-FJD, Fundación Jiménez Díaz University Hospital and TACTI-002 and TACTI-003 investigator said, “The high overall and complete response rates for patients in Part C of the TACTI-002 trial, taken alongside their long-lasting persistence with the median Duration of Response not reached, provides a strong foundation for the ongoing TACTI-003 trial in 1st line HNSCC. The combination of the MHC Class II agonist, efti, with pembrolizumab is now showing an encouraging overall survival benefit in two different cancer indications.”
As seen in multiple clinical trials, efti is generating very durable responses when combined with anti-PD-(L)1 therapies. Notably, one of the five complete responses that lasted 28 months (as of the data cut-off) occurred in a patient with negative PD-L1 expression or CPS <1.
The safety profile of efti in combination with pembrolizumab continues to be safe and very well tolerated. No new safety signals were observed from Part C of the TACTI-002 Phase II trial. The dual immuno-oncology approach had adverse reactions that led to treatment discontinuation in only two patients (5.1%)2, which compares favorably to the treatment discontinuation rate from adverse reactions with anti-PD-1 monotherapy in the same patient population (6.1%).1
“It’s noteworthy to see efti combined with pembrolizumab generating a response in 29.7% of patients with 2nd line HNSCC, including five patients with complete responses, regardless of PD-L1 expression. In patients expressing PD-L1 CPS >1 or PD-L1 CPS >20, overall survival, progression-free survival, and response rates from the dual immuno-oncology approach compare rather favourably to reported results from anti-PD-1 monotherapy approved for the treatment of platinum refractory metastatic HNSCC,” stated Frédéric Triebel, M.D., Ph.D., Immutep’s CSO.
“These final results in 2nd line HNSCC are very encouraging in a difficult to treat patient population. It was the strength of interim results from TACTI-002, along with efti’s potential to address an unmet medical need, that secured FDA Fast Track designation for 1st line treatment of HNSCC. In 1st line HNSCC, we are now focused on completing enrolment for TACTI-003 by mid-year and expect to report top-line results later in H2 of CY2023,” said Marc Voigt, Immutep’s CEO.
In addition to the abstract and information that was announced to the ASX on 263 and 31 May 20234, the Final results from TACTI-002 Part C: A Phase II study of eftilagimod alpha (soluble LAG-3 protein) and pembrolizumab in patients with metastatic 2nd line head and neck squamous cell carcinoma unselected for PD-L1 poster will be available on the Posters & Publication section of Immutep’s website following its presentation between 2:15PM-5:15PM EDT at ASCO today.
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