Immutep Announces Improving Results from Stage I of Phase II TACTI-002 Study

Date posted 22 September 2020

Release date 18 September 2020

  • Three complete responses (complete disappearance of all lesions) reported: two in 2nd line head and neck squamous cell carcinoma (HNSCC) and one in 1st line non-small cell lung cancer (NSCLC)
  • Five responses in patients (both indications) with negative (< 1%) or moderate PD-L1 expression where pembrolizumab monotherapy does not work well
  • Median Progression Free Survival (PFS) of 4.3 months in HNSCC patients and 47% progression free at 6 months in this very aggressive late stage disease
  • PFS continues to improve in 1st line NSCLC patients with median PFS of 11.8 months and patients with responses have durable ones

Immutep Limited announces new interim data from its ongoing Phase II TACTI-002 study. The data was presented in two poster presentations at the ESMO Virtual Congress 2020 on 17 September 2020 and relates to the cut-off date of 21 August 2020.

The posters are available on Immutep’s website at media/presentations.html

TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as “MSD” outside the United States and Canada). The study is evaluating the combination of Immutep’s lead product candidate eftilagimod alpha (“efti” or “IMP321”) with MSD’s KEYTRUDA® (pembrolizumab) in up to 109 patients with 2nd line head and neck squamous cell carcinoma (HNSCC, Part C) or non-small cell lung cancer (NSCLC) in 1st and 2nd line (Parts A and B, respectively).

Principal investigator, Dr Martin Forster, University College London Hospital, said: “We are very encouraged by the results in this patient group with resistant late stage Head & Neck Cancers where the likelihood of response to other treatments is small. The durability of responses and the two patients with a complete response are extremely promising signals and this combination should be further investigated.”

Immutep CSO and CMO, Dr Frederic Triebel said: “The combination of efti and pembrolizumab is reporting encouraging progression free survival in patients with HNSCC and NSCLC, improving on the results from separate historical trials. For example, in comparable studies, HNSCC patients receiving 1,2 pembrolizumab monotherapy had a PFS of 2.1 months, or 2.3 months if given chemotherapy . This compares to a PFS of 4.3 months in HNSCC patients from the TACTI-002 trial, thus far. To have these very good and durable responses in both groups and without the use of chemotherapy is highly encouraging for efti.”

Read the full media release. 


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