Immutep’s TACTI-002 trial meets primary endpoint in lung cancer

Posted: 6 June 2022

Immutep reports positive Overall Response Rate

in its Phase II clinical trial in 1st line NSCLC for PD-L1 all-comers 

  • TACTI-002 has met its primary objective for 1st line non-small cell lung cancer (NSCLC) patients in a PD-L1 all-comer Phase II clinical trial conducted in collaboration with MSD (N=114)
  • Combination of efti plus pembrolizumab shows favourable anti-tumour activity:
  • Improved Overall Response Rate (ORR) by local read of 38.6% (intent to treat, 44/114 patients) and 42.7% (evaluable patients, 44/103) compared with data reported at ASCO 2021 (N=36)
  • Encouraging responses observed in all PD-L1 status groups, including those patients with PD-L1 negative (TPS < 1%) and PD-L1 low (TPS 1-49%) expressing tumours who are less likely to respond to anti-PD-1 monotherapy
  • Other secondary endpoints including Disease Control Rate (DCR) and interim median Progression Free Survival (PFS) continue to demonstrate improvement across all PD-L1 expression levels
  • Safe and well tolerated, with a safety profile that is consistent with that observed in previously reported studies for pembrolizumab monotherapy
  • Results support continued late stage clinical development of efti 

SYDNEY, AUSTRALIA – 6 June 2022 – Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, announces new data from 1st line NSCLC patients (Part A) of the Phase II TACTI-002 trial evaluating Immutep’s lead product candidate, eftilagimod alpha (“efti” or “IMP321”) in combination with MSD’s anti-PD-1 therapy KEYTRUDA® (pembrolizumab) in 114 patients.

The data was presented in an Oral Presentation at the American Society of Clinical Oncology’s (ASCO) 2022 Annual Meeting which is also available on Immutep’s website.

TACTI-002 Principal Investigator, Dr Enriqueta Felip of Vall d’Hebron University Hospital Barcelona, Spain, said: “It is very encouraging to see the combination of efti plus pembrolizumab is showing favourable anti-tumour activity in patients with 1st line NSCLC. These responses were deep and durable and there has also been a low patient discontinuation rate. I believe the combination of efti plus pembrolizumab warrants late stage clinical investigation.” 

Immutep CSO and CMO, Dr Frederic Triebel, noted: “Our ORR by local read of 38.6% in 1st line NSCLC patients is comparing favourably to historical results from anti-PD-1 monotherapies where response rates in PD-L1 all-comer trials are typically around 20%. We are particularly pleased to see encouraging responses across all PD-L1 status groups, showing that efti may kick start an anti-tumour immune response even in patients with no or low PD-L1 expression. In addition, the combination of efti plus pembrolizumab has a safety profile consistent with that observed in previously reported studies for pembrolizumab monotherapy. We continue to believe that efti, with its unique mechanism of action, may ultimately provide a very meaningful benefit to diverse sets of cancer patients including those with more limited treatment options.”

Immutep CEO Marc Voigt said: “We are delighted that patient outcomes are improved with the combination of efti plus pembrolizumab across different patient groups. The data is encouraging for patients, as there is an unmet medical need particularly for those with NSCLC with no or low PD-L1 expression. We enlarged this part of the study in order to see if the strong earlier results in a smaller group of patients are holding true in more than a hundred patients. By biotech standards, we consider this to be a large patient population for a Phase II trial.”

“For Immutep, these highly favourable results are of strategic importance, as they support late-stage development for an attractive and very large addressable market,” he said.


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