Immutep’s Efti Shows Excellent Survival Data from INSIGHT-003 Trial in Non-Small Cell Lung Cancer

In This Article:

Immutep Limited
Immutep Limited

Media Release

  • Mature data in patients with a minimum follow-up of 22 months (N=21) shows excellent results, well above historical controls and exceeding expectations:

    • Median Overall Survival is 32.9 months, with median Progression Free Survival reaching 12.7 months, and a 24-month Overall Survival rate of 81.0%

  • Data from all evaluable patients to date (N=40) demonstrates significant improvement of Overall Response Rate compared to historical controls

  • Safety continues to be favourable with no new safety signals

  • INSIGHT-003, which is nearing completion of enrolment, evaluates efti with the most widely used immunotherapy-chemo combination today in a similar population to upcoming TACTI-004 Phase III trial

 SYDNEY, AUSTRALIA, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces positive data from the investigator-initiated INSIGHT-003 Phase I trial evaluating eftilagimod alpha (efti) in combination with KEYTRUDA® (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC) patients.

Prof. Dr. Salah-Eddin Al-Batran of the Frankfurt Institute of Clinical Cancer Research (IKF) and project lead stated, “The strength of these mature survival results coupled with a favourable safety profile in first-line treatment of patients with non-squamous NSCLC, the vast majority of whom have negative or low PD-L1 expression, is very encouraging. This promising data in INSIGHT-003 suggests a complementary effect from the addition of efti, a unique MHC Class II agonist, to the standard-of-care combination of pembrolizumab and chemotherapy which has revolutionised the treatment landscape in lung cancer. The IKF will also support and is looking forward to participating in the upcoming TACTI-004 study, which has PFS and OS as dual primary endpoints.”

Key Results - Data cutoff - 15 October 2024
The survival data from the triple combination therapy in patients irrespective of PD-L1 expression with a minimum follow-up of 22 months (N=21) at data cut-off shows:

INSIGHT-003 Results

Median Overall Survival (OS)

32.9 months

Median Progression-Free Survival (PFS)

12.7 months

24-month Overall Survival (OS)

81.0%


These results compare favourably to the 22.0-month median OS, 9.0-month median PFS, and 24-month OS rate of 45.5% from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression.1 Notably, ~19% of the 21 patients in INSIGHT-003 with mature survival data have high PD-L1 expression, who typically respond better to anti-PD-1 therapy, versus ~32% in the registrational trial of anti-PD-1 and doublet chemotherapy.

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