Patient Enrolment Completed for INSIGHT-003

Rhea-AI Summary

Immutep (ASX: IMM; NASDAQ: IMMP), a clinical-stage biotechnology company, announced the completion of patient enrolment for the INSIGHT-003 trial. This multi-centre Phase I trial evaluates the combination of eftilagimod alpha (efti), pembrolizumab (KEYTRUDA®), and doublet chemotherapy as a first-line treatment for advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).

The trial has enrolled approximately 50 evaluable patients across multiple sites in Germany, led by the Frankfurt Institute of Clinical Cancer Research IKF. Initial results, reported on 14 November 2024, showed a median Overall Survival (OS) of 32.9 months and a 24-month OS rate of 81.0% in patients with a minimum follow-up of 22 months (N=21). These results compare favourably to a registrational trial showing a median OS of 22.0 months and a 24-month OS rate of 45.5% for anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression.

Further data updates from the INSIGHT-003 trial are expected in 2025 and beyond. For more information on the trial, visit clinicaltrials.gov (NCT03252938).

Positive

• Completion of patient enrolment for INSIGHT-003 trial.
• Initial median OS of 32.9 months and 24-month OS rate of 81.0%, outperforming a comparable trial.
• Approximately 50 evaluable patients enrolled across multiple sites in Germany.

Negative

• None.

Insights

Oncology Research Analyst

The completion of patient enrollment in INSIGHT-003 marks a critical milestone for Immutep's efti program in first-line NSCLC treatment. The preliminary Overall Survival data showing 32.9 months median OS and 81.0% 24-month OS rate significantly outperforms historical benchmarks of 22.0 months median OS and 45.5% OS rate for standard anti-PD-1/chemo combinations. This 10.9-month improvement in median survival and nearly double 24-month survival rate suggests the triple combination could represent a meaningful advance in treating advanced NSCLC. The full enrollment of approximately 50 evaluable patients will provide a more robust dataset to validate these promising early signals. A simple way to understand this: imagine current treatments allow about 45 out of 100 patients to survive for 2 years, while this new combination appears to help 81 out of 100 patients reach that milestone - a dramatic improvement in survival odds.

Clinical Trial Specialist

The trial's completion of enrollment ahead of planned data updates in 2025 demonstrates strong operational execution and investigator interest. The multi-center German trial setting provides credibility through established research infrastructure. The focus on first-line treatment in the metastatic setting addresses a critical therapeutic need where improving upon current standards could significantly impact patient care. For non-experts: First-line treatment means this is used when patients are first diagnosed with advanced lung cancer, not after other treatments have failed. This timing is important because patients typically have the best chance of responding when treated earlier in their disease course. The trial's design evaluating a novel triple combination builds on established treatment backbones (pembrolizumab plus chemotherapy) while adding efti's unique LAG-3 targeting mechanism.

• Multi-centre trial evaluating efti in combination with pembrolizumab and chemotherapy in patients with non-small cell lung cancer reaches enrolment target of approximately 50 evaluable patients
• Data updates from INSIGHT-003 are expected in 2025 and beyond

SYDNEY, AUSTRALIA, Jan. 06, 2025 (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 that patient enrolment has been completed in the investigator-initiated INSIGHT-003 trial. INSIGHT-003 is evaluating eftilagimod alpha (efti) in combination with the anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) and doublet chemotherapy as first line treatment for patients with advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).

The Phase I trial has reached its enrolment target of approximately 50 evaluable patients across multiple clinical sites in Germany led by the Frankfurt Institute of Clinical Cancer Research IKF.

First Overall Survival results from INSIGHT-003 were reported on 14 November 2024, showing mature data in patients with a minimum follow-up of 22 months (N=21) achieved a median Overall Survival of 32.9 months and a 24-month Overall Survival rate of 81.0%¹. These results compare favourably to the 22.0-month median OS 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.²

Additional data updates from INSIGHT-003 are expected in 2025 and beyond. For more information on the trial, please visit clinicaltrials.gov (NCT03252938).

About INSIGHT-003
INSIGHT-003 is an investigator-initiated study conducted by the Frankfurt Institute of Clinical Cancer Research IKF and several other German centres. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in first line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.

About Immutep
Immutep is a clinical-stage biotechnology company developing novel LAG-3 immunotherapy for cancer and autoimmune disease. We are pioneers in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and our diversified product portfolio harnesses its unique ability to stimulate or suppress the immune response. Immutep is dedicated to leveraging its expertise to bring innovative treatment options to patients in need and to maximise value for shareholders. For more information, please visit www.immutep.com.

<sub>1. Data cutoff - 15 October 2024
2. Shirish Gadgeel et al., Updated Analysis From KEYNOTE-189: Pembrolizumab or Placebo Plus Pemetrexed and Platinum for Previously Untreated Metastatic Nonsquamous Non–Small-Cell Lung Cancer. JCO 38, 1505-1517(2020). DOI:10.1200/JCO.19.03136</sub>

_{KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.}

Australian Investors/Media:
Catherine Strong, Sodali & Co.
+61 (0)406 759 268; catherine.strong@sodali.com

U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com

FAQ

What is the INSIGHT-003 trial about?

The INSIGHT-003 trial is a Phase I study evaluating the combination of eftilagimod alpha (efti), pembrolizumab (KEYTRUDA®), and doublet chemotherapy as a first-line treatment for advanced or metastatic non-squamous non-small cell lung cancer (1L NSCLC).

When was patient enrolment for the INSIGHT-003 trial completed?

Patient enrolment for the INSIGHT-003 trial was completed as announced on January 6, 2025.

What were the initial results of the INSIGHT-003 trial?

Initial results showed a median Overall Survival (OS) of 32.9 months and a 24-month OS rate of 81.0% in patients with a minimum follow-up of 22 months.

How do the INSIGHT-003 trial results compare to existing treatments?

The INSIGHT-003 trial results compare favourably to a registrational trial which showed a median OS of 22.0 months and a 24-month OS rate of 45.5% for anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC.

What is the significance of the INSIGHT-003 trial for IMMP shareholders?

The completion of enrolment and promising initial results from the INSIGHT-003 trial could positively impact IMMP shareholders by potentially leading to effective new treatments for non-squamous 1L NSCLC.

When can further data updates from the INSIGHT-003 trial be expected?

Further data updates from the INSIGHT-003 trial are expected in 2025 and beyond.

How many patients were enrolled in the INSIGHT-003 trial?

Approximately 50 evaluable patients were enrolled in the INSIGHT-003 trial.