Immutep's Efti with KEYTRUDA® (pembrolizumab) & Chemotherapy Achieves High Response Rates in First-Line Non-Small Cell Lung Cancer
MWN-AI** Summary
Immutep Limited has reported promising results from its investigator-initiated INSIGHT-003 trial, achieving a 60.8% overall response rate (ORR) and a 90.2% disease control rate (DCR) in patients with first-line non-small cell lung cancer (1L NSCLC). The trial combines eftilagimod alpha (efti) with KEYTRUDA® (pembrolizumab) and doublet chemotherapy, specifically targeting patients with non-squamous advanced or metastatic NSCLC. Notably, approximately 92% of evaluable patients had a PD-L1 tumor proportion score (TPS) of less than 50%, underscoring the unmet need in this population, particularly with 43% exhibiting a TPS below 1%.
These results show a significant improvement over historical controls, with the efti combination yielding higher response rates across all PD-L1 expression levels compared to previous trials. For instance, patients with PD-L1 TPS below 50% demonstrated a 59.6% response rate, compared to 40.8% from historical controls. Overall, the triple combination therapy has provided a substantial advancement in the treatment strategy for 1L NSCLC, particularly for patients often deemed difficult to treat.
Immutep CEO Marc Voigt expressed confidence in efti's potential to establish a new standard of care in this field, supported by strong efficacy data from both the INSIGHT-003 and TACTI-002 trials involving 165 patients. Safety profiles remain favorable with no new safety signals reported. Continued results and data from the INSIGHT-003 trial are expected to be showcased at an upcoming medical conference, furthering the company’s aim to bring innovative treatments to the forefront of cancer therapy.
MWN-AI** Analysis
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has made remarkable strides with its investigational asset, eftilagimod alpha (efti), particularly in conjunction with KEYTRUDA® (pembrolizumab) and chemotherapy for first-line treatment of non-small cell lung cancer (NSCLC). The recent results from the INSIGHT-003 trial indicate a significant response rate of 60.8% and a disease control rate of 90.2% among evaluable patients, showcasing the potential for efti as part of a new standard of care in this challenging cancer population.
What’s noteworthy is that approximately 92% of evaluable patients harbor PD-L1 tumor proportion scores (TPS) below 50%. The trial yielded impressive results, especially for patients with TPS <1%, where a 54.5% response rate was achieved compared to historic figures, marking a substantial improvement in an area of high unmet need. This positions efti favorably, especially considering that traditional anti-PD-1 therapies are known to underperform in this demographic.
Given these compelling data points, investors should closely monitor the upcoming presentations at medical conferences, where further insights into the INSIGHT-003 trial may emerge. Strong performance metrics, coupled with a favourable safety profile, paint a promising picture for both efti and Immutep’s broader immunotherapy pipeline. The multi-centre approach and continued positive trends strengthen investor confidence.
From a market perspective, given these recent advancements and the potential for efti to significantly carve out its niche within the NSCLC treatment landscape, the stock presents an attractive proposition for growth-focused investors. Additionally, the positive phase results could catalyze institutional interest, further enhancing Immutep's market valuation. The outlook appears optimistic; however, stakeholders should remain vigilant for regulatory updates and competitive landscape developments as they evaluate their positions.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
- Novel combination achieves 60.8% response rate and 90.2% disease control rate in first-line non-small cell lung cancer (1L NSCLC)
- Notably, ~92% of all evaluable patients have PD-L1 TPS <50%, including 43% with PD-L1 below 1 (TPS <1%), who represent an area of high unmet need
- Data demonstrates significant improvement in response rates compared to historical controls, and safety continues to be favourable
- Multi-centre INSIGHT-003 is evaluating the same immunotherapy/chemotherapy combination used in the pivotal TACTI-004 Phase III in 1L NSCLC
- Additional data from INSIGHT-003 is planned for presentation at a medical conference later this year
SYDNEY, AUSTRALIA, May 15, 2025 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a late-stage immunotherapy company targeting cancer and autoimmune diseases, today announces that a 60.8% response rate and 90.2% disease control rate, according to RECIST1.1, has been achieved in the investigator-initiated INSIGHT-003 trial as of the data-cut off date of 06 May 2025. 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).
Marc Voigt, CEO of Immutep, stated , “Our level of confidence in efti driving a new standard of care for patients with non-small cell lung cancer via our pivotal TACTI-004 trial continues to rise with the strength of the data from INSIGHT-003 and TACTI-002. Across two trials we have now efficacy data from 165 patients with 1L NSCLC who have been treated with efti and KEYTRUDA, either with or without chemotherapy. In multi-national settings, efti has generated consistent and remarkable improvements in response rates. In particular, the interim ORR data in patients with PD-L1 expression below 50% in the ongoing INSIGHT-003 trial, who represent over two-thirds of the 1L NSCLC patient population, is very encouraging.”
Majority of Patients have PD-L1 TPS <50%
Notably, ~92% of all evaluable patients (N=51) in the INSIGHT-003 study have PD-L1 TPS <50%. This includes 49% of patients with PD-L1 Tumour Proportion Score (TPS) of 1-49% and 43% of patients with PD-L1 TPS <1%, as shown in the table below.
Strong Response Rates Across All PD-L1 Expression Levels
Data from all evaluable patients demonstrates significant improvement of Overall Response Rate (ORR) according to RECIST 1.1 across all levels of PD-L1 expression compared to historical control from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC 1 :
- 75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression (TPS > 50%)
- 64.0% ORR versus 49.2% ORR in patients with low PD-L1 expression (TPS 1-49%)
- 54.5% ORR versus 32.3% ORR in patients with negative PD-L1 expression (TPS <1%)
The 60.8% response rate regardless of PD-L1 expression (TPS 0-100%) represents a substantial improvement compared to historical control of 48.0%. 1 The relative outperformance is particularly strong given the registrational trial has four times as many patients with high PD-L1 expression (~32% of patients versus ~8% in INSIGHT-003), who have the highest response rates.
Importantly, in patients with TPS <50% (N=47), who have a high unmet need and represent over two-thirds of the 1L NSCLC patient populaton, the triple combination with efti achieved a 59.6% response rate as compared to historical control of 40.8%. 1
| INSIGHT-003 Overall Response Rate & Disease Control Rate, according to RECIST1.1 | |||||
| PD-L1 Expression Levels | TPS 0-100% (N=51) | TPS <1% (N=22) | TPS 1-49% (N=25) | TPS <50% (N=47) | TPS ?50% (N=4) |
| ORR % | 60.8 | 54.5 | 64.0 | 59.6 | 75.0 |
| DCR % | 90.2 | 86.4 | 92.0 | 89.4 | 100 |
Safety
Safety continues to be favourable for the triple combination in 1L NSCLC with no new safety signals.
Next Steps
Additional data updates from this trial are expected to be presented at a medical conference in 2025 and beyond.
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 front-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 Eftilagimod Alfa (efti)
Efti is Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist that stimulates both innate and adaptive immunity for the treatment of cancer. As a first-in-class antigen presenting cell (APC) activator, efti binds to MHC (major histocompatibility complex) Class II molecules on APC leading to activation and proliferation of CD8+ cytotoxic T cells, CD4+ helper T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-? and CXCL10 that further boost the immune system’s ability to fight cancer.
Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track designation in first line HNSCC and in first line NSCLC from the United States Food and Drug Administration (FDA).
About Immutep
Immutep is a late-stage biotechnology company developing novel immunotherapies for cancer and autoimmune disease. The Company is a pioneer in the understanding and advancement of therapeutics related to Lymphocyte Activation Gene-3 (LAG-3), and its diversified product portfolio harnesses LAG-3’s 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 .
1. 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
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**
How does the 60.8% response rate in the INSIGHT-003 trial for Immutep Limited IMMP compare to existing treatments for patients with NSCLC, particularly those with PD-L1 TPS <50%?
What factors contribute to the favorable safety profile observed with the combination therapy in Immutep Limited IMMP’s INSIGHT-003 trial?
Given the promising results from the INSIGHT-003 trial, what are Immutep Limited IMMP's plans for potential partnerships or collaborations to advance the development of eftilagimod alpha?
How does the multi-centre design of INSIGHT-003 enhance the reliability of the findings for Immutep Limited IMMP's novel combination therapy in a diverse patient population?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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