Immutep Presents Data from Safety Lead-in Phase of AIPAC-003 at ESMO Breast 2024
Immutep presented promising data from the safety lead-in phase of their AIPAC-003 Phase II/III trial at the ESMO Breast Cancer Congress 2024. The trial, combining 90mg efti with paclitaxel, showed a 50% overall response rate and a 100% disease control rate in six metastatic breast cancer patients. Notably, one patient achieved a complete response which is ongoing with efti monotherapy. The combination has been well tolerated with no severe adverse events. Higher efti concentrations were observed, remaining pharmacologically active up to 96 hours post-administration. The randomized Phase II portion continues, with more data expected in 2024.
- 50% overall response rate in six metastatic breast cancer patients.
- 100% disease control rate observed in the safety lead-in phase.
- A patient achieved and maintained a complete response with efti monotherapy.
- 90mg efti dose demonstrated a favourable safety profile with no grade 3 or higher adverse events.
- Higher maximum concentration of efti achieved, remaining active up to 96 hours.
- No mention of significant financial benefits or immediate market impact.
- patient sample size (six) might not provide comprehensive efficacy data.
- No long-term data on safety and efficacy beyond the current study phase.
The data presented by Immutep in the AIPAC-003 trial offers significant insights into the therapeutic potential of eftilagimod alpha (efti) combined with paclitaxel for metastatic breast cancer (MBC). A remarkable 50% overall response rate (ORR) in patients who have already exhausted other treatment options, including CDK 4/6 inhibitors, is indeed notable. This includes one complete response (CR) and two partial responses (PR). The safety profile of the 90mg efti dose is also promising, with no dose-limiting toxicities or severe adverse events reported. These results are particularly encouraging given the refractory nature of the patient population. The retention of a pharmacologically active level of efti up to 96 hours post-administration indicates sustained engagement with the immune system, an important factor in the efficacy of immunotherapies. The increases in immune cell levels and Th1 biomarkers signify a robust immune activation, which could be an underlying mechanism driving the observed clinical responses.
From a financial perspective, Immutep's recent results could translate into substantial value for investors. The demonstrated efficacy and favorable safety profile of the 90mg efti dose in a patient population with limited treatment options can bolster confidence in the market potential of efti. Investors should keep an eye on the upcoming data from the randomized Phase II portion of the AIPAC-003 trial, expected in CY2024. Achieving positive results in a larger cohort could pave the way for efti's advancement to later-stage trials and eventually regulatory approval. It’s important to note that continued positive outcomes linked with FDA's Project Optimus initiative could expedite the development process. Moreover, maintaining a strong safety profile will be pivotal in differentiating efti from other treatments, potentially increasing its market adoption. However, investors should also stay cautious of any unforeseen adverse events or efficacy issues that could arise in larger trials.
The data from Immutep's AIPAC-003 trial positions the company favorably within the competitive landscape of metastatic breast cancer treatments. The oncology market is highly competitive, with numerous players developing novel therapies. The demonstration that a higher dose of efti is both safe and potentially more effective could provide Immutep with a competitive edge. The complete response observed in a patient with triple-negative breast carcinoma, a particularly aggressive and hard-to-treat subtype, underscores the potential of efti in addressing unmet medical needs. Market acceptance will however hinge on the results from the larger Phase II trial and eventual Phase III outcomes. Additionally, the alignment with the FDA’s Project Optimus could streamline regulatory pathways, enhancing market positioning. Investors should monitor how Immutep strategically navigates partnerships, as collaborations with larger pharmaceutical firms can significantly enhance market reach and financial backing.
Media Release
- Confirmed complete response in a patient with metastatic breast cancer refractory to several lines of therapy achieved during combination treatment with 90mg efti and paclitaxel
- Ongoing complete response has been maintained since the patient started treatment with efti monotherapy
- Efti + paclitaxel combination continues to be well tolerated with a favourable safety profile
- First-ever 90mg dosing leads to higher maximum concentration of efti, as well as pharmacologically active level up to 96 hours after administration
- Data from randomized Phase II portion of study expected in CY2024
SYDNEY, AUSTRALIA, May 15, 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 encouraging efficacy, safety, and pharmacodynamic data from the safety lead-in of the AIPAC-003 Phase II/III trial presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2024 Congress. This lead-in represents the first ever 90mg dosing of eftilagimod alpha (“efti”), a soluble LAG-3 protein and MHC Class II agonist, given in combination with weekly paclitaxel.
Efficacy
The poster titled “Testing a higher dose (90 mg s.c.) of eftilagimod alpha, a soluble LAG-3 protein, in metastatic breast cancer patients receiving weekly paclitaxel in AIPAC-003” details positive results in six metastatic breast cancer (MBC) patients, who exhausted endocrine therapy including cyclin-dependent kinase 4/6 (CDK4/6) inhibitors. The data shows a confirmed
Complete Response Patient Case Study
The patient with a confirmed complete response (CR) was diagnosed with triple-negative breast carcinoma (TNBC) in 2019 and has failed multiple lines of therapy including a CDK 4/6 inhibitor for ER+/PR+ metastasis. During the immuno-oncology (IO)-chemotherapy treatment of efti and paclitaxel, this patient achieved a partial response (PR) that subsequently turned into a CR. This patient’s ongoing CR has been maintained since stopping paclitaxel and being treated with efti monotherapy.
Safety & Pharmacodynamic Effects
The lead-in has also shown that the first-ever 90mg efti dosing in combination with weekly paclitaxel continues to be well tolerated with a favourable safety profile. As of the data cut-off (April 3), no dose-limiting toxicities and no treatment-emergent adverse events of grade 3 or higher severity were recorded.
The 90mg efti dosing leads to a higher maximum concentration of efti in the blood as compared to lower efti doses in past clinical trials, and efti remains detectable at a pharmacologically active level (>1 ng/mL) up to 96 hours after administration. Pharmacodynamic effects also showed an increase of circulating levels of immune cells such as CD8 & CD4 T cells and plasma Th1 biomarker levels. All patients in the AIPAC-003 safety lead-in had a ≥1.4-fold change in interferon-gamma (IFN-γ) and ~
Dr. Serafin Morales Murillo, University Hospital Arnau de Vilanova, Lleida, Spain, and AIPAC-003 investigator stated, "It is encouraging to see the high efti dose of 90mg with weekly paclitaxel continue to be safe and well tolerated in these metastatic breast cancer patients. It is also positive at this early stage to see high response and disease control rates, including a complete response, in these patients who have unfortunately all seen their cancers progress after endocrine therapy including CDK 4/6 inhibitors. We are looking forward to further data emerging from this study."
The randomized Phase II portion of the trial, which will include up to 58 evaluable patients, is underway and focused on whether 90mg efti dosing is more efficacious than 30mg dosing. This portion of the trial has enrolled 35 patients to date. Importantly, the determination of the optimal dose in AIPAC-003 is directly tied to the FDA’s Project Optimus initiative and is relevant for the entire efti program.
Further data updates in terms of safety and efficacy from AIPAC-003 are expected in CY2024. The ESMO Breast 2024 poster will be available on the Posters & Publications section of Immutep’s website.
About Eftilagimod Alpha (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-ƴ 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 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.
Australian Investors/Media:
Catherine Strong, Morrow Sodali
+61 (0)406 759 268; c.strong@morrowsodali.com
U.S. Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
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