Immutep Reports Positive Results in First Line Head and Neck Squamous Cell Carcinoma Patients with Negative PD-L1 Expression
Immutep has announced positive results from Cohort B of their TACTI-003 Phase IIb trial, which evaluates the combination of eftilagimod alfa (efti) and KEYTRUDA® (pembrolizumab) as a first-line treatment for head and neck squamous cell carcinoma (HNSCC) patients with negative PD-L1 expression. The combination achieved a 35.5% response rate and a 58.1% disease control rate, significantly higher than historical controls for anti-PD-1 monotherapy.
Additionally, the combination showed a high complete response rate of 9.7%, with over 50% of patients receiving treatment for at least six months. No new safety signals were observed, making the treatment favorable in terms of safety.
Immutep will discuss the path forward with regulatory agencies based on these promising results. The company has received FDA Fast Track designation for efti in 1L HNSCC regardless of PD-L1 expression.
A webcast to discuss the clinical data will be held on July 12, 2024, at 9am AEST.
- Immutep reported a 35.5% response rate in Cohort B of their TACTI-003 Phase IIb trial.
- 58.1% disease control rate achieved in patients with negative PD-L1 expression.
- High complete response rate of 9.7%.
- Over 50% of patients received treatment for at least six months.
- No new safety signals observed.
- FDA Fast Track designation for efti in 1L HNSCC regardless of PD-L1 expression.
- None.
Insights
The results presented by Immutep show a promising advancement in the treatment of head and neck squamous cell carcinoma (HNSCC) with negative PD-L1 expression. The combination of efti and KEYTRUDA achieved a 35.5% response rate, which is significant considering traditional treatments like anti-PD-1 monotherapy typically record much lower response rates. For patients whose tumors do not express PD-L1, achieving complete responses is particularly challenging, making the 9.7% complete response rate noteworthy. This suggests the combination therapy could be a viable option for patients who have limited treatment choices due to their PD-L1 status.
Additionally, the safety profile of the combination therapy remains favorable, which is important as it offers a less toxic alternative to chemotherapy. This is important because the severe side effects associated with chemotherapy can significantly impact a patient’s quality of life. The durable responses seen in over half of the patients treated for at least six months further bolster the potential for this combination to be a game-changer in this therapeutic area, providing sustained benefits.
Overall, these findings provide a solid foundation for continued investigation of this combination therapy. The next step involving discussions with regulatory agencies is vital to moving this therapy into broader clinical use, potentially offering new hope to patients with limited options.
From a financial perspective, Immutep's positive clinical results for the combination of efti and KEYTRUDA in treating head and neck cancers could be a substantial growth driver for the company. The reported 35.5% response rate and durable responses reflect favorably on the commercial potential of this therapy. Investors should note that these results are among the highest recorded for a chemotherapy-free approach in negative PD-L1 patients, positioning Immutep well within a highly competitive oncology market.
Moreover, the favorable safety profile is a important aspect. One of the biggest challenges in cancer treatment is balancing efficacy with manageable side effects. The ability to offer an efficacious treatment with fewer side effects enhances the therapy's attractiveness to both patients and clinicians. Given that the patient population with negative PD-L1 expression has limited options, this combination therapy could capture a significant market share.
Financially, positive clinical outcomes typically lead to milestone payments, increased investor interest and higher valuation. Immutep’s move to discuss these results with regulatory agencies suggests a pathway towards FDA approval, which could open the door to accelerated revenue growth. Retail investors should keep an eye on the company’s next announcements regarding regulatory progress and potential partnerships, which can further validate the commercial viability of their therapy.
The clinical trial results for the combination of efti and KEYTRUDA are promising, particularly in the context of head and neck squamous cell carcinoma (HNSCC) with negative PD-L1 expression. The objective response rate (ORR) of 35.5% and the disease control rate (DCR) of 58.1% indicate a robust anti-tumor activity. These figures are quite impressive when compared to the historical control rates of ant-PD-1 monotherapy, which had a much lower ORR and DCR. The high complete response rate of 9.7% adds an additional layer of optimism regarding the efficacy of this combination therapy.
One important aspect to highlight is the durability of responses. Over 50% of patients treated for at least six months suggests that the therapeutic effects are not only significant but also lasting. This is a key factor in cancer treatment as it can lead to better long-term outcomes for patients. The absence of new safety signals further supports the potential of this therapeutic approach, reinforcing its viability as a less toxic alternative to chemotherapy.
Furthermore, the unique mechanism of efti, which activates antigen-presenting cells to boost the immune response, sets it apart from other therapies. This novel approach could be particularly beneficial in patients with low or negative PD-L1 expression, who typically respond poorly to existing treatments. The ongoing discussions with regulatory agencies and the potential for FDA Fast Track designation could expedite the availability of this treatment to patients in need.
Media Release
- Efti in combination with KEYTRUDA® (pembrolizumab) achieved a
35.5% response rate in evaluable patients (N=31), according to RECIST 1.1, among the highest recorded for a treatment approach not containing chemotherapy in patients with CPS <1 - High complete response rate of
9.7% with three patients showing a disappearance of cancer lesions post treatment - Durability of responses tracks well and over
50% of patients received treatment for at least six months - Combination continues to have a favourable safety profile with no new safety signals observed
- Based on encouraging results and high unmet medical need, the path forward will be discussed with regulatory agencies
- Company to host webcast today at 9am AEST (7pm ET, 11 July), details below
SYDNEY, AUSTRALIA, July 12, 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 results from Cohort B of the TACTI-003 (KEYNOTE-PNC-34) Phase IIb trial evaluating eftilagimod alfa (efti) in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma patients (1L HNSCC) with negative PD-L1 expression. The updated efficacy and safety data was presented by Dr. Robert Metcalf during an oral presentation at the ESMO Virtual Plenary session at 18:30-19:30 CEST on 11 July 2024.
Results
The investigational immuno-oncology (IO) combination utilising efti and KEYTRUDA achieved an objective response rate (ORR) of
Additionally, the IO combination attained a high complete response rate of
Robert Metcalf, MD, PhD, The Christie NHS Foundation Trust, Manchester, U.K., stated, "The high response rate from this novel immunotherapy combination is well above other treatment approaches without chemotherapy. It matches historical response rates from chemotherapy-based treatments but without the associated toxicities. This is really significant for patients with head and neck squamous cell carcinomas who have a CPS less than one and for whom chemotherapy is the current first line treatment. Achieving complete responses in this group bodes well for this immunotherapy combination's future potential, especially given the positive trend in response durability. The clinically meaningful response rate and high unmet medical need warrant further investigation of eftilagimod plus pembrolizumab in this patient population."
Durability of Responses and Favourable Safety
Durability of responses is tracking well as has been seen in other clinical trials when efti is combined with KEYTRUDA. Over
This new data adds to the body of evidence that efti’s novel activation of antigen-presenting cells provides a strong boost to the immune system, enhancing the potential of immune checkpoint inhibitors such as KEYTRUDA. Importantly, as the only MHC Class II agonist in clinical development today, efti is generating a broad anti-cancer immune response in a unique and safe manner across all levels of PD-L1 expression, especially in patients with negative expression (CPS <1).
Next Steps
Based on the encouraging efficacy and high unmet medical need, Immutep will discuss the path forward with regulatory agencies. Efti has received FDA Fast Track designation in 1L HNSCC regardless of PD-L1 expression. The prevalence for CPS <1, CPS 1-19, and CPS >20 PD-L1 expression levels are approximately
Webcast Details
Immutep will host a webcast to discuss the clinical data. A replay of the webcast will be available under the Events section of Immutep’s website after the event.
Date/Time: Friday, July 12, at 9am AEST (7pm ET July 11)
Register: Link to register for webcast
Questions: Investors are invited to submit questions in advance via immutep@morrowsodali.com
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
About the TACTI-003 Trial
The TACTI-003 (KEYNOTE-PNC-34) trial is an ongoing Phase IIb study evaluating eftilagimod alfa (efti), Immutep’s proprietary soluble LAG-3 protein and MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC). The randomized Cohort A portion of the study is evaluating efti in combination with pembrolizumab as compared to pembrolizumab monotherapy in patients with PD-L1 positive (Combined Positive Score [CPS] ≥1) tumours, whereas Cohort B is evaluating efti in combination with pembrolizumab in patients with PD-L1 negative tumours.
The primary endpoint of the study is Overall Response Rate of evaluable patients according to RECIST 1.1. Secondary endpoints include Overall Survival, Overall Response Rate according to iRECIST, Progression Free Survival, and Duration of Response. For more information about the Phase IIb trial, visit clinicaltrials.gov (NCT04811027).
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-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
1,2 Burtness, B. et al. Pembrolizumab Alone or With Chemotherapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma in KEYNOTE-048: Subgroup Analysis by Programmed Death Ligand-1 Combined Positive Score. Journal of Clinical Oncology 2022 40:21, 2321-2332. Note, the
3 Burtness, B. et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study The Lancet Volume 394, Issue 10212, P1915-1928, Nov 2019.
FAQ
What are the results of Immutep's TACTI-003 Phase IIb trial in HNSCC patients?
How does the combination of efti and KEYTRUDA® compare to anti-PD-1 monotherapy in HNSCC?
What safety profile was observed in Immutep's TACTI-003 trial?
Did the TACTI-003 trial for IMMP achieve any regulatory designations?
When will the webcast discussing Immutep's clinical data be held?
