Immutep Receives Positive Feedback from FDA on Late-Stage Clinical Development of Eftilagimod Alfa in Head and Neck Cancer with CPS <1
MWN-AI** Summary
Immutep Limited, an innovative immunotherapy company, announced on August 5, 2025, that it has received favorable feedback from the U.S. Food and Drug Administration (FDA) regarding its late-stage development of eftilagimod alfa (efti) for first-line treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) in patients with low PD-L1 expression (Combined Positive Score [CPS] <1). This feedback follows the promising results from the TACTI-003 Phase IIb trial, where efti was evaluated in combination with Merck's KEYTRUDA (pembrolizumab).
The FDA acknowledges the potential of this combination therapy to fill a significant treatment gap for patients with low PD-L1 expression, a group that currently has limited options—primarily chemotherapy. Immutep is now considering multiple development strategies, including a randomized registrational trial comparing efti with KEYTRUDA against standard therapies, or a smaller single-arm trial focusing on safety and efficacy outcomes, followed by further confirmatory studies.
Marc Voigt, CEO of Immutep, expressed satisfaction with the FDA's constructive input and highlighted the necessity of new treatment options for HNSCC patients with CPS <1. He reaffirmed the company's commitment to advancing their pivotal TACTI-004 Phase III trial for efti as a first-line therapy for non-small cell lung cancer, while also exploring collaborative approaches for head and neck cancer therapies. This aligns with the FDA's Project FrontRunner initiative, which aims to expedite the development and approval of innovative cancer treatments for advanced conditions.
Immutep, recognized for its pioneering work in LAG-3-based therapeutics, continues to strive for groundbreaking treatment solutions that address unmet medical needs in oncology and autoimmune diseases.
MWN-AI** Analysis
Immutep Limited (ASX: IMM; NASDAQ: IMMP) has garnered significant positive momentum following the FDA's supportive feedback on the late-stage clinical development of its immunotherapy candidate, eftilagimod alfa (efti), for treating head and neck squamous cell carcinoma (HNSCC) in patients with PD-L1 expression below 1. This development marks a pivotal moment for the company, offering potential pathways towards accelerated approval amid a high unmet need for effective treatments in this patient demographic.
The FDA's endorsement highlights the promising data from the TACTI-003 Phase IIb trial, which showcased the efficacy of combining efti with Merck's KEYTRUDA, addressing the void in treatment options for patients with CPS <1. As a result, investors should consider the implications of this FDA feedback as a crucial milestone that bodes well for future clinical trials and partnership opportunities.
With Project FrontRunner encouraging earlier drug development, Immutep is positioned to trailblaze in a substantial market segment. The potential for a randomized registrational trial versus standard-of-care options or a smaller study could expedite development timelines significantly. This represents a strategic opportunity for Immutep to capitalize on its innovative therapeutic platform.
However, investor caution is warranted. Although the outlook appears optimistic, there are inherent risks associated with clinical trials and regulatory approvals. The construction of trial designs, patient enrollment, and eventual efficacy results will be critical to meeting investor expectations. Therefore, while the current sentiment surrounding Immutep appears bullish, stakeholders should closely monitor trial progress and regulatory developments before making substantive investment decisions.
In summary, Immutep stands at a crossroads of opportunity and risk, and prudent investors should weigh the potential upside against clinical trial uncertainties as the company endeavors to reshape the treatment landscape for HNSCC.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
SYDNEY, AUSTRALIA, Aug. 05, 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 it has received positive and constructive feedback from the US Food and Drug Administration (FDA), regarding future clinical development of its first-in-class MHC Class II agonist, eftilagimod alfa (“efti”), for first line treatment of recurrent/metastatic head and neck squamous cell carcinoma (1L HNSCC) patients who have PD-L1 expression below 1 (Combined Positive Score [CPS] <1).
Based on its review of the encouraging data in 1L HNSCC with CPS <1 from the TACTI-003 (KEYNOTE-C34) Phase IIb trial evaluating efti in combination with MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 KEYTRUDA ® (pembrolizumab), the FDA agreed on the potential of efti in combination with KEYTRUDA to address the high unmet need in this CPS <1 patient segment and is supportive of the combination’s further development.
Paths for future clinical development and potential accelerated approval in light of the FDA’s Project FrontRunner include a randomised registrational trial evaluating efti in combination with KEYTRUDA against standard-of-care therapy or alternatively a smaller single-arm study (e.g. 70 - 90 patients) with safety, response rate, and duration of response as key endpoints, followed by a confirmatory randomised study that builds on the existing data.
“We are pleased with the FDA’s feedback and guidance that underscores the high unmet need of head and neck cancer patients whose PD-L1 expression level is below one. The FDA feedback positions Immutep to evaluate options for future collaborative clinical development paths to bring a new, effective and safe treatment option to this underserved patient population,” said Marc Voigt, CEO of Immutep.
“Our primary focus clearly remains the pivotal TACTI-004 Phase III evaluating efti as first line therapy for non-small cell lung cancer and we are excited with its progress to date and the consistent, encouraging feedback we hear from physicians. This focus and additional considerations will be reviewed internally and discussed with stakeholders and potential strategic partners in regards to forward paths in head and neck cancer,” added Mr Voigt.
Project FrontRunner is an FDA Oncology Center of Excellence (OCE) initiative to encourage drug sponsors to consider when it may be appropriate to develop and seek approval of cancer drugs for advanced/metastatic disease, in an earlier clinical setting rather than the usual approach to develop and seek approval of a drug for treatment of patients who have received numerous prior lines of therapies or have exhausted available treatment options. In this setting, advancing new effective therapies has the greatest potential to significantly improve quantity and quality of patients’ lives.
Patients with CPS <1 in 1L HNSCC represent a treatment population with high unmet medical need. Up to 20% of 1L HNSCC patients have CPS <1 and despite immunotherapy’s progress in fighting cancer, anti-PD-1 therapy alone (without chemotherapy) is only approved for patients who express PD-L1 (CPS > 1). All currently available treatment options for patients with PD-L1 CPS <1 include chemotherapy.
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 .
KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.
Australian Investors/Media:
Eleanor Pearson, Sodali & Co.
+61 2 9066 4071; eleanor.pearson@sodali.com
U.S. Investors/Media:
Chris Basta, VP, Investor Relations and Corporate Communications
+1 (631) 318 4000; chris.basta@immutep.com
FAQ**
How does Immutep Limited (ASX: IMM; NASDAQ: IMMP) plan to leverage FDA feedback for its clinical development of eftilagimod alfa in HNSCC patients with CPS <1 in terms of investment opportunities?
What potential collaborations or partnerships is Immutep Limited (ASX: IMM; NASDAQ: IMMP) exploring to advance the development of eftilagimod alfa in recurrent/metastatic head and neck cancer?
Given the FDA's positive feedback, what is Immutep Limited (ASX: IMM; NASDAQ: IMMP)'s timeline for launching the next phase of clinical trials for eftilagimod alfa, particularly regarding accelerated approval paths?
How is Immutep Limited (ASX: IMM; NASDAQ: IMMP) positioning itself financially to address the high unmet need for treatment options in CPS <1 1L HNSCC patients amidst ongoing trials for non-small cell lung cancer?
**MWN-AI FAQ is based on asking OpenAI questions about Immutep Limited (NASDAQ: IMMP).
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