Immutep’s Breakthrough Immunotherapy Delivers Strong Survival Gains in ASX200 Cancer Trial

May 05, 2025 02:54 PM AEST | By Team Kalkine Media

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Immutep’s Breakthrough Immunotherapy Delivers Strong Survival Gains in ASX200 Cancer Trial — Image source: Shutterstock

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Highlights

Strong survival outcomes in head and neck cancer trial

Potential step forward in chemotherapy-free immunotherapy

Addresses high unmet need in immune-resistant tumours

Immutep (ASX:IMM) has released promising results from its Phase IIb TACTI-003 (Keynote-C34) trial, demonstrating encouraging overall survival outcomes for patients with recurrent or metastatic head and neck squamous cell carcinoma (1L HNSCC). The trial focused on individuals whose tumours show low levels of PD-L1 protein expression (combined positive score <1), a group that currently lacks approved chemotherapy-free treatment options.

The combination therapy of eftilagimod alfa (efti), Immutep’s proprietary immune-stimulating agent, with the widely used anti-PD-1 therapy Keytruda (pembrolizumab), delivered a median overall survival of 17.6 months. This represents a notable advancement for patients who historically have had limited response to immunotherapy alone.

Importantly, the trial data confirmed that this combination continues to show a favourable safety profile, with no new adverse events reported. This supports the potential for less toxic treatment regimens compared to conventional chemotherapy-heavy protocols.

The patient group in focus — those with PD-L1 CPS <1 — accounts for around 20% of individuals diagnosed with first-line HNSCC. Currently, all available options for these patients involve chemotherapy. The latest trial results mark a significant development by delivering a sevenfold increase in response rates and doubling of survival times compared to previous results with anti-PD-1 therapy on its own.

The trial builds on earlier positive data, including multiple complete responses. Immutep’s CEO noted that the combination approach is particularly promising for patients with immune-resistant or “cold” tumours, providing evidence that dual immunotherapy can activate both innate and adaptive immunity effectively.

This innovation is timely, considering the ongoing demand for more tolerable treatment pathways. With no approved immunotherapy-only regimens currently available for this subgroup and limited competition in the chemotherapy-free space, these findings address a clear unmet medical need.

Efti’s ability to combine safely with other treatments positions it as a versatile candidate for multiple cancers. The agent is also being studied in non-small cell lung cancer and metastatic breast cancer, and has received fast-track designation from the US FDA for use in both HNSCC and NSCLC.

As Immutep (IMM) advances its clinical pipeline, this breakthrough aligns with broader market interests in ASX dividend stocks, where healthcare and biotech sectors continue to attract attention. Moreover, as a component of the ASX200, the company’s latest progress underscores its growing influence within Australia's premier equity index.

Further regulatory discussions are expected as Immutep explores the next steps toward potential approval of this combination therapy, offering new hope for a patient group long underserved by existing treatments.

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