Immunotherapy combo doubles survival in hard-to-treat head and neck cancer, challenging standard of care

An ASX-listed biotech has released new survival data demonstrating the potential of its novel immunotherapy combination in first-line recurrent or metastatic head and neck squamous cell cancer (1L HNSCC) and PD-L1 expression below 1 (CPS <1).

Sydney-based Immutep reported a median overall survival (OS) of 17.6 months from its Phase IIb TACTI-003 (KEYNOTE-C34) trial using its first-in-class lymphocyte activation gene-3 (LAG-3) and MHC Class II agonist, eftilagimod alfa (efti), in combination with MSD’s anti-PD-1 therapy Keytruda (pembrolizumab).

Under current regulatory guidelines, anti-PD-1 monotherapy is limited to patients with higher PD-L1 expression, leaving chemotherapy-based regimens as the predominant treatment option for those with CPS <1.

“We are excited to see this strong survival benefit for head and neck cancer patients with such cold tumours. Combining these two complementary immunotherapies has led to a 7-fold increase in response rates and a more than doubling of median overall survival as compared to historical results from anti-PD-1 monotherapy,” said Marc Voigt, CEO of Immutep.

“Driving durable responses that translate into clinically meaningful survival holds tremendous promise for these patients in need of more tolerable and efficacious therapies.”

Immutep’s combination therapy outperformed historical benchmarks. Standard-of-care data shows median OS of 10.7 months for cetuximab plus chemotherapy, 11.3 months for anti-PD-1 plus chemotherapy, and only 7.9 months for anti-PD-1 monotherapy in 1L HNSCC patients with CPS <1.

“There is a high unmet need in 1L HNSCC patients with cold tumors and PD-L1 CPS <1, due to the lack of an approved immunotherapy-only treatment regimen and a lack of competitor trials with chemotherapy-free approaches targeting this patient population.

“Given the strength of the efficacy and safety results generated to date with efti in combination with pembrolizumab, we will meet with regulators to discuss next steps and potential paths to approval,” Voigt added.

Efti has already received Fast Track designation in 1L HNSCC, and Immutep has requested a meeting with the U.S. Food and Drug Administration (FDA) to explore regulatory pathways for approval in this patient group. The company continues to monitor patients in the TACTI-003 trial and plans to share further updates later this year.

Beyond head and neck cancer, efti is also being evaluated across a range of solid tumour indications, including non-small cell lung cancer (NSCLC) and metastatic breast cancer.

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