Puma Biotechnology has reported positive interim data from the Phase II SUMMIT clinical trial of neratinib in HER2-mutated, metastatic cervical cancer patients.

Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) designed to block signal transduction through the epidermal growth factor receptors (EGFRs), HER1, HER2 and HER4.

The ongoing, open-label, multi-centre Phase II basket trial is assessing the safety and efficacy of neratinib in HER2-mutated solid tumours.

Data from the cervical cancer cohort involved 11 subjects who had advanced and / or metastatic disease and previously received a median of two regimens in the recurrent or metastatic setting.

“We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer.”

The objective response rate was 27.3%, while the clinical benefit rate was 54.5%, with three patients experiencing confirmed partial responses and three having stable disease that lasted more than 16 weeks.

Results also showed seven months of median progression-free survival. The safety profile of the drug was found to be consistent with that observed in HER2-amplified metastatic breast cancer.

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The most frequent adverse event was diarrhoea. However, none of the diarrhoea events led to dose reduction, discontinuation or hospitalisation.

Puma Biotechnology CEO and president Alan Auerbach said: “We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer. We look forward to the further development of neratinib in this patient population.”

In Australia, neratinib (Nerlynx) has secured approval from the Therapeutic Goods Administration (TGA) to treat early-stage HER2-overexpressed/amplified breast cancer.

During clinical studies, the drug was found to significantly lower the risk of cancer recurrence or death by 42% at 12 months following the treatment.