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April 8, 2019

Puma Biotechnology expands neratinib’s SUMMIT trial

Puma Biotechnology has expanded the Phase II SUMMIT clinical trial of its drug candidate neratinib to include cohorts of patients with HER2 mutant metastatic salivary gland cancer and those suffering from EGFR exon 18 mutation-positive lung cancer.

Puma Biotechnology has expanded the Phase II SUMMIT clinical trial of its drug candidate neratinib to include cohorts of patients with HER2 mutant metastatic salivary gland cancer and those suffering from EGFR exon 18 mutation-positive lung cancer.

The new cohorts will each recruit around 18 subjects. SUMMIT is an open-label, multi-centre, basket trial assessing the safety and efficacy of neratinib in patients having solid tumours with activating EGFR, or HER2 mutations.

Salivary gland cancer patients were initially included in the ‘other solid tumours with a HER2 mutation’ trial group. Based on the preliminary activity, a separate cohort is being created for this patient population, pursuant to the study protocol.

“We believe this once again demonstrates the value of the basket study approach, in particular for developing targeted therapy for rare diseases.”

Puma Biotechnology CEO and president Alan Auerbach said: “We are pleased to expand our evaluation of neratinib in metastatic HER2 mutant salivary gland cancer and exon 18 mutated lung cancer from SUMMIT, as they both represent orphan and deadly diseases with few treatment options.

“We believe this once again demonstrates the value of the basket study approach, in particular for developing targeted therapy for rare diseases with clinically-actionable mutations.”

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

The drug candidate is being developed to treat various tumours, including breast and cervical cancers.

Puma Biotechnology last month reported positive interim results from the cervical cancer cohort of the SUMMIT trial.

The cohort involved patients with advanced and/or metastatic disease and previously received a median of two regimens in the recurrent or metastatic setting.

Data showed an objective response rate of 27.3% and 54.5% clinical benefit rate. Median progression-free survival was observed to be seven months.

The Phase II SUMMIT trial commenced in 2013 and is expected to be completed in 2022.

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