Puma Biotechnology's neratinib (NERLYNX®) has been included in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Cervical Cancer. The update recommends neratinib monotherapy as a second-line or subsequent treatment option for patients with recurrent or metastatic cervical cancer harboring HER2 mutations.
The NCCN guidelines now list neratinib as a Category 2A preference, suggesting it is a useful treatment in certain circumstances for HER2-mutated tumors. This inclusion is based on data from the Phase II SUMMIT trial (NCT01953926), which evaluated neratinib in patients with histologically confirmed recurrent or metastatic cervical cancer who had no curative treatment options and demonstrated somatic, activating HER2 mutations.
Clinical Evidence from the SUMMIT Trial
The Phase II SUMMIT trial (NCT01953926) provided the clinical evidence supporting the NCCN's decision. The trial focused on patients with recurrent or metastatic cervical cancer who had documented HER2 mutations and for whom no curative treatments were available. The results of this trial demonstrated the potential of neratinib in this specific patient population.
HER2 Mutations in Cervical Cancer
HER2 (ERBB2) mutations are found in up to 9% of cervical cancers and are associated with a poorer prognosis. Identifying these mutations is crucial for directing therapy choices toward targeted treatments. A recent study highlighted HER2 mutations as one of the more prevalent genomic alterations in cervical cancer, underscoring the need for therapies that specifically target this mutation.
Expert Commentary
Alan H. Auerbach, CEO and President of Puma Biotechnology, stated, "We are pleased with the additional inclusion of neratinib in the NCCN Guidelines for Cervical Cancer for patients with HER2 activating mutations. Physicians use the NCCN Guidelines as the standard resource for determining the best course of treatment for patients. We believe the updated NCCN guidelines will increase awareness, which will help assist patients, their caregivers and their healthcare providers in making informed decisions while treating this significant unmet need in advanced cervical cancer."
About NERLYNX
NERLYNX® (neratinib) is an oral kinase inhibitor. It is approved by the FDA as a single agent for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, following adjuvant trastuzumab-based therapy. It is also approved in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
Safety Information
Key safety considerations for NERLYNX include managing diarrhea through dose adjustments or loperamide prophylaxis, monitoring for hepatotoxicity, and advising women of potential embryo-fetal toxicity. Common adverse reactions include diarrhea, nausea, abdominal pain, and fatigue. Drug interactions should be carefully considered, especially with gastric acid-reducing agents and CYP3A4 inhibitors.
