On February 1, 2023 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Breast Cancer were updated to include an addition involving neratinib (NERLYNX) (Press release, Puma Biotechnology, FEB 1, 2023, View Source [SID1234626745]).
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The updated NCCN Practice Guidelines for Breast Cancer include neratinib combinations as category 2B potential targeted therapies for patients with ER+/HER2- or ER-/HER2- metastatic (stage IV) breast cancer and activating mutations in the HER2 gene as detected by next generation sequencing of tumor tissue or ctDNA. Neratinib is included 1) with or without fulvestrant, and 2) with or without trastuzumab/fulvestrant. The NCCN Guidelines’ Category of Preference is designated as "useful in certain circumstances" and for ER+/HER2- disease, "useful in certain circumstances in patients who have already received CDK 4/6 inhibitor therapy." This update is described in a table entitled, "Emerging Biomarkers to Identify Novel Therapies for Patients with Stage IV (M1) Disease."
This addition was based on results from the Phase 2 SUMMIT trial (NCT01953926), which enrolled a cohort of patients with locally assessed HR+/ HER2- metastatic breast cancer with activating HER2 mutations who had received prior CDK4/6 inhibitor therapy (Jhaveri KL, J Clin Oncol 2022; 40:1028-1028*), as well as results from the Phase 2 MutHER trial (NCT01670877), a single-arm, multi-cohort trial that evaluated neratinib in combination with fulvestrant in patients with HER2-mutated, non-amplified metastatic breast cancer (Ma CX, Clin Cancer Res 2022; 28:1258-1267**).
Additionally, in its recent update, NCCN included dose escalation in the neratinib dosing schedule for recurrent unresectable or metastatic breast cancer. The neratinib dose escalation schedule was previously included in the 2022 NCCN Guidelines for Breast Cancer under preoperative/adjuvant therapy regimens as an approach to improve the tolerability of neratinib in the treatment of adjuvant HER2-positive breast cancer. This latest update aligns with the labeling supplement to the U.S. Prescribing Information approved by the U.S. Food and Drug Administration in June 2021, which incorporated the use of NERLYNX dose escalation as evaluated in the Phase II CONTROL study.
Alan H. Auerbach, Chief Executive Officer and President of Puma, said, "We are pleased with the additional inclusion of neratinib in the NCCN Guidelines for Breast 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 breast cancer."
About HER2-Positive Breast Cancer
Up to 20% of patients with breast cancer tumors over-express the HER2 protein (HER2-positive disease) and in the ExteNET study, 57% of patients were found to have tumors that were hormone-receptor positive. HER2-positive breast cancer is often more aggressive than other types of breast cancer, increasing the risk of disease progression and death. Although research has shown that trastuzumab can reduce the risk of early stage HER2-positive breast cancer recurring, up to 25% of patients treated with trastuzumab experience recurrence within 10 years, the majority of which are metastatic recurrences.
About the National Comprehensive Cancer Network
The National Comprehensive Cancer Network (NCCN) is a not-for-profit alliance of leading cancer centers devoted to patient care, research, and education. NCCN is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) provide transparent, evidence-based, expert consensus recommendations for cancer treatment, prevention, and supportive services; they are the recognized standard for clinical direction and policy in cancer management and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The NCCN Guidelines for Patients provide expert cancer treatment information to inform and empower patients and caregivers, through support from the NCCN Foundation. NCCN also advances continuing education, global initiatives, policy, and research collaboration and publication in oncology. Visit NCCN.org for more information.