NEW YORK – The National Comprehensive Cancer Network's Oncology Research Program on Thursday announced the selection of three projects exploring the activity of Puma Biotechnology's neratinib (Nerlynx) in various gastric cancer indications, which will be supported by $1.4 million from the drug sponsor.
The studies, which NCCN's research program will oversee, are slated to begin in late 2021 and continue over two years. The study proposals were reviewed by NCCN and chosen based on scientific merit, existing data, feasibility, and the types of studies needed to further understand the safety and efficacy of neratinib.
Among the studies chosen by NCCN is a Phase II trial out of Moffitt Cancer Center that will explore neratinib in combination with chemotherapy and trastuzumab (Genentech's Herceptin) in HER2-overexpressing gastroesophageal cancers. This study will be led by Rutika Mehta, a medical oncologist at Moffitt.
Another funded program is a multicenter Phase I trial of neratinib and fam-trastuzumab deruxtecan (Daiichi Sankyo/AstraZeneca's Enhertu) in advanced refractory gastric cancer patients. That study is led by Namrata Vijayvergia, assistant chief of gastrointestinal medical oncology at Fox Chase Cancer Center.
The third funded study is exploring neratinib in the noncancerous genetic disorder neurofibromatosis 2, or NF2, and progressive NF2-related neoplasms.
Neratinib is currently approved in the US as an adjuvant treatment after adjuvant trastuzumab-based therapy for patients with early-stage HER2-positive breast cancer and as a combination treatment with capecitabine for patients with advanced or metastatic, HER2-positive breast cancer who have received two or more anti-HER2 therapies.