US Oncology Research Played Key Role in Neratinib Clinical Trial, FDA Approval

Nerlynx is indicated to treat early-stage HER2-positive breast cancer following trastuzumab-based therapy.

US Oncology Research and McKesson Specialty Health played a pivotal role in the clinical development and approval for (neratinib) Nerlynx, according to a press release.

Neratinib is a tyrosine kinase inhibitor approved by the FDA on July 17, 2017. It is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer previously treated with trastuzumab-based therapy.

The approval was based on the randomized, double-blind, multicenter, placebo-controlled ExteNET trial of neratinib following adjuvant trastuzumab treatment.

Included in the study were 2840 women with early-stage HER2-positive breast cancer randomized within 2 years of completing adjuvant trastuzumab to either receive neratinib or placebo for 1 year.

After 2 years of follow up, the results of the study showed a 34% reduction in recurrence risk in patients who received neratinib compared with placebo. Invasive disease-free survival was 94.2% in patients treated with neratinib compared with 91.9% in the placebo cohort.

A 27% reduction in risk of recurrence was observed with neratinib via an exploratory analysis after 5 years of follow up.

The most common adverse events (AEs) were diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight loss, and urinary tract infection. The most common AE leading to discontinuation was diarrhea.

“Neratinib gives our patients with HER2-positive tumors another highly effective oral treatment that can reduce the risk of their cancer returning,” said Frankie Ann Holmes, MD, oncologist with Texas Oncology and member of The US Oncology Network Breast Cancer Research Committee.

Dr Holmes was the principal investigator for US Oncology Research, which played a leading role in the neratinib clinical trial, according to the release. US Oncology Research enrolled the largest number of patients from any network, which represented approximately 10% of the 2840 trial participants from North and South America, Europe, Australia, New Zealand, and Japan, according to the release.

Neratinib is the 69th FDA approval to which US Oncology Research has contributed, according to the release.

“Collaboration between US Oncology Research and organizations such as Puma Biotechnology, Inc, are extremely critical to the success of clinical trials such as this,” Sandy Smith, vice president of US Oncology Research, said in the release. “Everyone involved in these trials understands the importance and significance of working together and the importance of always keeping the patient as the primary focus.”

US Oncology Research is the pioneering research arm of The US Oncology Network and is supported by McKesson Specialty Health, according to the release.