Breast cancer treatment Nerlynx (neratinib) will be exclusively commercialized in Canada by Knight Therapeutics, under an agreement with the therapy’s developer, Puma Biotechnology.
Nerlynx is currently being reviewed by Health Canada as a way to reduce the risk of recurrence among breast cancer patients who underwent surgery and received trastuzumab-based therapy.
According to the terms of the exclusive licensing agreement, Knight will be responsible for all commercial activities and future regulatory submissions of Nerlynx in Canada.
“We are excited to partner with Puma to offer a new treatment option to Canadian breast cancer patients,” Jonathan Ross Goodman, CEO of Knight, said in a press release.
“While adjuvant trastuzumab-based therapy has been shown to reduce the risk of recurrence in early stage HER2-positive breast cancer, up to 25% of patients treated with adjuvant trastuzumab will have a recurrence. Nerlynx has been shown to significantly reduce the risk of recurrence in those patients who were previously treated with trastuzumab,” he added.
Nerlynx works by blocking the action of several proteins that promote cell growth, including epidermal growth factor receptors (EGFRs) and human epidermal growth factor receptor 2 (HER2).
The treatment is already approved in the U.S. and Europe as an extended adjuvant treatment for early-stage, HER2-positive breast cancer patients who received prior Herceptin (trastuzumab) or a trastuzumab-based therapy as part of their adjuvant treatment.
An adjuvant treatment is one given after the primary treatment – usually surgery – to lower the risk that the cancer will come back.
The approvals were supported by data from the ExteNET Phase 3 trial (NCT00878709), where Nerlynx significantly delayed the time to invasive disease or death — meaning patients lived longer without a recurrence.
The trial included 2,840 patients with early-stage, HER2-positive breast cancer who had completed treatment with Herceptin within the previous year and had not experienced recurrence or metastatic disease.
Participants were randomly assigned Nerlynx or a placebo, given continuously for one year.
After five years, more patients on Nerlynx remained without invasive disease (90.2%) than those on placebo (87.7%). Overall, the risk of invasive disease or death was decreased by 27% in Nerlynx-treated patients.
Nerlynx was particularly effective among patients who were also hormone receptor positive, reducing the risk of invasive disease or death at five years by 42% and the risk of metastasis or death by 43%.
Some of the most common adverse reactions were diarrhea, nausea, abdominal pain, fatigue, vomiting, and changes in liver enzymes. A significant proportion of patients (16.8%) discontinued treatment due to diarrhea, leading researchers to advise loperamide treatment (sold as Imodium, among others) in the first 56 days of treatment.
“Our new agreement with Knight demonstrates our commitment to bringing Nerlynx to patients around the world while continuing to focus our commercial resources on the U.S. market,” said Alan H. Auerbach, CEO and president of Puma. “We are confident this new partnership will help patients in Canada access Nerlynx at the earliest opportunity.”