Treatment with neratinib plus chemotherapy significantly improved progression-free survival for patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapies, according to the manufacturer.
Neratinib, marketed as Nerlynx, is a kinase inhibitor indicated for the extended adjuvant treatment of adult patients with HER2 overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.
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Researchers conducted the phase 3 NALA trial at sites in North America, Europe, Asia Pacific and South America. The analysis included 621 patients with previously treated metastatic HER2-positive breast cancer.
Patients were randomly assigned 1:1 to neratinib plus capecitabine or lapatinib plus capecitabine.
Results showed neratinib plus chemotherapy resulted in a statistically significant improvement in centrally confirmed progression-free survival compared with chemotherapy alone (P = .0059). The combination was associated with an improvement in overall survival, though the association did not reach statistical significant (P = .21).
Neratinib plus chemotherapy also improved the time to intervention for symptomatic brain metastases compared with lapatinib plus capecitabine (P = .043).
The safety of neratinib appeared consistent with previous studies of the agent.
Neratinib is not currently approved to treat HER2-positive breast cancer. The manufacturer said they plan to submit data to the FDA for approval in the near future.
“We are highly encouraged by these results from the NALA trial with the combination of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments,” Alan H Auerbach, Chief Executive Officer and President of Puma Biotechnology, said in a press release. “We look forward to working with the regulatory authorities in the hope of bringing another potential treatment option to patients with HER2-positive metastatic breast cancer as soon as possible."
Researchers plan to present full results from the NALA trial at an upcoming medical conference.