PBYI - Puma's Nerlynx shows promise in lung cancer patients in phase 2 trial

Puma Biotechnology ( NASDAQ: PBYI ) reported updated data from a phase 2 basket trial called SUMMIT of neratinib to treat patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC).

Neratinib is approved in the U.S. under the name Nerlynx to treat certain patients with a type of breast cancer.

In the EGFR exon 18-mutant group, patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR tyrosine kinase inhibitor (TKI) naïve or were previously exposed to EGFR TKI, were enrolled in the study and received 240 mg of neratinib monotherapy once daily.

Puma said that the interim data showed that the objective response rate (ORR) was 35% overall, 30% in patients pretreated with TKIs, and 50% in patients not pretreated with TKIs.

In addition, Response or stable disease lasting for ? 48 weeks was seen in 7 patients.

The company noted that the safety profile in the group of patients with EGFR exon 18-mutant NSCLC showed that for the 31 patients who received at least one dose of neratinib, diarrhea, constipation, and nausea were the most commonly reported adverse events.

There were no reports of grade 4 diarrhea, 3 patients had grade 3 diarrhea, and 1 patient permanently discontinued neratinib due to diarrhea, according to the company.

Puma said final data from the study will be presented at a later date.

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