The P-II (SUMMIT) basket trial evaluating neratinib in 582 patients with EGFR exon 18-mutant NSCLC. 79% of patients prior treated with an EGFR-targeted TKI
In an interim efficacy, the therapy showed ORR (35%), 30% of patients pretreated with TKIs, and 50% not pretreated with TKIs, response or SD lasting for ≥ 48wks. was observed in 7 patients (6 PR, 1 SD), 3% permanently discontinued the treatment due to diarrhea
Neratinib was approved in the US for early-stage HER2-overexpressed/amplified breast cancer & is marketed as Nerlynx. The therapy was also approved in the US in combination with capecitabine for advanced or metastatic HER2+ breast cancer & has received EC’s marketing authorization for early-stage HR+ HER2-overexpressed/amplified breast cancer
Ref: Businesswire | Image: Puma Bio
