Puma: Interim Phase 2 Results for Neratinib in Lung Cancer at WCLC 2020

 The interim efficacy results from the trial showed that for the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, 6 patients (60%) experienced a partial response, which included 4 patients (40%) with a confirmed partial response. 8 patients (80%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 16 weeks). The median duration of response was 7.5 months and the median progression-free survival was 9.1 months. The success criteria for both the 1^st stage and the 2^nd stage of the Simon’s 2-stage design were met and enrollment in the 2^nd stage of this cohort continues.

The safety profile observed in the subgroup of patients with EGFR exon 18-mutated NSCLC showed that for the 11 patients who received neratinib in the trial, there were no reports of grade 3 or higher diarrhea. 4 patients (36%) reported grade 1 and 1 patient (9%) reported grade 2 diarrhea. No patients required a dose hold, dose reduction, hospitalization or permanently discontinued neratinib due to diarrhea.

Dr. Boni, an investigator of the trial, said, “We are very excited about these early study results in EGFR exon 18 mutant lung cancer, for whom very few effective treatment options are available once they fail first-line FDA approved EGFR TKI therapy.”

https://www.biospace.com/article/releases/puma-biotechnology-presents-interim-results-from-the-phase-ii-summit-trial-of-neratinib-for-egfr-exon-18-mutated-metastatic-non-small-cell-lung-cancer-at-wclc-2020/