Puma Biotechnology Presents Data from the EGFR Exon 18-mutant NSCLC Cohort of the Phase II SUMMIT Trial at the 2021 ASCO Annual Meeting
June 04, 2021 at 09:05 am EDT
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Puma Biotechnology, Inc., presented interim results from the Phase II SUMMIT basket trial, assessing the efficacy of neratinib in patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC), including patients with central nervous system (CNS) involvement, at the virtual 2021 ASCO Annual Meeting. The presentation, entitled “Neratinib efficacy in a subgroup of patients with EGFR exon 18-mutant non-small cell lung cancer and central nervous system involvement: findings from the SUMMIT basket trial,” is included in the Lung Cancer—Non-Small Cell Metastatic Poster Session (#9068). The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study that includes a cohort evaluating the safety and efficacy of neratinib administered daily to patients with EGFR exon 18-mutant non-small cell lung cancer (NSCLC). Patients received 240 mg of neratinib daily as a single agent with mandatory loperamide prophylaxis. A cohort of 11 patients with EGFR exon 18-mutant NSCLC from the Phase II SUMMIT basket trial, including patients with central nervous system involvement, were evaluated for safety and efficacy. Prior lines of therapies included EGFR tyrosine kinase inhibitors (TKIs) (91%), chemotherapy (55%) and checkpoint inhibitors (IOs) (27%). Patients with stable, asymptomatic CNS metastasis were enrolled. Of the 11 patients, 3 patients had baseline CNS metastasis. Of the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, 6 patients (60%) experienced a partial response (PR), and 4 patients (40%) demonstrated a confirmed partial response. Four additional patients showed stable disease (SD) lasting =16 weeks – bringing the experienced clinical benefit that includes confirmed complete response or partial response or stable disease for at least 16 weeks to 80%. The median duration of response (DOR) was 7.5 months, and the median progression-free survival (PFS) was 9.1 months with some patients remaining on treatment. Of the 3 patients who had CNS metastases, best responses were 2 PR and 1 SD and individual PFS times were 1.9 to 9.1 months. These results suggest that neratinib can be a potential treatment option for patients with NSCLC and hard-to-treat CNS metastases. Neratinib was well tolerated in this study, with no occurrences of grade 3 diarrhea reported and there was no incident of any patient requiring a dose hold, dose reduction, hospitalization, or discontinuation of treatment due to diarrhea.
Puma Biotechnology, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of products to enhance cancer care. The Company's lead product is NERLYNX, an oral version of neratinib, for the treatment of HER2-positive breast cancer. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4 It also engaged in the development and commercialization of, alisertib. Alisertib is a selective, small molecule inhibitor of aurora kinase A that is designed to disrupt mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Its neratinib has clinical application in the treatment of several other cancers as well, including other tumor types that over-express or have a mutation in HER2 or epidermal growth factor receptor (EGFR), such as breast cancer, cervical cancer, lung cancer, or other solid tumors.
PUMA BIOTECHNOLOGY, INC. 
