On June 4, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that 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 (Free ASCO Whitepaper) Annual Meeting (Press release, Puma Biotechnology, JUN 4, 2021, View Source [SID1234583593]). 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).

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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.

Jonathan W. Goldman, MD, Associate Professor of Hematology & Oncology, Associate Director of Drug Development and Director of Clinical Trials in Thoracic Oncology at UCLA, an investigator on the trial, said, "EGFR exon 18-mutant lung cancer patients have no effective targeted options after first-line FDA-approved EGFR TKI therapy. This study shows that neratinib has the potential to be an efficacious and safe option to treat their disease, possibly with CNS activity as well."

Alan H. Auerbach, Chief Executive Officer and President of Puma, added, "The descriptive findings from this study indicate that neratinib may have a role as a treatment option for rare cancers. We are excited to explore the full potential of neratinib and help patients with difficult to treat conditions."