Interim Results Announced for SUMMIT Trial Evaluating Neratinib for Metastatic NSCLC


The results for the phase 2 SUMMIT trial examining neratinib to treat patients of metastatic non-small cell lung cancer (NSCLC) were recently announced by Puma Biotechnology.

Interim results were announced from the phase 2 SUMMIT trial examining neratinib to treat patients of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor (EGFR) exon 18 mutations who were previously treated with an EGFR targeted tyrosine kinase inhibitor (TKI), according to a Puma Biotechnology press release.

The open-label, multicenter, multinational, SUMMIT basket trial evaluates the safety and efficacy of neratinib administered daily to patients with solid tumors with activating EGFR exon 18 or HER2 mutations. More, patients of lung cancer with single or complex EGFR exon 18 mutations, who were previously exposed to EGFR TKI, were enrolled and administered received 240 mg of neratinib daily.

“These early study results are very exciting and may prove to be an effective option for NSCLC patients with EGFR exon 18 mutations for whom very few effective treatments exist once they fail first-line FDA approved TKI therapy,” Jonathan Goldman, MD, associate professor of hematology & oncology, associate director of drug development, and director of clinical trials in thoracic oncology at UCLA, said in a press release.

The interim results revealed that, of the 10 evaluable patients included in the cohort, 6 patients (60%) experienced a partial response, of which 4 patients (40%) had a confirmed partial response. More, 8 patients (80%) experienced a clinical benefit from treatment.

The median duration of response for the 10 patients was 7.5 months and the median progression free survival was recorded as 9.1 months. Both the 1st stage and the 2nd stage of the Simon’s 2-stage design met its success criteria, while enrollment for the 2nd stage continues.

The safety profile of the 11 patients who received neratinib reported no grade 3 or higher diarrhea for the subgroup with EGFR exon 18 mutated NSCLC. More, 4 patients (36%) reported grade 1 diarrhea and only 1 patient (9%) reported grade 2 diarrhea. Dose holds, dose reductions, hospitalizations or permanent discontinuation were not required due to diarrhea.

The study included 11 patients in its cohort who received 2 prior lines of therapy in the metastatic setting. Of those 11 patients, 10 were previously treated with an EGFR targeted TKI.

“We are very pleased with the preliminary activity seen with neratinib in this cohort of patients with EGFR exon 18 mutated NSCLC who have previously been treated with EGFR targeted tyrosine kinase inhibitors,” Alan H. Auerbach, CEO and president of Puma Biotechnology, said in a press release. “We believe that there is a need for new treatments for these patients and we look forward to the further development of neratinib in this patient population.”


Puma Biotechnology Announces Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18 Mutated, Metastatic Non-Small Cell Lung Cancer [news release]. Los Angeles, California. Published November 5, 2020. Accessed November 6, 2020.

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