Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib for HER2-Mutant, Recurrent/Metastatic Cervical Cancer at the ESMO Congress 2022

LOS ANGELES--(BUSINESS WIRE)--Sep 11, 2022--

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the presentation of updated findings from the Phase II SUMMIT basket trial of neratinib for HER2 (ERBB2)-mutant, metastatic cervical cancer at the 2022 European Society for Medical Oncology (ESMO) Congress, currently taking place in Paris, France. The poster (#559P) entitled, "Neratinib in HER2 -mutant, recurrent/metastatic cervical cancer: updated findings from the phase 2 SUMMIT basket trial,” was presented by Claire F. Friedman, M.D., Melanoma and Immunotherapy Service, Memorial Sloan Kettering Cancer Center, on September 11 at 11:10 a.m. CEST.

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The Phase II SUMMIT ‘basket’ trial is an open-label, multicenter, multi-national study evaluating the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating, somatic HER2 mutations. The cervical cancer cohort was comprised of 22 patients with persistent, recurrent, or metastatic cervical cancer and a HER2 mutation, as documented by institutional testing at a CLIA/CAP- (or regionally equivalent) certified laboratory. Patients were treated with neratinib monotherapy (240 mg/day); 22 patients (100%) had previously received platinum-based chemotherapy, 16 patients (73%) had prior bevacizumab, and 4 patients (18%) received prior pembrolizumab. Overall, the objective response rate was 18.2% (95% CI: 5.2–40.3%) and the clinical benefit rate was 45.5% (95% CI: 24.4–67.8%), which included 1 patient with a confirmed complete response, 3 patients with confirmed partial responses, and 6 patients with stable disease at equal or greater than 16 weeks. The median progression-free survival was 5.1 months (95% CI: 1.7–7.2 months). Among the 13 patients (59.1%) who had tumors with a highly activating HER2 S310F/Y mutation, 4 had confirmed responses.