{"id":701503,"date":"2022-10-27T04:08:08","date_gmt":"2022-10-27T08:08:08","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/puma-biotechnology-presents-updated-findings-from-the-phase-ii-summit-basket-trial-of-neratinib-in-egfr-exon-18-mutant-nsclc-at-the-2022-eortc-nci-aacr-symposium\/"},"modified":"2022-10-27T04:08:08","modified_gmt":"2022-10-27T08:08:08","slug":"puma-biotechnology-presents-updated-findings-from-the-phase-ii-summit-basket-trial-of-neratinib-in-egfr-exon-18-mutant-nsclc-at-the-2022-eortc-nci-aacr-symposium","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/puma-biotechnology-presents-updated-findings-from-the-phase-ii-summit-basket-trial-of-neratinib-in-egfr-exon-18-mutant-nsclc-at-the-2022-eortc-nci-aacr-symposium\/","title":{"rendered":"Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR Exon 18-Mutant NSCLC at the 2022 EORTC\/NCI\/AACR Symposium"},"content":{"rendered":"

<\/p>\n

Puma Biotechnology Presents Updated Findings from the Phase II SUMMIT Basket Trial of Neratinib in EGFR<\/i> Exon 18-Mutant NSCLC <\/b>at the 2022 EORTC\/NCI\/AACR Symposium<\/b><\/p>\n

LOS ANGELES–(BUSINESS WIRE<\/a>)–
\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented updated findings from the Phase II SUMMIT basket trial of neratinib for EGFR<\/i> exon 18-mutant non-small cell lung cancer (NSCLC) patients at the EORTC\/NCI\/AACR Molecular Targets and Cancer Therapeutics Symposium that is taking place in Barcelona, Spain. The poster, entitled, “Neratinib efficacy in patients with EGFR<\/i> exon 18-mutant non-small cell lung cancer: findings from the SUMMIT basket trial,\u201d was presented by Alejandro Mart\u00ednez Bueno, Head of Medical Oncology Service, Hospital Quir\u00f3n Deuxes, Barcelona, Spain, on October 27 beginning at 10:00 a.m. CEST.\n<\/p>\n

\nThe Phase II SUMMIT \u2018basket\u2019 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, EGFR<\/i> exon 18 or HER2<\/i> mutations. In the EGFR<\/i> exon 18-mutant cohort, patients with lung cancer with single or complex EGFR<\/i> exon 18 mutations, who were EGFR tyrosine kinase inhibitor (TKI) na\u00efve or were previously exposed to EGFR TKI, were enrolled into this study and received 240 mg of neratinib monotherapy once daily. Anti-diarrheal prophylaxis with loperamide was required for the first 2 cycles.\n<\/p>\n

\nThis cohort of 29 patients had received 1-6 prior lines of therapy in the metastatic setting before entering the trial. Twenty-three patients (79%) had been previously treated with an EGFR-targeted TKI (e.g., afatinib, osimertinib).\n<\/p>\n

\nThe interim efficacy results showed that the objective response rate (ORR) was 35% overall, 30% in patients pretreated with TKIs, and 50% in patients not pretreated with TKIs. Response or stable disease lasting for \u2265 48 weeks was observed in 7 patients (6 PR, 1 SD). Final data will be presented at a later date.\n<\/p>\n

\nThe safety profile observed in the cohort of patients with EGFR<\/i> exon 18-mutant NSCLC showed that for the 31 patients who received at least one dose of neratinib, diarrhea, constipation, and nausea were the most commonly reported adverse events. There were no reports of grade 4 diarrhea, 3 patients (10%) reported grade 3 diarrhea, and 1 patient (3%) permanently discontinued neratinib due to diarrhea.\n<\/p>\n

\nDr. Mart\u00ednez, an investigator of the study from Hospital Quir\u00f3n Deuxes, said, \u201cWe are very excited about these interim study results in patients with EGFR<\/i> exon 18-mutant lung cancer, for whom treatment options are limited. This study shows that neratinib has the potential to be an efficacious and safe option to treat their disease, even following treatment with other TKIs and chemotherapy.\u201d\n<\/p>\n

\nAlan H. Auerbach, CEO and President of Puma Biotechnology, added, \u201cWe are very pleased to observe that treatment with neratinib led to meaningful responses in patients with EGFR<\/i> exon 18-mutated NSCLC. Improving the lives of our cancer patients is our foremost goal, and we are pleased to see the benefit that was provided to these patients in the SUMMIT trial.\u201d\n<\/p>\n

About Puma Biotechnology<\/strong><\/p>\n

\nPuma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed\/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX\u00ae<\/sup> (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed\/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.\n<\/p>\n

\nIn September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer.\n<\/p>\n

\nFurther information about Puma Biotechnology may be found at https:\/\/www.pumabiotechnology.com<\/a>.\n<\/p>\n

\nTo help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at https:\/\/www.NERLYNX.com<\/a> or 1-855-816-5421.\n<\/p>\n

INDICATIONS:<\/b><\/p>\n

NERLYNX\u00ae<\/sup> (neratinib) tablets, for oral use, is a kinase inhibitor indicated:<\/b><\/p>\n