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LOS ANGELES--(BUSINESS WIRE)--Oct 27, 2022--
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented updated findings from the Phase II SUMMIT basket trial of neratinib for EGFR 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 exon 18-mutant non-small cell lung cancer: findings from the SUMMIT basket trial,” was presented by Alejandro Martínez Bueno, Head of Medical Oncology Service, Hospital Quirón Deuxes, Barcelona, Spain, on October 27 beginning at 10:00 a.m. CEST.
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, EGFR exon 18 or HER2 mutations. In the EGFR exon 18-mutant cohort, patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR tyrosine kinase inhibitor (TKI) naïve 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.
This 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).
The 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 ≥ 48 weeks was observed in 7 patients (6 PR, 1 SD). Final data will be presented at a later date.
The safety profile observed in the cohort of patients with EGFR 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.
Dr. Martínez, an investigator of the study from Hospital Quirón Deuxes, said, “We are very excited about these interim study results in patients with EGFR 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.”
Alan H. Auerbach, CEO and President of Puma Biotechnology, added, “We are very pleased to observe that treatment with neratinib led to meaningful responses in patients with EGFR 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.”
About Puma Biotechnology
Puma 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 ® (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.
In 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.
Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.
To 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 or 1-855-816-5421.
INDICATIONS:
NERLYNX ® (neratinib) tablets, for oral use, is a kinase inhibitor indicated:
IMPORTANT SAFETY INFORMATION Regarding NERLYNX® (neratinib) U.S. Indication:
CONTRAINDICATIONS: None
WARNINGS AND PRECAUTIONS:
ADVERSE REACTIONS: The most common adverse reactions (reported in ≥ 5% of patients) were as follows:
To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 orhttps://www.fda.gov/medwatch.
DRUG INTERACTIONS:
USE IN SPECIFIC POPULATIONS:
Please see Full Prescribing Information for additional safety information.
Forward-Looking Statements
This press release contains forward-looking statements, including statements regarding the development of Puma’s product candidates. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2021, and subsequent reports. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law.
View source version on businesswire.com:https://www.businesswire.com/news/home/20221027005333/en/
CONTACT: Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.comDavid Schull or Olipriya Das, Russo Partners, +1-212-845-4271
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
KEYWORD: CALIFORNIA EUROPE SPAIN UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: RESEARCH GENERAL HEALTH PHARMACEUTICAL ONCOLOGY PUBLIC RELATIONS/INVESTOR RELATIONS CLINICAL TRIALS SCIENCE BIOTECHNOLOGY COMMUNICATIONS FDA OTHER SCIENCE HEALTH
SOURCE: Puma Biotechnology, Inc.
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PUB: 10/27/2022 04:05 AM/DISC: 10/27/2022 04:06 AM
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