Results from the Phase II SUMMIT study evaluating the safety and efficacy of neratinib in HER2-mutated cancers have been published. According to Puma Biotechnology Inc. (NASDAQ:PBYI), a company focused on enhancing cancer care across the globe. The data of the Phase II SUMMIT ‘basket’ trial were published in the journal Gynecologic Oncology.
Sixteen patients with a broad range of cancers and whose tumors harbor activating HER2 somatic mutations received a daily neratinib dose. There was also a mandatory administration of loperamide prophylaxis during the first cycle.
Encouraging Clinical Activity in Metastatic Cervical Cancer Patients
The data was presented during the scientific plenary session at the Society of Gynecologic Oncology (SGO). According to Dr. Bradley J. Monk, the Medical Director of the US Oncology Research Network Gynecological Program, Neratinib’s clinical activity was encouraging. A consistent safety profile was observed in cervical cancer patients.
Nonetheless, various adverse events included decreased appetite of 38%, nausea, and diarrhea at 44% and 75%, respectively.
“We are very pleased with the activity seen with neratinib in this cohort of patients with HER2-mutated cervical cancer,’’ the CEO of Puma Alan H. Auerbach, announced. The results warrant the need for further investigation of Neratinib, given the failure of platinum-based therapy and now the limited options for treating cervical cancer.
The Inducement Awards to Puma under NASDAQ Listing Rule 5635(c) (4)
Puma says that it has received marketing authorization for NERLYNX® (neratinib) from the European Commission (EC). It continues to put its commitment and dedication to supporting clinical testing of drug candidates in different development levels. The company has the expertise and the technology to accomplish these goals all in the name of improving the lives of the cancer population. The biotech is among the many other companies combating the killer disease.
Meanwhile, Puma’s grant of inducement restricted stock unit awards was approved by the Compensation Committee of Puma’s Board of Directors. The award granted under Puma’s 2017 Employment Inducement Incentive Award Plan covers an aggregate of 32,000 shares of Puma common stock and six new non-executive employees.