Lung cancer patients, mesothelioma patients and oncologists are closely following a Phase II clinical trial after researchers reported “unprecedented response rates” in lung cancer patients. All of the patients who were treated with a previously abandoned drug showed some tumor shrinkage.
A team of researchers from the Moon Shots program at MD Anderson Cancer Center were looking for a way to treat patients with the epidermal growth factor receptor (EGFR) mutation called an exon 20 insertion. Referred to as a “harsh” or treatment-resistant mutation, it is extremely challenging, if not impossible, to treat in non-small cell lung cancer patients.
The team turned to poziotinib, an investigational oncology drug from Spectrum Pharmaceuticals, a U.S. based biotechnology company with a core mission to bring pharmaceutical products to patients for unmet medical needs. Although, according to the researchers, poziotinib “had been tried and abandoned as a general EGFR inhibitor against lung cancer,” they looked twice after a drug-screening program pointed to it.
In the study of 11 non-small cell lung cancer patients who expressed EGFR exon 20 insertion treated with poziotinib, all patients experienced some tumor shrinkage. Eight of the 11 patients saw their tumors shrink by at least 30 percent. The shrinkage ranged from 30 percent to 50 percent among the eight patients reaching partial response. The trial began in March and is scheduled to run through March 2021. The goal is to recruit 80 patients.
“These early results are highly encouraging, and our research shows that poziotinib’s structure makes it a great potential fit for attacking this mutation,” said clinical trial leader John Heymach, M.D., Ph.D., chair of Thoracic/Head and Neck Medical Oncology at MD Anderson and holder of the David Bruton Junior Chair in Cancer Research in an Oct. 17 press release.
The EGFR gene has been the focus of researchers for finding new, effective treatments for both lung cancer and mesothelioma patients. The gene, that is overexpressed in more than 50% of pleural mesothelioma patients, and in approximately 15% of lung cancer patients, is one of the primary targets for bringing personalized care to the cancer patients. About two percent, or 3,500 annually in the U.S., of non-small cell lung cancer patients have an EGFR exon 20 insertion.
Patients with pleural mesothelioma, an asbestos-caused cancer that infects the lining of the lungs, often undergo a treatment protocol the same as lung cancer patients. The move to targeted medicine, where oncologists check for genetic biomarkers like the EGFR exon 20 insertion, often drives the selection of the drug more than the cancer itself. Research like this is critical for extending the survival of mesothelioma, an incurable cancer. See here for information on the first drug approved by the FDA based on a biomarker and not the cancer type.
Expert Insight“We are greatly encouraged with the clinical data emerging from poziotinib and plan to pursue its clinical development expeditiously and aggressively.”
This research is being funded by the Lung Cancer Moon Shots Program. Preliminary results were presented at the International Association for the Study of Lung Cancer 18th World Conference on Lung Cancer in Yokohama, Japan in October.
The Moon Shots Program, launched in Sept. 2012, was undertaken “to dramatically accelerate the pace of converting scientific discoveries into clinical advances that reduce cancer deaths.” According to the website, “the Lung Cancer Moon Shot team, led by Dr. Heymech, is revolutionizing the conventional medical research approach to rapidly adapt pre-clinical findings into lung cancer treatment options.”
“To date poziotinib has shown promising results in patients with exon 20 insertion mutations and we are fortunate to be leading the efforts in the continuing development of this product,” said Dr. Heymech.
To find out more about the trial see ClinicalTrials.gov.