On December 12, 2019 Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, reported that its collaborators at The Institute of Cancer Research, London, presented results from the cohort of patients in the plasmaMATCH trial treated with Puma’s drug neratinib at the 2019 San Antonio Breast Cancer Symposium (SABCS) in San Antonio, Texas (Press release, Puma Biotechnology, DEC 12, 2019, View Source [SID1234552317]). The oral presentation entitled, "Results from the plasmaMATCH trial: A multiple parallel cohort, multi-centre clinical trial of circulating tumour DNA testing to direct targeted therapies in patients with advanced breast cancer (CRUK/15/010)," and the poster presentation entitled, "Results from plasmaMATCH trial treatment Cohort B: A phase II trial of neratinib plus fulvestrant in ER positive breast cancer or neratinib alone in ER negative breast cancer in patients with a ERBB2 (HER2) mutation identified via ctDNA screening (CRUK/15/010)" were presented by Professor Nicholas Turner, M.D., Ph.D., Professor of Molecular Oncology at The Institute of Cancer Research (ICR) and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, who is the principal investigator of the plasmaMATCH trial, and Andrew M. Wardley, M.D., consultant medical oncologist at The Christie NHS Foundation Trust in Manchester, England and Medical Director of the National Institute for Health Research (NIHR) Manchester Clinical Research Facility at The Christie, respectively. The plasmaMATCH trial was funded by Cancer Research UK.
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The plasma-based Molecular profiling of Advanced breast cancer to inform Therapeutic Choices (plasmaMATCH) trial is a phase IIa, multiple parallel cohort, open-label, multicentre trial in patients with advanced breast cancer, which aims to assess whether analyzing a blood sample for circulating tumor DNA (ctDNA) could provide an alternative to biopsies for identifying the genetic mutations present in advanced breast cancer and whether subgroups of patients with advanced breast cancer, identified through ctDNA screening, may benefit from a treatment targeting their type of cancer.
Approximately 1,044 patients with advanced breast cancer from approximately 20 sites in the United Kingdom registered for the trial and ctDNA results were available for 1,033 (98.9%) of the patients. Depending on the results of the ctDNA screening, patients were enrolled in one of five treatment cohorts and received therapy to target their type of breast cancer. Patients with HER2 mutations were enrolled in the cohort of patients who received either neratinib monotherapy (for patients with hormone receptor negative disease) or neratinib in combination with fulvestrant (for patients with hormone receptor positive disease). Twenty-one patients with HER2 mutations were enrolled in the cohort and 20 patients were evaluable for the primary endpoint of the trial, which was confirmed objective response rate as determined by RECIST 1.1 assessed by the investigator.
In the HER2-mutant cohort, 18 (86%) of the 21 patients had hormone receptor positive breast cancer, 18 patients (86%) had visceral disease, 18 patients (86%) had received prior chemotherapy for metastatic disease, and 11 patients (52%) had received two or more prior lines of chemotherapy for metastatic disease.
The efficacy results from the trial showed that for the 20 efficacy evaluable patients, 5 patients (25%) experienced a confirmed objective response, and three further patients had unconfirmed responses. The median duration of response was 5.7 months, and the median progression free survival in this cohort of patients was 5.4 months.
Prof. Nicholas Turner, Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, said, "Somatic HER2 mutations can be readily and accurately identified from ctDNA blood samples and are clinically actionable for targeted therapy in metastatic breast cancers. The combination of neratinib plus fulvestrant therapy demonstrates encouraging clinical activity with durable responses in this heavily pretreated metastatic breast cancer patient population with HER2-mutated disease."
Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, added, "We are very pleased with the activity seen in this cohort of patients with HER2-mutated breast cancer with neratinib in plasmaMATCH. This data correlates with the data observed in the neratinib plus fulvestrant arm of the SUMMIT trial, and we look forward to the further development of the combination of neratinib plus trastuzumab plus fulvestrant in this patient population."