Webinar: A Clinician’s Perspective on Cancer Drugs Development
Cytel's team of oncology trial design and advanced analytics experts are hosting a series of complimentary webinars covering a range of innovative topics and solutions. On April 28, 2020, Cytel conducted a webinar with Professor Martin Fey, Medical Oncologist, “A Clinician’s Perspective on Cancer Drugs Development”. Our previous blog features an interview with Professor Fey where he talks about his experience of over forty years in medical oncology, the evolution of clinical cancer trials, the difference between clinically meaningful and statistically significant results, the debate around patient perspectives and other important topics around cancer drugs development.
In his webinar, Professor Fey provides us an overview of drug development for cancer treatments, clinician’s perspective on endpoints, importance of patient reported outcomes and patient perspective, and the significance of biomarkers. Continue reading this post for key highlights from the webinar.
Access webinar slides and recording by clicking on the button below.
Design and conduct of clinical cancer trials have significantly evolved over the past few decades. From simple designs, we have now reached a stage of using complex innovative designs including basket trials and umbrella trials. In the webinar, Professor Fey presents the aims of clinical trials testing of a new drug or new treatment, from patients’ perspective. The treatment goals in this scenario are achieving a longer and/or healthier life for the patients. He provides us a list of current curative systemic cancer treatment, and how we arrived at them through decades of evolution of cancer therapies, since the 1950s. He also speaks about the “new” side effects of various immunotherapies, for example, cardiotoxicity resulting from Anti–HER2 MAB therapy in metastatic HER2+++ breast cancer (trastuzumab).
Introduction of molecular biology and tumour immunology in clinical oncology has increased our understanding of the biology of cancer. As a result, biomarkers have gained tremendous importance. Professor Fey explains how we need to employ the appropriate diagnostic procedures to find these biomarkers in a tumour biopsy taken from a patient. Molecular diagnostics (i.e. detecting gene mutations in tumours) usually provides a Yes-No answer (i.e. the mutation is present or absent). Detection of protein expression by immunohistochemistry, however, yields a scale ranging from negative samples to intensely positive samples, and any possible result in between. Setting a threshold to split “positive” cases from “negative” ones may be difficult. Using examples, he demonstrates how predictive biomarkers for immune checkpoint inhibitors are not yet satisfactory. According to him, we still have a long way to go in order to link biomarkers to specific cancer treatment, on an individual or truly personalized medicine basis.
Professor Fey further explains the typical endpoints in phase 2 clinical cancer trials. He presents his arguments against using progression-free survival, remission rates, and remission duration as 1o endpoints in phase III trials used for clinical practice. In his opinion, we should replace these by clinical endpoints that reflect the wishes of cancer patients to live longer, better, or both.
For a detailed explanation of a clinician’s perspective on endpoints, PRO and patients’ perspectives, watch a recording of professor Fey’s webinar and download the presentation slides.
About Professor Martin Fey
Professor Martin Fey is an experienced board-certified Medical Oncologist who provides expertise in the design and conduct of clinical cancer trials. He was a Professor and Head of the University Department of Medical Oncology at the University of Bern and the University Hospital of Bern, Inselspital, from 1994 until 2017. Since then he continues to work as a Senior Consultant in Medical Oncology at the same institution.