MedicalResearch.com Interview with:
Bishal Gyawali, MD, PhD
Department of Medicine
Brigham and Women’s Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: PD-1 inhibitors are an interesting class of cancer drugs with atypical response patterns in clinical trials. There is a lot of debate over cancer drugs that improve progression-free survival (PFS) – a surrogate measure of clinical benefit– without affecting patients’ overall survival (OS), but in some studies, PD-1 inhibitors appears to improve overall survival (OS) without affecting PFS.
We therefore conducted a systematic review and meta-analysis of randomized trials of PD-1 inhibitors (nivolumab and pembrolizumab) to assess the effect of these drugs on OS versus PFS. We showed that PD-1 inhibitors do appear to improve OS more than PFS.
MedicalResearch.com: What should readers take away from your report?
Response: Traditionally, PFS is measured using the definition of “progression” as defined by a criteria called RECIST in cancer drug clinical trials. However, our study shows that RECIST-based measurement of PFS may not be appropriate for the endpoints in trials of PD-1 inhibitors. Thus, until a better surrogate becomes available, overall survival is most appropriate to use if investigators want to observe the true benefit from these drugs.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We recommend that overall survival should be the default primary endpoint of all RCTs of PD-1 inhibitors.
MedicalResearch.com: Is there anything else you would like to add?
Response: This work was supported by a grant from the Laura and John Arnold Foundation to create the PORTAL Biomarker Research Consortium. We have no relevant COI.
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