Hossein Borghaei, DO
In a 2-year follow-up of the phase III CheckMate-057 and -017 trials, second-line treatment with nivolumab (Opdivo) was found to significantly improve overall survival (OS) versus docetaxel in both patients with nonsquamous and squamous non–small cell lung cancer (NSCLC).
Results of the follow-up, which were presented at the 2016 ASCO Annual Meeting, confirm that the immunotherapy agent is superior to chemotherapy in this patient population, explains lead study author Hossein Borghaei, DO.
In the CheckMate-057 trial, which looked at the combination in patients with nonsquamous NSCLC, the 2-year OS rate was 29% with nivolumab versus 16% with docetaxel. In the CheckMate-017 study, the 2-year OS rate for squamous patients was 23% in the nivolumab arm compared with 8% in the docetaxel group.
In an interview with OncLive
, Borghaei, chief of Thoracic Oncology, director of Lung Cancer Risk Assessment, associate professor in the Department of Hematology/Oncology, Fox Chase Cancer Center, discusses the significance of the 2-year follow-up results, the evolving role of PD-L1 as a biomarker and others that are in development, and emerging immunotherapy agents in the field of NSCLC.
OncLive: Can you give an overview of the updated CheckMate-057/-017 results you presented at the 2016 ASCO Annual Meeting?
: This is a 2-year update of the results of 2 separate phase III studies that have already been published in The New England Journal of Medicine
. The CheckMate-017 study was done in patients with squamous NSCLC in the second-line setting, and the CheckMate-057 study was for patients with nonsquamous NSCLC. We clearly showed that nivolumab was superior to docetaxel when it comes to overall survival.
What we have at the 2016 ASCO Annual Meeting is a poster presentation where we showed 2-year survival data for patients with squamous and nonsquamous NSCLC. It showed that survival is still superior in favor of nivolumab. This gives us confirmation that the drug is active and that patients do truly benefit from immunotherapy.
We fully acknowledge that this is not for every patient—clearly, unfortunately—but we are hoping that we can learn more and expand the patient population that can benefit from this drug. As far as 2-year survival goes with a monotherapy in the second-line setting, for a very difficult patient population and disease, we think the data are very exciting and very much confirmatory in favor of nivolumab.
We are also presenting a unique set of cytokine data as part of this abstract. The cytokine data doesn’t necessarily indicate to us which patients will benefit from nivolumab; however, the data does point to a specific population that seemed to do better in general—in patients that have a high expression of cytokines versus those who don’t have much of a cytokine expression. That requires more research, and we’re hoping we can test it in a more prospective manner.
What do we know about patients who are appropriate to receive nivolumab? What kind of criteria do they need to have?
That’s a fair question, and it’s not necessarily easy to answer. As far as nivolumab is considered, we don’t really have a good biomarker selection, so to speak, because the study was done in all comers. In a retrospective manner, we have PD-L1 expression and the data that has come out suggest that in patients who have higher expression of PD-L1, they will benefit more from nivolumab therapy.
However, it also appears that at least a certain number of patients who don’t have a specific biomarker or PD-L1 expression still draw some benefit from nivolumab. As it stands, the population that I think benefit the most from this immunotherapy are patients who have gone through frontline chemotherapy, who have progression of disease, who still have a good performance status, who don’t have any evidence of autoimmunity, and have more of a smoking history. That is not something that has been proven, but we do see the data in multiple clinical trials.