![]() ![]() “These findings continue to support first-line pembrolizumab in patients with locally advanced/metastatic PD-L1–positive NSCLC without sensitizing EGFR/ALK alterations,” explained lead investigator, Byoung Chul Cho, MD, PhD, in a virtual presentation of the data. A second course pembrolizumab was found to be feasible and was also associated with antitumor activity. As a matter of fact, this is has just been published by in The Lancet just about last week.Patients with locally advanced or metastatic PD-L1–positive non–small cell lung cancer (NSCLC) without sensitizing EGFR/ ALK alterations were evaluated on long-term treatment with pembrolizumab (Keytruda) and continued to demonstrate improvement in overall survival (OS), overall response rate (ORR), and time to progression on next-line therapy (PFS-2) compared with chemotherapy, according to follow-up results from the KEYNOTE-042 study (NCT02220894).Īccording to a presented on the data given as part of the 2020 World Conference on Lung Cancer Singapore (WCLC) Singapore, patients who completed 35 cycles of pembrolizumab treatment saw durable responses, and many patients experienced a continued response after the completion of therapy. ![]() So that pretty well gives you a capsule of what we have learned from this important randomised study. This group of patients then I think we can consider the single agent use as per 042. On the other hand, there are some patients who are physically not capable of receiving chemotherapy. So this group probably can be considered the utilisation of a KEYNOTE-189 regimen. So I wouldn’t promote to replace chemotherapy with the single agent pembrolizumab and especially there are data from KEYNOTE-189 demonstrating that the combination of chemo with pembrolizumab is actually superior to chemotherapy. Now, we come to the question that can we use single agent pembrolizumab in the 1-49% subgroup as a first line? In this study we actually did not show any superiority but then there is some advantage in terms of toxicity. So, in other words, whether you use 1% or 20% the benefit is mostly driven by the 50% subgroup. With this one we did not observe any overall survival benefit. But then, speaking of that, we also performed an exploratory analysis looking at the subgroup of 1-49%. At the same time we also find that there is an improvement in the over 20% cut-off and the over 1% cut-off. Now, the 50% subgroup of patients the advantage is actually similar with a very nice hazard ratio although the median is not as impressive as what we observed in 024. ![]() We were actually able to demonstrate an overall survival benefit when we looked at using a cut-off at 1%, 20% or 50%. In this randomised study we actually compared patients with over 1% expression, single agent pembrolizumab versus standard chemotherapy. Now, the importance of KEYNOTE-042 is, number one, it will support the efficacy of the patient over 50% and, second, it’s to say how about if we use 1% as a cut-off, are we going to observe an overall survival benefit? So those are the major differences about these two studies. KEYNOTE-042 is a similar design however we select the patients over 1% and using overall survival as the primary endpoint. So KEYNOTE-024 is actually selecting the patients of PD-L1 expression 50% or more and a primary endpoint of progression free survival. KEYNOTE-042 is the sister trial of KEYNOTE-024 – 24, 42. Professor Tony Mok – Chinese University of Hong Kong, Hong Kong Latest data from KEYNOTE 42: Pembrolizumab vs chemotherapy in treatment-naive patients (pts) with PD-L1 advanced NSCLC ![]()
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