“The response rate now with the updated dataset has gone up to just about 50% across the cohort,” says Martin H. Voss, MD.
In this video, Martin H. Voss, MD, shares key findings from the study, “First-line pembrolizumab plus lenvatinib for non–clear cell renal carcinomas (nccRCC): Extended follow-up of the phase 2 KEYNOTE-B61 study,” which was presented at the 2024 ASCO Genitourinary Cancers Symposium in San Francisco, California. Voss is a genitourinary medical oncologist at Memorial Sloan Kettering Cancer Center in New York, New York.
At this year's ASCO GU meeting 2024, we are presenting an updated analysis on the KEYNOTE-B61 dataset. The original publication I had mentioned before had a median follow-up of 15 months. Since then, data has been re-analyzed with added follow-up. The data we present today is data with median follow-up of 22.8 months, almost 23 months. We are looking at a re-analysis of the primary end point, objective response, in various subgroups, and also other efficacy measures such as duration of response [and] progression-free survival. What we see is that the robust signals seen on the original report are confirmed. As one might imagine, with added follow-up, some of the responders have seen added benefit, responses have deepened, and there are a handful of additional complete remissions, which brings up the response rates and the CR rate a little bit. The overall picture is the same. The response rate now with the updated dataset has gone up to just about 50% across the cohort. The CR rate has increased, because I think 2 or 3 patients who previously had a reported PR, which since then has further deepened into complete remissions, which, obviously, is nice to see.
The other update that I think is relevant is that in the original reporting, due to the limited follow-up at the time of that analysis, the duration of response was not reached by median. Now, with more time, median duration across the entirety of the cohort is defined. The median for this cohort of 158 patients with non-clear cell kidney cancer and a response is about 19 months, which I think is very encouraging and an important signal. We also have updated PFS data. The median PFS here now is in the 9-month range for the cohort, which also helps contextualize the findings a little bit more as we look at historical data by comparison. There are no new toxicity signals that have emerged with more time, as one would not have expected. We didn't see that with lenvatinib/pembrolizumab in other disease settings.
This transcription has been edited for clarity.