Robert J. Motzer, MD, on Main HRQOL Takeaways From Phase 3 CLEAR Trial

Motzer discussed time to deterioration end points for patients with advanced renal cell carcinoma treated with pembrolizumab and lenvatinib in the first-line setting.

Robert J. Motzer, MD, of the Memorial Sloan Kettering Cancer Center, spoke with CancerNetwork® about the key health-related quality of life (HRQOL) takeaways from the CLEAR trial (NCT02811861) in patients with advanced renal cell carcinoma treated with lenvatinib (Lenvima) plus pembrolizumab (Keytruda) or everolimus (Afinitor) compared with sunitinib (Sutent) at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.


Well, we did a number of different analyses. There [were] really 2 main types of analysis. One was an analysis where we looked at longitudinal changes from baseline in patients on study using what's called a mixed-model analysis. And the other is that we looked at an end point called time to deterioration as well as another end point, time until definitive deterioration, which gives you a little bit more of a sense [of QOL] over time. What we found in the analysis is that the quality-of-life study suggested that [outcomes] were either similar or better with some scales with lenvatinib plus pembrolizumab compared to sunitinib. And in fact, the time until definitive deterioration really was the standout in favor of lenvatinib and pembrolizumab in that the hallmark of that analysis is that it looks at quality of life by these scales over time. Patients who continue on trial, even treated beyond progression or on progression-free survival for a long time, they seem to really have a better quality of life. I think that was a standout.

In general, I would say that the scores were the same or better with lenvatinib plus pembrolizumab. On the other side of the coin, when we looked at lenvatinib plus everolimus, for the most part, the scores were the same or worse, more severe than sunitinib. That appeared to have somewhat lower scores with regard to quality-of-life assessments than sunitinib. I think that also makes sense. It's comprised of 2 targeted therapies; there's a fair amount of toxicity that’s been associated with that regimen. The results were quite fitting with what we’ve seen with regard to efficacy and safety for both of those regimens.


Motzer RJ, Porta C, Alekseev B, et al. Health-related quality-of-life (HRQoL) analysis from the phase 3 CLEAR trial of lenvatinib (LEN) plus pembrolizumab (PEMBRO) or everolimus (EVE) versus sunitinib (SUN) for patients (pts) with advanced renal cell carcinoma (aRCC). J Clin Oncol. 2021;39(suppl 15):4502. doi: 10.1200/JCO.2021.39.15_suppl.4502