Clinical Summary:

• Daniel Heng, MD, discusses updated results from the LITESPARK-011 trial evaluating belzutifan plus lenvatinib versus cabozantinib in patients with advanced renal cell carcinoma, focusing on progression-free survival, response rates, and durability of treatment benefit.
• Belzutifan plus lenvatinib significantly improved progression-free survival and demonstrated a higher objective response rate (53% vs 40%) and longer duration of response (22 vs 11 months) compared with cabozantinib, while the numerical overall survival improvement had not reached statistical significance.
• These findings support belzutifan plus lenvatinib as an additional treatment option for advanced  renal cell carcinoma, highlighting the importance of durable disease control and continued follow-up to clarify the overall survival benefit.

Daniel Heng, MD,  Arthur J.E. Child Comprehensive Cancer Centre, Calgary, Canada, discusses updated results from the LITESPARK-011 trial comparing belzutifan plus lenvatinib with cabozantinib in patients with advanced renal cell carcinoma. 

Dr Heng reviews the significant progression-free survival benefit observed with belzutifan plus lenvatinib, including higher objective response rates and longer response duration compared with cabozantinib. He also discusses the numerical overall survival improvement, which has not reached statistical significance, and the implications of these findings for treatment selection in advanced renal cell carcinoma.

Transcript: 

Welcome to ESMO 2026. Today I had the pleasure of presenting the LITESPARK-011 data, which is a randomized controlled trial of belzutifan plus lenvatinib versus cabozantinib.

There is a statistically significant progression-free survival benefit, and there is an overall survival difference of 5 months, it's not yet statistically significant. This is the final analysis that's preplanned, and hopefully we see that it will be updated again soon.

What's most striking about this data, though, is that the duration of response is quite high, 22 months versus 11 months, and the overall response rate is quite high, 53% versus 40%. So we're trying to push that needle in the second-line setting to give our patients more of that overall response rate, more of that duration of response.

We've never seen anything like it before in terms of an overall duration of response of 22 months– that's very, very long. And I suspect that if we look at the overall survival again later, the curves will continue to separate because the duration of response is so long.

I'm excited to look forward, it's already FDA-approved, it's under EMA review right now, and I think it pushes the needle forward for our patients more.

Source: 

Heng DY, McDermott RS, Park SH, et al. Final analysis of the phase 3 LITESPARK-011 study: Belzutifan (bel) plus lenvatinib (len) versus cabozantinib (cabo) for advanced renal cell carcinoma (RCC) after anti–PD-(L)1 therapy. Presented at ESMO Congress. October 23-27, 2026; Madrid, Spain. Abstract 3587O.