LITESPARK-012

Abstract 3586OESMO 2026GenitourinaryPicked by Dr. Gil Morgan and Dr. Toni Choueiri and Dr. Silke Gillessen and Dr. Neeraj Agarwal and Dr. Tian Zhang and Dr. Tom Powles and Dr. Brian Rini and Dr. Petros Grivas and Dr. Axel Merseburger and Dr. Aurelius Omlin and Dr. Andrea Apolo and Dr. Daniel Heng and Dr. Sumanta Pal and Dr. Enrique Grande and Dr. Hans Hammers and Dr. Natalia Gandur

What it tests: First-line pembrolizumab plus lenvatinib, with or without belzutifan or MK-1308A, in advanced renal cell carcinoma (RCC). Randomized open-label phase 3 study.

4Sight: LITESPARK-012

All ESMO 2026 4Sights

In brief

OncoAlert 4Sight, #ESMO2026

First-Line Pembrolizumab + Lenvatinib + Belzutifan or MK-1308A + Lenvatinib in Advanced RCC: The Randomized Open-Label Phase 3 LITESPARK-012 Study

Phase 3 (n=1688), untreated advanced ccRCC: pembrolizumab + lenvatinib + belzutifan (Arm A) or MK-1308A + lenvatinib (Arm B) vs pembrolizumab + lenvatinib. Dual primary: PFS by BICR and OS.

Arm A: PFS HR 1.08 (0.93–1.26); OS HR 1.04 (0.87–1.25)
Arm B: PFS HR 1.07 (0.92–1.25); OS HR 1.12 (0.94–1.35)
Discontinuation due to AEs: 51.6% (A), 51.4% (B), 36.2% (control)
Neither belzutifan nor CTLA-4 blockade added to pembrolizumab + lenvatinib improved efficacy; pembrolizumab + lenvatinib remains a 1L SOC.

Toni Choueiri

Thomas Powles · Martin Voss · Elizabeth Plimack · Howard Gurney · Yue Song · Rodolfo Perini · Karla Rodriguez-Lopez · Brian Rini

The OncoAlert Newsletter goes to 10,000+ oncologists and cancer stakeholders: every week, and every day during the major congresses. Free, independent, GDPR-compliant and easy to leave.

Email address

Your role

Your country

How we use your details

LITESPARK-012

4Sight: LITESPARK-012

In brief

The week in oncology, in your inbox