Kɪᴅɴᴇʏ Cᴀɴᴄᴇʀ Jᴏᴜʀɴᴀʟ

🔊SUBMIT your manuscript. kidney-cancer-journal.com/submit.php Our #FreeAccess, #peerreview content reach out to millions of #genitourinary #renal clinicians/researchers worldwide. #FreeAccess #peerreview #cancerresearch #RenalCellCarcinoma

Development & validation of a Computational Histology AI (CHAI) prognostic biomarker in RCC AI-derived digital pathology features predicted PFS, DSS, and OS; offering potential to refine risk stratification beyond traditional clinicopathologic models #GU26 @montypal

Terrific presentation from @DrChoueiri - another sea change in adjuvant treatment. If we see survival, a very strong consideration for most patients in this setting. Even now, worth a discussion … of note, door is still open to adjuvant trials like #STRIKE (@BradMcG04) & ISTs that are pembro-based. Super proud of see @cityofhope #urology superstar @WesleyYipMD showcased in this practice-changing trial at #GU26! @SoCalYuman @ClaytonLauMD @COHurol @DrMvandenBrink @cityofhopeoc @CityofHopeSurg

LITESPARK-011 | Phase III | #ASCOGU26 #GU26 Belzutifan + Lenvatinib vs Cabozantinib in advanced clear-cell RCC post anti–PD-(L)1 A pivotal study redefining the post-IO VEGFR-TKI landscape. @motzermd @OncoAlert 🔬 Primary endpoints • Superior PFS vs cabozantinib • Higher ORR • OS numerically favored but not statistically significant (final analysis pending) 📊 Key efficacy data • mPFS: 14.6 vs 10.0 mo (HR 0.74) • ORR: 52% vs 40% • mOS: 34.9 vs 27.6 mo (NS) 🧠 Why this matters • First phase III of a HIF-2α inhibitor + VEGFR-TKI • First phase III RCC study post–PD-(L)1 showing superiority over a contemporary VEGFR-TKI • Expands mechanistic targeting beyond pure VEGF inhibition 🛡 Safety • Profile consistent with known individual drugs • No unexpected signals • QoL and symptom deterioration similar between arms 🎯 Big picture Belzutifan + lenvatinib addresses a clear unmet need in IO-pretreated RCC and may represent a new standard option in this setting. Kidney cancer continues to evolve toward rational biology-driven combinations.

BREAKING at #GU26: The Phase 3 LITESPARK-022 study meets its primary endpoint. Adjuvant pembrolizumab + belzutifan significantly improved Disease-Free Survival (DFS) vs pembro alone for clear cell RCC at risk of recurrence: 🔹 HR: 0.72 (95% CI, 0.59–0.87) 🔹 P = 0.0003 🔹 OS data still immature (HR 0.78) Safety: Anemia was the most common AE in the combo arm (84%). #KidneyCancer #RCC #OncTwitter

I’m so proud of @DrChoueiri! Here is LITESPARK022 which is the first combination IO in adjuvant @kidneycancer. DFS positive and OS immature. Looking forward to more OS, QOL endpoints and subsequent therapy. Largest trial in IO adjuvant RCC. #oncoalert #GU26 #Toniiscool

Phase 3 LITESPARK-011: In advanced ccRCC post–PD-(L)1 therapy, belzutifan + lenvatinib improved PFS (IA1/IA2) and ORR vs cabozantinib. Median DOR 23.0 vs 12.3 mo. OS not yet significant. Grade ≥3 AEs: 84% vs 83%. @DrYukselUrun @OncoAlert @DrChoueiri @ASCO #GU26 @motzermd #kidneycancer #oncology #Cancer

@motzermd with awaited #LITESPARK011 results! Lenvatinib-belzutifan showing PFS benefit and OS trend. Excellent duration of response. 1st phase 3 trial/combo to “beat” cabozantinib - likely need to use cabo earlier. @ASCO #GU26 @OncoAlert @urotoday

Now enrolling through @ALLIANCE_org - STRIKE! (A032201) exploring the role of Tivozanib with pembrolizumab following resection of ccRCC - check out our TIP at #GU26 @ASCO @DanaFarber_GU clinicaltrials.gov/study/NCT06661…

So proud of these young colleagues I have the privilege to work with. Come to see and discuss our data after adjuvant IO in RCC, trial in progress & concurrence of mutations in PCa presented at #GU26. Thanks to Daniela Arduini, Paola Troisi, Denis Occhipinti. @OncoAlert @Unicatt

🗣️Innovation in RCC #GU26 👉Dr @lalaniMD presenting phase 2 #CYTOSHRINK utilizing primary SBRT w/ Nivo/Ipi for pts with I/P risk ccRCC. 👥 (n=67) randomized 2:1 Nivo/Ipi +/- SBRT 💉C1 Nivo/Ipi ⚡️ SBRT x5 to Primary Kidney Mass 💉C2-4 Nivo/Ipi followed by Nivo maintenance 📊12mo PFS Nivo/Ipi + SBRT: 35% Nivo/Ipi alone: 48% (HR 1.29; 0.69-2.4) 📊ORR Nivo/Ipi + SBRT: 33% Nivo/Ipi alone: 42% 📊18mo OS Nivo/Ipi + SBRT: 59% Nivo/Ipi alone: 70% ⚠️G3 TRAE 23% vs 29% 🔑Key Data underscoring that SBRT to the primary kidney after C1 did not improve outcomes for pt with I/P ccRCC treated with Nivo/Ipi. Patient selection remains critical when incorporating radiation & cytoreductive nephrectomy with systemic therapy. @DrChoueiri @montypal @motzermd @tompowles1 @ChadTangMD @VincentWenxinXu @katy_beckermann @bergsa83 @DrKarineTawagi @drenriquegrande @yekeduz_emre @OncoAlert @OncBrothers @urotoday @Uromigos @kidneycan

A Great Start to Day 3⃣ at #GU26 ⛄️ OncoAlert🚨Brings Dr. Toni Choueiri 🇺🇸from the PODIUM in San Francisco to your Screen Presenting LITESPARK-022 Adjuvant pembrolizumab plus belzutifan versus pembrolizumab for clear cell renal cell carcinoma (ccRCC) #KidneyCancer ➡️ adj pembro + belz improved DFS🆚 pembro alone ➡️OS immature ➡️Manageable safety; ↑ grade ≥3 AEs ⭐️ Potential new Standard of Care! Dr Choueiri Showing us that no matter the Weather❄️ Science NEVER stops!! @DrChoueiri @motzermd @DrIacovelli @DrYukselUrun @elena_verzoni @tompowles1 @montypal @crisbergerot @DrDanielHeng @apolo_andrea @PGrivasMDPhD @TiansterZhang @neerajaiims @amerseburger @drenriquegrande @BraunMDPhD @cdanicas @brian_rini @AUC3_Official @nataliagandur @MarcMachaalani @Mustafajsalehmd @NazliDizman @DrYukselUrun @yekeduz_emre @WeiweiBian @ReneeSaliby @eddy_saad @Clara__Steiner @marc_eid @pablombarrios @WDKhatoun @Jad_El_Masri @lilli_ash @RashadNawfal @RazaneHChehade @elioibrahim8 @NafehGaelle @shaye_carver @zeyun_lu @SylvanBacaLab

@ShuchiGulati Hereditary kidney cancer requires structured imaging. Start early. Screen regularly. MRI is preferred in most syndromes. Risk varies by gene. Surveillance saves kidneys and lives. #gu26 #cancer #oncology #ASCO @oncoalert @ASCO @yekeduz_emre @CParkMD @OncBrothers @Larvol @nataliagandur @crisbergerot @ONCOassist @IMG_Oncologists @kidneycan @KidneyCancer @IKCCorg

⁦@HHammersMD⁩ discussing ⁦@KCPUTSW⁩ spinoff #belzutifan @ASCO #GU26

Dr. McDermott @BIDMChealth PhI/II LITESPARK-024 trial of belzutifan + palbociclib in adv #ccRCC (>2 prior lines) ➡️ at MTD 125 mg palbo, ORR 21.1%, median PFS 9.1 mos, most common G>3 AE being neutropenia @OncoAlert #GU26

Belzutifan + palbociclib in pretreated ccRCC. Manageable safety. Grade ≥3 anemia common. Neutropenia dose-related. At highest dose: ORR 21% Median PFS 9.1 mo Signal, not practice changing. #gu26 #cancer #oncology @oncoalert @ASCO @medicalwatchBC @DrChoueiri @yekeduz_emre @neerajaiims @CParkMD @Silke_Gillessen @PGrivasMDPhD @VivekSubbiah @TwoOncDocs @OncBrothers @Larvol @nataliagandur @montypal @crisbergerot @DrDanielHeng @TiansterZhang @HHammersMD @sonpavde @drenriquegrande @scserendipity1 @tompowles1 @BraunMDPhD @uromigos @MattGalsky @apolo_andrea @bavilima @SuyogCancer @ONCOassist @gbanna74 @ravikanesvaran @NazliDizman @MedicalwatchFTW @OncLive @urologysummit @IMG_Oncologists @AmandaBinDC @sarah_c_hopkins @MikeSerzanMD

Comprehensive presentation by Dr. @HHammersMD spotlighting emerging targets in RCC: From HIF-2α inhibition to mRNA vaccines, CAR-T cells, and bispecific antibodies. The field is evolving fast, with so much on the horizon. #GU26 @OncoAlert @OncBrothers

Pts achieving pCR following ICI-based therapy for RCC exhibit more favorable onc outcomes vs pts with residual disease. Long term surveillance still important. @alirezaghoreifi @DukeCancer #GU26 @MRHarrisonMD

Incredible start at Saturday at #GU26 LITESPARK 011 presented by Dr Motzer finding Ph3 superiority in PFS of Len/bel vs cabo benefit appears to appear late, 30% fall off early in both arms, impressive durability for responders in Len/bel

Breaking news from @ASCO #GU26 👉Adding belzutifan to adjuvant pembrolizumab significantly improves disease free survival (HR: 0.72)👉Congrats @drchoueiri & team for changing SOC again in pts with #kidneycancer @kidneycan @OncoAlert @urotoday

R3 LITESPARK-022: Adjuvant Pembrolizumab + Belzutifan vs Pembrolizumab for Clear Cell Renal Cell Carcinoma #GU26 showed significantly delayed DFS HR 0.72 (95% CI, 0.59–0.87) active across all subgroups. Immature OS (30 mnth OS 93% CDs 96%). ⬆️ Anaemia fatigue and transaminitis but only 4% discontinuation rate for belzutifan. The shape of the DFS curve and early OS trending the right way looks like initial analysis of KN564 and we know where that ended, making pem/bel attractive. @OncoAlert @DrChoueiri