ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 4873 条
LITESPARK-011
19 人 · 23 条
本事件热度走势
当前热度 3·可比范围峰值 3（10月26日 03:00）·近 24 小时可比范围变化 –·当前参与者 6
参与者计数6
热度走势
深度解读
Belzutifan 是口服小分子 HIF-2α 抑制剂，在经治透明细胞肾癌中已显示出抗肿瘤活性；HIF-2α 同时调控 VEGF 表达并参与抗 VEGF 治疗耐药，这为其与 TKI lenvatinib 联合提供了生物学依据[1]。该药已获批用于三线、四线难治性 RCC，HIF-2α 靶向由此进入临床实践[4]，而 PD-(L)1 之后二线方案的生存获益与生活质量仍然有限，是公认的临床未满足需求[2]。LITESPARK-011 正是在这一背景下设计的开放标签 III 期研究：184 家中心、25 个国家，患者按 1:1 随机接受 belzutifan 120mg + lenvatinib 20mg 或 cabozantinib 60mg[3]。其结果此前已在 2026 年 ASCO GU 报告：PFS 14.8 vs 10.7 个月（HR 0.70）、ORR 52.6% vs 40%、DOR 23 vs 12 个月[4]，并被评价为确立了免疫治疗后优于 cabozantinib 的地位[5]。
本次 ESMO26 报告的是 LITESPARK-011 的最终分析（摘要号 3587O，Daniel Heng 报告），共 747 例抗 PD-(L)1 治疗后进展的晚期 ccRCC，中位随访 38.8 个月。PFS 获益维持：14.8 vs 10.8 个月（HR 0.74，95% CI 0.62–0.88）；ORR 53.1% vs 40.2%，CR 6.7% vs 1.3%，DOR 22.0 vs 11.9 个月，PFS2 为 28.7 vs 23.4 个月（HR 0.80）。最终 OS 数值上倾向于 belzutifan + lenvatinib（33.7 vs 28.6 个月，HR 0.85，95% CI 0.70–1.03；36 个月 OS 率 48.9% vs 40.6%），但单侧 p 值 0.047（0.04689）未达到预设显著性界值 0.0223。安全性方面，≥3 级治疗期间不良事件发生率 85.4% vs 83.0%；贫血（70.8% vs 27%）与缺氧（15.7% vs 0%）在 belzutifan 组更突出，腹泻与手足综合征在 cabozantinib 组更常见。结果同步发表于 Annals of Oncology。
与此前 GU26 已知的 PFS、ORR 优势相比[4]，本次读数推进的一步在于成熟 OS 与 PFS2：更高的 CR 率与近乎翻倍的 DOR 支持更深、更持久的疾病控制，且此前的获益在一线 IO+TKI 和 IO+IO 经治人群中均得以维持，但这一优势尚未转化为有统计学意义的生存获益，该方案相对 cabozantinib 及其他日益增多选择的排序位置成为下一个临床问题。会上另有两条相关内容：一项 741 例患者的探索性分析显示，较好的基线生活质量与更长 PFS 和 OS 相关；Albiges 的 HIF-2α 抑制专题综述还提到 casdatifan 显示出令人关注的活性（ORR 35%），血清 EPO 可能是疗效生物标志物，最优组合与序贯策略仍不清晰。
局限同样明确：OS 仅为数值性优势，未跨过预设统计界值；两组 ≥3 级不良事件比例均高，贫血与缺氧仍是 belzutifan 联合方案的重要代价；生活质量关联与 EPO 生物标志物均为探索性分析，其临床价值有待前瞻验证。
参考来源
- 1.LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy · Future Oncol 2023
- 2.Second-Line Systemic Therapies in Metastatic Renal Cell Carcinoma: Current Insights and Future Directions · J Cancer Immunol (Wilmington) 2025
- 3.Belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (LITESPARK-011): an open-label, randomised, controlled, phase 3 trial · Lancet 2026
- 4.From prevention to progression: can belzutifan-based strategies deliver across the RCC disease continuum? · Oncologist 2026
- 5.Therapeutic Optimization, Biomarker Development, and Emerging Strategies in Kidney Cancer · Kidney Cancer J 2026
现场
Toni Choueiri, MD@DrChoueiri OncoAlert@OncoAlert Toni Choueiri, MD@DrChoueiri Toni Choueiri, MD@DrChoueiri Dra. María Natalia Gandur Quiroga@nataliagandur 引用@OncoAlert 🚨 #ESMO26 #Podium2Screen LITESPARK-011 final analysis in #RCC Our @OncoAlert founding faculty @DanielHengMD 🇨🇦 presents belzutifan + lenvatinib vs cabo after anti–PD-(L)1: ➡️ PFS HR 0.74 (14.8 vs 10.8 mo) ➡️ ORR 53% vs 40%, DOR 22.0 vs 11.9 mo ➡️ OS HR 0.85, not significant 👇 #KidneyCancer #GUOnc Pinging Our Faculty @DrChoueiri, @tompowles1, @apolo_andrea, @neerajaiims, @montypal, @Silke_Gillessen, @AOmlin, @brian_rini, @PGrivasMDPhD, @TiansterZhang, @amerseburger, @DrDanielHeng, @HHammersMD, @scocmem, @AndreaNecchi, @AmandaNizamMD, @drenriquegrande, @nataliagandur, @AlbigesL, @cdanicas, @declangmurphy, @seanmmcbride, @shilpaonc, @DrRanaMcKay, @scserendipity1, @DrYukselUrun, @ravikanesvaran, @BraunMDPhD, @EfstathiouEleni, @mzugman, @crisbergerot, @niklas_kluemper @Markuseckstein3
Dr Rishabh Jain@DrRishabhOnco 引用@🚨 ESMO 2026 | TOP 10 GU CANCER TRIALS TO WATCH! From perioperative immunotherapy and AR pathway intensification to HIF-2α inhibition and long-term survival updates, GU oncology is set for some major presentations at #ESMO26. Here are my Top 10, grouped by subspecialty. 👇 🔵 PROSTATE CANCER 1️⃣ DASL-HiCaP (LBA4) Can adding darolutamide to ADT + radiotherapy improve outcomes in very high-risk localized prostate cancer? 2️⃣ PROTEUS (LBA53) Perioperative apalutamide + ADT in high-risk localized prostate cancer. Important additional data from the PROTEUS programme. 3️⃣ CAPItello-281 (LBA56) Updated overall survival with capivasertib + abiraterone in PTEN-deficient mHSPC. Could AKT inhibition redefine biomarker-driven treatment? 4️⃣ PEACE-1 (2215O) Long-term survival outcomes with abiraterone-based treatment intensification in de novo metastatic castration-sensitive prostate cancer. 🟢 BLADDER / UROTHELIAL CANCER 5️⃣ VOLGA (LBA2) One of the biggest presentations at ESMO 2026! Can perioperative durvalumab ± tremelimumab with neoadjuvant enfortumab vedotin improve outcomes in cisplatin-ineligible muscle-invasive bladder cancer? 6️⃣ KEYNOTE-866 (4735O) Perioperative pembrolizumab + gemcitabine/cisplatin in cisplatin-eligible MIBC. Will the detailed results clarify the role of adding immunotherapy to conventional perioperative chemotherapy? 7️⃣ ENERGIZE / CA017-078 (4736O) Does adding perioperative nivolumab to cisplatin-based chemotherapy improve outcomes in MIBC? 🟠 RENAL CELL CARCINOMA 8️⃣ LITESPARK-011 (3587O) Belzutifan + lenvatinib versus cabozantinib following prior PD-(L)1 therapy in advanced RCC. Can a HIF-2α inhibitor combination improve treatment outcomes? 9️⃣ LITESPARK-012 (3586O) Belzutifan- or quavonlimab-containing regimens with pembrolizumab + lenvatinib in first-line advanced RCC. Important efficacy and safety data for next-generation combinations. 🔟 KEYNOTE-564 (3589RO) Final prespecified analysis of adjuvant pembrolizumab in clear-cell RCC. How durable is the benefit with extended follow-up? 🔬 ALSO ON MY RADAR • PE-PE: Perioperative immunotherapy in oligometastatic RCC • KEYNOTE-B15: ctDNA analysis in MIBC • TALAPRO-3: Molecular and patient-reported outcomes • NIAGARA: Molecular subtype analysis • SWOG S2200: Papillary RCC 🔥 THREE BIG QUESTIONS FOR ESMO 2026 🔹 Will perioperative treatment strategies redefine management of MIBC? 🔹 Can treatment intensification and biomarker selection improve prostate cancer outcomes? 🔹 Will HIF-2α combinations reshape advanced RCC treatment sequencing? 📌 Pre-congress watchlist. Not all trials are expected to report positive results. Which GU trial has the greatest potential to change your clinical practice? 👇 @myesmo @ESMO_open @ASCO @oncoalert #ESMO26 #GUOncology #ClinicalTrials #Oncology
Enrique Grande@drenriquegrande Elisabetta Bonzano MD, PhD@to_be_elizabeth 引用@OncoAlert 🚨 #ESMO26 #Podium2Screen LITESPARK-011 final analysis in #RCC Our @OncoAlert founding faculty @DanielHengMD 🇨🇦 presents belzutifan + lenvatinib vs cabo after anti–PD-(L)1: ➡️ PFS HR 0.74 (14.8 vs 10.8 mo) ➡️ ORR 53% vs 40%, DOR 22.0 vs 11.9 mo ➡️ OS HR 0.85, not significant 👇 #KidneyCancer #GUOnc Pinging Our Faculty @DrChoueiri, @tompowles1, @apolo_andrea, @neerajaiims, @montypal, @Silke_Gillessen, @AOmlin, @brian_rini, @PGrivasMDPhD, @TiansterZhang, @amerseburger, @DrDanielHeng, @HHammersMD, @scocmem, @AndreaNecchi, @AmandaNizamMD, @drenriquegrande, @nataliagandur, @AlbigesL, @cdanicas, @declangmurphy, @seanmmcbride, @shilpaonc, @DrRanaMcKay, @scserendipity1, @DrYukselUrun, @ravikanesvaran, @BraunMDPhD, @EfstathiouEleni, @mzugman, @crisbergerot, @niklas_kluemper @Markuseckstein3
Jeff Ryckman@jryckman3 Urology Times@UrologyTimes Uromigos@Uromigos UroToday.com@urotoday OncologyEducation@OncEd OncologyEducation@OncEd UroToday.com@urotoday OncLive.com@OncLive ScienceLink@sciencelinkonco Rashid K. Sayyid@RKSayyid Mario Balsa@MarioBalsaMD 引用@OncoAlert 🚨 #ESMO26 #Podium2Screen LITESPARK-011 final analysis in #RCC Our @OncoAlert founding faculty @DanielHengMD 🇨🇦 presents belzutifan + lenvatinib vs cabo after anti–PD-(L)1: ➡️ PFS HR 0.74 (14.8 vs 10.8 mo) ➡️ ORR 53% vs 40%, DOR 22.0 vs 11.9 mo ➡️ OS HR 0.85, not significant 👇 #KidneyCancer #GUOnc Pinging Our Faculty @DrChoueiri, @tompowles1, @apolo_andrea, @neerajaiims, @montypal, @Silke_Gillessen, @AOmlin, @brian_rini, @PGrivasMDPhD, @TiansterZhang, @amerseburger, @DrDanielHeng, @HHammersMD, @scocmem, @AndreaNecchi, @AmandaNizamMD, @drenriquegrande, @nataliagandur, @AlbigesL, @cdanicas, @declangmurphy, @seanmmcbride, @shilpaonc, @DrRanaMcKay, @scserendipity1, @DrYukselUrun, @ravikanesvaran, @BraunMDPhD, @EfstathiouEleni, @mzugman, @crisbergerot, @niklas_kluemper @Markuseckstein3
Martin ZapataLaguado@zapatalaguadomd Kohji Takemura, MD@KohjiToncol Álvaro Pinto@dralvaropinto Annals of Oncology@Annals_Oncology