NRG-GY020: Phase III randomized trial of radiation +/- MK-3475 (pembrolizumab) for newly diagnosed early-stage high intermediate risk (HIR) mismatch repair deficient (dMMR) endometrioid endometrial cancer
https://esmocongress.esmo.org
ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 2740 条
pembrolizumab
★★★48 人 · 52 条 · 8 篇摘要
本事件热度走势
当前热度 7·可比范围峰值 8(10月25日 00:00)·近 24 小时可比范围变化 –·当前参与者 11
帕博利珠单抗这类PD-1抗体的循证基础由关键III期奠定:KEYNOTE-024在未经治疗、PD-L1表达≥50%且无EGFR/ALK异常的晚期NSCLC中,将帕博利珠单抗与研究者选择的铂类化疗对比,中位PFS为10.3对6.0个月[1],帕博利珠单抗单药由此在PD-L1≥50%人群中取代细胞毒化疗成为一线治疗首选[5];KEYNOTE-189则在无敏感突变的转移性非鳞NSCLC中评估培美曲塞+铂类联合帕博利珠单抗或安慰剂,以OS和PFS为主要终点[5],延续了此前联合方案较单纯化疗缓解率更高、PFS更长的证据[5]。两条路径并行,而PD-L1≥50%人群内部单药与联合的头对头比较,正是本次PERSEE要回答的问题。
本次ESMO 26上,GFPC的III期PERSEE(01-2020)给出了直接答案:321例一线PD-L1≥50%晚期NSCLC患者以开放标签方式随机接受帕博利珠单抗+铂类化疗或帕博利珠单抗单药,主要终点为盲态中心评估的PFS,由Chantal Decroisette报告。联合组中位PFS为16.1个月对比单药6.9个月,HR 0.56(0.43–0.74),p<0.001;ORR 77.5%对比50.3%;中位OS为50.2对比29.9个月,HR 0.77(0.57–1.05),数值差异明显但未达统计学显著,现场多位评论者提醒OS并非主要终点;代价是≥3级治疗相关不良事件53.8%对比19.3%。
相对已有认识,PERSEE把PD-L1≥50%人群从默认单药推向按肿瘤负荷、病程速度、并发症与生物标志物做分层决策:加化疗确实带来更深更快的疾病控制,但≥3级毒性接近三倍,问题从要不要加转为给谁加,这与既往全外显子测序显示突变负荷、新抗原负荷与PD-1阻断疗效相关的方向一致[3]。另需注意,PERSEE单药组6.9个月的中位PFS与KEYNOTE-024单药组的10.3个月[1]分属不同试验,跨试验比较应谨慎。
同场还有多条帕博利珠单抗相关读数,不宜与PERSEE主线混为一谈:IOV-COM-202最终II期显示lifileucel联合帕博利珠单抗在免疫检查点抑制剂初治晚期黑色素瘤中ORR 62.5%、CR 29.2%、中位PFS 19.8个月、mDOR未达到,13/15例缓解持续≥12个月,后续III期TILVANCE-301将推进该信号;neoHIP显示早期HER2+乳腺癌新辅助THP加入帕博利珠单抗将pCR从48.3%提至67.2%(+18.9%,p=0.03);另有试验显示帕博利珠单抗联合dCRT未改善食管/GEJ癌的EFS或OS,即使PD-L1 CPS≥10;个体化mRNA疫苗intismeran autogene联合帕博利珠单抗减少黑色素瘤复发的数据亦有报道。局限在于PERSEE为开放标签设计,OS未达统计学显著且未设为主要终点,毒性换获益的人群选择标准仍待明确。
- 1.Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer · N Engl J Med 2016
- 2.PD-1 Blockade in Tumors with Mismatch-Repair Deficiency · N Engl J Med 2015
- 3.Cancer immunology. Mutational landscape determines sensitivity to PD-1 blockade in non-small cell lung cancer · Science 2015
- 4.PD-1 blockade induces responses by inhibiting adaptive immune resistance · Nature 2014
- 5.Pembrolizumab plus Chemotherapy in Metastatic Non-Small-Cell Lung Cancer · N Engl J Med 2018
- 6.Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial · Lancet 2016
Sacituzumab tirumotecan (Sac-TMT) + pembrolizumab (Pembro) in post-platinum advanced mismatch repair proficient (pMMR) endometrial cancer (EC)
https://esmocongress.esmo.orgSTARBOARD phase 3: A randomized, double-blind study of first-line (1L) encorafenib (enco), binimetinib (bini), and pembrolizumab (pembro) vs placebo (pbo) and pembro for unresectable locally advanced or metastatic BRAF V600-mutant melanoma
https://esmocongress.esmo.orgEfficacy and safety of lifileucel and pembrolizumab in patients with immune check point inhibitor-naïve advanced melanoma: Final results from IOV-COM-202 study
https://esmocongress.esmo.orgUpdated results from the phase 1b/2 KEYNOTE-365 cohort I: Pembrolizumab (pembro) + carboplatin and etoposide chemotherapy (chemo) or chemo alone for neuroendocrine prostate cancer (NEPC)
https://esmocongress.esmo.orgFirst-line (1L) olomorasib + pembrolizumab in KRAS G12C-mutant NSCLC: Updated results from LOXO-RAS-20001 and SUNRAY-01
https://esmocongress.esmo.orgPembrolizumab or placebo plus concurrent definitive chemoradiotherapy in esophageal and gastroesophageal junction (GEJ) cancer: The phase 3 randomized KEYNOTE-975 study
https://esmocongress.esmo.orgAdjuvant pembrolizumab plus belzutifan versus placebo in clear cell renal cell carcinoma: A reconstructed survival data analysis of the KEYNOTE-564 and the LITESPARK-022 trials
https://esmocongress.esmo.orgIovance Biotherapeutics@IovanceBio dr_yakupergun@dr_yakupergun Project Kai@kainvests OncoAlert@OncoAlert Gil Morgan, MD@weoncologists 引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 2875O: Pembrolizumab or Placebo Plus Concurrent Definitive Chemoradiotherapy in Esophageal and Gastroesophageal Junction (GEJ) Cancer: The Phase 3 Randomized KEYNOTE-975 Study @MDmanishshah @BennounaJaafar @cbcbc1971 🔬 Phase 3, double-blind trial (n=703): pembrolizumab or placebo plus definitive chemoradiotherapy in untreated, unresectable esophageal/GEJ cancer. Dual primary endpoints: EFS and OS. ➡️ CPS ≥10 EFS: median 15.2 vs 14.7 mo; HR 0.97 (0.77–1.23); P=0.3994 ➡️ CPS ≥10 OS: median 32.2 vs 35.0 mo; HR 1.00 (0.77–1.30); nominal P=0.5003 ➡️ Grade 5 AEs 13% vs 10%; discontinuation due to AEs 34% vs 27% ✅ Pembrolizumab + dCRT did not significantly improve EFS in PD-L1 CPS ≥10; no new safety signals observed. 🎙️ Manish Shah 👥 Jaafar Bennouna · Toshihiko Doi · Lin Shen · Ken Kato · Antoine Adenis · Harvey Mamon · Markus Moehler · Xiaolong Fu · Byoung Chul Cho · Sonal Bordia · Pooja Bhagia · Chie-Schin Shih · Anjali Desai · Peter Enzinger (4Sight Made from Abstracts publicly available at the ESMO website) Pinging OncoAlert Faculty @CathyEngMD, @BenWestphalen, @graokane, @NiuSanford, , @GillSharlene, @pashtoonkasi, @DrVilmaPBarcia, @Erman_Akkus, @GIMedOnc, @UOzkerim, @MarioBalsaMD, @p_ciracimd, @DraMartinezLago, @DaisukeKotani, @Aiims1742, @ARosen380, @realbowtiedoc, @KoheiShitara,
AACR 2026 现场信号@ Aya Mohamed | MSc, MD 🎗@Dr_Oncologista Mario Balsa@MarioBalsaMD GFPC@myGFPC Journal for ImmunoTherapy of Cancer@jitcancer Matteo Lambertini, MD PhD@matteolambe Dra. María Natalia Gandur Quiroga@nataliagandur 引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Pembrolizumab With or Without Platinum-Based Chemotherapy as First-Line Treatment in Advanced NSCLC With PD-L1 ≥50%: PERSEE Phase 3 Trial (GFPC 01-2020) @decroisette @BenjaminBesseMD @LGreillier @C_Ricordel @FGuisier 🫁 Phase 3, open-label (n=321): pembrolizumab + platinum-based chemotherapy vs pembrolizumab alone, first-line advanced NSCLC with PD-L1 ≥50%. Primary endpoint: PFS by blinded central review. ➡️ Median PFS 16.1 vs 6.9 mo; HR 0.56 (0.43–0.74); p<0.001 ➡️ Median OS 50.2 vs 29.9 mo; HR 0.77 (0.57–1.05); ORR 77.5% vs 50.3% ➡️ Grade ≥3 TRAEs 53.8% vs 19.3% ✅ Pembrolizumab-chemotherapy significantly improved PFS vs pembrolizumab monotherapy and may help refine treatment selection. #NSCLC #LungCancer 🎙️ Chantal Decroisette 👥 Renaud Descourt · Christos Chouaid · Maurice Pérol · Benjamin Besse · Laurent Greillier · Olivier Bylicki · Charles Ricordel · Florian Guisier · Radj Gervais · Roland Schott · Jean-Bernard Auliac · Gilles Robinet (4Sight Made from Abstracts publicly available at the ESMO website) Pinging our OncoAlert Lung Cancer Faculty @christine_lovly, @GlopesMd, @DrSanjayPopat, @StephenVLiu, @jillfeldman4, @UOzkerim, @DrMirallas, @MartinReck2 , @bmassutis @UmbertoMalapel1 , @CharuAggarwalMD @peters_solange, @HenningWillers, @HHorinouchi, @BRicciutiMD, @PercyLeeMD, @bensolomon1, @Latinamd, @DrJNaidoo, @barlesi, @VanitaNoronha, @ChristianRolfo @Tony_Calles @s_couraud @marinagarassino @g_mountzios @BairdAM @barlesi @JFreemanDaily @Piuchagarrido @LeciaSequist @bensolomon1 @VanitaNoronha +@alexdrilon @JordiRemon @caliraf @JulienMazieres @TerriConneran
AACR 2026 现场信号@ Gil Morgan, MD@weoncologists 引用@OncoAlert 4Sight Abstracts to be Presented at #ESMO26 Pembrolizumab With or Without Platinum-Based Chemotherapy as First-Line Treatment in Advanced NSCLC With PD-L1 ≥50%: PERSEE Phase 3 Trial (GFPC 01-2020) @decroisette @BenjaminBesseMD @LGreillier @C_Ricordel @FGuisier 🫁 Phase 3, open-label (n=321): pembrolizumab + platinum-based chemotherapy vs pembrolizumab alone, first-line advanced NSCLC with PD-L1 ≥50%. Primary endpoint: PFS by blinded central review. ➡️ Median PFS 16.1 vs 6.9 mo; HR 0.56 (0.43–0.74); p<0.001 ➡️ Median OS 50.2 vs 29.9 mo; HR 0.77 (0.57–1.05); ORR 77.5% vs 50.3% ➡️ Grade ≥3 TRAEs 53.8% vs 19.3% ✅ Pembrolizumab-chemotherapy significantly improved PFS vs pembrolizumab monotherapy and may help refine treatment selection. #NSCLC #LungCancer 🎙️ Chantal Decroisette 👥 Renaud Descourt · Christos Chouaid · Maurice Pérol · Benjamin Besse · Laurent Greillier · Olivier Bylicki · Charles Ricordel · Florian Guisier · Radj Gervais · Roland Schott · Jean-Bernard Auliac · Gilles Robinet (4Sight Made from Abstracts publicly available at the ESMO website) Pinging our OncoAlert Lung Cancer Faculty @christine_lovly, @GlopesMd, @DrSanjayPopat, @StephenVLiu, @jillfeldman4, @UOzkerim, @DrMirallas, @MartinReck2 , @bmassutis @UmbertoMalapel1 , @CharuAggarwalMD @peters_solange, @HenningWillers, @HHorinouchi, @BRicciutiMD, @PercyLeeMD, @bensolomon1, @Latinamd, @DrJNaidoo, @barlesi, @VanitaNoronha, @ChristianRolfo @Tony_Calles @s_couraud @marinagarassino @g_mountzios @BairdAM @barlesi @JFreemanDaily @Piuchagarrido @LeciaSequist @bensolomon1 @VanitaNoronha +@alexdrilon @JordiRemon @caliraf @JulienMazieres @TerriConneran
Personalis, Inc.@PersonalisInc がんナビ通信@cancer_navi PLN-101095(一种口服的整合素 αvβ8/αvβ1 双重抑制剂)与 pembrolizumab 的组合已在1期试验中被证明可能对经过多种治疗后对免疫检查点抑制剂产生耐药的晚期实体瘤有效。
Julian Chavarriaga@chavarriagaj Spontonic@spontonic Dr Amol Akhade@SuyogCancer Keynote B49 - 帕博利珠单抗在这一 HR阳性、HER2阴性的 MBC 人群(内分泌治疗耐药)中效果不佳 @myESMO @dr_yakupergun @OncoAlert #esmo26
Yakup Ergün@dr_yakupergun Dr Amol Akhade@SuyogCancer 引用@🚨 ESMO 2026 | INTErpath-001 (LBA1) - as data is released by Esmo 🔹 24-month RFS: 82.2% vs 70.0% HR 0.58 (95% CI 0.45–0.75); P<0.001 🔹 24-month DMFS: 88.5% vs 80.2% HR 0.62 (95% CI 0.45–0.85); P=0.002 🔹 Grade ≥3 adverse events: 23.6% vs 20.3% The trial randomized 1,137 patients with resected stage IIB–IV melanoma. Both arms received pembrolizumab; the experimental arm added an individualized mRNA neoantigen therapy. The key question now: will better recurrence control translate into an overall survival benefit? Looking forward to full dataset on day 2 . #ESMO26 @myESMO
Targeted Oncology@TargetedOnc Daniel Aparicio@DanielAparicio MedPage Today@medpagetoday Daniel Heng@DrDanielHeng Julian Chavarriaga@chavarriagaj Shameel Shafqat MD@shameel_shafqat Dr Adam Januszewski@AdamJanuszewski AACR 2026 现场信号@ AIM at Melanoma Foundation@AIMatMelanoma