Presented at #ESMO26: In a prespecified interim analysis of a phase 3 trial involving patients with extensive-stage SCLC, the median overall survival was 21.1 months with tarlatamab–durvalumab maintenance therapy and 12.7 months with durvalumab alone. Full DeLLphi-305 trial results: https://nej.md/4iveIgW @myESMO

ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 4873 条
tarlatamab
24 人 · 29 条
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当前热度 1·可比范围峰值 1(10月26日 21:00)·近 24 小时可比范围变化 –·当前参与者 1
Tarlatamab是靶向DLL3×CD3的双特异性T细胞衔接器(BiTE),DLL3在SCLC细胞表面高表达而正常细胞极少表达,使其成为较理想的治疗靶点[9]。这一资产在经治SCLC中的证据链已经站住:I期研究(107例)中细胞因子释放综合征是最常见治疗相关不良事件(52%),其中3级仅1例[7];II期研究中10mg组客观缓解率为40%(97.5% CI 29–52)[6];2025年发表的III期研究(509例)显示二线tarlatamab对比化疗显著延长总生存[8]。该药以IMDELLTRA之名已于2024年获批上市[10]。
本次ESMO 2026总统研讨会I上,Jacob Sands报告了DeLLphi-305 III期主要分析[4],并同日发表于NEJM:ES-SCLC患者在度伐利尤单抗+铂类+依托泊苷一线诱导后,随机接受tarlatamab+度伐利尤单抗或度伐利尤单抗单药维持。预设中期分析显示中位OS为21.1 vs 12.7个月(HR 0.42),绝对获益8.4个月;PFS为7.4 vs 1.9个月;ORR为26.4% vs 4.1%;CRS约50%且多为1–2级,不良事件增加但符合预期、可行门诊治疗。现场多位专家称之为practice changing、新标准治疗,报告获起立鼓掌;讨论环节聚焦维持策略的合理性、疗效生物标志物、可及性与公平实施,以及BiTE监测的落地难题。同场3821P还报告了DeLLphi-303 Ib期tarlatamab+抗PD-L1一线维持延长随访的持续生存[1]。
主站新闻从两条独立线索补充了图景。其一,Cancer Cell研究(Nomura等)显示肺神经内分泌癌通过上调TPH1增加血清素(5-HT),经HTR7通路诱导免疫抑制性肿瘤相关巨噬细胞、削弱CD8+ T细胞功能,从而驱动tarlatamab耐药并介导ICB耐药,且提示HTR7是潜在可成药脆弱点[N1][N3]。其二,FierceBiotech报道勃林格殷格海姆在会上展示晚期DLL3双抗管线数据,意在挑战安进Imdelltra的地位[N2]。这两条与现场读数互相印证:疗效确立的同时,耐药机制与竞争格局成为下一阶段的焦点。
相对已有认识,这次读数把tarlatamab从经治/二线推入一线维持,现场称OS几乎翻倍、中位OS接近两年,DLL3类药物正在改变SCLC的预后。局限也须交代:结果来自预设中期分析;现场帖中12个月OS率数字不完整,完整值待确认;维持与二线的最优排序、前线数据及疗效预测生物标志物仍不明,广覆盖、公平可及与BiTE门诊监测体系是现实门槛。
- 1.3821P Sustained survival with extended follow-up of tarlatamab plus anti-PD-L1 as first-line maintenance (1LM) after chemoimmunotherapy for extensive-stage small cell lung cancer (ES-SCLC): DeLLphi-303 phase 1b study · ESMO 2026 2026
- 2.LBA1 INTerpath-001: Phase 3 study of the mRNA-based individualized neoantigen therapy (INT) intismeran autogene (intismeran) plus pembrolizumab (pembro) vs pembro alone for adjuvant treatment of resected stage IIB-IV melanoma… · ESMO 2026 2026
- 3.LBA2 Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: Results from the phase 3 VOLGA trial · ESMO 2026 2026
- 4.LBA3 Tarlatamab plus durvalumab (durva) vs durva as 1L maintenance (1LM) therapy following durva, platinum, and etoposide (1L durva + EP) in extensive-stage small cell lung cancer (ES-SCLC): Primary analysis of the phase 3 De… · ESMO 2026 2026
- 5.LBA4 Darolutamide with androgen deprivation therapy (ADT) and definitive or salvage locoregional radiation therapy (RT) for localised, very high-risk prostate cancer: Interim analysis of an international, placebo-controlled,… · ESMO 2026 2026
- 6.Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer · N Engl J Med 2023
- 7.Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study · J Clin Oncol 2023
- 8.Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy · N Engl J Med 2025
- 9.Emerging therapies targeting the delta-like ligand 3 (DLL3) in small cell lung cancer · J Hematol Oncol 2023
- 10.Antibodies to watch in 2025 · MAbs 2025
- 11.Small Cell Lung Cancer: A Review · JAMA 2025
Christine Lovly, MD, PhD, FASCO@christine_lovly 引用@Julien Mazieres@JulienMazieres Rami Manochakian MD, FASCO@RManochakian 引用@🚨🔥@OncoAlert Hot off the press. Just published @NEJM in conjunction with presentation @myESMO #ESMO26 the long-awaited #PracticeChanging results of: ⭐️#DeLLphi305 phase 3 trial of: ❇️1st line maintenance #Tarlatamab + #Durvalumab) vs #Durvalumab alone in patients with #ExtensiveStage #SmallCell #LungCancer after initial induction Tx with #Chemo + Durvalumab. Study showed: ‼️#Impressive statistically significant & clinically meaningful ⬆️#OverallSurvival Benefit. ✅#mOS: 21.1 vs 12.7 months (HR 0.42) ✅12-month OS: 79.4% vs 53.3% ✅#mPFS: 7.4 vs 1.9 months (HR 0.34) ⚠️ Grade ≥3 #AEs: 46.8% vs 40.6% * In Tarlatamab arm: #CRS: 49.6% (Grade ≥3: 0.4%) #ICANS: 1.1% (Grade ≥3: 0%) 👇🏻 https://www.nejm.org/doi/full/10.1056/NEJMoa2609482?query=featured_home
Rami Manochakian MD, FASCO@RManochakian FJ ⭐️⭐️+⭐️@pistoto2017 Giannis Mountzios@g_mountzios Prof Tom John@TommyJohn00 C. Michael Gibson MD@CMichaelGibson Mustafa Özdoğan, MD@ozdogan_md 引用@Presented at #ESMO26: In a prespecified interim analysis of a phase 3 trial involving patients with extensive-stage SCLC, the median overall survival was 21.1 months with tarlatamab–durvalumab maintenance therapy and 12.7 months with durvalumab alone. Full DeLLphi-305 trial results: https://nej.md/4iveIgW @myESMO
Hidehito HORINOUCHI@HHorinouchi 引用@🆙#ESMO26 Presidential Symposium I: #LCSM 🔥DeLLphi-305: Tarlatamab Plus Durvalumab (Durva) vs Durva as 1L Maintenance (1LM) Therapy Following Durva, Platinum, and Etoposide in Extensive-Stage Small Cell Lung Cancer (ES-SCLC): Primary Analysis of the Phase 3 Trial 🎙️ @sands_jacob 🔢LBA3 🎯Met Primary Endpoint: Significantly Improved OS 🎯mOS 21.1 vs 12.7m, HR 0.42 🎯mPFS 7.4 vs 1.9m, HR 0.34 🎯ORR 26.4% vs 4.1% 🎯CRS 49.6% (Mostly Low Grade), No Fatal Events ☑️NCT06211036 🔗 https://cslide.ctimeetingtech.com/esmo2026/attendee/confcal/show/session/346 @OncoAlert @Larvol @myESMO @IASLC
Anirban Maitra@Aiims1742 Tian Zhang, MD, MHS, FASCO (@tiansterzhangmd.bsky)@TiansterZhang Jose Fernando Moura, PhD@FernandoOnco @myESMO #Tarlatamab #sclc #ESMO26 @StephenVLiu @BalazsHalmosMD @OncoAlert
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FJ ⭐️⭐️+⭐️@pistoto2017 引用@Let’s take a look at #DeLLphi-305: the trial yields poor results in the "Americas," so you bring in a large number of Asian patients (±40%) #sclc #ESMO26 Opinions??? @StephenVLiu @drshieldsmd @Tony_Calles @LuisPaz_Ares @lungoncdoc @Annechiangmd @LealTiciana @latina @MartinReck2
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VJ Oncology@VJOncology MeDucation@MeDucationai 引用@Outstanding discussion by @StephenVLiu on the practice-changing DeLLphi-305 trial @sands_jacob . A new chapter in the treatment of ES-SCLC! #ESMO26. One year ago, we anticipated that we might finally be bending gravity. Today, that vision is becoming a reality!!!!!!👏👏👏👏👏
KOL Pulse AI@KolPulseAI Correo Farmacéutico@CFarmaceutico David Heredia.@HerediaOncologo Diario Médico@diariomedico Dr. Estela Rodriguez@Latinamd FJ ⭐️⭐️+⭐️@pistoto2017 引用@@pistoto2017 Very relevant question! Platinum rechallenge or lurbinectedin may be options. But optimal 2L sequencing after tarlatamab maintenance remains an important unanswered question!
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MedPage Today@medpagetoday Perlmutter Cancer Center at NYU Langone Health@Perlmutter_CC Jorge Benitez@benitezja Dana-Farber News@DanaFarberNews Pharma Jonpi . / 1.1 / .@pharma_jonpi Pharma Jonpi . / 1.1 / .@pharma_jonpi Pharma Jonpi . / 1.1 / .@pharma_jonpi