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 DeLLphi-305 trial
https://esmocongress.esmo.org
ESMO 2026
2026 年 10 月 23–27 日 · Madrid · 共 3194 条
DELLPHI-305
★★★晚破65 人 · 88 条 · 1 篇摘要
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当前热度 36·可比范围峰值 41(10月25日 02:00)·近 24 小时可比范围变化 –·当前参与者 56
Tarlatamab是靶向DLL3×CD3的双特异性T细胞衔接器(BiTE),2024年获美国FDA批准用于小细胞肺癌(SCLC),是当年获批的抗体新分子之一,获批依据是在经治SCLC中较标准治疗改善缓解率与无进展生存的II期数据,此后多项III期研究持续跟进[1][2][6]。这一瘤种对铂类化疗初始敏感但耐药极快、预后恶劣,PD-(L)1抑制剂与ADC带来的获益仍然有限[4]。安全性上CRS是主要顾虑,DeLLphi-300子研究显示,周期1改为6–8小时门诊监测后任意级别CRS约60%,与48小时住院监测(62%)相当,为更大规模应用提供了可行性依据[5]。
本次ESMO 2026主席专场的LBA3报告DeLLphi-305 III期结果:ES-SCLC患者经一线化疗+度伐利尤单抗诱导后,随机接受tarlatamab+度伐利尤单抗对比度伐利尤单抗单药维持治疗。Amgen于9月8日宣布研究在期中分析即达到OS终点;会上公布的数字为:OS 21.1 vs 12.7个月(HR 0.42),PFS 7.4 vs 1.9个月(HR 0.34),CRS发生率49.6%,≥3级仅0.4%。报告人为Jacob Sands,10月24日(周六)17:18,Hall 6。
相对已有认识,DeLLphi-305把tarlatamab的证据从经治后线人群[2][5]推进到一线维持阶段,并直接与PD-L1抑制剂联合,OS HR 0.42的幅度也使其成为主席专场三场报告之一。现场帖同时在谈的另一条线是与IMforte(阿替利珠单抗+鲁比克替丁维持,OS HR 0.73)的间接对照:发帖者明确表示跨试验比较不恰当,但tarlatamab组的OS获益在数值上明显更大;另有帖文提出tarlatamab可入脑而IMforte方案不能,此点属发帖者观点,会上未见相应数据,待确认。
局限在于目前仅有会议顶线数字,OS成熟度、后续治疗线、CNS疗效、生活质量与完整安全性谱均待全文披露;durvalumab单药组PFS仅1.9个月,联合组获益能否长期维持也需更长随访验证。
- 1.Antibodies to watch in 2025 · MAbs 2025
- 2.DLL3-guided therapies in small-cell lung cancer: from antibody-drug conjugate to precision immunotherapy and radioimmunotherapy · Mol Cancer 2024
- 3.Development of pharmacological immunoregulatory anti-cancer therapeutics: current mechanistic studies and clinical opportunities · Signal Transduct Target Ther 2024
- 4.Current and future therapies for small cell lung carcinoma · J Hematol Oncol 2025
- 5.Safety of tarlatamab with 6-8-h outpatient versus 48-h inpatient monitoring during cycle 1: DeLLphi-300 phase 1 substudy · ESMO Open 2025
- 6.Structure and function of therapeutic antibodies approved by the US FDA in 2024 · Antib Ther 2025
International Lung Cancer Summit@LungSummit Misty Dawn Shields@drshieldsmd Noemi Reguart@NReguart OncLive.com@OncLive Paul H, PharmD, RPH@phsiao4 引用@‼️ Impressive results from DeLLphi-305 (phase III) just out this afternoon #ESMO26. Tarlatamab + durvalumab vs durvalumab alone, 1L maintenance ES-SCLC. Median OS 21.1 vs 12.7 months, HR 0.42, 58% reduction in risk of death. This is great news for people affected by small cell #lungcancer. Both drugs already have EU and UK approvals on their own. The real gap: new medicines can still take 600+ days to reach patients in lower-income European countries. Practice-changing data is only half the story. https://lungcancereurope.eu/news/tarlatamab-durvalumab-dellphi-305-sclc-survival #LCSM
Elvina Almuradova@Dr_ElvinaA OncUpdates@OncUpdates Tejas Patil@TejasPatilMD Aydah AlAwadhi, MD 🇦🇪@Aydah_AlAwadhi Alfredo Addeo MD@Alfdoc2 Noemi Reguart@NReguart Ahmed Alanazi | أحمد العنزي@alanazi002 Carlo Genova@CarloGenova5 在#ESMO2026上,DELLPHI-305获得全场起立鼓掌。看到ED-SCLC在生存方面展现出显著优势,令人倍感欣慰。
Dr Riyaz Shah@DrRiyazShah DeLLphi-305;ES-SCLC;接近2年的mOS;强劲的PFS信号;这几乎是我在这一领域见过的最强数据。@BTOGORG #ESMO26
Alfredo Addeo MD@Alfdoc2 Mustafa Özdoğan, MD@ozdogan_md Jose Fernando Moura, PhD@FernandoOnco OncLive.com@OncLive OncLive@OncLive Biotech Explained@Explainbiotech 引用@ESMO 2026 just started in Madrid, one of the biggest oncology congresses of the year. Schedule of the key presentations + what already came out on Day 1 : full breakdown in the article. https://x.com/i/article/2113769981779357697
Dr. Estela Rodriguez@Latinamd Philippe Aftimos, MD @aftimosp Leonardo Brunetti@Brunet3Leon Alan Tan@alantanmd Yakup Ergün@dr_yakupergun 引用@#ESMO26 | DeLLphi-305 – Phase III | Presidential Symposium-1 In ES-SCLC, tarlatamab + durvalumab maintenance significantly improved outcomes vs durvalumab alone following first-line chemotherapy + durvalumab: OS: 21.1 vs 12.7 months (HR 0.42) PFS: 7.4 vs 1.9 months (HR 0.34) CRS: 49.6%; grade ≥3: 0.4%. An impressive OS benefit! Atezolizumab + lurbinectedin maintenance also demonstrated an OS benefit in IMforte (HR 0.73). Although cross-trial comparisons are inappropriate, the magnitude of the OS benefit with tarlatamab appears numerically much greater.
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Yakup Ergün@dr_yakupergun 引用@#ESMO26 | DeLLphi-305 – Phase III | Presidential Symposium-1 In ES-SCLC, tarlatamab + durvalumab maintenance significantly improved outcomes vs durvalumab alone following first-line chemotherapy + durvalumab: OS: 21.1 vs 12.7 months (HR 0.42) PFS: 7.4 vs 1.9 months (HR 0.34) CRS: 49.6%; grade ≥3: 0.4%. An impressive OS benefit! Atezolizumab + lurbinectedin maintenance also demonstrated an OS benefit in IMforte (HR 0.73). Although cross-trial comparisons are inappropriate, the magnitude of the OS benefit with tarlatamab appears numerically much greater.
Jose Fernando Moura, PhD@FernandoOnco Patrick Forde@FordePatrick Dr Timos Papagatsias@_timos_ KOL Pulse AI@KolPulseAI