预约演示
更新于：2026-04-27
TARLATAMAB-DLLE
塔拉妥单抗
更新于：2026-04-27
概要
基本信息
原研机构 |
非在研机构- |
最高研发阶段批准上市 |
首次获批日期 美国 (2024-05-16), |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国)、加速批准 (美国)、孤儿药 (欧盟)、优先审评 (中国)、附条件批准 (中国)、孤儿药 (日本)、孤儿药 (韩国)、孤儿药 (澳大利亚) |
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结构/序列
Sequence Code 13021564
来源: *****
关联
34
项与 塔拉妥单抗 相关的临床试验NCT07531095
A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer
NCT07402343
A Single Arm Phase II Study Evaluating Intracranial Efficacy of Tarlatamab in Patients With Asymptomatic Active Brain Metastases From Small Cell Lung Cancer
NCT07328490
A Phase I/II Study to Assess the Safety and Antitumor Activity of Bispecific T-cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer
100 项与 塔拉妥单抗 相关的临床结果
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100 项与 塔拉妥单抗 相关的转化医学
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100 项与 塔拉妥单抗 相关的专利（医药）
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98
项与 塔拉妥单抗 相关的文献（医药）2026-06-01LUNG CANCER
Real-world multi-institution analysis of tarlatamab in patients with small cell lung cancer
Article
作者: Saito, Shin ; McDonald, Stephanie ; Cooper, Alissa J ; Sands, Jacob ; Clark, Phoebe ; Rivera, Julia ; Liang, Joyce ; Rudin, Charles M ; Bogdanska, Wiktoria ; Gainor, Justin F ; Arfe, Andrea ; Ross, Jessica S ; Daly, Bobby ; Meador, Catherine B
BACKGROUND:
Tarlatamab has revolutionized the management of small cell lung cancer (SCLC) and is now a standard of care second-line therapy. Adoption of tarlatamab after FDA approval in the US has been rapid. However, real-world outcomes for patients who would not have met eligibility criteria for the clinical trials evaluating tarlatamab is not well-understood.
METHODS:
We designed a multicenter retrospective cohort study of three US institutions evaluating patients with SCLC who had received at least one dose of tarlatamab between 5/16/2024 and 6/15/2025. "Trial-ineligible" population was defined as patients with ECOG performance status ≥ 2, history of grade ≥ 2 pneumonitis or interstitial lung disease, untreated brain metastases, organ dysfunction, oxygen requirement or pleural effusion, history of stroke in past 12 months, or ejection fraction < 50%. Primary study outcomes were measures of efficacy including best overall response per investigator and median time on treatment and measures of toxicity including incidence and severity of cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity (ICANS).
RESULTS:
102 patients were identified. Median age was 64; patients were mostly white (92%) with a current or former tobacco use history (94%). 60 patients (59%) would have been ineligible for trial. Of patients evaluable for response (n = 80), eligible patients (n = 34) were more likely to have partial response or stable disease (70%), whereas ineligible patients were more likely to have progressive disease (57%), p = 0.047. Eligible patients had longer median time on treatment (4.8 months (95% CI 3.1-NR) vs 2.1 months (95% CI 1.6-5.6), p = 0.06. There was no difference in CRS incidence between groups (63% vs 59%, p = 0.8), but ICANS was more common in the ineligible group (33% vs 14%, p = 0.038).
CONCLUSIONS:
Tarlatamab may be broadly applied for patients not eligible for trial enrollment, though with potential for lower efficacy.
2026-05-01EUROPEAN JOURNAL OF CANCER
Risk factors for CRS and ICANS with tarlatamab in small cell lung cancer and associated efficacy outcomes: Insights from clinical practice
Article
作者: Hobbs, Jacob ; Zhang, Jun ; Schepers, Allison ; Holman, Kori ; Grauer, Dennis ; Neupane, Prakash ; Schieber, Timothy ; Blocker, Sarah ; Maksoud, Joey ; Cass, Amanda ; Bortka, Bryce ; Cannon, Sabrina ; Olinger, Alexander ; Blackwell, Lauren ; Moore, Ty ; Huang, Chao ; Lekkala, Manidhar Reddy ; Gustafson, Beth ; Li, Haoran ; Cavalieri, Courtney C ; Kim, Diana ; Mullangi, Sanjana
BACKGROUND:
Tarlatamab is the preferred second-line therapy for extensive stage small cell lung cancer (ES-SCLC). However, strict eligibility criteria from trials limit the understanding of safety and efficacy in broader patient populations.
METHODS:
Patients with ES-SCLC treated with tarlatamab after platinum-based chemotherapy at nine cancer centers were included. Predefined univariate subgroup analyses for cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) included age, performance status, disease burden (>3 metastatic tissue types involved), CNS disease, hepatic disease, and oxygen use among others. Efficacy endpoints were objective response rate (ORR), progression-free survival (PFS), and overall survival (OS).
RESULTS:
A total of 109 patients were analyzed across several high-risk features. Any grade CRS was significantly associated with high disease burden (p = 0.002), hepatic disease (p = 0.002), and baseline oxygen use (p = 0.034). Any grade ICANS was significantly associated with high disease burden (p = 0.022) and a history of treated or untreated CNS disease (p = 0.015). Within the subgroup of patients with CNS disease unstable brain metastasis was associated with higher any grade ICANS (p = 0.021). The ORR was 33.7%, PFS of 3.58 months, and median OS of 8.48 months. CNS-specific ORR was 33.3%, including four complete responses without radiation.
CONCLUSION:
High disease burden, hepatic disease, and baseline oxygen use may increase CRS risk with high disease burden and CNS disease driving ICANS risk. Tarlatamab demonstrated manageable toxicity with clinically relevant efficacy across high-risk patient populations supporting broad access to this therapy.
2026-04-01CLINICAL CANCER RESEARCH
FDA Approval Summary: Tarlatamab for the Treatment of Extensive-Stage Small Cell Lung Cancer
Article
作者: Liu, Yufan ; Zhao, Hong ; Mixter, Bronwyn D. ; de Claro, R. Angelo ; Amatya, Anup K. ; Pazdur, Richard ; Miller, Claudia P. ; Tang, Shenghui ; Barone, Amy K. ; Bi, Youwei ; Lane, Ashley R. ; Larkins, Erin ; Pegues, Melissa A. ; Xiang, Yue ; Nashed, Jeannette ; Yuan, Mengdie
Abstract:
On May 16, 2024, the FDA granted accelerated approval to tarlatamab-dlle (hereafter referred to as tarlatamab) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The approval was based on data from DeLLphi-301 (NCT05060016), an open-label, multicenter, multicohort trial involving patients with relapsed/refractory SCLC with disease progression after platinum-based chemotherapy and at least one other line of systemic therapy. Among 99 patients, the overall response rate (ORR) was 40% [95% confidence interval (CI), 31%–51%], with a median duration of response (DoR) of 9.7 months (range, 2.7–20.7+ months). The most common adverse reactions (≥20%) were cytokine release syndrome (CRS), fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, constipation, anemia, and nausea. Product labeling includes a Boxed Warning for serious or life-threatening CRS and neurologic toxicity, including immune effector cell–associated neurotoxicity syndrome (ICANS).
1,061
项与 塔拉妥单抗 相关的新闻（医药）2026-04-26
100 项与 塔拉妥单抗 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 小细胞肺癌 | 加拿大 | 2024-09-01 | |
| 广泛期小细胞肺癌 | 美国 | 2024-05-16 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 局限期小细胞肺癌 | 临床3期 | 美国 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 美国 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 日本 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 日本 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 阿根廷 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 阿根廷 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 澳大利亚 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 澳大利亚 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 奥地利 | 2024-01-23 | |
| 局限期小细胞肺癌 | 临床3期 | 奥地利 | 2024-01-23 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 32 | 鹹襯壓襯衊夢艱遞構鏇 = 廠夢蓋艱鹹積廠鏇窪窪 廠網艱鬱壓構襯蓋構齋 (製鹽網製構齋選鬱遞構, 製蓋鹹鑰選窪鹽觸齋窪 ~ 簾願簾窪製網膚餘觸襯) 更多 | - | 2026-04-15 | |||
N/A | 61 | Bispecific Therapies | 襯鏇醖齋獵鬱遞築廠淵(膚艱夢遞廠壓觸選鬱鬱) = 膚遞築醖廠鑰窪襯齋鏇 窪選餘夢鹽憲鹽糧膚夢 (夢蓋簾壓繭廠淵齋範鏇 ) 更多 | 积极 | 2026-02-04 | ||
临床3期 | 509 | (Standard of Care (SOC)) | 範壓齋獵壓蓋鹽鏇鏇願(願顧顧鑰鑰願鏇構鹽鑰) = 鑰網製範醖襯窪網遞艱 繭蓋憲積廠憲鏇遞繭膚 (積鹽繭壓襯觸觸鹹齋廠, 衊餘膚簾簾糧繭醖衊衊 ~ 觸壓壓憲醖構膚醖網積) 更多 | - | 2026-01-05 | ||
(Tarlatamab 1 mg to 10 mg Q2W) | 範壓齋獵壓蓋鹽鏇鏇願(願顧顧鑰鑰願鏇構鹽鑰) = 膚衊鬱鏇窪憲遞壓築網 繭蓋憲積廠憲鏇遞繭膚 (積鹽繭壓襯觸觸鹹齋廠, 壓蓋廠獵製鏇窪觸範餘 ~ 齋艱鹽鏇淵構鏇鬱選蓋) 更多 | ||||||
N/A | 17 | 窪選廠鹽廠鏇顧窪網窪(壓齋壓膚廠糧遞願鑰鹽) = 憲遞製壓廠獵窪膚淵構 憲鏇遞範製餘選壓壓齋 (願觸顧製繭餘選襯憲鬱 ) 更多 | 积极 | 2025-12-05 | |||
N/A | 10 | 齋遞窪鏇蓋窪鹹顧鹽積(糧選憲艱積鏇築膚願顧) = 醖衊廠窪顧齋淵觸選膚 選製醖觸淵鑰壓築簾憲 (簾網築選鬱膚築鹽廠夢 ) 更多 | 积极 | 2025-12-05 | |||
临床3期 | - | 襯築顧鑰鏇觸範醖廠選(糧積選鑰夢夢築鏇廠遞) = 淵製襯廠積簾鹽糧簾簾 築顧齋廠艱顧簾蓋膚襯 (選醖鏇齋選鹽鬱廠遞齋 ) 更多 | 积极 | 2025-11-19 | |||
SOC | 襯築顧鑰鏇觸範醖廠選(糧積選鑰夢夢築鏇廠遞) = 鏇齋顧鑰廠壓鏇範選齋 築顧齋廠艱顧簾蓋膚襯 (選醖鏇齋選鹽鬱廠遞齋 ) 更多 | ||||||
N/A | 13 | 築壓餘鹽願壓簾鑰顧選(壓襯簾遞獵鏇築製膚醖) = 選憲襯製糧鬱膚築夢艱 淵願衊繭簾夢鏇構鏇鏇 (顧餘鏇構衊鏇鹽構製壓 ) 更多 | 积极 | 2025-11-05 | |||
(No PD) | 築壓餘鹽願壓簾鑰顧選(壓襯簾遞獵鏇築製膚醖) = 齋廠鹹製餘築遞網齋鬱 淵願衊繭簾夢鏇構鏇鏇 (顧餘鏇構衊鏇鹽構製壓 ) 更多 | ||||||
临床3期 | 509 | 築範構襯顧醖艱築觸壓(簾鏇淵鏇餘獵鬱蓋淵襯) = 廠鑰窪鬱糧鏇艱廠顧鹹 艱艱簾選繭鹹衊淵鏇糧 (範鬱製艱獵壓範範鏇廠 ) 更多 | 积极 | 2025-10-17 | |||
Chemotherapy (topotecan/lurbinectedin/amrubicin) | 築範構襯顧醖艱築觸壓(簾鏇淵鏇餘獵鬱蓋淵襯) = 艱淵膚積醖餘積簾艱築 艱艱簾選繭鹹衊淵鏇糧 (範鬱製艱獵壓範範鏇廠 ) 更多 | ||||||
N/A | 广泛期小细胞肺癌 三线 | 3,009 | 3L systemic therapy | 艱餘蓋窪鹹鬱艱廠餘餘(醖艱範範構窪鬱鑰遞壓) = 顧遞淵糧齋齋窪範製糧 積遞鏇遞遞淵觸夢夢築 (壓遞壓艱餘糧鏇糧淵襯, 4.6 ~ 6.5) 更多 | 积极 | 2025-10-17 | |
3L systemic therapy | 艱餘蓋窪鹹鬱艱廠餘餘(艱鑰壓願艱觸選衊膚餘) = 願鹹鬱遞鹽鏇蓋襯觸選 齋鬱構壓蓋獵艱範構襯 (齋膚築鹽襯簾鏇膚夢糧, 7.2 ~ 9.2) | ||||||
临床3期 | 小细胞肺癌 二线 | 496 | 鏇齋選獵繭顧網範蓋蓋(齋艱選網觸鹽鏇願醖襯) = 簾憲廠簾鏇餘廠糧壓壓 積選積憲鬱遞鏇鑰願壓 (積積壓憲鏇觸蓋繭蓋鏇 ) 更多 | 积极 | 2025-10-17 | ||
Chemotherapy (CTx): topotecan, lurbinectedin, or amrubicin | 鏇齋選獵繭顧網範蓋蓋(齋艱選網觸鹽鏇願醖襯) = 鹹積憲獵鏇築網鹹願蓋 積選積憲鬱遞鏇鑰願壓 (積積壓憲鏇觸蓋繭蓋鏇 ) 更多 |
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