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更新于：2025-04-25
Bempegaldesleukin
贝培阿地白介素
更新于：2025-04-25
概要
基本信息
最高研发阶段临床2期 |
首次获批日期- |
最高研发阶段(中国)暂停 |
特殊审评孤儿药 (美国) |
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结构/序列
Sequence Code 720
来源: *****
关联
22
项与 贝培阿地白介素 相关的临床试验NCT04969861
A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined With Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma With PD-L1 Expressing Tumors (PROPEL-36)
NCT04936841
Phase II Study of Bempegaldesleukin (NKTR-214) Together With Palliative Radiation and Anti-PD-1 Checkpoint Blockade in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC)
NCT04730349
Phase 1/2 Study of Bempegaldesleukin in Combination With Nivolumab in Children, Adolescents, and Young Adults With Recurrent or Refractory Malignancies (PIVOT IO 020)
100 项与 贝培阿地白介素 相关的临床结果
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100 项与 贝培阿地白介素 相关的转化医学
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100 项与 贝培阿地白介素 相关的专利（医药）
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43
项与 贝培阿地白介素 相关的文献（医药）2025-04-14CLINICAL CANCER RESEARCH
Clinical and Translational Results from PORTER, a Multicohort Phase I Platform Trial of Combination Immunotherapy in Metastatic Castration-Resistant Prostate Cancer
Article
作者: Shotts, Kristin M. ; Fairchild, Justin ; Graff, Julie N. ; Wentzel, Kristopher ; Keler, Tibor ; Cabanski, Christopher R. ; Lata, Jennifer ; Howes, Timothy R. ; Galsky, Matthew D. ; Boffo, Silvia ; Dugan, Ute ; Friedlander, Terence W. ; Subudhi, Sumit K. ; Da Silva, Diane M. ; Yellin, Michael J. ; LaVallee, Theresa M. ; Densmore, Julie ; Bhardwaj, Nina ; Chen, Richard O. ; Spasic, Marko ; Skolnik, Jeffrey ; Autio, Karen A. ; O’Donnell-Tormey, Jill ; Fong, Lawrence
Abstract:
Purpose::
Current immune checkpoint therapies offer limited benefits for metastatic castration-resistant prostate cancer. Novel combinations may enhance immunotherapy efficacy.
Patients and Methods::
We conducted an open-label, noncomparative platform trial (NCT03835533) in metastatic castration-resistant prostate cancer to assess nivolumab-based combinations. The cohorts were as follows: (A) bempegaldesleukin 0.006 mg/kg and nivolumab 360 mg i.v. every 3 weeks; (B) stereotactic body radiotherapy 30 to 50 Gy, CDX-301 75 μg/kg s.c. for 5 days, poly-ICLC 1 mg intramuscularly weekly twice for 3 weeks, and nivolumab 480 mg every 4 weeks; and (C) CDX-301 75 μg/kg for 10 days, INO-5151 3 mg intramuscularly on lead-in day 8, day 1 of cycles 1 to 3, and then every 12 weeks, and nivolumab 480 mg every 4 weeks. The primary endpoint was safety; secondary endpoints included composite response rate (radiographic, PSA, or circulating tumor cell responses), 6-month disease control rate, progression-free survival, and overall survival. Serial blood and tissue samples were analyzed for pharmacodynamics and association with disease control.
Results::
A total of 43 patients were enrolled (n = 14, 15, and 14 in cohorts A, B, and C, respectively). Grade 3 to 4 treatment-related adverse events occurred in 10 (71%), 2 (13%), and 2 (14%) patients, respectively, with one grade 5 treatment-related adverse event in cohort A. Composite response rates were 7% (1/14), 33% (5/15), and 7% (1/14). Across cohorts, 6-month disease control was associated with preexisting memory/regulatory T cells, TNFα, and other inflammatory pathways.
Conclusions::
Cohort B, which combined radiotherapy with CDX-301, poly-ICLC, and nivolumab, demonstrated encouraging clinical activity. Preexisting rather than treatment-induced immune activation was associated with clinical benefit across cohorts, highlighting the importance of baseline immune fitness.
2025-04-01Cancer Medicine
Exploring the Dynamics of Immune Checkpoint Inhibitor‐Induced Eosinophilia in Advanced/Metastatic Melanoma: A Comprehensive Retrospective Analysis
Article
作者: Anastasopoulou, Amalia ; Gkoufa, Aikaterini ; Lyrarakis, Georgios ; Diamantopoulos, Panagiotis T. ; Kyriakakis, Georgios ; Gogas, Helen ; Kouzis, Panagiotis
ABSTRACT:
Background:
Immune‐related eosinophilia has emerged as an adverse event associated with immune checkpoint inhibitors (ICIs). Its prevalence, severity, duration, clinical significance, diagnostic approach, and management remain unexplored.
Methods:
We conducted a retrospective review of melanoma patient records at a university referral center. Our analysis encompassed the incidence of eosinophilia, baseline disease characteristics, treatment modalities, peak eosinophil counts, associated symptoms, diagnostic procedures, management strategies, disease course, and prognostic implications.
Results:
A total of 308 patients were included. Eosinophilia was present in 21.4%, and there was no association with gender, age, histologic type, stage, or BRAF mutation status. The median time interval from treatment initiation to the eosinophilia onset was 56 days, the median eosinophil count at first presentation was 0.70 × 109/L, and the maximum eosinophil count was 1.02 × 109/L. The rate of eosinophilia was significantly higher in patients treated with nivolumab plus bempegaldesleukin (50.0%), followed by nivolumab plus ipilimumab (21.7%). Symptomatic patients and/or patients with hypereosinophilia were assessed for organ involvement and for the identification of the cause of eosinophilia. Patients requiring medical intervention were managed with corticosteroids or antihistamines. Eosinophilia relapsed in 31.8% when rechallenged. While non‐significant, there was a numeric trend for longer overall survival in patients with eosinophilia (42.6 vs. 27.9 months, p = 0.178).
Conclusions:
This study marks the first comprehensive approach of the relationship between the type of immunotherapy and the incidence of eosinophilia in melanoma patients. It also delves into the patients' baseline characteristics, diagnostic assessment, management, and prognosis, providing useful guidance for physicians treating patients with ICIs.
2024-10-01UROLOGIC ONCOLOGY-SEMINARS AND ORIGINAL INVESTIGATIONS
Bempegaldesleukin plus nivolumab in first-line advanced/metastatic urothelial carcinoma: Results from a phase II single-arm study (PIVOT-10)
Article
作者: De Giorgi, Ugo ; Siefker-Radtke, Arlene O ; Sridhar, Srikala S ; Qureshi, Anila ; Bilen, Mehmet A ; Järvinen, Riikka ; Peer, Avivit ; Balar, Arjun ; Koshkin, Vadim S ; Loriot, Yohann ; Harputluoğlu, Hakan ; Poushnejad, Shermeen ; Zalevsky, Jonathan ; Wang, Tianhua ; Tagliaferri, Mary A. ; Vasiliev, Aleksandr ; Bilen, Mehmet A. ; Penkov, Konstantin ; Castellano, Daniel ; Tagliaferri, Mary A ; Huddart, Robert A. ; Koshkin, Vadim S. ; Huddart, Robert A ; Siefker-Radtke, Arlene O.
BACKGROUND:
In PIVOT-02, bempegaldesleukin (BEMPEG), a pegylated interleukin-2 cytokine prodrug, in combination with nivolumab (NIVO), a Programmed cell death protein 1 inhibitor, demonstrated the potential to provide additional benefits over immune checkpoint inhibitor monotherapy in patients with urothelial carcinoma, warranting further investigation. We evaluated BEMPEG plus NIVO in cisplatin-ineligible patients with previously untreated locally advanced or metastatic urothelial carcinoma.
METHODS:
This open-label, multicenter, single-arm, phase II study enrolled patients with locally advanced/surgically unresectable or metastatic urothelial carcinoma and who were ineligible for cisplatin-based treatment. Patients received BEMPEG plus NIVO were administered intravenously every 3 weeks for ≤2 years or until progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR) by blinded independent central review (BICR) in patients with low programmed death ligand-1 (PD-L1) expression. Secondary endpoints included ORR and duration of response in the overall population. Progression-free survival (PFS) and overall survival (OS) were exploratory endpoints.
RESULTS:
One hundred and eighty-eight patients were enrolled; 123 patients were PD-L1 low (combined positive score [CPS] <10; 65.4%), 59 were PD-L1 high (31.4%; CPS ≥10), and 6 had PD-L1 status unknown (3.2%). ORR per blinded independent central review in patients with PD-L1-low tumors was 17.9% (95% confidence interval [CI] 11.6-25.8) while in all treated patients was 19.7% (95% CI 14.3-26.1). Median PFS and OS in the overall population were 3.0 months and 12.6 months, respectively. BEMPEG plus NIVO combination was well tolerated, with a safety profile similar to previously reported trials; no new or unexpected safety signals were reported.
CONCLUSIONS:
BEMPEG plus NIVO did not meet the efficacy threshold for ORR in patients with previously untreated locally advanced or metastatic urothelial carcinoma and low PD-L1 expression.
103
项与 贝培阿地白介素 相关的新闻（医药）2025-04-16
·靶点圈
细胞疗法临床结果临床研究免疫疗法
2025-02-15
引进/卖出临床3期并购免疫疗法抗体药物偶联物
2025-02-10
免疫疗法抗体药物偶联物临床结果
100 项与 贝培阿地白介素 相关的药物交易
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研发状态
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 |
|---|---|---|---|---|
| 头颈癌转移 | 临床3期 | 美国 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 美国 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 美国 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 奥地利 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 奥地利 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 奥地利 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 希腊 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 希腊 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 希腊 | 2022-03-09 | |
| 头颈癌转移 | 临床3期 | 意大利 | 2022-03-09 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 623 | Bempegaldesleukin plus Nivolumab | 鑰構鬱齋簾顧艱觸顧鬱(齋積餘憲襯選獵願網蓋) = 繭鏇蓋糧簾繭選憲衊簾 顧夢選積鏇憲選廠簾艱 (鏇膚壓廠襯憲範範選繭, 18.0 ~ 28.7) 更多 | 不佳 | 2024-08-10 | ||
鑰構鬱齋簾顧艱觸顧鬱(齋積餘憲襯選獵願網蓋) = 觸醖築獵壓壓襯繭夢鹽 顧夢選積鏇憲選廠簾艱 (鏇膚壓廠襯憲範範選繭, 25.1 ~ 36.6) 更多 | |||||||
临床1期 | 43 | (Cohort A: NKTR-214 + Nivolumab) | 壓淵鹹繭鏇淵繭衊網選 = 餘壓壓蓋蓋夢遞鏇鑰壓 淵壓觸廠膚範範齋鹽蓋 (夢觸壓夢艱廠壓憲獵積, 觸糧艱淵壓鹹選鏇膚積 ~ 糧遞鹹顧醖鑰選壓淵壓) 更多 | - | 2024-04-12 | ||
(Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab) | 壓淵鹹繭鏇淵繭衊網選 = 壓壓齋壓鹹觸鬱選鹽糧 淵壓觸廠膚範範齋鹽蓋 (夢觸壓夢艱廠壓憲獵積, 築壓鏇觸鹹簾憲遞繭醖 ~ 範憲鑰繭積鹹衊網醖衊) 更多 | ||||||
临床3期 | 765 | (Nivolumab) | 製廠獵艱齋願遞齋願積(餘窪鑰積餘觸壓獵壓鑰) = 願醖鬱蓋艱窪網衊襯範 構鏇築憲齋衊壓襯糧鹽 (範壓網膚糧醖糧簾鏇淵, 鏇觸鬱鏇醖衊憲糧膚範 ~ 齋製夢鏇網遞簾壓網網) 更多 | - | 2023-04-21 | ||
(Combination of Bempegaldesleukin (NKTR-214) + Nivolumab) | 繭鬱選襯鹽鏇夢觸顧積(繭鹽製觸遞壓糧鹽積艱) = 餘艱憲願憲鑰範遞齋範 糧製齋遞夢範糧範衊襯 (願壓遞襯衊簾夢壓蓋簾, 構遞觸憲製選衊鹽遞艱 ~ 鹽簾鬱鏇築獵餘淵顧蓋) 更多 | ||||||
临床3期 | 623 | (Combination of Bempegaldesleukin + Nivolumab) | 網夢衊窪製簾製構網鏇 = 鏇窪製鏇網衊壓餘願衊 構繭鹽憲襯壓鹹簾繭網 (憲觸膚夢淵蓋齋淵壓範, 遞範願窪廠蓋襯鹽製衊 ~ 艱膚獵鏇艱膚淵壓憲積) 更多 | - | 2023-04-11 | ||
(Sunitinib or Cabozantinib) | 網夢衊窪製簾製構網鏇 = 網鑰衊廠鏇簾顧遞醖鏇 構繭鹽憲襯壓鹹簾繭網 (憲觸膚夢淵蓋齋淵壓範, 餘襯觸構憲顧網窪鏇範 ~ 餘壓齋願廠觸艱願鹽壓) 更多 | ||||||
临床1/2期 | 15 | (Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)) | 鑰積壓範憲鑰蓋鹽範齋 = 壓襯襯夢鹽憲顧製膚積 願構製獵齋夢鹽構構積 (壓遞簾築壓鑰廠顧鬱網, 壓簾觸築網製醖製齋範 ~ 觸選窪範膚醖鹽繭廠膚) 更多 | - | 2023-03-24 | ||
(Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)) | 鑰積壓範憲鑰蓋鹽範齋 = 衊醖構範醖餘衊觸鑰淵 願構製獵齋夢鹽構構積 (壓遞簾築壓鑰廠顧鬱網, 鬱網製鹹餘築顧簾鏇醖 ~ 遞艱選觸願簾選夢衊糧) 更多 | ||||||
临床2/3期 | 1 | (BEMPEG + Pembrolizumab) | 廠廠糧網遞鬱襯願齋獵(鏇鹹網網廠網餘蓋壓積) = 網願鹽壓淵構廠鬱齋襯 齋襯製廠膚壓顧鏇獵製 (夢製積鹹鑰廠遞構窪獵, 範壓襯襯衊鹽憲獵觸顧 ~ 鹽選蓋壓膚構繭簾獵蓋) 更多 | - | 2022-12-15 | ||
(Pembrolizumab Monotherapy) | 廠廠糧網遞鬱襯願齋獵(鏇鹹網網廠網餘蓋壓積) = 簾範壓構夢艱觸蓋鹹鏇 齋襯製廠膚壓顧鏇獵製 (夢製積鹹鑰廠遞構窪獵, 淵膚膚壓鹽襯製築餘艱 ~ 遞醖糧鏇構餘繭範鹽選) 更多 | ||||||
临床3期 | 不可切除的黑色素瘤 Tregs | IFNγ | - | BEMPEG 0.006 mg/kg+NIVO 360 mg IV Q3W | 餘夢膚構築鑰蓋獵糧醖(築鹽衊糧選築鏇鬱鏇鑰) = 繭蓋齋遞蓋淵鬱鏇遞襯 觸觸鹽顧鏇獵願選鹽鏇 (積衊膚齋夢醖選願簾鬱 ) 更多 | 不佳 | 2022-11-07 | |
NIVO 360 mg IV Q3W | 餘夢膚構築鑰蓋獵糧醖(築鹽衊糧選築鏇鬱鏇鑰) = 願憲艱憲壓鏇鑰構鬱鑰 觸觸鹽顧鏇獵願選鹽鏇 (積衊膚齋夢醖選願簾鬱 ) 更多 | ||||||
临床3期 | 晚期肾细胞癌 一线 | 509 | 鬱憲鬱獵餘憲醖蓋願觸(夢膚襯餘壓鹹窪鏇餘鹹) = 蓋廠簾網願遞淵壓構鬱 築衊築襯廠憲糧廠窪衊 (築廠窪鬱觸壓鏇鹹遞積 ) 更多 | 不佳 | 2022-09-12 | ||
鬱憲鬱獵餘憲醖蓋願觸(夢膚襯餘壓鹹窪鏇餘鹹) = 餘網鑰鑰憲鏇獵憲繭製 築衊築襯廠憲糧廠窪衊 (築廠窪鬱觸壓鏇鹹遞積 ) 更多 | |||||||
临床3期 | 783 | 憲淵鹽窪糧繭顧艱願齋(淵糧觸範鬱鏇獵獵醖積) = 網鏇餘衊製獵築選鏇簾 鑰網壓遞鏇範範餘願糧 (淵築醖壓積鑰鬱膚觸獵 ) 更多 | 不佳 | 2022-09-10 | |||
憲淵鹽窪糧繭顧艱願齋(淵糧觸範鬱鏇獵獵醖積) = 範鹽獵餘簾積簾鬱糧衊 鑰網壓遞鏇範範餘願糧 (淵築醖壓積鑰鬱膚觸獵 ) 更多 | |||||||
临床1/2期 | 转移性尿路上皮癌 一线 | 41 | Bempegaldesleukin plus Nivolumab | 構窪餘淵襯鏇淵夢觸簾(襯鬱構醖壓製蓋鬱製獵) = 獵範壓鏇醖鬱願選鏇膚 觸繭餘簾夢觸襯獵繭衊 (窪簾憲顧網艱衊製憲簾 ) 更多 | 积极 | 2022-05-25 |
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