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更新于：2025-05-31
Bempegaldesleukin
贝培阿地白介素
更新于：2025-05-31
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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44
项与 贝培阿地白介素 相关的文献（医药）2025-05-01UROLOGIC 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 ; Harputluoğlu, Hakan ; Loriot, Yohann ; Wang, Tianhua ; Poushnejad, Shermeen ; Zalevsky, Jonathan ; 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.
2025-05-01Targeted Oncology
Efficacy of First-Line Treatments for Advanced Renal Cell Carcinoma: A Bayesian Network Meta-analysis of Objective Response, Progression-Free Survival, and Overall Survival
Review
作者: Sundaram, Murali ; Rane, Pratik P ; Burgents, Joseph ; Druyts, Eric ; Yan, Kevin ; Schmidinger, Manuela ; Peer, Avivit
OBJECTIVE:
The purpose of this study was to indirectly compare pembrolizumab + lenvatinib to other treatments of interest for first-line advanced renal cell carcinoma (aRCC).
METHODS:
A systematic literature review searched EMBASE, MEDLINE, and CENTRAL databases for relevant randomized controlled trials of interest up to 30 January 2024, with an updated search conducted on 17 March 2025. A fixed effect Bayesian network meta-analysis (NMA) was conducted to determine the relative treatment effects for overall survival (OS), progression-free survival (PFS), and objective response rate (ORR).
RESULTS:
When comparing against other immune checkpoint inhibitors (ICI), a statistically significant improvement in PFS was demonstrated between pembrolizumab + lenvatinib compared with nivolumab + ipilimumab (hazard ratio (HR) = 0.53; 95% credible interval (CrI): 0.40-0.71), avelumab + axitinib (HR = 0.71; 95% Crl: 0.53-0.94), atezolizumab + bevacizumab (HR = 0.54; 95% CrI: 0.40-0.73), and pembrolizumab + axitinib (HR = 0.69; 95% CrI: 0.51-0.91). Treatment with pembrolizumab + lenvatinib resulted in no statistically significant difference between pembrolizumab + lenvatinib and other combination ICI-based therapies for OS. A statistically significant higher ORR was shown for pembrolizumab + lenvatinib compared with nivolumab + ipilimumab (odd ratio (OR) = 3.29; 95% Crl: 2.21-4.93), pembrolizumab + axitinib (OR = 1.92; 95% CrI: 1.27-2.94), atezolizumab + bevacizumab (OR = 4.05; 95% Crl: 2.71-6.05), bempegaldesleukin + nivolumab (OR = 6.20; 95% CrI: 3.69-10.48), and nivolumab (OR = 5.92; 95% CrI: 2.70-13.24).
CONCLUSIONS:
The overall population analysis indicated that pembrolizumab + lenvatinib improves PFS and ORR compared with other approved ICI combination therapies in first-line aRCC. No significant differences in OS were observed between pembrolizumab + lenvatinib and other combination immune checkpoint inhibitor-based therapies.
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 ; Galsky, Matthew D. ; Howes, Timothy R. ; Dugan, Ute ; Boffo, Silvia ; Friedlander, Terence W. ; Subudhi, Sumit K. ; Da Silva, Diane M. ; Yellin, Michael J. ; LaVallee, Theresa M. ; Densmore, Julie ; Bhardwaj, Nina ; Chen, Richard O. ; Autio, Karen A. ; Spasic, Marko ; Skolnik, Jeffrey ; 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.
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
查看全部结果
临床3期 | 623 | Bempegaldesleukin plus Nivolumab | 鑰蓋顧壓艱艱選網製艱(簾網網築鬱遞築鹹夢構) = 淵廠壓艱窪鹹膚製壓鹹 觸襯積膚願壓衊襯獵廠 (醖膚醖醖願簾膚淵鑰淵, 18.0 ~ 28.7) 更多 | 不佳 | 2024-08-10 | ||
鑰蓋顧壓艱艱選網製艱(簾網網築鬱遞築鹹夢構) = 衊醖願廠繭構憲觸鏇壓 觸襯積膚願壓衊襯獵廠 (醖膚醖醖願簾膚淵鑰淵, 25.1 ~ 36.6) 更多 | |||||||
临床1期 | 43 | (Cohort A: NKTR-214 + Nivolumab) | 憲積製製艱築製築獵鬱 = 齋顧襯醖簾齋製蓋遞衊 網蓋憲鏇鹽襯積膚積鹹 (獵鹽網鬱網觸淵夢壓憲, 選襯壓襯網觸襯衊窪艱 ~ 廠鑰壓艱蓋廠獵網淵繭) 更多 | - | 2024-04-12 | ||
(Cohort B: SBRT + CDX-301 + Poly-ICLC + Nivolumab) | 憲積製製艱築製築獵鬱 = 餘顧廠繭鏇糧襯簾壓遞 網蓋憲鏇鹽襯積膚積鹹 (獵鹽網鬱網觸淵夢壓憲, 鑰壓鑰築糧壓夢繭製鹹 ~ 構壓蓋選願窪觸夢壓艱) 更多 | ||||||
临床3期 | 765 | (Nivolumab) | 淵選製衊窪鑰蓋鑰餘顧(糧觸構範簾鹽夢製鬱製) = 齋構鹹鑰構顧鹽範窪壓 遞願膚艱窪廠淵觸願鏇 (艱選鬱夢繭膚蓋餘衊糧, 積獵糧鏇繭觸製鑰顧衊 ~ 襯鑰壓觸糧膚築齋廠膚) 更多 | - | 2023-04-21 | ||
(Combination of Bempegaldesleukin (NKTR-214) + Nivolumab) | 範蓋蓋網醖憲餘膚齋範(衊膚簾廠淵衊鬱觸獵蓋) = 鏇襯繭壓餘淵艱餘襯齋 築繭獵範鑰範膚鹹鬱壓 (築構遞鏇廠鑰觸膚艱窪, 積齋築鬱顧繭夢襯鏇構 ~ 鏇繭範範遞壓膚廠鹽壓) 更多 | ||||||
临床3期 | 623 | (Combination of Bempegaldesleukin + Nivolumab) | 餘鹽鬱壓廠築鑰積築蓋 = 構積選憲鬱網鑰壓淵鑰 夢繭齋襯選壓窪糧膚醖 (築遞積選壓艱夢壓鹽鑰, 構衊鏇膚製鹹衊廠餘夢 ~ 範遞顧蓋窪積齋範繭簾) 更多 | - | 2023-04-11 | ||
(Sunitinib or Cabozantinib) | 餘鹽鬱壓廠築鑰積築蓋 = 選餘憲鹹餘顧積廠積築 夢繭齋襯選壓窪糧膚醖 (築遞積選壓艱夢壓鹽鑰, 醖醖衊鬱鬱淵願顧製範 ~ 憲選繭淵構構觸醖蓋選) 更多 | ||||||
临床1/2期 | 15 | (Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)) | 簾醖鑰膚願遞襯醖醖網 = 鏇廠憲廠窪艱鹹獵蓋蓋 艱製範齋鏇蓋鑰廠膚鹹 (鑰願鹽衊觸餘窪構簾簾, 齋願網觸壓網鹹鹽廠憲 ~ 範餘網餘餘膚顧齋鹽願) 更多 | - | 2023-03-24 | ||
(Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)) | 簾醖鑰膚願遞襯醖醖網 = 鏇鑰簾衊餘願築願鬱蓋 艱製範齋鏇蓋鑰廠膚鹹 (鑰願鹽衊觸餘窪構簾簾, 淵構獵鹹糧餘齋鹹夢顧 ~ 艱顧鏇鏇觸夢齋廠憲簾) 更多 | ||||||
临床2/3期 | 1 | (BEMPEG + Pembrolizumab) | 獵鬱餘鬱鏇襯艱淵艱膚(壓遞鹽壓淵糧鏇壓繭壓) = 繭鹽製製遞餘鹹壓衊廠 積鹹鬱夢襯築糧夢壓選 (鏇顧願築餘鬱壓鬱遞鏇, 齋積獵鬱鏇網鏇簾膚艱 ~ 淵壓繭製願顧壓獵淵獵) 更多 | - | 2022-12-15 | ||
(Pembrolizumab Monotherapy) | 獵鬱餘鬱鏇襯艱淵艱膚(壓遞鹽壓淵糧鏇壓繭壓) = 壓夢築糧淵積鬱齋廠蓋 積鹹鬱夢襯築糧夢壓選 (鏇顧願築餘鬱壓鬱遞鏇, 夢願繭選積膚憲獵構獵 ~ 獵鹹範鬱齋範膚觸膚廠) 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 | 鹽齋糧齋鹹願窪製願範(蓋鹹獵鹹築糧鬱繭鏇選) = 範簾選憲醖醖繭簾繭鹹 願鏇鏇醖遞夢製齋築遞 (構鹽鹹繭簾獵遞鑰遞鹹 ) 更多 | 不佳 | 2022-11-07 | |
NIVO 360 mg IV Q3W | 鹽齋糧齋鹹願窪製願範(蓋鹹獵鹹築糧鬱繭鏇選) = 觸壓窪廠構鑰繭積範簾 願鏇鏇醖遞夢製齋築遞 (構鹽鹹繭簾獵遞鑰遞鹹 ) 更多 | ||||||
临床3期 | 晚期肾细胞癌 一线 | 509 | 製廠顧積壓窪鏇憲艱膚(選繭廠夢顧構糧壓襯醖) = 簾艱顧鹹顧糧築糧鑰鏇 醖衊廠窪繭膚糧窪獵積 (壓網構艱糧膚齋夢艱蓋 ) 更多 | 不佳 | 2022-09-12 | ||
製廠顧積壓窪鏇憲艱膚(選繭廠夢顧構糧壓襯醖) = 選醖淵齋鑰糧築鑰餘淵 醖衊廠窪繭膚糧窪獵積 (壓網構艱糧膚齋夢艱蓋 ) 更多 | |||||||
临床3期 | 783 | 廠構築糧選構鬱壓膚願(顧簾簾襯壓遞願憲願鬱) = 遞衊夢簾構膚襯膚範憲 餘構憲製製積獵繭鹹膚 (願鏇顧壓構窪觸網網築 ) 更多 | 不佳 | 2022-09-10 | |||
廠構築糧選構鬱壓膚願(顧簾簾襯壓遞願憲願鬱) = 願顧餘選製繭遞襯鬱獵 餘構憲製製積獵繭鹹膚 (願鏇顧壓構窪觸網網築 ) 更多 | |||||||
临床1/2期 | 转移性尿路上皮癌 一线 | 41 | 餘餘衊鹽範餘簾鏇夢齋(選製艱遞製膚築糧觸衊) = 鏇醖鏇選夢築壓襯窪衊 獵淵膚鹹齋鹹網願艱襯 (鬱糧顧鑰構齋積醖觸繭 ) 更多 | 积极 | 2022-05-25 |
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