Drugs / Bempegaldesleukin
Bempegaldesleukin
also known as
NKTR 214 · BEMPEG · Aldesleukin prodrug nktr-214 · Bempegaldesleukina · Bempegaldesleukine · NKTR-214 PRODRUG
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04646044 | Nov 2020 → May 2021 | COVID-19 | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT04955262 | Aug 2019 → Jun 2021 | metastatic melanoma | Nektar Therapeutics | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT03835533 | Jun 2019 → Oct 2022 | prostate carcinoma | Parker Institute for Cancer Immunotherapy | Completed | No outcome recorded |
| Phase 1 | NCT03745807 | Apr → Dec 2019 | cancer of unknown primary site | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT03772288 | Apr 2019 → Nov 2021 | non-Hodgkin lymphoma | Calithera Biosciences, Inc | Withdrawn | No outcome recorded Stop: Business |
| Phase 1/26 trials · 1 met primary | ||||||
| Phase 1/2 | NCT04730349 | Jun 2021 → Jun 2022 | Ewing sarcoma, ependymoma, high grade astrocytic tumor, lymphoid hemopathy +3 | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT04052204 | Dec 2019 → Sep 2020 | castration-resistant prostate carcinoma, head and neck squamous cell carcinoma | Pfizer | Terminated | No outcome recorded |
| Phase 1/2 | NCT03548467 | Apr 2018 → Jan 2023 | — | Nykode Therapeutics ASA | Completed | No outcome recorded |
| Phase 1/2 | NCT03138889 | Jun 2017 → Jul 2022 | non-small cell lung carcinoma | Nektar Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT02983045 | Dec 2016 → Apr 2022 | gastric cancer, hormone receptor-positive breast cancer, melanoma, non-small cell lung carcinoma +3 | Nektar Therapeutics | Completed | Met primary |
| Phase 1/2 | NCT02869295 | Dec 2015 → Oct 2018 | cancer of unknown primary site | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT07156643 | Oct 2025 → Oct 2030 expected | soft tissue sarcoma | The First Affiliated Hospital with Nanjing Medical University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04936841 | Aug 2021 → Oct 2022 | head and neck squamous cell carcinoma | University of Wisconsin, Madison | Terminated | No outcome recorded |
| Phase 2 | NCT03785925 | Apr 2019 → Feb 2022 | metastatic neoplasm, urinary bladder neoplasm | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT03282344 | Sep 2017 → Sep 2026 overdue | sarcoma | Memorial Sloan Kettering Cancer Center | Active not recruiting | Met primary |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT04969861 | Mar → Apr 2022 | head and neck cancer | Nektar Therapeutics | Terminated | No outcome recorded |
| Phase 34 trials · 2 missed | ||||||
| Phase 3 | NCT04410445 | Jul 2020 → Sep 2022 | cutaneous melanoma | Nektar Therapeutics | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04209114 | Feb 2020 → Jun 2023 | infiltrating bladder urothelial carcinoma | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT03729245 | Dec 2018 → Jan 2022 | renal cell carcinoma | Nektar Therapeutics | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT03635983 | Sep 2018 → Nov 2021 | melanoma | Bristol-Myers Squibb | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 1/2 | NCT03435640 Background | Mar 2018 → May 2022 | colorectal cancer, cutaneous neuroendocrine carcinoma, head and neck squamous cell carcinoma, melanoma +3 | Nektar Therapeutics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 35
| Date | Issuer | Release |
|---|---|---|
| 2022-04-14 | Bristol-Myers Squibb | Results Nektar and Bristol Myers Squibb Announce Update on Clinical Development Program for Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) bms.com ↗
An interim analysis of overall survival (OS) also did not meet the prespecified boundary for statistical significance in either of these populations. |
| 2022-04-14 | Nektar Therapeutics | Results Nektar and Bristol Myers Squibb Announce Update on Clinical Development Program for Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) nektar.com ↗
An interim analysis of overall survival (OS) also did not meet the prespecified boundary for statistical significance in either of these populations. |
| 2022-03-14 | Bristol-Myers Squibb | Results Bristol Myers Squibb and Nektar Announce Update on Phase 3 PIVOT IO-001 Trial Evaluating Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) in Previously Untreated Unresectable or Metastatic Melanoma bms.com ↗
Following a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers Squibb and Nektar were informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR). |
| 2022-03-14 | Nektar Therapeutics | Results Bristol Myers Squibb and Nektar Announce Update on Phase 3 PIVOT IO-001 Trial Evaluating Bempegaldesleukin (BEMPEG) in Combination with Opdivo (nivolumab) in Previously Untreated Unresectable or Metastatic Melanoma nektar.com ↗
Following a review of the study for efficacy and safety by an independent Data Monitoring Committee (DMC), Bristol Myers Squibb and Nektar were informed that the study did not meet the primary endpoints of progression-free survival (PFS) and objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR). |
| 2020-11-11 | Nektar Therapeutics | Results Nektar Therapeutics Presents New Data from Its Immuno-Oncology Pipeline at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting nektar.com ↗
Updated Clinical Data for Patients with Metastatic Melanoma Treated in PIVOT-02 Study of Bempegaldesleukin with Nivolumab Show Durable Clinical Benefit with Median Progression-Free Survival of 30.9 Months |
| 2020-05-22 | Nektar Therapeutics | Results Nektar Therapeutics Announces Publication of Results from Phase 1 Dose-Escalation Study for Bempegaldesleukin Plus Nivolumab in 'Cancer Discovery' Journal nektar.com ↗
The manuscript published today presents the safety, immune-activation and efficacy results from a Phase 1 dose-escalation study conducted in 38 patients with immunotherapy-naïve, advanced solid tumors, including melanoma, renal cell carcinoma (RCC), and non-small cell lung cancer (NSCLC). |
| 2020-02-03 | Nektar Therapeutics | Results Nektar Therapeutics Announces Publication of Two Manuscripts on Lead Immuno-oncology Candidate, Bempegaldesleukin (Bempeg) in Nature Communications nektar.com ↗
The published data demonstrate that bempeg, in combination with immune-based therapies including checkpoint inhibition (CPI), antigen-specific vaccination and adoptive cell transfer (ACT) therapy, enhanced T-cell mediated tumor control by selectively expanding effector T cells (Teffs) over T regulatory cells (Tregs) in the tumor microenvironment. |
| 2019-11-09 | Nektar Therapeutics | Results Nektar Therapeutics Presents New Clinical and Preclinical Data from its Immuno-Oncology Pipeline at the 2019 Society for Immunotherapy of Cancer (SITC) Annual Meeting nektar.com ↗
Clinical activity of BEMPEG plus NIVO in previously untreated patients with metastatic melanoma: updated results from the Phase 1/2 PIVOT-02 Study |
| 2019-09-26 | Nektar Therapeutics | Results Clinical Data Presented from PIVOT-02 Study of Bempegaldesleukin (NKTR-214) with Nivolumab in Triple-Negative Breast Cancer Patients at the 2019 CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference nektar.com ↗ |
| 2019-08-01 | Bristol-Myers Squibb | Regulatory Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma bms.com ↗
Nektar Therapeutics (Nasdaq: NKTR) and Bristol-Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo ® (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. |
| 2019-08-01 | Nektar Therapeutics | Regulatory Nektar Therapeutics and Bristol-Myers Squibb Announce U.S. FDA Breakthrough Therapy Designation for Bempegaldesleukin (NKTR-214) in Combination with Opdivo® (nivolumab) for the Treatment of Patients with Untreated Advanced Melanoma nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) and Bristol-Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration ( FDA ) has granted Breakthrough Therapy Designation for investigational agent bempegaldesleukin (NKTR-214) in combination with Bristol-Myers Squibb's Opdivo ® (nivolumab) for the treatment of patients with previously untreated unresectable or metastatic melanoma. |
| 2019-06-01 | Nektar Therapeutics | Results Nektar Therapeutics Presents Biomarker and Clinical Data from PIVOT-02 Phase 2 Study of Bempegaldesleukin with Nivolumab at 2019 ASCO Annual Meeting nektar.com ↗
This translated into a 34% rate of complete response at a 12-month follow-up for the 38 efficacy-evaluable patients in this cohort. |
| 2019-04-02 | Nektar Therapeutics | Results Nektar Therapeutics Presents Preclinical Data on its Immuno-Oncology Pipeline Candidates at the American Association for Cancer Research (AACR) Annual Meeting 2019 nektar.com ↗
Combination of neoantigen DNA plasmid vaccine VB10.NEO and NKTR-214, a CD122-biased immunostimulatory cytokine, induces strong neoantigen-specific T cell responses and sustained tumor regression in pre-clinical models |
| 2019-04-01 | Nektar Therapeutics | Results Vaccibody AS and Nektar Therapeutics Present New Preclinical Data from their Immuno-Oncology Collaboration at the American Association for Cancer Research (AACR) Annual Meeting 2019 nektar.com ↗
These unique and non-overlapping mechanisms produced an expansion of the VB10.NEO elicited neoantigen-specific T cells and demonstrated enhanced anti-tumor efficacy in mice. |
| 2019-03-01 | Nektar Therapeutics | Results Nektar Therapeutics Presents Preliminary Immune Activation, Safety and Clinical Activity Data from the Ongoing Dose-Escalation Stage of the REVEAL Study at 2019 ASCO-SITC Meeting nektar.com ↗
The early data from REVEAL demonstrate that a comprehensive approach to activating the body's immune system can drive abscopal anti-tumor responses even in the absence of a checkpoint inhibitor. |
| 2019-02-15 | Nektar Therapeutics | Results Clinical Data Presented from PIVOT-02 Study of Bempegaldesleukin (NKTR-214) with Nivolumab in Metastatic Urothelial Carcinoma Patients at the 2019 ASCO Genitourinary Cancers Symposium nektar.com ↗ |
| 2018-11-09 | Nektar Therapeutics | Results Nektar Therapeutics Presents New Clinical and Preclinical Data for its Immuno-Oncology Pipeline at the 2018 Society for Immunotherapy of Cancer (SITC) Annual Meeting nektar.com ↗
NKTR-214 paired with rucaparib provided significantly increased survival and durable complete response than either treatment alone in murine models of ovarian cancer. |
| 2018-06-04 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics and Nektar Therapeutics Present Preclinical Pancreatic Cancer Data for BXCL701, NKTR-214 and Anti-PD1 Combination Therapy at ASCO 2018 Annual Meeting bioxceltherapeutics.com ↗
Results from the preclinical study demonstrate that BXCL701, a dipeptidyl peptidase (DPP) and fibroblast activation protein (FAP) inhibitor, in combination with NKTR-214, a CD122-biased agonist, and an anti-PD-1 antibody represents a new treatment approach against pancreatic cancer. |
| 2018-06-02 | Bristol-Myers Squibb | Results Preliminary Data for NKTR-214 in Combination with Opdivo (nivolumab) for Patients with Stage IV Metastatic Melanoma, Renal Cell Carcinoma, and Urothelial Cancers Presented at ASCO 2018 bms.com ↗
Preliminary results from the ongoing PIVOT study presented today showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. |
| 2018-06-02 | Nektar Therapeutics | Results Preliminary Data for NKTR-214 in Combination with Opdivo (nivolumab) for Patients with Stage IV Metastatic Melanoma, Renal Cell Carcinoma, and Urothelial Cancers Presented at ASCO 2018 nektar.com ↗
Preliminary results from the ongoing PIVOT study presented today showed that pre-specified efficacy criteria were achieved in three tumor types: first-line melanoma, first-line renal cell carcinoma and first-line urothelial cancer. |
| 2018-05-17 | BioXcel Therapeutics Inc | Results BioXcel Therapeutics Announces Data Presentation at ASCO 2018 Annual Meeting bioxceltherapeutics.com ↗
which achieved not only 100% tumor durable regression, but also functional evidence of memory T cell formation in mice |
| 2017-11-11 | Nektar Therapeutics | Results First Data for NKTR-214 in Combination with OPDIVO® (nivolumab) for Patients with Stage IV Melanoma, Renal Cell Carcinoma and Non-Small Cell Lung Cancers, Including Patients with PD-L1 Negative Status, Revealed at SITC 2017 nektar.com ↗
The initial results presented at the 2017 Society for Immunotherapy of Cancer (SITC) Annual Meeting reported both safety and efficacy data for patients enrolled in the dose-escalation phase of the trial. |
| 2017-06-05 | Nektar Therapeutics | Results Nektar Presents New Clinical Data from Two Studies of NKTR-214, a CD122-Biased Agonist, at 2017 American Society of Clinical Oncology (ASCO) Annual Meeting nektar.com ↗
The combination is showing early clinical benefit in patients with both melanoma and renal cell carcinoma. |
| 2017-04-04 | Nektar Therapeutics | Results Nektar Therapeutics Presents New Preclinical Data for its Immuno-Oncology Programs at the American Association for Cancer Research (AACR) Annual Meeting nektar.com ↗
The presentations featured new preclinical data on NKTR-214, the Company's immuno-stimulatory CD122-biased agonist, as well as on NKTR-255, the Company's IL-15 therapeutic candidate. |
| 2017-02-18 | Nektar Therapeutics | Results Clinical Data from Phase 1 Dose-Escalation Study of Single-Agent NKTR-214 in Patients with Renal Cell Carcinoma Presented at the ASCO 2017 Genitourinary Cancers Symposium nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced that positive Phase 1 clinical data for Nektar's lead immuno-oncology agent, NKTR-214, in patients with renal cell carcinoma (RCC) were presented at ASCO GU 2017. |
| 2016-11-09 | Nektar Therapeutics | Results Nektar Therapeutics Presents New Clinical Data from Ongoing Phase 1 Dose-Escalation Study of NKTR-214 at the Society for Immunotherapy of Cancer (SITC) 2016 Annual Meeting nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced that new Phase 1 clinical data for Nektar's lead immuno-oncology agent, NKTR-214, were presented at the SITC 2016 Annual Meeting. |
| 2016-06-06 | Nektar Therapeutics | Results Preclinical Data Presented at ASCO 2016 Annual Meeting Demonstrate that Single-Agent NKTR-214 Produces a Large Increase in Tumor-Infiltrating Lymphocytes to Provide Durable Anti-Tumor Activity nektar.com ↗
The new preclinical data presented demonstrate that treatment with single-agent NKTR-214 mobilizes tumor-killing T cells into colon cancer tumors. |
| 2016-04-18 | Nektar Therapeutics | Results Preclinical Data Presented at AACR Demonstrate that Combining NKTR-214 with Checkpoint Blockade is Superior to Dual Checkpoint Inhibition in Increasing Clonality of the T Cell Receptor (TCR) Repertoire and T Cell Tumor Infiltration nektar.com ↗
In a TCR repertoire analysis conducted to assess both anti-tumor T cell clonality and T cell tumor infiltration (TIL clonality and infiltration), the combination of NKTR-214 and a checkpoint inhibitor resulted in dramatically higher increases for both parameters as compared to dual checkpoint inhibition. |
| 2016-02-01 | Nektar Therapeutics | Results Nektar Publishes Pre-clinical Results for NKTR-214, an Investigational CD122-Biased Immune-Stimulatory Cytokine for the Treatment of Cancer in Clinical Cancer Research nektar.com ↗
Among the findings reported, treatment with NKTR-214 led to durable and specific anti-tumor immunity in multiple syngeneic mouse models both as a single agent and as combination therapy with checkpoint inhibitors. |
| 2015-10-07 | Nektar Therapeutics | Regulatory Nektar Submits Investigational New Drug Application (IND) for NKTR-214 To Treat Solid Tumor Malignancies nektar.com ↗
Nektar Therapeutics (NASDAQ:NKTR) today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for NKTR-214, its lead immuno-oncology candidate. |
| 2015-09-21 | Nektar Therapeutics | Results Nektar Presents Data Demonstrating that NKTR-214, a CD122-Biased Immunostimulatory Cytokine, Induces Durable and Specific Anti-Tumor Immunity As a Single-Agent and When Combined with Checkpoint Inhibitors in Preclinical Models nektar.com ↗
NKTR-214 shows efficacy in multiple preclinical models as a single agent. |
| 2014-06-01 | Nektar Therapeutics | Results Nektar Presents Positive Preclinical Data for NKTR-214, a Novel Cancer Immunotherapy, at 50th ASCO Meeting nektar.com ↗
Nektar Therapeutics (NASDAQ:NKTR) announced positive preclinical data for NKTR-214, a new investigational cancer immunotherapy which selectively activates the IL-2 receptor complex and is being developed as a potential treatment for multiple cancers. |
| 2014-04-09 | Nektar Therapeutics | Results Nektar Reports Positive Preclinical Data for Two Oncology Programs at 2014 AACR nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR), a biopharmaceutical company developing novel therapeutics based on its PEGylation and advanced polymer conjugation technologies, today announced that preclinical data for NKTR-102 and NKTR-214 were presented at the 2014 Annual Meeting of the American Association of Cancer Research (AACR) being held in San Diego , California. |
| 2013-06-03 | Nektar Therapeutics | Results Nektar Presents Positive Preclinical Data for NKTR-214, a Novel Cancer Immunotherapy, At the 2013 American Society of Clinical Oncology Annual Meeting nektar.com ↗
In the preclinical data presented at ASCO, NKTR-214 exhibits efficacy and tolerability that is superior to the clinically approved cytokine aldesleukin (Proleukin®). |
| 2013-04-07 | Nektar Therapeutics | Results Positive Preclinical Data for NKTR-214, an Investigational Cancer Immunotherapy Targeting the IL-2 Receptor Complex, Presented at AACR Annual Meeting 2013 nektar.com ↗
In a well-validated animal model of melanoma, NKTR-214 demonstrated significantly improved dosing, at once every 9 days as compared to twice a day dosing with aldesleukin. |
All press releases naming this drug 53 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | bempegaldesleukin | “NKTR-214 (bempegaldesleukin) is a novel IL2 pathway agonist, designed to provide sustained signaling through heterodimeric IL2 receptor βγ to drive increased proliferation and...” PMID 30988166 ↗ Apr 201912“OBJECTIVE: To evaluate the immunostimulatory interleukin-2 cytokine prodrug bempegaldesleukin (BEMPEG) plus nivolumab in patients with advanced/mUC from the phase 2 multicenter...” PMID 35643589 ↗ May 2022 |
| Known as | Aldesleukin prodrug nktr-214 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298058 ↗ |
| Known as | BEMPEG | “This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab...” NCT04969861 ↗3“A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) Plus Standard of Care Versus Placebo Plus Standard of Care...” NCT04646044 ↗ “OBJECTIVE: To evaluate the immunostimulatory interleukin-2 cytokine prodrug bempegaldesleukin (BEMPEG) plus nivolumab in patients with advanced/mUC from the phase 2 multicenter...” PMID 35643589 ↗ May 2022 “Bempegaldesleukin (BEMPEG), a pegylated interleukin-2 (IL-2) cytokine prodrug, demonstrated efficacy in the phase II PIVOT-02 trial.” PMID 37651676 ↗ Aug 2023 |
| Known as | Bempegaldesleukina | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298058 ↗ |
| Known as | Bempegaldesleukine | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298058 ↗ |
| Known as | NKTR 214 | “This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab...” NCT04969861 ↗11“Here, we report a patient with metastatic melanoma who had a durable clinical response after treatment with the programmed cell death protein 1 inhibitor, nivolumab, combined...” PMID 33298619 ↗ Dec 2020 “A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) Plus Standard of Care Versus Placebo Plus Standard of Care...” NCT04646044 ↗ |
| Known as | NKTR-214 PRODRUG | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298058 ↗ |
| Action | Activate | “NKTR-214 (bempegaldesleukin) is a novel IL2 pathway agonist” PMID 30988166 ↗ Apr 2019 |
| Modality | Protein / enzyme biologic | “NKTR-214, a Novel IL2Rβγ-Biased Cytokine, in Patients with Advanced or Metastatic Solid Tumors.” PMID 30988166 ↗ Apr 2019 |
| Route | Intravenous | “Patients received BEMPEG 0.006 mg/kg plus nivolumab 360 mg intravenously every 3 wk.” PMID 35643589 ↗ May 2022 |