Drugs / Etirinotecan Pegol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Onzeald | — | 2018-01-08 | europa.eu ↗ |
Trials 12
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT01976143 | Feb 2014 → Jun 2016 | cancer of unknown primary site, metastatic neoplasm | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01991678 | Nov 2013 → May 2017 | — | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 28 trials · 1 missed | ||||||
| Phase 2 | NCT02312622 | Aug 2015 → Sep 2018 | breast cancer, metastatic malignant neoplasm in the brain, non-small cell lung carcinoma, small cell lung carcinoma | Joel Neal | Completed | No outcome recorded |
| Phase 2 | NCT01876446 | Aug 2013 → Jul 2017 | small cell lung carcinoma | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 2 | NCT01773109 | Jan 2013 → Jan 2016 | non-small cell lung carcinoma | Abramson Cancer Center at Penn Medicine | Completed | No outcome recorded |
| Phase 2 | NCT01663012 | Jul 2012 → Feb 2015 | anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma | Lawrence Recht | Completed | No outcome recorded |
| Phase 2 | NCT01457118 | Oct 2011 → Aug 2017 | cancer | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00856375 | Dec 2008 → Jul 2014 | colorectal cancer | Nektar Therapeutics | Completed | Missed primary |
| Phase 2 | NCT00802945 | Oct 2008 → Oct 2011 | breast cancer | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00806156 | Oct 2008 → Oct 2012 | ovarian cancer | Nektar Therapeutics | Completed | No outcome recorded |
| Phase 32 trials · 2 missed | ||||||
| Phase 3 | NCT02915744 | Nov 2016 → Jul 2020 | breast cancer, metastatic neoplasm | Nektar Therapeutics | Completed | Missed primary |
| Phase 3 | NCT01492101 | Dec 2011 → Apr 2016 | female breast carcinoma | Nektar Therapeutics | Completed | Missed primary |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT00598975 Comparator | Feb 2008 → May 2009 | colorectal cancer | Nektar Therapeutics | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 29
| Date | Issuer | Release |
|---|---|---|
| 2015-03-17 | Nektar Therapeutics | Results Etirinotecan Pegol (NKTR-102) Prolonged Median Overall Survival by 2.1 Months versus Active Control in Patients with Advanced Breast Cancer in Phase 3 Study; Trial Did Not Achieve Statistical Significance (p=0.08) nektar.com ↗
Nektar Therapeutics (NASDAQ: NKTR) today announced topline results from its Phase 3 BEACON study evaluating single-agent NKTR-102 in patients with advanced breast cancer. |
| 2014-12-11 | Nektar Therapeutics | Results Nektar Presents Data on Target-Specific Biomarkers from Circulating Tumor Cell Sub-Study of Phase 3 BEACON Study of Etirinotecan Pegol (NKTR-102) in Patients with Advanced Breast Cancer nektar.com ↗
For the 611 evaluable baseline patient samples which yielded CTCs, potential NKTR-102 target-specific pharmacodynamic biomarkers (Top1, Top2, and Ki67) were detected in the majority of samples. |
| 2014-11-20 | Nektar Therapeutics | Results Nektar Presents Preclinical Study Findings for Etirinotecan Pegol (NKTR-102) in Combination with a PARP Inhibitor in BRCA1-deficient Cancer Model nektar.com ↗
The preclinical study results demonstrated that all dose combinations of NKTR-102 and rucaparib were well-tolerated, synergistic, and led to 100% prolonged survival in this tumor model. |
| 2014-05-31 | Nektar Therapeutics | Results Positive Data from Phase 2 Trial of NKTR-102 in Patients with Avastin®-Refractory High-Grade Glioma Presented at 50th ASCO Meeting nektar.com ↗
The primary endpoint was met and exceeded with fifty-five percent (95% CI: 31%-75%) of patients in the study achieving six-week progression-free survival. |
| 2014-04-09 | Nektar Therapeutics | Results Nektar Reports Positive Preclinical Data for Two Oncology Programs at 2014 AACR nektar.com ↗
In a model of triple-negative breast cancer with brain metastases (MDA-MB-231Br cell line), NKTR-102 reduced the size and number of brain metastases and also prolonged survival as compared to both placebo and irinotecan, a first-generation topoisomerase-I inhibitor. |
| 2014-01-18 | Nektar Therapeutics | Results Nektar Presents Positive Clinical Data from a Phase 1 Study of Etirinotecan Pegol (NKTR-102) in Combination with 5-Fluorouracil/Leucovorin at the 2014 Gastrointestinal Cancers Symposium nektar.com ↗
Nektar Therapeutics' (Nasdaq: NKTR) presented favorable data today from a Phase 1 study of etirinotecan pegol (EP, NKTR-102) in combination with 5-fluorouracil (5-FU)/Leucovorin (LV) in patients with advanced cancer. |
| 2012-11-07 | Nektar Therapeutics | Regulatory Nektar Announces that FDA Grants Fast Track Designation to Etirinotecan Pegol (NKTR-102) for the Treatment of Metastatic Breast Cancer nektar.com ↗
Nektar Therapeutics (NASDAQ:NKTR) announced today that the U.S. Food and Drug Administration (FDA) has designated etirinotecan pegol (NKTR-102) as a Fast Track development program for the treatment of patients with locally recurrent or metastatic breast cancer progressing after treatment with an anthracycline, a taxane, and capecitabine (ATC). |
| 2011-11-15 | Nektar Therapeutics | Results NKTR-102 Demonstrates Synergistic Anti-Tumor Activity in Combination with Pegylated Liposomal Doxorubicin in Platinum-Resistant Ovarian Cancer nektar.com ↗
The preclinical data demonstrates that NKTR-102 administered in combination with pegylated liposomal doxorubicin (PLD) in vivo has strong synergistic anti-cancer properties exhibiting a 100% complete response rate with no tumor re-growth in over 90% of animals. |
| 2011-09-09 | Nektar Therapeutics | Results Positive Results from Phase 2 Clinical Study of NKTR-102 in Metastatic Breast Cancer Presented in Oral Session at the ASCO 2011 Breast Cancer Symposium nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) announced today that positive results from the company's Phase 2 clinical study of NKTR-102 in patients with metastatic breast cancer were presented at the ASCO 2011 Breast Cancer Symposium in San Francisco , California. |
| 2011-07-18 | Nektar Therapeutics | Regulatory NKTR-102 Receives Positive Opinion From EMA COMP for Orphan Medicinal Product Designation in Ovarian Cancer nektar.com ↗ |
| 2011-06-05 | Nektar Therapeutics | Results NKTR-102 Shows High Response Rate and Sustained Duration of Response in Women with Platinum-Resistant/Refractory Ovarian Cancer Previously Treated with Doxil® nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced positive results from a subpopulation of patients in a Phase 2 clinical study evaluating single-agent NKTR-102 in women with platinum-resistant/refractory ovarian cancer. |
| 2011-06-04 | Nektar Therapeutics | Results NKTR-102 Demonstrates Sustained Clinical Benefit in 46% of Patients with Metastatic Breast Cancer in Data Presented at 2011 American Society of Clinical Oncology Annual Meeting nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 as a second- and third-line treatment in patients with metastatic breast cancer during the 2011 American Society of Clinical Oncology Meeting (ASCO). |
| 2011-04-21 | Nektar Therapeutics | Regulatory FDA Grants Orphan Drug Designation for Nektar's Investigational Drug, NKTR-102, for Treatment of Women with Ovarian Cancer nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced that the company's oncology drug candidate, NKTR-102, has been granted orphan drug status for the treatment of women with ovarian cancer by the U.S. Food and Drug Administration (FDA). |
| 2010-12-12 | Nektar Therapeutics | Results NKTR-102 Demonstrates Significant Efficacy as Single-Agent in Second- or Third-Line Treatment in Metastatic Breast Cancer Patients nektar.com ↗
As of October 26, 2010 , confirmed ORR for all evaluable patients was 32% (10/31) for the q14d schedule and 26% (9/35) for the q21d schedule, including two confirmed complete responses (CRs) on the q14d schedule. |
| 2010-07-06 | Nektar Therapeutics | Results NKTR-102 Demonstrates Superior Activity to Irinotecan in Nonclinical Studies Presented at ESMO 12th World Congress on Gastrointestinal Cancer nektar.com ↗ |
| 2010-06-09 | Nektar Therapeutics | Results Nektar Therapeutics Announces Positive Initial Results from Phase 2 Study of NKTR-102 in Metastatic Breast Cancer nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced positive preliminary initial results from a two-stage Phase 2 clinical study evaluating single-agent NKTR-102 in women with advanced/metastatic breast cancer patients who have received a prior taxane. |
| 2010-06-06 | Nektar Therapeutics | Results NKTR-102 Has High Response Rate and Sustained Clinical Benefit in 48 Percent of Women with Platinum-Resistant/Refractory Ovarian Cancer nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today announced positive results from a Phase 2 clinical study evaluating single-agent NKTR-102 in women with platinum-resistant/refractory ovarian cancer. |
| 2010-03-08 | Nektar Therapeutics | Results Nektar Announces Positive Phase 2 Clinical Data from First Stage of NKTR-102 Study in Women with Platinum-Resistant Ovarian Cancer nektar.com ↗
The study showed that women who received NKTR-102 once every 21 days (q21 day) had a median PFS of 21.0 weeks. |
| 2010-01-12 | Nektar Therapeutics | Results Nektar Therapeutics Announces Positive Topline Results for NKTR-102 From First Stage of Phase 2 Study in Platinum-Resistant Ovarian Cancer nektar.com ↗
Confirmed objective response rates using RECIST were 21% (4/19) and 22% (4/18) for the q14 day and q21 day dose schedules, respectively. |
| 2009-09-22 | Nektar Therapeutics | Results NKTR-102 Shows Encouraging Anti-Tumor Activity in Ovarian Cancer in Phase 1 and Preclinical Data Presented at the ECCO 15 and 34th ESMO Multidisciplinary Congress nektar.com ↗
Both patients showed significant anti-tumor activity, including tumor reductions of up to 37% and a decrease in CA-125 marker levels of up to 80%. |
| 2008-10-24 | Nektar Therapeutics | Results Significant Anti-Tumor Activity and Extended Half-Life of NKTR-102 (PEG-irinotecan) Highlighted in Phase 1 Data Presented at EORTC-NCI-AACR Symposium nektar.com ↗
Nektar Therapeutics (Nasdaq: NKTR) today reported positive Phase 1 data for its lead proprietary oncology product candidate, NKTR-102 (PEG-irinotecan). |
| 2008-06-02 | Nektar Therapeutics | Results New Positive Data Announced for NKTR-102 (PEG-irinotecan), Highlights Promise of Nektar's Innovative Small Molecule PEG-Oncolytics nektar.com ↗
Significant anti-tumor activity was observed in all dose schedules of the study for NKTR-102 with partial responses observed in seven out of 44 total patients (16 percent) in the trial. |
| 2008-05-16 | Nektar Therapeutics | Results Significant Anti-Tumor Activity of NKTR-102 in Patients With Refractory Solid Tumors; Interim Data Published in ASCO 2008 Proceedings nektar.com ↗
Results for the first schedule (weekly x3 q4 weeks) found anti-tumor activity in 7 out of the total 32 patients evaluable for efficacy. |
| 2008-04-14 | Nektar Therapeutics | Results Additive Anti-Tumor Activity of NKTR-102 in Combination With Bevacizumab Highlighted in Positive Preclinical Data Presented at AACR Meeting nektar.com ↗
Positive preclinical data was presented by Nektar Therapeutics (Nasdaq: NKTR) this week for its lead oncolytic candidate, NKTR-102 (PEG-irinotecan), which demonstrated enhanced anti-tumor activity in a mouse xenograft model of colorectal cancer when co-administered with bevacizumab. |
| 2008-04-10 | Nektar Therapeutics | Results Nektar Therapeutics to Present Positive Data at Upcoming Medical and Scientific Meetings nektar.com ↗
NKTR-102, a novel PEGylated-irinotecan, has an enhanced pharmacokinetic profile with reduced gastrointestinal and hematopoietic toxicity compared to irinotecan with repeat dosing |
| 2007-10-25 | Nektar Therapeutics | Results NKTR-102 (PEG-Irinotecan) Demonstrates Significant Tumor Growth Inhibition In Multiple Preclinical Tumor Models nektar.com ↗
In the two data presentations today, NKTR-102 inhibited tumor growth by greater than 90% in mouse xenograft models of colorectal (HT29), lung (NCI- H460) and breast (MCF-7) cancers as compared to controls. |
| 2007-10-10 | Nektar Therapeutics | Results Tumor Growth Inhibition and Pharmacokinetic Profile of NKTR-102 (PEG-Irinotecan) in Multiple Solid Tumors To Be Presented at Upcoming AACR-NCI-EORTC International Conference nektar.com ↗
In preclinical studies presented at ECCO 14 in September, NKTR-102 substantially suppressed tumor growth in an irinotecan-resistant mouse colorectal tumor model, while irinotecan-treated groups did not show a statistically significant decrease in tumor growth compared to controls. |
| 2007-09-27 | Nektar Therapeutics | Results NKTR-102 (PEG-Irinotecan) Demonstrates Significant Anti-Tumor Activity and Improved Pharmacokinetic Profile in Preclinical Studies Presented at ECCO nektar.com ↗
NKTR-102 substantially suppressed tumor growth in an irinotecan-resistant mouse colorectal tumor model, while irinotecan-treated groups did not show a statistically significant decrease in tumor growth compared to controls. |
| 2007-07-26 | Nektar Therapeutics | Results Anti-Tumor Activity and Pharmacokinetic Properties of NKTR-102 (PEG-irinotecan) to be Presented at Upcoming Oncology Meeting nektar.com ↗
In preclinical studies in tumor-bearing mice, NKTR-102 resulted in significantly reduced tumor growth compared to irinotecan in colon, lung and breast tumors. |
All press releases naming this drug 47 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 15 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etirinotecan Pegol | “Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine...” PMID 26482278 ↗ Oct 20158“The long-acting topoisomerase-1 inhibitor, etirinotecan pegol, was designed to preferentially accumulate in tumor tissue including brain metastases, providing sustained...” PMID 31074641 ↗ May 2019 “A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety” NCT01976143 ↗ “A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer” NCT01876446 ↗ “A Phase 2 Study of Etirinotecan Pegol (NKTR-102) in Patients With Refractory Brain Metastases and Advanced Lung Cancer or Metastatic Breast Cancer (MBC)” NCT02312622 ↗ “Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study.” PMID 24095299 ↗ Oct 2013 “A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)” NCT01991678 ↗ |
| Known as | NKTR-102 | “Etirinotecan pegol (NKTR-102) versus treatment of physician's choice in women with advanced breast cancer previously treated with an anthracycline, a taxane, and capecitabine...” PMID 26482278 ↗ Oct 201510“Two schedules of etirinotecan pegol (NKTR-102) in patients with previously treated metastatic breast cancer: a randomised phase 2 study.” PMID 24095299 ↗ Oct 2013 “A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)” NCT01991678 ↗ “A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)” NCT01991678 ↗ “Etirinotecan pegol (NKTR-102)” NCT01773109 ↗ |
| Known as | Pegylated irinotecan | “This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients with small cell lung cancer that has returned after a period of improvement.” NCT01876446 ↗ |
| Action | Inhibit | “Etirinotecan pegol is a long-acting topoisomerase-I inhibitor designed to provide prolonged tumour-cell exposure to SN38, the active metabolite.” PMID 24095299 ↗ Oct 20131“DNA topoisomerase I inhibitor” CHEMBL3039558 ↗ |
| Modality | Other / unclassified | “NKTR-102 (Topoisomerase I Inhibitor Polymer Conjugate)” NCT00856375 ↗ |
| Route | Intravenous | “NKTR-102 was administered intravenously (IV)” NCT00598975 ↗ |
| Target | TOP1 | “DNA topoisomerase I inhibitor” CHEMBL3039558 ↗ |