Drugs / Nelipepimut-S
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 2 missed | ||||||
| Phase 2 | NCT02636582 | Jun 2016 → Jul 2019 | ductal breast carcinoma in situ | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 2 | NCT02297698 | Oct 2014 → Dec 2021 | breast cancer | Cancer Insight, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01570036 | May 2013 → Sep 2018 | breast cancer | George E. Peoples | Completed | Missed primary |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT01479244 | Nov 2011 → Sep 2016 | breast carcinoma by gene expression profile | Galena Biopharma, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2020-12-11 | Sellas Life Sciences Group | Results SELLAS Announces Positive Follow-up Data from the Randomized Phase 2 VADIS Trial of Nelipepimut-S (NPS) in Women with Ductal Carcinoma In-Situ of the Breast sellaslifesciences.com ↗
The updated data, based on a 6-month follow-up, demonstrate that CD8+ T-cell responses persist long-term post-NPS treatment, with treated patients retaining and modestly enhancing their antigen-specific immune response. |
| 2020-03-18 | Sellas Life Sciences Group | Results SELLAS Announces Positive Antigen-Specific Immune Response Data for Nelipepimut-S (NPS) in Women with Ductal Carcinoma In Situ (DCIS) of the Breast from Phase 2 VADIS Study sellaslifesciences.com ↗ |
| 2019-06-03 | Sellas Life Sciences Group | Results SELLAS Announces Immune Response Data in Triple Negative Breast Cancer Patients from Phase 2b Study of Nelipepimut-S (NPS) Plus Trastuzumab Presented at ASCO 2019 sellaslifesciences.com ↗
This analysis was presented on June 2, 2019 at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, IL. |
| 2019-03-04 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Presentation of Final Data Analysis from Phase 2b Study of Nelipepimut-S Plus Trastuzumab at the 2019 ASCO-SITC Clinical Immuno-Oncology Meeting sellaslifesciences.com ↗
No safety-related statistically significant differences were seen between the treatment and control arms in the rate of grade 1-3 adverse events of either local or systemic nature, while no grade 4/5 toxicities were observed in either arm. |
| 2019-02-12 | Sellas Life Sciences Group | Results SELLAS Life Sciences Provides Galinpepimut-S and Nelipepimut-S Program Update sellaslifesciences.com ↗
Immune Response Data from the Phase 2b Nelipepimut-S (NPS) plus Trastuzumab Combination Study Demonstrates Antigen-Specific T-cell Clonal Expansion Over Time with Correlations to Clinical Activity in TNBC |
| 2018-12-06 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Additional Positive Triple Negative Breast Cancer (TNBC) Subgroup Data from Phase 2b Study of Nelipepimut-S Plus Trastuzumab at the 2018 San Antonio Breast Cancer Symposium sellaslifesciences.com ↗
These new data show a decrease in the total number of clinically detectable relapses with the combination of NPS + trastuzumab (7.5%) vs. trastuzumab alone (27.3%), p-value 0.004, which represents a 72.5% relative reduction in risk of relapse across time with a median follow up of 26.1 months in favor of the combination arm. |
| 2018-11-09 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Additional Data Showing Consistent Clinical Effect Across HLA Allele Subgroups in Triple Negative Breast Cancer (TNBC) Patients Treated with Nelipepimut-S Plus Trastuzumab Presented at the Society for Immunotherapy of Cancer (SITC) 2018 Annual Meeting sellaslifesciences.com ↗
The data presented confirm the therapeutic potential of NPS for patients with early-stage TNBC in the adjuvant setting across HLA types A-02, -03, -24 and -26 which cover approximately 80-85% of the North American/European populations and 86-90% of Asian/Pacific basin populations. |
| 2018-10-22 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Positive Final Data in Triple Negative Breast Cancer Patients from Phase 2b Clinical Trial of Nelipepimut-S (NeuVax™) in Combination with Trastuzumab (Herceptin®) Presented at the European Society for Medical Oncology (ESMO) 2018 Annual Meeting sellaslifesciences.com ↗
Clinically and statistically significant efficacy in the triple negative breast cancer cohort with a p-value of 0.013 and a 75.2% reduction in risk of relapse or death in favor of investigational nelipepimut-S plus trastuzumab arm |
| 2018-10-19 | Sellas Life Sciences Group | Results Data Safety Monitoring Board Confirms Triple Negative Breast Cancer as the Target Patient Population for Development of NeuVax™ (nelipepimut-S) in Combination with Trastuzumab (Herceptin®) in HER2 1+/2+ Breast Cancer Patients Following Final Analysis of Phase 2B Trial sellaslifesciences.com ↗
The DSMB concluded that there was an incremental improvement in the outcomes and statistics with a longer median follow-up (more than 7 months; 26.1 months at final vs. 18.8 months at interim analysis). |
| 2018-10-15 | Sellas Life Sciences Group | Results SELLAS to Host Conference Call Following Oral Presentation of Phase 2b Results of NeuVax™ + Herceptin® to Prevent Breast Cancer Recurrence at the European Society for Medical Oncology (ESMO) 2018 Annual Meeting sellaslifesciences.com ↗
Pre-specified interim analysis of a randomized phase 2b trial of trastuzumab + nelipepimut-S (NeuVax™) vs trastuzumab for the prevention of recurrence demonstrates benefit in triple negative (HER2 low-expressing) breast cancer patients |
| 2018-06-01 | Sellas Life Sciences Group | Results SELLAS Life Sciences Provides Clinical Update on Phase 2b NeuVax™ (nelipepimut-S) Study in Combination with Trastuzumab in HER2 1+/2+ Breast Cancer Patients sellaslifesciences.com ↗
Phase 2b trial met key clinical objectives and is being discontinued early by the sponsor |
| 2018-04-02 | Sellas Life Sciences Group | Results SELLAS Life Sciences Announces Positive Interim Data from Phase 2b NeuVax™ (nelipepimut-S) Clinical Trial in Combination with Herceptin® in HER2 1+/2+ Breast Cancer Patients sellaslifesciences.com ↗ |
All press releases naming this drug 15 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nelipepimut-S | “Efficacy and Safety Analysis of Nelipepimut-S Vaccine to Prevent Breast Cancer Recurrence: A Randomized, Multicenter, Phase III Clinical Trial.” PMID 31036542 ↗ Apr 20193“Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF.” PMID 32071118 ↗ Feb 2020 “Nelipepimut-S is a CD8-eliciting peptide vaccine” NCT02297698 ↗ |
| Known as | NPS | “In phase I/II studies, nelipepimut-S (NP-S) plus GM-CSF vaccine was well tolerated and effectively raised HER2-specific immunity in patients with breast cancer.” PMID 31036542 ↗ Apr 20191“Patients received trastuzumab for 1 year and were randomized to placebo (GM-CSF, control) or nelipepimut-S (NPS) with GM-CSF.” PMID 32071118 ↗ Feb 2020 |
| Modality | Vaccine | “Nelipepimut-S is a CD8-eliciting peptide vaccine” NCT02297698 ↗ |
| Route | Other | “nelipepimut-S (1000 mcg) and GM-CSF (250 mcg) administered intradermally every three weeks” NCT02297698 ↗ |