Drugs / Rovalpituzumab tesirine
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03086239 | Apr 2017 → Jan 2018 | small cell lung carcinoma | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT03000257 | Dec 2016 → Mar 2022 | cancer | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT02819999 | Oct 2016 → May 2019 | small cell lung carcinoma | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT02874664 | Sep 2016 → Sep 2018 | small cell lung carcinoma | Stemcentrx | Completed | No outcome recorded |
| Phase 1 | NCT02500914 | Jun 2015 → Aug 2018 | small cell lung carcinoma | Stemcentrx | Terminated | No outcome recorded Stop: Business |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT03026166 | Mar 2017 → Jul 2019 | small cell lung carcinoma | AbbVie | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/2 | NCT02709889 | Sep 2016 → Aug 2019 | glioblastoma, large cell neuroendocrine carcinoma, medullary thyroid gland carcinoma, melanoma +1 | AbbVie | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT01901653 | Jul 2013 → Nov 2016 | small cell lung carcinoma | Stemcentrx | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT03543358 | Sep 2018 → Nov 2019 | cancer | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT02674568 | Jan 2016 → Oct 2018 | small cell lung carcinoma | AbbVie | Completed | No outcome recorded |
| Phase 33 trials · 2 missed | ||||||
| Phase 3 | NCT03334487 | Mar → Dec 2018 | small cell lung carcinoma | AbbVie | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT03061812 | Apr 2017 → Feb 2020 | small cell lung carcinoma | AbbVie | Completed | Missed primary |
| Phase 3 | NCT03033511 | Feb 2017 → Nov 2019 | small cell lung carcinoma | AbbVie | Terminated | Missed primary |
| Comparator or background therapy1 trial | ||||||
| — | NCT03503890 Background | — | small cell lung carcinoma | AbbVie | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2019-08-29 | AbbVie | Results AbbVie Discontinues Rovalpituzumab Tesirine (Rova-T) Research and Development Program abbvie.com ↗
An Independent Data Monitoring Committee (IDMC) recommended terminating MERU due to lack of survival benefit for patients receiving Rova-T compared with the placebo control arm based on results at a pre-planned interim analysis. |
| 2018-12-05 | AbbVie | Results Phase 3 Trial of Rova-T as Second-line Therapy for Advanced Small-Cell Lung Cancer (TAHOE STUDY) Halted abbvie.com ↗
An Independent Data Monitoring Committee (IDMC) recommended stopping enrollment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm. |
| 2018-03-22 | AbbVie | Results AbbVie Announces Results from Phase 2 Study Evaluating Rovalpituzumab Tesirine (Rova-T) for Third-Line Treatment of Patients with DLL3-Expressing Relapsed/Refractory Small Cell Lung Cancer abbvie.com ↗
AbbVie (NYSE:ABBV), a global research and development-based biopharmaceutical company, today announced that after consulting with the U.S. Food and Drug Administration (FDA), it will not seek accelerated approval for Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC) based on magnitude of effect across multiple parameters in this single-arm study. |
| 2016-06-05 | AbbVie | Results Results of Phase 1a/1b Study of AbbVie's Investigational Medicine Rovalpituzumab Tesirine (Rova-T) Showed Overall Response Rate of 39 Percent in Pretreated Patients with Biomarker-Defined Small Cell Lung Cancer (SCLC) abbvie.com ↗
Rova-T demonstrated a one-year overall survival (OS) rate of 32 percent in the recurrent/refractory second- and third-line patient population. |
All press releases naming this drug 8 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | rovalpituzumab tesirine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03543358 ↗ |
| Known as | Rova-T | “Herein, we report results from the expansion arm of study NCT03000257 evaluating the combination of the anti-PD-1 antibody budigalimab and the targeted antibody-drug conjugate...” PMID 34329846 ↗ May 20212“A patient with a DLL3-expressing MCC was treated with rovalpituzumab tesirine (Rova-T) in the "other tumor" cohort of NCT02709889 and assessed for response.” PMID 32372416 ↗ May 2020 “Rovalpituzumab tesirine (Rova-T), an antibody-drug conjugate directed against Delta-like protein 3 (DLL3)” PMID 29290251 ↗ Nov 2017 |
| Known as | Rovalpituzumab tesirina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990011 ↗ |
| Known as | SC-002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02500914 ↗ |
| Known as | SC0002 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990011 ↗ |
| Known as | SC16LD6.5 | “Rovalpituzumab tesirine (SC16LD6.5)” NCT01901653 ↗ |
| Known as | SC16LD6.5-ADC | ChEMBL registry synonym — accepted as the source's own label CHEMBL3990011 ↗ |
| Modality | Other / unclassified | “Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).” NCT02819999 ↗ |
| Route | Intravenous | “SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks” NCT02500914 ↗ |
| Target | DLL3 | “Rovalpituzumab tesirine is a first-in-class antibody-drug conjugate directed against delta-like protein 3 (DLL3)” PMID 27932068 ↗ Dec 2016 |