Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2500 |
| INN | Rovalpituzumab tesirine |
| Status | Terminated |
| Drug code(s) | SC16LD6.5 |
| Brand name | Rova-T |
| mAb sequence source | mAb humanized |
| General Molecular Category | ADC |
| Format, general category | Full length Ab conjugate |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | Valine-alanine (Cleavable linker) |
| Ave. DAR | 2 (Site-specific) |
| Conjugated/fused moiety | DNA binding, Pyrrolobenzodiazepine (PBD) D6.5 |
| Discovery method/technology | None |
| Target(s) | DLL3 |
| Indications of clinical studies | Small cell lung cancer |
| Primary therapeutic area | Cancer |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | July 15, 2013 |
| Start of Phase 2 | January 15, 2016 |
| Start of Phase 3 | February 07, 2017 |
| Date BLA/NDA submitted to FDA | |
| Year of first approval (global) | None |
| Date of first US approval | |
| INN, US product name | None |
| US or EU approved indications | None |
| Company | AbbVie |
| Licensee/Partner | None |
| Comments about company or candidate | Aug. 29, 2019: AbbVie announced that MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The MERU trial is being closed, and the Rova-T research and development program has been terminated. AbbVie will move forward prioritizing other development programs within its oncology pipeline. NCT03033511 Phase 3 MERU study has primary completion date in Nov 2019; NCT03061812 Phase 3 TAHOE study has primary completion date in Feb 2020. Results of TRINITY Phase 2 study in SCLC: results demonstrate modest clinical activity in 3L+ SCLC, with associated toxicities. (doi: 10.1158/1078-0432.CCR-19-1133) March 2018: AbbVie 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. The ongoing Phase III studies, MERU and TAHOE, will continue to investigate Rova-T in first- and second-line SCLC. NCT03334487 Phase 3 for Third-Line and Later Treatment of Subjects With Relapsed or Refractory Small Cell Lung Cancer Withdrawn (Strategic considerations). NCT03033511 and NCT03061812 Phase 3 studies recruiting as of May 27, 2017. Preclinical data published (Saunders et al Science Translational Medicine Aug 2015). NCT01901653 Phase 1/2 started in July 2013. Orphan drug designation in US and Australia. |
| Full address of company | North Chicago, Illinois, United States North America United States of America https://www.abbvie.com/ |
The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. The ADC is composed of a humanized monoclonal antibody, dipeptide linker, and pyrrolobenzodiazepine (PBD) dimer toxin with a drug-to-antibody ratio of 2.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | Lack of efficacy, Safety issues |