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 will not seek accelerated approval for Rova-T in third-line relapsed/refractory small cell lung cancer (SCLC).
- Rova-T demonstrated single agent responses in advanced SCLC patients .
- Ongoing Phase 3 studies, MERU and TAHOE, will continue to investigate Rova-T in first- and second-line SCLC .
- Safety data in the TRINITY study were consistent with previously reported studies of Rova-T .
- Full data have been submitted to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting .
March 22, 2018 / PRNewswire .
-- 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.
"We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers," said Mike Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing Phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer."
Summary of Investigator Assessed Best Overall Response Rate, Independent Review Committee (IRC) Assessed Objective Response Rate, Duration of Response and Overall Survival in Third-Line SCLC Patients with High DLL3 Expression (N = 177)*
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