drulletje drie schreef op 22 maart 2018 14:20:
seekingalpha.com/news/3340976-abbvie-...Abbvie backs away from pursuing accelerated approval for Rova-T after disappointing mid-stage data in third-line lung cancer; shares down 7% premarket
Mar. 22, 2018 9:15 AM ET|By: Douglas W. House, SA News Editor
AbbVie (NYSE:ABBV) slips 7% premarket on the heels of its announcement that it will not seek accelerated approval for antibody-drug conjugate Rova-T (rovalpituzumab tesirine) in third-line relapsed/refractory small cell lung cancer (SCLC). The company made its decision after consulting with the FDA on results from a single-arm Phase 2 study, TRINITY, that apparently failed demonstrate enough of a treatment benefit to support accelerated approval.
EVP of R&D and CSO Mike Severino, M.D., says, "We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers. 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."
Top-line data from TRINITY showed a 16% overall response rate and a median duration of response of 4.1 months.
On the safety front, the most frequent treatment-emergent adverse events were fatigue (38%), photosensitivity reaction (36%), pleural effusion (fluid buildup in the lungs) (32%), peripheral edema (31%), decreased appetite (30%), nausea (26%) and dyspnea (difficulty breathing) (25%).