AbbVie Inc. (NYSE: ABBV) saw its shares pull back on Thursday after it reported less than favorable midstage results for its relapsed/refractory small cell lung cancer (SCLC) trial. Specifically, the firm reported Phase 2 data evaluating rovalpituzumab tesirine (Rova-T).
Unfortunately, the firm has decided that it will not pursue accelerated approval of Rova-T in third-line SCLC, based on magnitude of effect across multiple parameters in this single-arm study. This came after consulting with the U.S. Food and Drug Administration.
Note that ongoing Phase 3 studies, MERU and TAHOE, will continue to investigate Rova-T in first-line and second-line SCLC.
In the study, the most common treatment-emergent adverse events were fatigue (38%), photosensitivity reaction (36%), pleural effusion (32%), edema peripheral (31%), decreased appetite (30%), nausea (26%), dyspnea (25%), thrombocytopenia (25%), constipation (22%), vomiting (17%), anemia (17%), hypoalbuminemia (16%), and cough (16%). Grade three and higher severe toxicities ≥5% were thrombocytopenia (11%), photosensitivity reaction (7%) and pleural effusion (5%).
Mike Severino, M.D., executive vice president of research and development and chief scientific officer of AbbVie, commented:
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.
Shares of AbbVie were last seen down 11% at $99.59 on Thursday, with a consensus analyst price target of $125.90 and a 52-week range of $63.12 to $125.86.
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