Rova-T roadblock

A setback for lung cancer candidate Rova-T rovalpituzumab tesirine from AbbVie Inc. (NYSE:ABBV) has buysiders skeptical of the pharma’s broader business development strategy.

On March 22, AbbVie said it will not seek FDA accelerated approval for Rova-T as third-line treatment of relapsed or refractory small cell lung cancer (SCLC) based on the “magnitude of effect across multiple parameters” in the open-label, single-arm Phase II TRINITY trial. Among 177 patients with high delta-like 3 (DLL3) expression in TRINITY, Rova-T led to an investigator-assessed best overall response rate (ORR) of 29% and an independent review committee (IRC)-assessed ORR of 16%. ...