AbbVie not seeking accelerated approval of SCLC candidate

AbbVie Inc. (NYSE:ABBV) said it will not seek accelerated approval from FDA for Rova-T rovalpituzumab tesirine (SC16LD6.5) as third-line treatment of relapsed or refractory small cell lung cancer (SCLC). The company based its decision on the "magnitude of effect across multiple parameters" in the open-label, single-arm Phase II TRINITY trial of Rova-T in the third-line indication.

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%. The median duration of objective response was 4.1 months and median overall survival (OS) was 5.6 months, with a 12-month OS rate of 17.5%. AbbVie said the data represent 74% of the study population with high DLL3 expression. The company did not respond to an inquiry to define the cutoff for high DLL3 expression in TRINITY...