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# AbbVie Stops Enrollment in Rova-T Study
- URL: https://www.fdaweb.com/abbvie-stops-enrollment-in-rova-t-study/
- Published: 2018-12-07T12:00:00.000Z
- Updated: 2026-09-15T00:49:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142988

AbbVie has stopped enrollment in the TAHOE trial, a Phase 3 study evaluating rovalpituzumab tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC). The halt in enrollment is based on a recommendation from an independent data monitoring committee that found a shorter overall survival in the Rova-T arm compared with the topotecan control arm. The committee said that patients currently on treatment with Rova-T should make individual decisions as to whether or not to continue treatment based on patient level responses. The enrollment halt applies only to the TAHOE study and does not impact other Rova-T clinical studies, the company says.

TAHOE is assessing the efficacy, safety and tolerability of Rova-T versus topotecan in SCLC participants with high levels of delta-like protein 3 and who have disease progression during or following front-line platinum-based chemotherapy. AbbVie describes Rova-T as an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3, which is expressed in more than 80% of SCLC patient tumors.