Policy & Regulation
AbbVie halts admission under the TAHOE Phase 3 study of Rovalpituzumab Tesirine for advanced small-cell lung cancer
6 December 2018 -

Biopharmaceutical company AbbVie (NYSE:ABBV) said on Wednesday that it has decided to stop enrolment under the TAHOE Phase 3 study of Rovalpituzumab Tesirine (Rova-T) as a second-line therapy for advanced small-cell lung cancer (SCLC).

The company added an Independent Data Monitoring Committee (IDMC) recommended stopping enrolment in TAHOE due to shorter overall survival in the Rova-T arm compared with the topotecan control arm.

However, the IDMC has recommended that investigators and patients make individual decisions as to whether or not to continue treatment of patients currently on the Rova-T in TAHOE based on patient level response. The recommendation to halt enrolment does not impact other Rova-T clinical studies.

This randomised, open-label, two-arm, Phase 3 TAHOE trial is assessing the efficacy, safety and tolerability of Rova-T versus topotecan in participants with advanced or metastatic small-cell lung cancer (SCLC) with high levels of delta-like protein 3 (DLL3) and who have first disease progression during or following front-line platinum-based chemotherapy.

According to the company, Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein DLL3, which is expressed in more than 80% of small-cell lung cancer (SCLC) patient tumours, where it is prevalent on tumour cells, including cancer stem cells, but not present in healthy tissue. Rova-T combines a targeted antibody that delivers a cytotoxic agent directly to the DLL3-expressing cancer cells while minimising toxicity to healthy cells.

Rova-T is an investigational compound and its efficacy and safety have not been established by the US FDA or any other health authority, concluded the company.



Related Headlines