Illinois-based AbbVie announced that the Phase III MERU trial evaluating Rova-T as first-line maintenance therapy for advanced small-cell lung cancer (SCLC), failed to demonstrate a survival benefit following a pre-planned interim analysis.
While the safety profile remained the same as with other trials involving the drug, AbbVie’s disappointing
run with Rova-T has come to an end. The company said it was halting the MERU trial and discontinued
the R&D program it had established following the 2016 acquisition of South San Francisco-based Stemcentrix. AbbVie said it will use its funds to prioritize other development programs within its oncology
AbbVie halted the MERU trial following recommendation by an Independent Data Monitoring Committee (IDMC). Rova-T is an antibody-drug conjugate designed to target cancer-stem cell-associated delta-like protein 3 (DLL3), The DLL3 protein is expressed in more than 80% of small-cell lung cancer patient tumors.
It is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue, AbbVie said.
When AbbVie acquired Rova-T, the company was eying more than just the lung cancer market. AbbVie
was banking on using the drug to target other cancers where expression of DLL3 was high, such as metastatic melanoma, glioblastoma multiforme, prostate, pancreatic and colorectal cancers. In those cancers, DLL3 expression ranges from 50% to 80%.
Prior to the MERU trial, in December 2018, AbbVie halted a Phase III study of Rovalpituzumab Tesirine (Rova-T) as a second-line treatment for advanced small-cell lung cancer. That trial was halted after an IDMC called for the stoppage due to shorter overall survival in the Rova-T arm.