AbbVie announced that the Phase III MERU trial evaluating Rova-T as first-line maintenance therapy for advanced small-cell lung cancer, failed to demonstrate a survival benefit following a pre-planned interim analysis.
The writing has been on the wall for some time. After another clinical failure, AbbVie is terminating its Rova-T development program that cost the company $5.8 billion in upfront funds three years ago.
On Thursday, 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 pipeline. AbbVie did not mention any job cuts related to this failure in its announcement.
AbbVie halted the MERU trial following recommendation by an Independent Data Monitoring Committee (IDMC). The company did not provide many details of the halted trial other than Rova-T did not provide any survival benefits compared to placebo. Results from the MERU trial will be presented at a future medical meeting, AbbVie said.
Margaret Foley, global head of solid tumor development at AbbVie expressed her disappointment in the MERU results. Noting the difficulties of treating small-cell lung cancer, Foley said AbbVie remains “committed to researching and developing other therapies with the potential to transform care for patients with small-cell lung cancer and other malignancies.”
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%.
The failure of the MERU trial is the latest in a string of disappointments for Rova-T, which was the basis for the Stemcentrix deal. Earlier this year, the company culled 178 employees from Bay Area-based Stemcentrix as a response to those failures. 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. AbbVie also announced last year that it would not seek accelerated approval for Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC) following disappointing results in the Phase II TRINITY trial.
Shares of AbbVie are slightly down this morning to $661.6 as of 10:08 a.m. EDT.
