AbbVie announced MERU, a Phase 3 trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), demonstrated no survival benefit at a pre-planned interim analysis for patients receiving Rova-T as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The MERU trial is being closed, and the Rova-T research and development program has been terminated.
An Independent Data Monitoring Committee (IDMC) recommended terminating MERU due to lack of survival benefit for patients receiving Rova-T compared with the placebo control arm based on results at a pre-planned interim analysis. Results from the MERU trial will be presented at a future medical meeting and/or published in a peer-reviewed medical journal.
"Small-cell lung cancer continues to be one of the most difficult-to-treat cancers where there is a significant need for transformative therapies. We are disappointed with this outcome for the patients who suffer from this disease," said Margaret Foley, M.D., vice president, global head of solid tumor development, AbbVie. "We remain committed to researching and developing other therapies with the potential to transform care for patients with small-cell lung cancer and other malignancies."
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MERU is a Phase 3, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy of rovalpituzumab tesirine (Rova-T) as maintenance therapy following first-line, platinum-based chemotherapy in small-cell lung cancer (SCLC).
Rova-T is an investigational antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 (DLL3), which is expressed in more than 80 percent of small-cell lung cancer (SCLC) patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue. Rova-T combines a targeted antibody with a cytotoxic agent that is delivered directly to the DLL3-expressing cancer cells.
Rova-T is not approved, and its efficacy and safety have not been evaluated by health authorities.