AbbVie Discontinues Rovalpituzumab Tesirine (Rova-T) Research and Development Program

AbbVie announced that 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. AbbVie will move forward prioritizing other development programs within its oncology pipeline.

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.”

Moving forward, AbbVie will continue to focus research and development efforts on other therapies in its oncology portfolio of investigational and marketed medicines. AbbVie’s oncology portfolio currently consists of marketed medicines and investigational medicines being evaluated worldwide in more than 300 clinical trials and in more than 20 different tumor types.