AbbVie has announced that the research and development program for its investigational drug, Rova-T (rovalpituzumab tesirine), for advanced small-cell lung cancer (SCLC), will be terminated based on a lack of survival benefit in the phase 3 MERU trial.

MERU (N=740) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy of rovalpituzumab tesirine (Rova-T), an antibody-drug conjugate targeting the cancer-stem cell-associated delta-like protein 3 [DLL3], as maintenance therapy following first-line, platinum-based chemotherapy in SCLC. 

Based on trial results at a pre-planned interim analysis, an Independent Data Monitoring Committee (IDMC) recommended the termination of MERU because patients treated with Rova-T demonstrated a lack of survival benefit compared with placebo. Full detailed data from the MERU trial will be presented at a future medical meeting and/or published in a peer-reviewed medical journal, according to the Company. 

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“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, MD, 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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