Following undesired results from the phase 3 MERU clinical trial, US biopharma company AbbVie has terminated the research and development program of Rovalpituzumab Tesirine (Rova-T), an investigational lung cancer drug.
The MERU clinical trial is being closed over futility with the phase 3 study, which was assessing Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC) failed to show any survival benefit. This was at a pre-planned interim analysis in the Rova-T patient arm compared to the placebo arm.
AbbVie revealed that an independent data monitoring committee (IDMC) recommended terminating the MERU clinical trial because of the lack of survival benefit with Rova-T treatment. The MERU trial results will be presented at a medical meeting in the future and/or published in a peer-reviewed medical journal, said the US biopharma company.
The overall safety profile of Rova-T was in general in line with that observed in previous clinical trials, said AbbVie.
The US biopharma company will move ahead prioritizing other development programs from its oncology pipeline.
Commenting on the MERU clinical trial of Rova-T in advanced small-cell lung cancer, Margaret Foley – AbbVie vice president, global head of solid tumor development, said: “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.
“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.”