AbbVie has announced the discontinuation of its Rova-T (rovalpituzumab tesirine) research and development programme, following a failure to demonstrate survival benefit at a pre-planned interim analysis.
The company also announced that the overall safety profile, however, was generally consistent with that observed in previous studies, but the Phase III MERU trial is being closed, and the Rova-T research and development program has been terminated. AbbVie already incurred an impairment charge of $4 billion earlier this year following a previous Rova-T trial failure.
An Independent Data Monitoring Committee (IDMC) recommended terminating the trial, which evaluated Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer (SCLC), due to lack of survival benefit for patients receiving Rova-T compared with the placebo control arm based on results at the pre-planned interim analysis.
The failed drug 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 SCLC patient tumours.
SCLC “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, vice president, global head of solid tumor development, AbbVie.
She continuedt o say that the company “remains committed to researching and developing other therapies with the potential to transform care for patients with small-cell lung cancer and other malignancies."
Results from the MERU trial will be presented at a future medical meeting and/or published in a peer-reviewed medical journal.
Moving forward, AbbVie has said that it will continue to focus research and development efforts on other therapies in its oncology portfolio of investigational and marketed medicines.