Small Cell Lung Cáncer . Un Ensayo de Fase III que Evaluó Rova-T como una Terapia de Mantenimiento de Primera Línea para el Cáncer de Pulmón de Células Pequeñas Avanzado " No Demostró Ningún Beneficio de Supervivencia " ... Por lo que se ha Suspendido .

Rova-T Programme Discontinued Following Poor Trial Results .

Posted: 2 September 2019 | Rachael Harper (European Pharmaceutical Review) | 

A Phase III trial evaluating Rova-T as a first-line maintenance therapy for advanced small-cell lung cancer demonstrated no survival benefit.

MERU, a Phase III trial evaluating AbbVie’sRovalpituzumab Tesirine (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 a placebo. The overall safety profile was generally consistent with that observed in previous studies.

Therefore, 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, MD, Vice President, Global Head of Solid Tumour 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.”

AbbVie has said it will move forward prioritising other development programmes within its oncology pipeline.