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In a Phase III trial for advanced small-cell lung cancer, the investigational antibody drug conjugate, Rova-T (rovalpituzumab tesirine), did not demonstrate a survival benefit for patients taking it.
AbbVie announced on Aug. 29, 2019 that in a Phase III trial evaluating its investigational antibody drug conjugate (ADC), Rova-T (rovalpituzumab tesirine), 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 the treatment as compared with placebo. The overall safety profile was generally consistent with that observed in previous studies. The trial is thus being closed, and the Rova-T R&D program has been terminated. AbbVie will move forward prioritizing other development programs within its oncology pipeline.
Rova-T targets the cancer-stem cell-associated delta-like protein 3 (DLL3), which is expressed in more than 80% of SCLC patient tumors, where it is prevalent on tumor cells, including cancer stem cells, but not present in healthy tissue, according to the company. Rova-T combines a targeted antibody with a cytotoxic agent that is delivered directly to the DLL3-expressing cancer cells. This drug is not approved, and its efficacy and safety have not been evaluated by health authorities.
"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, in a company press release. "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.