AbbVie drops Rova-T development after Phase III trial failure

AbbVie suspended the research and development programme of lung cancer drug Rovalpituzumab Tesirine (Rova-T) after it failed to demonstrate benefit in the Phase III MERU clinical trial.

Rova-T is an investigational, antibody-drug conjugate made up of a targeted antibody and a cytotoxic agent, which targets cancer cells that express delta-like protein 3 (DLL3).

DLL3 is associated with more than 80% of small-cell lung cancer (SCLC) tumours. It is known to be present on tumour cells, including cancer stem cells but not in healthy tissue.

The randomised, double-blind, placebo-controlled MERU study investigated the efficacy of Rova-T as maintenance treatment in SCLC patients who received first-line, platinum-based chemotherapy.

An interim analysis revealed that the drug did not yield survival benefit when compared to placebo. Based on this data, an independent data monitoring committee (IDMC) suggested termination of the Phase III study.

Rova-T’s overall safety profile in MERU was generally consistent with that reported in prior studies.

AbbVie solid tumour development global head Margaret Foley 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.”

AbbVie gained Rova-T with $5.8bn acquisition of Stemcentrx in 2016.

Following the termination of the drug’s research and development programme, the company intends to focus on its other oncology therapeutics.

AbbVie’s portfolio comprises marketed and investigational drugs for cancer, which are being studied in over 300 clinical trials across more than 20 forms of cancer globally.