AbbVie not to seek accelerated approval for Rova-T after weak phase 2 SCLC trial data

The company said that it had consulted with the US Food and Drug Administration (FDA) and took the decision not to pursue the accelerated approval for the lung cancer drug based on magnitude of effect across various parameters in the phase 2 TRINITY study.

The single-arm study evaluated Rova-T T in delta-like protein 3 (DLL3)-expressing SCLC patients with relapsed/refractory disease who had received two or more prior treatment regimens, including more than one platinum-based regimen.

While the best overall response rate was 29% as measured by an independent review committee, the median overall survival was 5.6 months.

The phase 2 TRINITY study showed several adverse effects of the drug in the participants with 38% reporting fatigue, 26% getting nausea, 17% reported vomiting and 36% showing photosensitivity reaction.

AbbVie said that it will continue to assess Rova-T in its ongoing MERU and TAHOE phase 3 studies in first- and second-line SCLC.

AbbVie research and development executive vice president and chief scientific officer Mike Severino said: "We continue to believe Rova-T has potential for patients with small cell lung cancer and other DLL3-expressing cancers.

"Although the results from the study were not what we hoped for, we look forward to receiving data from the ongoing Phase 3 studies in the first- and second-line settings and remain committed to developing Rova-T for the treatment of patients with small cell lung cancer."

Rova-T, which is an antibody-drug conjugate derived from cancer stem cells, targets the cancer-stem cell-associated  DLL3 that is expressed in more than 80% of SCLC patient tumors.

The investigational lung cancer drug was bought by AbbVie as part of its $5.8bn acquisition of Stemcentrx, a California-based cancer drug startup, in 2016.

Image: AbbVie Corporate Headquarters. Photo: courtesy of AbbVie Inc.