Agent Shows Promise and Safety in Small Cell Lung Cancer

Rova-T proved to be safe and effective in patients with small cell lung cancer according to a recent study.
BY ALLIE CASEY
PUBLISHED: FEBRUARY 17, 2017
There was encouraging single-agent antitumor activity – and a manageble safety profile – when patients with recurrent small cell lung cancer (SCLC) were treated with rovalpituzumab tesirine (Rova-T), according to the results of a phase 1 study published in The Lancet Oncology.

Eleven of 60 assessable patients (18 percent) who received an active dose of Rova-T (0.2 mg/kg or 0.4 mg/kg every three weeks or 0.3 mg/kg or 0.4 mg/kg every six weeks) achieved a confirmed objective response, and 30 patients (50 percent) had stable disease. The median progression-free survival (PFS) was 2.8 months.

An exploratory analysis of available tumor tissue samples (34 patients) showed an overall response rate of 38 percent (10 patients) among 26 DLL3-high patients (tumor expression levels of at least 50 percent) compared with 0 percent in DLL3-low patients. The median PFS was 4.3 months versus 2.2 months, respectively.

“The impressive responses seen on our initial clinical trial appear to be restricted to those patients whose tumors had a high level expression of the DLL3 target,” lead study author Charles M. Rudin, M.D., Ph.D., chief, Thoracic Oncology Service; co-director, Druckenmiller Center for Lung Cancer Research; Sylvia Hassenfeld Chair in Lung Cancer Research, Memorial Sloan Kettering Cancer Center, said in an interview with CURE.

This first-in-human, first-in-class, open-label phase 1 study was carried out across 10 cancer centers in the United States. Eligible patients were aged 18 years or older and had to have histologically or cytologically confirmed SCLC or large-cell neuroendocrine tumors with progressive measurable disease, assessed by RECIST 1.1. Patients also had to have been previously treated with one or two chemotherapeutic regimens, including a platinum-based treatment.

Eighty-two patients were enrolled in the study between July 2013 and August 2015. This included 74 patients with SCLC and 8 patients with large-cell neuroendocrine carcinoma. All patients received at least 1 dose of Rova-T.

Patients were assigned to dose-escalation or expansion cohorts. Doses of Rova-T ranged from 0.05 mg/kg to 0.8 mg/kg intravenously every three weeks or every six weeks. Following that was an investigation of the dose schedules 0.3 mg/kg and 0.4 mg/kg every 6 weeks and 0.2 mg/kg every three weeks.

At the time of data cutoff in May 2016, the median duration of follow-up was 3.9 months. At that time, no patients remained on active treatment, and seven patients (9 percent) remained in follow-up.



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