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Reovirus showed activity in head and neck cancers
Combining reovirus type 3 Dearing with carboplatin and paclitaxel was safe and active as a treatment for patients with advanced head and neck cancers, according to study results.
Reovirus type 3 Dearing (RT3D) is a naturally occurring RNA virus. Prior studies have indicated that RT3D replicates in RAS-activated cancers, and that it has cytotoxicity when combined with platin- or taxane-based chemotherapies.
The phase 1/2 open-label study was conducted at two centers in the United Kingdom and included patients with histologically proven, incurable or metastatic solid tumors.
During phase 1, 31 patients were assigned to dose-escalating regimen of RT3D on days 1 to 5, carboplatin and paclitaxel three times weekly.
Once the maximum tolerated dose was found, researchers conducted phase 2, which was restricted to only those patients with incurable or metastatic head and neck cancers (n=19). During phase 2, patients received treatment up to eight cycles or until disease progression.
Treatment generally was well-tolerated, with no dose-limiting toxicities and a majority of adverse effects being grade-1/grade-2. In addition, the treatment showed evidence of activity, with one patient achieving complete response, six patients achieving partial response, two patients having major clinical response and nine patients with stable disease. Eight patients (30.8%) had disease progression.
The data provided the background for a subsequent successful application to the FDA for a license under a Special Protocol Agreement to conduct a randomized, two-arm, double blind, multicenter two-stage adaptive phase 3 study of paclitaxel and carboplatin with and without IV reovirus, the researchers said. The study will enroll up to 280 platinum-refractory, taxane-naive patients, and the primary endpoint will be survival.
References:
- Karapanagiotou EM. Clin Cancer Res. 2012;18:2080-2089.