Sunday, February 15, 2015

Obinutuzumab in Indolent NHL

The maker of Obinutuzumab has announced that a phase III trial has been stopped because were good enough to seek approval from the FDA for indolent NHL.

Obinutuzumab is a fully-humanized monoclonal antibody. In other words, rather than using mice cells in its manufacturing, as Rituxan does, Obinutuzumab uses only human cells. The idea is that the human cells might cut down on some of the allergic reactions that Rituxan can cause.

In this phase II trial, researchers looked to compare Obinutuzumab + Bendamustine with Obinutuzumab maintenance, with just plain ol' Bendamustine. They hoped to see some improvement
in Progression Free Survival, and in looking at 413 patients, they found some. They plan to announce the specifics soon.

Obinutuzumab is seen as an alternative to Rituxan. From a business standpoint, since Rituxan's patent protection will expire soon. While generic versions of Rituxan are expected to be available, there may be some patients who will switch to Obinutuzumab instead, especially since a number of studies (including this one) seem to suggest that Obinutuzumab will work on patients who have become resistant to Rituxan.

The landscape for Follicular Lymphoma is certainly changing. We're going to have quite a few choices -- even more than we have now -- in the very near future.