Roche's next-gen Rituxan candidate impresses in first look at PhIII data

Roche ($RHHBY) got a big boost for its bid to position the leukemia drug GA101 (obinutuzumab) as a next-gen successor to its blockbuster Rituxan, posting late-stage data last night that showed that a combination with chemotherapy performed much better than chemo alone or in combination with Rituxan.

In the first round of data put up ahead of the big ASCO meeting, the experimental drug--designated a breakthrough therapy by the FDA--sparked an 86% reduction in the risk of death and scored an average period of disease-free progression of 23 months compared to 10 months for the chemo arm of the study.

The summary of the data also shows that GA101 and chemo shrank tumors in 76% of the patients with chronic lymphocytic leukemia in the combo arm, compared to 30% in the chemo arm. That also beat out a 66% response rate among patients taking Rituxan and chemotherapy, setting up Roche to introduce a possible successor to Rituxan before biosimilar competition arrives in a few years.

Those are all good signs for Roche, but it's not the final word for analysts, who will be considering all the data, looking for clear evidence that the drug performs better than Rituxan in head-to-head competition. Roche has filed for an approval and a separate trial for non-Hodgkin's lymphoma is also under way.

"It's exciting because it appears that it may be more active, but we need to see the final data," Bill Wierda, from the University of Texas MD Anderson Center, told Bloomberg. "This is very encouraging data."   

"People with CLL, particularly the elderly and those with additional medical problems, need new options," said Sandra Horning, the global head of clinical development hematology/oncology. "As a former practicing hematologist, I believe GA101 has the potential to one day expand treatment options for people with CLL and we look forward to continuing to work with the FDA and health authorities around the world in an effort to bring GA101 to those in need."

- here's the release from Roche
- read the Bloomberg story
- see the Reuters story

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