Roche highlights more upbeat PhIII data for 'breakthrough' leukemia contender

Roche ($RHHBY) has added to a body of positive late-stage data on its next-generation version of Rituxan, reporting that the experimental therapy GA101 beat its predecessor in benefiting patients with a common form of blood cancer called chronic lymphocytic leukemia (CLL).

The Swiss drug giant revealed that GA101, also known as obinutuzumab, helped CLL patients live longer without their cancer worsening than Rituxan when given in addition to chemotherapy. Yet Roche is reserving details of the Phase III study for the annual American Society of Hematology meeting in December.

The GA101 program has generated some early evidence that it could become another blockbuster oncology product for Roche, which owns Genentech and has the largest cancer drug business in the world. The FDA has granted GA101 its coveted "breakthrough therapy" status and priority review, meaning that Roche's April application for approval of the new therapy is expected before the end of this year.

Roche's Genentech and Biogen Idec ($BIIB) also provide Rituxan, an antibody therapy that brings in more than $6 billion in annual sales, but Rituxan faces biosimilar rivals in the coming years that threaten those sales. If approved, GA101 could help reduce the hurt from biosimilars competition, yet sales expectations from many analysts have been lower than those for Rituxan.

Dr. Hal Barron

"These very strong results in CLL bode well for a potential efficacy in other types of blood cancer," Odile Rundquist, a Geneva-based analyst at Helvea AG, wrote this morning, as quoted by Bloomberg. The top analyst has estimated annual sales of $1.23 billion for GA101.

GA101 could be outperforming Rituxan because its sugar molecules have been engineered in such a way that the therapy helps spur the immune system into action against tumors. Like Rituxan, the experimental drug also targets CD20 to directly assault cancer cells. Dr. Hal Barron, Roche's medical chief, said in a statement that the company plans to explore the use of GA101 in a variety of cancers, including indolent forms of lymphoma.

- see the release
- check out Bloomberg's article
- and Reuters' report

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