ASCO '13 Preview: Roche's Next-Gen Rituxan Steps Up

CHICAGO ( TheStreet) -- Treatment with Roche's ( RHHBY) experimental GA101 -- the next-generation version of the company's blockbuster drug Rituxan -- helped elderly patients with chronic lymphocytic leukemia more than double the time before their disease worsened compared to chemotherapy. Initial data, not yet mature, also suggests GA101 may be superior to Rituxan.

Results from a pivotal phase III study of GA101 were posted in a research abstract Wednesday night ahead of a planned presentation at the American Society of Clinical Oncology (ASCO) annual meeting. Last January, Roche announced that the GA101 study had met its primary endpoint but detailed data were held for presentation at the ASCO meeting.

Roche has engineered GA101, also known as obinutuzumab, to be a more potent version of Rituxan, the company's top-selling hematological monoclonal antibody therapy with 2012 sales of approximately $7 billion. Rituxan sales, however, could start to fade in 2016 when a biosimilar version of the drug is expected to enter the market. For this reason, development and approval of GA101 has taken on some urgency for Roche in order to protect a key drug franchise.

An FDA approval approval application for GA101 in CLL was submitted earlier this year and another phase III study of the drug in non-Hodgkin's lymphoma -- where Rituxan generates the bulk of its sales -- is also underway.

In the phase III study, elderly CLL patients with other co-morbidities were randomized to treatment with GA101 plus chemotherapy, Rituxan plus chemotherapy or chemotherapy alone. In the first stage of the study, patients treated with GA101 plus chemotherapy had a median progression-free survival of 23 months (and growing because data are not yet mature) compared to 10.9 months for patients treated with chemotherapy alone.

At the time of the data cutoff, GA101 reduced the risk of disease progression in these CLL patients by 86% relative to chemotherapy. The result was statistically significant.

Seventy-five percent of CLL patients treated with GA101 reported tumor shrinkage, including 22 percent complete responses, compared to an overall response rate of 30% for chemotherapy and zero complete responses.

Sixty-seven percent of GA101-treated patients experience a serious side effect, including 34% reporting significant drops in white blood cell counts known as neutropenia. By comparison, the rate of serious adverse events associated with chemotherapy was 41 percent, including 15% occurrence of neutropenia.

These are the data Roche filed with FDA seeking GA101's approval but investors are more interested in how GA101 stacks up against Rituxan. The second stage of the phase III study is not ready for a final analysis, but preliminary data released Wednesday shows GA101 might be a better drug.

CLL patients treated with Rituxan reported a median PFS of 15.7 months, which is numerically inferior to the 23-month median PFS for GA101. The Rituxan data will change, however, as the study matures. Roche expects to have more definitive results from the second stage of the study later this year.

New CLL therapies are also being developed by Pharmacyclics ( PCYC) (ibrutinib) and Gilead Sciences ( GILD) (idelalisib.)

-- Reported by Adam Feuerstein in Boston.

Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback; click here to send him an email.

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