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news.Genentech, a wholly owned member of the Roche Group and Biogen Idec have presented data from the Phase III PRIMA study. The data showed that continuing Rituxan (rituximab) for two years in patients who responded to initial treatment with Rituxan plus chemotherapy, doubled the likelihood of them living without their disease worsening (progression-free survival or PFS) compared to those who stopped treatment (based on a hazard ratio of 0.50, 95% CI, 0.39; 0.64; p=
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According to the Genentech, the PRIMA study enrolled patients with previously untreated advanced follicular lymphoma. After two-years of follow-up, 82% of patients who received Rituxan maintenance were in remission compared to 66% of patients who did not. No new safety signals were observed in this study and the safety profile was consistent with previous experience with Rituxan.
Genentech, Roche and Biogen Idec recently submitted an sBLA (supplemental biologics license application) to the US FDA and an extension of the Rituxan marketing authorization application to the European Medicines Agency (EMA) based on the PRIMA study data.
PRIMA is an international, multicenter, randomized, Phase III clinical study that enrolled 1,217 patients with previously untreated advanced follicular lymphoma. The study evaluated the efficacy and safety profile of maintenance Rituxan in patients who responded to initial treatment with Rituxan plus chemotherapy (induction treatment).
In the study, Rituxan plus either CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone), CVP (cyclophosphamide, vincristine, prednisone) or FCM (fludarabine, cyclophosphamide, mitoxantrone) chemotherapy was used as initial treatment. Patients who responded (1,018/1,217) were randomized to receive Rituxan alone, given once every two months for two years (maintenance), or observation alone.
Genentech has added that the safety profile was consistent with those previously reported in pivotal studies of Rituxan alone or in combination with chemotherapy. Serious adverse events (Grade 3 or 4) were reported in 23% of patients who received Rituxan maintenance compared to 16% who did not, including low white blood cell (neutrophil) counts (4% vs. 1%) and infections (4% vs. 1%).
Hal Barron, executive vice president, global development and chief medical officer at Roche, said: “Follicular lymphoma is an incurable cancer that may return many times during a person’s life and require additional therapy. The study is important because in those people who continued Rituxan, the risk of the cancer progressing was half of the risk than in those people who did not receive maintenance Rituxan.”
Greg Reyes, senior vice president of oncology research and development at Biogen Idec, said: “The Prima study results add to the body of evidence supporting Rituxan in non-Hodgkin’s lymphoma and emphasize the role Rituxan plays in helping people with this cancer that will most likely recur. We look forward to discussing these new data with the FDA and European regulatory authorities.”