Roche has received a positive recommendation from Europe's scientific advisory board for the use of MabThera (rituximab) as maintenance therapy for patients with relapsed or refractory follicular non-Hodgkin's lymphoma (NHL) and for treating patients with severe active rheumatoid arthritis. The June 2nd announcement coincided with the start of this year's meeting of the American Society of Clinical Oncology (ASCO) where Roche was busy showcasing a host of new data on its broad oncology portfolio.
According to Roche, the CHMP recommendation means that maintenance therapy with MabThera may well become the new standard of care in this indication, while a nod in severe active RA will open the door to another burgeoning market for the drug, although it can only be given to patients who have failed on other treatments, including tumour-necorsis factor inhibitors such as Wyeth's top-selling Enbrel (etanercept). "The positive opinion is an important step forward leading towards the availability of MabThera maintenance therapy for all patients who could benefit," said Ed Holdener, Head of Roche's Global Pharma Development. And it will also help drive what are already positive sales, with revenues during the first quarter gaining 16% to 1.15 billion Swiss francs; in Europe, MabThera is currently approved only for follicular lymphoma.
At ASCO, data from a randomised Phase III study showing that Xeloda (capecitabine) plus paclitaxel is as effective but safer than epirubicin plus paclitaxel in advanced breast cancer was presented. Anthracyclines such as epirubicin are associated with cumulative cardiac toxicity, which can be life-threatening, restricting the number of treatments a patient can receive.
Results from the REAL 2 study - the largest-ever Phase III study in advanced oesophagogastric cancer were also presented. The results showed Xeloda to be as effective as 5-fluorouracil (5-FU), and oxaliplatin as effective as cisplatin, for the primary endpoint of overall survival, suggesting that Xeloda can replace 5-FU and oxaliplatin can replace cisplatin for first line treatment, says Roche. The trial also showed that patients treated with oral Xeloda plus oxaliplatin and epirubicin (known as 'EOX') live significantly longer, compared to patients treated with standard chemotherapy which has to be administered via a cumbersome infusion pump.
A second study, presented by lead investigator Professor Y K Kang of the Asan Medical Center, Seoul, South Korea, confirmed that Xeloda can replace intravenous 5-FU, in combination with cisplatin, as first-line therapy for stomach cancer.
Turning to Roche's MabThera, final results of the German Low Grade Lymphoma Study Group (GLSG) trial showed that patients who received MabThera as maintenance therapy for indolent lymphoma experienced significantly longer remission and overall survival versus observation, irrespective of their initial treatment at relapse. 82% of patients who received MabThera maintenance therapy were alive after 3 years, compared to only 55% who were not receiving additional courses of MabThera.
Finally, new 23-month follow-up data from HERA (HERceptin Adjuvant study) one of the largest breast cancer trials ever carried out, show that Herceptin (trastuzumab) following standard chemotherapy significantly reduced the risk of death by 34% for women with early-stage HER2-positive breast cancer. The data also show that Herceptin continues to provide patients with a reduced risk of their cancer coming back.
The follow-up data showed that taking Herceptin for 12 months increases the chance of long-term survival by preventing the development of advanced (metastatic) disease. Similar disease-free and overall survival benefits from Herceptin in this setting have also been seen in two large US trials but the HERA study allowed for the use of a wide range of standard chemotherapy regimens before treatment with Herceptin, making these results highly meaningful to many parts of the world, says Roche.
Speaking at ASCO, Andreas Abt, Commercial Director/Deputy Head of Oncology, Roche, gave new figures on global totals for cancer patients receiving Roche products. He said that more than one million head been treated with Xeloda; 730,000 with MabThera; 230,000 with Herceptin; 92,000 with Avastin; and 51,000 with Tarceva. He added that Roche will file an additional 20 indications for these five products up to 2009.