IHS Global Insight Perspective | |
Significance | Swiss pharma major Roche has ended the European Society of Medical Oncology congress on a high note after reporting a series of positive data for its cancer drugs. |
Implications | Roche has reported full data from the phase III ICON7 study that tout Avastin's benefits in ovarian cancer, following on from the positive results of another phase III study, GOG 0218. Roche has also reported some positive results for trastuzumab-DM1 (T-DM1) in first-line breast cancer. The drug demonstrated comparable tumour shrinkage rates with the current standard of care, as well as reduced levels of some adverse effects. |
Outlook | Going forward, regulatory filings for Avastin in ovarian cancer are expected to be initiated in the short term, and if approved, sales of the drugs could potentially be boosted by 0.5–1 billion francs. Overall survival data from the two phase III studies will be presented at a later stage. For T-DM1, Roche expects to report full data from clinical studies in the second quarter of 2011. |
Avastin in Ovarian Cancer
Swiss pharma major Roche as has reported new results for blockbuster drug Avastin (bevacizumab) in ovarian cancer. The phase III ICON7 study looked at patients with previously untreated ovarian cancer taking Avastin in combination with current standard of care and paclitaxel chemotherapy, followed by continued use of Avastin, in comparison with chemotherapy alone. According to the results, patients who were treated with Avastin combination therapy followed by Avastin monotherapy for 12 months reported a 27% improvement in progression-free survival (PFS) compared with those on chemotherapy alone (median PFS of 18.3 months versus 16 months). The full results from the study were presented at the European Society of Medical Oncology (ESMO) congress.
T-DM1 in Breast Cancer
At the same ESMO meeting, Roche also presented data for new compound trastuzumab-DM1 (T-DM1) for the treatment of first-line, advanced, HER2-positive breast cancer. A Phase III study is currently under way to compare T-DM1 with current standard of care Herceptin (trastuzumab) in combination with docetaxel. According to the results, tumour shrinkage (objective response rate) was comparable between the two treatments (47.8% versus 41.4%) after follow up at 5.9 months. Importantly, the side affects of treatment with T-DM1 were considerably less than those of treatment with Herceptin plus docetaxel: 1.5% versus 66.2% for complete hair loss; 7.5% versus 57.4% for neutropenia; and 10.4% versus 45.6% for diarrhoea. Roche said that further follow-up is required before data on PFS and final mature objective response rate can be reported.
Outlook and Implications
These latest results for Avastin in breast cancer follow on from Roche's announcement in July that it would provide the full results from the ICON7 study after announcing that the study met its primary endpoint (see Switzerland: 5 July 2010: Second Phase III Study Supports Avastin's Benefits in Ovarian Cancer). This is also the second study confirming the benefits of Avastin in ovarian cancer. At the recent meeting of the American Society of Clinical Oncology in August, Roche presented data form the GOG 0218 study, which looked at women taking Avastin in combination with paclitaxel and carboplatin followed by Avastin monotherapy for up to 15 months. According to the results, those in the Avastin arm of the study had a PFS of 14.1 months, in comparison with a PFS of 10.3 months for those on paclitaxel and carboplatin alone. In terms of data on overall survival for Avastin in breast cancer, Roche has said that although the data are still immature, early analysis suggests that the data are favourable. Despite the number of Avastin-related setbacks this year, in breast cancer, prostate cancer, stomach cancer, and colon cancer (see Switzerland: 23 September 2010: Avastin's Clinical Setbacks Persist, FDA Delays Final Decision on Breast Cancer Indication), the drug continues to perform well in ovarian cancer. According to a report by Ohio University, the ovarian cancer drug market is expected to reach US$1.6 billion by 2016, and Roche's head of oncology estimates that an ovarian cancer approval could boost sales of the drug by between 500 million francs (US$517.2 million) and 1 billion francs. Despite the fact that Avastin may offer an important advance in ovarian cancer, it has been noted that beyond the first year of treatment, the effects of the drug appear to dwindle. With the ovarian cancer market becoming an increasingly crowded space, it remains to be seen whether Roche will be able to maximise sales of Avastin in this setting. Regulatory filings are expected as early as next year.
For T-DM1, the data presented at the ESMO meeting are still premature, and according to Roche they only support the continued investigation of the drug in first-line, HER2 positive, metastatic breast cancer. The full data on PFS are expected in the second quarter of 2011. On a positive note, this preliminary data is encouraging, as it indicates there is still hope for the investigative compound in the aftermath of the U.S. FDA's issuance of a refuse-to-file letter relating to the Biologics License Application for the accelerated approval of T-DM1 in the treatment of advanced HER2-positive breast cancer in patients who have previously received multiple HER2-targeted medicines and chemotherapies (see United States: 27 August 2010: FDA Issues Refuse-to-File Letter for Trastuzumab-DM1).