Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that data showing new personalized approaches for people with skin and lung cancer, plus new data with Avastin® (bevacizumab) in ovarian cancer, will be presented at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). At the meeting that is taking place June 3 to 7, 2011 in Chicago, Roche and Genentech's investigational and approved cancer medicines will be featured in approximately 300 abstracts across more than 30 cancer types.
"Our goal is to develop cancer medicines that improve care in a way that is meaningful to patients and their doctors," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "Developing medicines that are tailored to a person's specific cancer type is part of this strategy, and our data at ASCO will show that we are making substantial strides in the delivery of personalized healthcare."
Key Study Results to be Presented Include:
- Vemurafenib (RG7204/PLX4032): Phase III data (BRIM3) in people with previously untreated metastatic melanoma with a mutated BRAF gene will be presented for the first time. Updated Phase II data (BRIM2) will also be presented.
- Tarceva® (erlotinib): Important new data from EURTAC, the first Phase III study of Tarceva compared with chemotherapy in a Western population of people who had not previously been treated for a genetically distinct form of advanced lung cancer.
- MetMAb: Randomized Phase II data comparing MetMAb plus Tarceva to placebo plus Tarceva in people with advanced lung cancer with high or low levels of the Met receptor (Met diagnostic-positive or -negative).
- Avastin: Phase III data (OCEANS) in women with ovarian cancer that has progressed following initial treatment with platinum-based chemotherapy will be presented for the first time. New analyses from the Phase III ICON7 study in women with newly diagnosed ovarian cancer and with poor prognosis will also be presented.
New Data on a Personalized Approach for People With a Specific Type of Advanced Skin Cancer (Metastatic Melanoma)
Data will be presented for the first time from the Phase III BRIM3 study of vemurafenib that met its co-primary endpoints showing a statistically significant improvement in survival and progression-free survival in people with previously untreated BRAF V600 mutation-positive metastatic melanoma. The safety profile was generally consistent with previous vemurafenib studies. Possible serious side effects of vemurafenib include liver problems, changes in heartbeat or very fast or abnormal heartbeats and allergic reactions.
BRIM3: Phase III randomized, open-label, multicenter trial (BRIM3) comparing BRAF inhibitor vemurafenib with dacarbazine in patients with V600E BRAF mutated melanoma (Abstract #LBA4). ASCO press briefing, Sunday, June 5, 10:00 a.m. CDT, onsite press briefing room E271; Plenary Session, Sunday, June 5, 3:15 - 3:30 p.m. CDT, Hall B1.
A Phase II study, BRIM2, showed that vemurafenib shrank tumors in more than half of people with previously treated BRAF V600 mutation-positive metastatic melanoma and that the safety profile was generally consistent with the Phase I study. Updated results from this study will be presented.
BRIM2: An open-label, multicenter Phase II study of RG7204 (PLX4032) in previously treated patients with BRAF V600E mutation-positive metastatic melanoma (Abstract #8509). Oral Presentation, Saturday, June 4, 4:00 - 4:15 p.m. CDT, Arie Crown Theater.
Data on New Approaches in Advanced Non-Small Cell Lung Cancer (NSCLC)
EURTAC is the first Phase III study of Tarceva in a Western population with a genetically distinct form of advanced lung cancer. New data will be presented following an interim analysis that showed people with EGFR activating mutation-positive advanced NSCLC lived significantly longer without their disease getting worse when receiving Tarceva as initial therapy compared to platinum-based chemotherapy. A preliminary safety analysis showed the safety profile was consistent with previous studies of Tarceva. Serious side effects (including deaths) in patients taking Tarceva include serious Interstitial Lung Disease (ILD)-like events; liver and/or kidney problems; gastrointestinal (GI) perforations (the development of a hole in the stomach, small intestine or large intestine); and severe blistering skin reactions including cases similar to Stevens-Johnson syndrome.
EURTAC: Erlotinib vs. chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) activating mutations: Interim results of the European Tarceva vs. chemotherapy (EURTAC) Phase III randomized trial (Abstract #7503). Oral Presentation, Sunday, June 5, 9:30 - 9:45 a.m. CDT, Hall D1.
MetMAb is an investigational personalized medicine and a unique one-armed antibody that is designed to block the Met receptor, a switch that controls a key signaling pathway in lung cancer. Final efficacy results will be presented from a Phase II study (OAM4558g), including progression-free survival, overall survival and safety data. Details from this study will be provided in a press release on May 18, 2011 at 6:00 p.m. EDT.
OAM4558g: Final efficacy results from OAM4558g, a randomized Phase II study evaluating MetMAb or placebo in combination with erlotinib in advanced NSCLC (Abstract #7505). Oral Presentation, Sunday, June 5, 10:00 - 10:15 a.m. CDT, Hall D1.
New Phase III Data on Avastin in Advanced Ovarian Cancer
Data will be presented from OCEANS, a Phase III study of Avastin in advanced ovarian cancer. OCEANS showed that women with platinum-sensitive ovarian cancer that had progressed following initial chemotherapy lived significantly longer without their disease getting worse when given Avastin in combination with chemotherapy (carboplatin and gemcitabine) followed by continued use of Avastin alone, compared to chemotherapy alone. No new safety findings were observed and adverse events were consistent with those seen in previous pivotal trials of Avastin. These include serious and sometimes fatal side effects including GI perforation, surgery and wound healing complications, and severe bleeding.
OCEANS: A randomized, double-blinded, placebo-controlled, Phase III trial of chemotherapy with or without bevacizumab (BEV) in patients with platinum-sensitive recurrent epithelial ovarian (EOC), primary peritoneal (PPC), or fallopian tube cancer (FTC) (Abstract #LBA5007). ASCO press briefing, Saturday, June 4, 10:30 a.m. CDT, onsite press briefing room E271; Oral Presentation, Saturday, June 4, 4:15 - 4:30 p.m. CDT, room E354a.
Results of a new analysis from the ICON7 Phase III randomized trial of an Avastin-based regimen in women with newly diagnosed ovarian cancer will also be presented, including an interim analysis of overall survival and a subset analysis in women with poor prognosis.
ICON7: Result of interim analysis of overall survival in the GCIG ICON7 Phase III randomized trial of bevacizumab in women with newly diagnosed ovarian cancer (Abstract #LBA5006). ASCO press briefing, Saturday, June 4, 10:30 a.m. CDT, onsite press briefing room E271; Oral Presentation, Saturday, June 4, 4:00 - 4:15 p.m. CDT, room E354a.