Tuesday, May 17, 2011

Genentech to Present Significant Progress in Advanced Skin, Lung and Ovarian Cancers at ASCO

Progress in Advanced Skin and Lung Cancers Through Personalized Healthcare

New Phase III Data for Avastin in Ovarian Cancer to be Presented

South San Francisco, Calif. -- May 17, 2011 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that data showing new personalized therapeutic 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.


Full session details for the 2011 Annual Meeting can be found through the ASCO ePlanner: http://apps.asco.org/ePlanner/am2011.aspx.


Important Safety Information for the Investigational Medicine Vemurafenib
The most frequent Grade 3 adverse event observed in clinical trials of vemurafenib was cutaneous squamous cell carcinoma, a common skin cancer treated by local excision (minor surgery done in a physician's office). The most common adverse events were rash, increased sun sensitivity, joint pain, hair loss and fatigue. Possible serious side effects of vemurafenib include liver problems, changes in heartbeat or very fast or abnormal heartbeats and allergic reactions.


Important Safety Information for Tarceva in Advanced NSCLC
Tarceva is approved for patients with advanced NSCLC whose cancer has not spread or grown after initial treatment with certain types of chemotherapy (maintenance treatment). Tarceva is also approved for patients with advanced NSCLC whose cancer has spread or grown after receiving at least one chemotherapy regimen (second-/third-line treatment). Tarceva is not meant to be used at the same time as certain types of chemotherapy for NSCLC.


There have been reports of serious ILD-like events including deaths in patients taking Tarceva. Serious side effects (including deaths) in patients taking Tarceva include liver and/or kidney problems; GI perforations; and severe blistering skin reactions including cases similar to Stevens-Johnson syndrome.


Eye irritation and damage to the cornea have been reported in patients taking Tarceva. Difficulty with blood clotting, and bleeding events, including gastrointestinal and non-gastrointestinal bleeding, have been reported in clinical studies. Women should avoid becoming pregnant and avoid breastfeeding while taking Tarceva. Patients should call their doctor right away if they have these signs or symptoms: new or worsening skin rash; serious or ongoing diarrhea, nausea, loss of appetite, vomiting, or stomach pain; new or worsening shortness of breath or cough; fever; eye irritation. Rash and diarrhea were the most common side effects associated with Tarceva in the NSCLC clinical studies.


For full prescribing information on Tarceva, please visit http://www.tarceva.com.


Tarceva is a registered trademark of OSI Pharmaceuticals, LLC, a member of the Astellas global group of companies.


Avastin BOXED WARNINGS and Additional Important Safety Information
People receiving Avastin may experience side effects. In clinical trials, some people treated with Avastin experienced serious and sometimes fatal side effects, including:


GI perforation: Treatment with Avastin can result in the development of a serious side effect called GI perforation, which is the development of a hole in the stomach, small intestine, or large intestine. In clinical trials, this event occurred in more people who received Avastin than in the comparison group (0.3 percent to 2.4 percent). In some cases, GI perforation resulted in fatality. Avastin therapy should be permanently stopped if GI perforation occurs.


Surgery and wound healing problems: Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Surgery and wound healing problems occurred more often in people who received Avastin than in the comparison group. In a controlled clinical trial, in patients with advanced colorectal cancer who had surgery during the course of treatment, the incidence of wound healing complications, including serious and fatal complications, was 15 percent for patients who received Avastin and four percent for patients who did not receive Avastin.


Avastin therapy should not be started for at least 28 days after surgery and until the surgical wound is fully healed. The length of time between stopping Avastin and having voluntary surgery without the risk of wound healing problems following surgery has not been determined. Treatment with Avastin should be stopped at least 28 days before voluntary surgery and in people with wound healing problems following surgery that requires medical treatment. Treatment with Avastin should be stopped in patients with slow or incomplete wound healing.


Severe bleeding: Treatment with Avastin can result in serious or fatal bleeding, including coughing up blood, bleeding in the stomach, vomiting of blood, bleeding in the brain, nosebleeds and vaginal bleeding. These events occurred up to five times more often in people who received Avastin compared to patients who received only chemotherapy. Across cancer types, 1.2 percent to 4.6 percent of people who received Avastin experienced severe to fatal bleeding. People who have recently coughed up blood (greater than or equal to a half teaspoon of red blood) or have serious bleeding should not receive Avastin. Treatment with Avastin should be permanently stopped if serious bleeding occurs.


In clinical trials for different cancer types, there were additional serious and sometimes fatal side effects that occurred in more people who received Avastin than in those in the comparison group. The formation of an abnormal passage from parts of the body to another part (non-GI fistula formation) was seen in 0.3 percent or less of people. Severe to life-threatening stroke or heart problems were seen in 2.4 percent of people. Too much protein in the urine that led to kidney problems was seen in less than one percent of people. Additional serious side effects that occurred in more people who received Avastin than those in the comparison group included severe to life-threatening high blood pressure, which was seen in five percent to 18 percent of people, and nervous system and vision disturbances (reversible posterior leukoencephalopathy syndrome), which was seen in less than 0.1 percent of people. Infusion reactions with the first dose of Avastin were uncommon and occurred in less than three percent of people, and severe reactions occurred in 0.2 percent of people.


Common side effects that occurred in more than 10 percent of people who received Avastin for different cancer types, and at least twice the rate of the comparison group, were nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain and inflammation of the skin (exfoliative dermatitis). Across all trials, treatment with Avastin was permanently stopped in 8.4 percent to 21 percent of people because of side effects.


Avastin may impair fertility. Patients who are pregnant or thinking of becoming pregnant should talk with their doctor about the potential risk of loss of the pregnancy or the potential risk of Avastin to the fetus during and following Avastin therapy, and the need to continue an effective birth control method for at least six months following the last dose of Avastin. Women should be advised to discontinue nursing or discontinue treatment with Avastin, taking into account the importance of Avastin to the mother.


For full prescribing information and Boxed WARNINGS on Avastin, please visit http://www.avastin.com.


About Genentech
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.


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