Thursday, May 20, 2010

Roche and Genentech to Present New Data on Different Approaches to Treating Cancer at ASCO

New Results for Avastin in Ovarian Cancer and Rituxan in Lymphoma

South San Francisco, Calif. -- May 20, 2010 --

Genentech, Inc., a wholly owned member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that it will present new data for its targeted cancer medicines and the way they may be used in several different cancer types at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO). Approximately 400 abstracts featuring Genentech and Roche's cancer medicines and investigational agents across 30 cancer types will be presented during the meeting that is taking place June 4 to 8, 2010 in Chicago.

Key study results to be presented at the meeting include:

  • Avastin® (bevacizumab): Late-breaking Phase III data (GOG 0218) in advanced ovarian cancer where new therapies are urgently needed, as well as new data on the use of Avastin in multiple lines of therapy in advanced colorectal cancer.
  • Rituxan® (rituximab): Phase III data (PRIMA) on maintenance use of Rituxan in follicular lymphoma, an incurable cancer where people experience periods of relapse and remission as the disease progresses (see separate press release issued today).
  • Novel combination of HER2-targeted medicines: Phase Ib/II preliminary efficacy, safety and tolerability data for the HER2 antibody-drug conjugate, trastuzumab-DM1 (T-DM1), in combination with pertuzumab, a HER dimerization inhibitor, in previously treated women with advanced HER2-positive breast cancer.

"Our targeted medicines have helped millions of people with cancer and we continue to learn more about who may benefit the most and how best to use our medicines," said Pascal Soriot, chief operating officer of Roche's Pharmaceuticals Division. "We're also excited to share data on the medicines in our pipeline that we hope will give people new options for fighting this devastating disease."

The combined Roche and Genentech worldwide oncology pipeline includes 22 new investigational medicines, five of which are in late-stage development.

Avastin in Various Cancer Types
Phase III Trial of Bevacizumab in the Primary Treatment of Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer: A Gynecologic Oncology Group (GOG) Study (Abstract #LBA1) - Sunday, June 6, 2010, 1:45 - 2:00 p.m. CDT, North Hall B1. Data will also be highlighted in an ASCO press briefing at 8:00 a.m. CDT on Sunday, June 6

Results from the first Phase III trial (GOG 0218) of Avastin in ovarian cancer are under ASCO embargo and will be presented during the plenary session at the meeting. The trial met its primary endpoint and showed the combination of Avastin plus carboplatin and paclitaxel chemotherapy followed by maintenance use of Avastin alone increased the time women with previously untreated advanced ovarian cancer lived without the disease worsening (progression-free survival or PFS), compared to carboplatin and paclitaxel chemotherapy alone. A preliminary assessment of the safety profile performed by the GOG identified Avastin-related serious adverse events that have been observed in previous pivotal studies, including fatal neutropenic infection and gastrointestinal perforation.

GOG 0218 is the first Phase III study of an anti-angiogenic medicine in advanced ovarian cancer to meet its primary endpoint. Avastin is not approved for use in ovarian cancer.

Clinical Outcomes in Bevacizumab-Treated Patients With Metastatic Colorectal Cancer: Results from ARIES Observational Cohort Study and Confirmation of BRiTE Data on Bevacizumab Beyond Progression (Abstract #3596) - Sunday, June 6, 2010, 2:00 - 6:00 p.m. CDT, South Hall A2

An analysis from the ongoing non-randomized Phase IV ARIES observational study evaluated survival in more than 1,000 people with advanced colorectal cancer who initially received Avastin in combination with chemotherapy and then, following growth or spread of the cancer, continued with an Avastin-based regimen. The results suggested that people who continued an Avastin-based regimen after the cancer progressed lived longer than people who switched to a non-Avastin containing regimen or stopped treatment altogether.

In this analysis, people who continued an Avastin-based regimen after the cancer worsened had a 59 percent decrease in the risk of death compared to those who switched to a non-Avastin containing regimen or stopped therapy altogether (based on a hazard ratio of 0.41, p0.001). Median survival after the first disease progression was:

  • 16.3 months for patients who continued an Avastin-based regimen
  • 8.5 months for those who received a non-Avastin containing regimen
  • 5.2 months for those who stopped therapy altogether

Rates of adverse events were similar to those previously observed in pivotal trials with Avastin. The Avastin-associated adverse events for people who continued an Avastin-based regimen after disease progression were gastrointestinal perforations (0.2 percent), arteriothromboembolic events (1.9 percent) and bleeding (3.7 percent). Updated efficacy and safety data, including results for PFS and overall survival, will be reported at the meeting.

A large, randomized Phase III trial is evaluating the continued use of an Avastin-based regimen, compared to chemotherapy alone, in the second-line after progression following first-line use of Avastin plus chemotherapy. This trial will soon complete enrollment. Avastin is not currently approved for this use.

Advances in Combining HER2-Targeted Medicines
A Phase Ib/II Trial of Trastuzumab-DM1 (T-DM1) With Pertuzumab for Women With HER2-Positive Locally-Advanced or Metastatic Breast Cancer Who Were Previously Treated With Trastuzumab (Abstract #1012) - Saturday, June 5, 2010, 8:00 a.m. - 12:00 p.m. CDT in E450b; 12:00 - 1:00 p.m. CDT in East Hall D1

This early-phase trial evaluated the combination of investigational medicines T-DM1 and pertuzumab in 67 women with advanced HER2-positive breast cancer. Preliminary results from 23 patients whose disease had worsened after receiving a median of eight prior treatments (range: 4-15), including Herceptin® (trastuzumab) and lapatinib, showed the combination of these two investigational medicines shrank tumors in 9 of 23 women.

Safety results suggested the T-DM1 plus pertuzumab combination did not result in an increase in serious (Grade 3 or 4) adverse events compared to those previously reported for T-DM1 alone. The most common adverse events with the combination were nausea (57 percent), fatigue (52 percent), decreased appetite (44 percent), dysgeusia (39 percent), diarrhea (30 percent), dyspnea (26 percent), headache (26 percent) and mucosal inflammation (26 percent). One patient had a serious adverse event comprised of diarrhea, fatigue, nausea and vomiting, and another patient had a serious adverse event of dyspnea. One patient died from pneumonia following disease progression.

Updated safety and efficacy results from additional patients will be presented at the meeting.

Avastin Information: Avastin in combination with intravenous 5-FU-based chemotherapy is indicated for first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum.

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

Gastrointestinal (GI) perforation: Treatment with Avastin can result in the development of a potentially 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 side effect 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.

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. 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 having surgery and wound healing problems following surgery has not been determined.

Severe bleeding: Treatment with Avastin can result in serious 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. 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.

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, which led to kidney problems, was seen in less than 1 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 5 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 3 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.

First-line Metastatic Colorectal Cancer: In the first-line metastatic colorectal cancer trial, the most common severe to life-threatening side effects that increased by 2 percent or more in people who received Avastin plus IFL chemotherapy vs. IFL alone were weakness (10 percent vs. 7 percent), abdominal pain (8 percent vs. 5 percent), pain (8 percent vs. 5 percent), high blood pressure (12 percent vs. 2 percent), blood clots in the veins of the body (9 percent vs. 5 percent), blood clots inside the abdomen (3 percent vs. 1 percent), a brief loss of consciousness (3 percent vs. 1 percent), diarrhea (34 percent vs. 25 percent), constipation (4 percent vs. 2 percent), reduced white blood cell counts (37 percent vs. 31 percent), and reduced white blood cell counts that may increase the chance of infection (21 percent vs. 14 percent).

Second-line Metastatic Colorectal Cancer: In the second-line metastatic colorectal cancer trial, the most common severe to life-threatening and fatal side effects that increased by 2 percent or more in people who received Avastin plus FOLFOX4 chemotherapy vs. FOLFOX4 alone were diarrhea (18 percent vs. 13 percent), nausea (12 percent vs. 5 percent), vomiting (11 percent vs. 4 percent), dehydration (10 percent vs. 5 percent), blockage of the bowel (4 percent vs. 1 percent), numbness and tingling in fingers and toes (17 percent vs. 9 percent), nervous system disturbances (5 percent vs. 3 percent), tiredness (19 percent vs. 13 percent), abdominal pain (8 percent vs. 5 percent), headache (3 percent vs. 0 percent), high blood pressure (9 percent vs. 2 percent), and severe bleeding (5 percent vs. 1 percent).

For full Prescribing Information and Boxed WARNINGS on Avastin please visit http://www.avastin.com.

Rituxan Information: Rituxan is approved for the treatment of previously untreated follicular, CD20-positive, B-cell NHL in combination with CVP chemotherapy as well as non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent, after first-line CVP chemotherapy.

Rituxan Boxed WARNINGS and Additional Important Safety Information
Rituxan therapy can result in serious side effects, some which can be life-threatening. These include infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions and progressive multifocal leukoencephalopathy (PML). Other serious side effects that can result in death are: hepatitis B infection that may become active again, other infections, heart problems, serious kidney problems and serious stomach and bowel problems.

The most common side effects of Rituxan in clinical trials of patients with non-Hodgkin's lymphoma (NHL) were infusion reactions, fever, chills, low white blood cells, infections, body aches, and tiredness. The most common serious side effect in NHL patients was low white blood cells.

For full Prescribing Information and Boxed WARNINGS on Rituxan and the Medication Guide, please visit http://www.rituxan.com.

Herceptin Information: Herceptin is approved for one year of adjuvant treatment for HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature) breast cancer:

  • As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
  • With docetaxel and carboplatin
  • As a single agent following multi-modality anthracycline-based therapy

Herceptin is also approved for metastatic breast cancer:

  • In combination with paclitaxel for the first-line treatment of HER2-overexpressing metastatic breast cancer
  • As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease

Herceptin Boxed WARNINGS and Additional Important Safety Information
Herceptin treatment can result in heart problems, including those without symptoms (reduced heart function) and those with symptoms (congestive heart failure). Some patients have had serious infusion reactions and lung problems; fatal infusion reactions have been reported.
Worsening of low white blood cell counts associated with chemotherapy has also occurred. Herceptin can cause low amniotic fluid levels and harm to the fetus when taken by a pregnant woman. The most common side effects associated with Herceptin were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, shortness of breath, rash, low white and red blood cells, and muscle pain. Because everyone is different, it is not possible to predict what side effects any one person will have. Patients with questions or concerns about side effects should talk to their doctor.

For full Prescribing Information and Boxed WARNINGS on Herceptin please visit http://www.herceptin.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 wholly owned 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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