Genentech to present new data for targeted cancer medicines at 46th ASCO

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.

“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”

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, p<0.001). 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.




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