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

February 10, 2016

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.

SOURCE Genentech