- Advances in HER2-targeted therapy: Positive Phase III results
for Herceptin in advanced HER2-positive stomach cancer and encouraging
Phase II data in metastatic HER2-positive breast cancer with the novel
Treatment trastuzumab-DM1 (T-DM1) that uses the Herceptin antibody to
deliver a specialised cancer cell-killing agent to tumour cells.
- New approaches to treating lung cancer: Positive Phase III
studies of Avastin and Tarceva as first-line maintenance treatments in
advanced non-small cell lung cancer (NSCLC), including important
information about biomarkers in lung cancer.
- Avastin in early-stage colon cancer: Full results on the first
Phase III study (C-08).
- Personalising cancer treatment: encouraging early data for Roche's
targeted BRAF inhibitor in malignant melanoma.
- Combined Roche and Genentech oncology pipeline: includes 27
investigational agents in clinical studies.
William M. Burns, CEO of Roche's Pharmaceuticals Division: "We are presenting strong data for our targeted medicines for difficult-to-treat cancers including inoperable stomach cancer, lung cancer and melanoma. Data on Herceptin will show that it is a very effective treatment in patients with HER2-positive gastric cancer where current therapies are associated with poor survival and toxicity." Burns added: "We will also show very encouraging early data on a new, highly selective drug for malignant melanoma, the most serious type of skin cancer for which there are few treatments and no established standard of care."
Targeted therapy with Herceptin prolongs lives of patients with HER2-positive advanced stomach cancer
Results from the pivotal ToGA study will demonstrate unprecedented benefits associated with the targeted therapy Herceptin (trastuzumab) in helping patients with inoperable stomach cancer live longer, similar to the proven survival benefit of Herceptin observed in HER2-positive breast cancer. Results from the ToGA study which investigated the use of Herceptin in combination with chemotherapy (Xeloda [capecitabine] /intravenous 5-FU and cisplatin) will show how biomarker guided therapy could change the treatment of this devastating disease. Every year one million people worldwide are diagnosed with stomach cancer and 800,000 people die. ASCO abstract LBA4509
New combination approach to attack HER2-positive breast cancer
Final efficacy results will be presented from a Phase II study (TDM4258g) of T-DM1 in women whose breast cancer had progressed following previous treatment with two or more HER2-targeted therapies. These patients who have nearly no treatment options left, still could benefit from T-DM1. T-DM1 is a novel antibody-drug combination that links Herceptin and the cell-killing agent DM1. A Phase III study (EMILIA) evaluating T-DM1 for second-line advanced HER2-positive breast cancer was initiated this year.
Chemo-free targeted maintenance treatment for lung cancer
Two pivotal Phase III studies will show that effective maintenance treatment can help lung cancer patients continue to fight their disease without the need for continued chemotherapy, potentially creating a new treatment strategy in lung cancer. The first of the studies (SATURN) demonstrates the benefits of the targeted agent Tarceva (erlotinib) in helping patients with NSCLC live longer without their disease progressing when given after chemotherapy. The second study (ATLAS) will highlight efficacy data in patients treated with 'Avastin (bevacizumab) followed by combined maintenance treatment with Avastin and Tarceva. SATURN ASCO abstract 8001: http://www.abstract.asco.org
First trial results of Avastin in the adjuvant setting
Full results from the first trial of Avastin in early-stage colon cancer (known as NSABP C-08) will be presented. Although the study did not meet its primary endpoint of improving disease free survival, initial review of the data suggests Avastin may be active in patients with early-stage colon cancer. The ongoing adjuvant program in colon, breast and lung cancer involves over 26,000 patients. This includes the AVANT trial in early-stage colon cancer, results of which are expected in 2010. These results also do not impact Avastin's approved use in advanced or metastatic colorectal cancer.
Continuing proof in metastatic colorectal cancer
A number of significant data presentations will be made at ASCO which confirm Avastin-based therapy as the standard of care in metastatic colorectal cancer with proven efficacy in all patient sub-groups. These will also highlight the extensive ongoing research program which will help unlock Avastin's full potential across all stages of the disease.
CO-8 and ATLAS are two of 10 oral presentations on Avastin at the meeting. Results will be presented for mid-stage studies in other types of cancer as well. Avastin is being studied in more than 450 clinical studies worldwide and more than 30 different tumour types.
Potential new personalised treatment for malignant melanoma
Roche and its partner, Plexxikon Inc., will present promising results from a Phase I trial of PLX4032/R7204. This is a highly selective medicine that targets the mutated cancer-causing BRAF protein that occurs in 60% of melanoma (skin) cancers and up to eight percent of all solid tumours. Based on the significant responses seen in the phase I study, the medicine could enter registration trials for malignant melanoma later this year. Melanoma is an aggressive cancer for which few treatment options are currently available. If successful in treating melanoma PLX4032 is expected to be launched with a companion diagnostic, also being co-developed by Roche and Plexxikon which would be another step forward in personalising this cancer treatment. ASCO abstract 9000: http://www.abstract.asco.org
The 2009 ASCO Annual Meeting takes place from 29 May to 2 June, Orlando, Florida, USA. Full details can be found at http://www.asco.org/ASCO/Meetings/ASCO+Annual+Meeting.
Full details of key Roche data presentations will be given on Friday 29 May at an invitation-only media event for non-USA journalists. If you or your media colleagues are interested in attending this event please contact Roche Group Media Relations.