Roche to share important oncology data at European Cancer Congress (ECC)

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data for several of its established and investigational cancer medicines will be presented at the European Cancer Congress (ECC) in Amsterdam between September 27 to October 1, 2013. Roche medicines will be featured in more than 138 scientific presentations. The data presented come from 18 Roche medicines that are directed against a broad range of therapeutic targets.

“At ECC this year we will present important updates for both investigational and approved medicines,” said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development at Roche. “These data reflect our commitment to develop new targeted anti-cancer medicines as well as to explore how our approved medicines, such as Zelboraf, Avastin and Herceptin, can benefit more patients.”

Key Roche meeting highlights include:

Kadcyla and Herceptin SC: HER2 blockade
Roche has been leading the field of HER2-positive breast cancer research for more than 30 years. The company has developed three medicines that target the HER2 receptor. For all of Roche’s HER2 medicines a diagnostic test will determine who is most likely to benefit from treatment. At ECC, important new efficacy and quality of life data will be presented for two of these medicines:

• First results from the TH3RESA study will be presented. TH3RESA is a phase III study of Kadcyla (T-DM1 or trastuzumab emtansine) vs. treatment of physician’s choice in women with HER2-positive metastatic breast cancer who have been previously treated with both Herceptin and lapatinib based treatments. The TH3RESA data will be presented as a late breaker and are featured in the ECC media programme.
• Two sets of data from the phase II PrefHER study will be presented. PrefHER is investigating the impact of the newly EU approved subcutaneous formulation of Herceptin on the care of women with early-stage HER2-positive breast cancer and healthcare system resources.

Alectinib: Addressing high unmet medical need in patients with advanced NSCLC

Despite significant recent advances, patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) still frequently develop resistance to available treatment and their disease relapses.

A number of patients develop new tumours in the brain because many anti-cancer therapies have difficulty crossing the blood-brain barrier. At ECC, encouraging efficacy and safety data in patients with metastatic NSCLC that has progressed on crizotinib will be presented for alectinib, a promising investigational 2nd generation ALK inhibitor, in a late breaking report. Alectinib was created by Chugai Pharmaceutical Co., Ltd, a member of the Roche group. The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for Roche’s alectinib based on data that will be presented at ECC

MPDL3280A (Anti-PD-L1): Cancer immunotherapy

Anti-PD-L1 antibody MPDL3280A (RG7446) is an investigational medicine designed to make cancer cells more vulnerable to the body’s own immune system by interfering with a protein called PD-L1.

MPDL3280A has potential application in many cancer types; at ECC this year a data set evaluating an anti-PD-L1 antibody in patients with non-small cell lung cancer (NSCLC) will be presented. Earlier data from the study in a smaller number of patients had previously been reported at ASCO.

Zelboraf and cobimetinib: BRAF and MEK inhibition

Zelboraf (vemurafenib) is an oral, small molecule, kinase inhibitor specifically designed to target and inhibit mutated forms of the BRAF protein that is found in various cancer types. Zelboraf is currently approved for the treatment of BRAF V600 mutation positive metastatic melanoma. Updated data from the phase Ib BRIM7 trial assessing the combination of Zelboraf with the investigational MEK inhibitor cobimetinib (GDC-0973) will be presented. Following presentation of preliminary BRIM7 data at ESMO 2012, Roche announced the initiation of a pivotal, phase III study to evaluate the combination of Zelboraf and cobimetinib in patients with previously untreated BRAF V600 mutation-positive metastatic melanoma. This study is ongoing.

Additionally, late-breaking results from a phase II study of Zelboraf in patients with thyroid cancer will be presented.

Avastin: Interfering with the tumour blood supply

Avastin (bevacizumab) precisely targets VEGF (vascular endothelial growth factor), an early and persistent promoter of tumour angiogenesis, for continued tumour control. At ECC, more than 66 abstracts of Avastin will be presented across several different cancers. Presentation highlights include:

• Final overall survival outcomes will be presented from two phase III studies of Avastin in ovarian cancer in ECC Presidential Session II (ICON7 in previously untreated patients and AURELIA for platinum-resistant recurrent ovarian cancer).
• New data on the impact of the disease and treatment on the well-being of the patient (health related quality of life) from a phase III study in advanced cervical cancer (GOG240) will be presented as a late breaker.

List of studies referred to above

Kadcyla:

• Abstract #15: LATE BREAKING ABSTRACT T-DM1 for HER2-positive metastatic breast cancer (MBC): Primary results from TH3RESA, a phase 3 study of T-DM1 vs treatment of physician’s choice. ECC media briefing September 28. Proffered papers session, Saturday, September 28, 13:03 – 13:15 in Hall 7.1

Herceptin SC:

• Abstract #1759: Reasons for patients’ preferences for subcutaneous or intravenous trastuzumab in the PrefHer study. Poster session, Saturday, September 28, 09:30 – 16:30 in Hall 4

Alectinib:

• Abstract #44: LATE BREAKING ABSTRACT Safety and efficacy analysis of RO5424802/CH5424802 in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients who have failed crizotinib in a dose-finding phase I study (AF-002JG, NCT01588028). Proffered Papers Session, Monday, September 30, 11:22 – 11:34 in Room G104

MPDL3280A (Anti-PD-L1):

• Abstract #3408: Clinical activity, safety and biomarkers of PD-L1 blockade in non-small cell lung cancer (NSCLC): Additional analyses from a clinical study of the engineered antibody MPDL3280A (anti-PDL1). Proffered Papers Session, Sunday, September 29, 09:14 – 09:26 in Elicium 2

Zelboraf:

• Abstract #3703: Vemurafenib (VEM) and MEK inhibitor, cobimetinib (GDC-0973), in advanced BRAFV600-mutated melanoma (BRIM7): dose-escalation and expansion results of a phase IB study. Proffered papers session, Saturday, September 28, 12:15 – 12:27 in Elicium 1
• Abstract #28: LATE BREAKING ABSTRACT An open label, multi-center phase 2 study of the BRAF inhibitor vemurafenib in patients with metastatic or unresectable papillary thyroid cancer positive for the BRAF V600 mutation and resistant to radioactive iodine (nct01286753, no25530). Proffered Papers Session, Saturday, September 28, 17:50 – 18:02 in Hall 3.1

Avastin:

• Abstract #6: LATE BREAKING ABSTRACT ICON7: Final overall survival results in the GCIG phase III randomized trial of bevacizumab in women with newly diagnosed ovarian cancer. Presidential Session, Sunday, September 29, 14:05 – 14:15 in Hall 7.1
• Abstract #5: LATE BREAKING ABSTRACT Final overall survival (OS) results from AURELIA, an open-label randomised phase III trial of chemotherapy (CT) with or without bevacizumab (BEV) for platinum-resistant recurrent ovarian cancer (OC). Presidential Session, Sunday, September 29, 13:55 – 14:05 in Hall 7.1
• Abstract #42: LATE BREAKING ABSTRACT Patient reported outcomes in a practice changing randomized trial of bevacizumab in the treatment of advanced cervical cancer: A gynecologic oncology group study. Proffered Papers Session, Tuesday, October 1, 11:05 – 11:17 in Hall 7.2