Investor Update
Basel, 6 June 2006 1
New
study suggests
combining breakthrough therapies Tarceva and Avastin may provide more hope for lung cancer patients
A
new study
“These findings signal the potential for combining novel therapies
that target different cancer growth pathways, to achieve better overall patient outcomes, with a low
incidence of serious side effects,” said Willem Verhoofstad, Global Business Director for Roche Oncology.
“We are continuing to invest and explore the safety and efficacy of the Avastin and Tarceva combination
and are currently conducting Phase III trials with both products in first-line and relapsed NSCLC settings.”
The
randomised, Phase II exploratory study evaluated three treatment regimens in patients with recurrent
or refractory NSCLC:
- Avastin in addition to Tarceva
- Avastin in addition to chemotherapy (either pemetrexed or docetaxel)
- Chemotherapy alone (either pemetrexed or docetaxel) as control arm
The study suggests that Avastin in combination
with Tarceva or chemotherapy improves progression-free survival, the primary study endpoint, compared
to chemotherapy alone. Median progression-free survival in the Avastin plus chemotherapy arm was 4.8
months, and was 4.4 months in the Avastin plus Tarceva arm, compared to just 3.0 months in the chemotherapy
alone arm. The study results also showed that the toxicity profile of the Avastin plus Tarceva combination
was favourable, resulting in fewer serious adverse events, when compared to either chemotherapy-containing
arm. Due to the exploratory nature of this randomised Phase II study, these data do not provide definitive
conclusions with respect to differences between the three treatment arms.
About
the Phase II Exploratory Study
120 patients with recurrent or refractory NSCLC,
who had not received previous treatment with Avastin or Tarceva, were enrolled into this study. Patients
in the study had histologically or cytologically confirmed non-squamous NSCLC and had experienced clinical
or radiographic disease progression during or following one platinum-based chemotherapy regimen for
advanced stage disease (IIIb or IV).
The key study results showed:
- Treatment with Avastin plus Tarceva reduced the risk of cancer progression or death by 28 percent compared to chemotherapy alone (based on a hazard ratio of 0.72).
- Treatment with Avastin plus chemotherapy reduced the risk of cancer progression or death by 34 percent compared to chemotherapy alone (based on a hazard ratio of 0.66),
- Treatment with Avastin plus Tarceva saw 78% of patients alive at six months (median progression-free survival 4.4 months)
- Treatment with Avastin plus chemotherapy saw 72% of patients alive at six months (median progression-free survival 4.8 months)
- Treatment with chemotherapy alone saw 62% of patients alive at six months (median progression-free survival 3.0 months)
- The toxicity profile of the Avastin plus Tarceva combination was favourable, resulting in fewer serious adverse events, when compared to either chemotherapy-containing arm
- Adverse events in the Avastin plus Tarceva arm were similar to those observed in previous clinical trials of Avastin in combination with Tarceva, and included diarrhoea and rash
- Adverse events in the Avastin plus chemotherapy arm were similar to those observed in previous clinical trials of Avastin in combination with chemotherapy, and included hypertension and bleeding
*******
About
Tarceva
Tarceva is an investigational small molecule that targets the human epidermal
growth factor receptor (HER1) pathway. HER1, also known as EGFR, is a key component of this signalling
pathway, which plays a role in the formation and growth of numerous cancers. Tarceva blocks tumour
cell growth by inhibiting the tyrosine kinase activity of the HER1 signalling pathway inside the cell.
Taken as an oral, once-daily therapy, Tarceva is the only EGFR-inhibitor
to have demonstrated a survival benefit in lung cancer. Currently most lung cancer patients are
treated with chemotherapy which can be very debilitating due to its toxic nature. Tarceva works
differently to chemotherapy by specifically targeting tumour cells, and avoids the typical side-effects
of chemotherapy.
Tarceva is approved in the US and across the European
Union for patients with locally advanced or metastatic non small cell lung cancer (NSCLC) after failure
of at least one prior chemotherapy regimen. Tarceva is approved in the US in combination with gemcitabine
chemotherapy for the treatment of patients with locally advanced, inoperable or metastatic pancreatic
cancer. A Marketing Authorisation Application was submitted to the European health authorities in November
2005.
Tarceva is currently being evaluated in an extensive clinical development
programme by a global alliance among OSI Pharmaceuticals, Genentech, and Roche, focussing on earlier
stages of NSCLC. Additionally, Tarceva is being studied in combination with Avastin in NSCLC.
Trials are also being conducted with Tarceva in other solid tumours, such as ovarian, bronchioloalveolar
(BAC), colorectal, pancreatic, head and neck and glioma (brain).
About
Avastin
Avastin is the first treatment that inhibits angiogenesis – the growth
of a network of blood vessels that supplies nutrients and oxygen to cancerous tissues. Avastin targets
a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis,
thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout
the body (metastasis).
Avastin is the first and only anti-angiogenic
agent to have demonstrated improved overall and/or progression-free survival in the three major types
of cancer leading to death: colorectal cancer, non-small cell lung cancer and breast cancer. In Europe,
Avastin was approved in early 2005 for first-line treatment of patients with metastatic carcinoma of
the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic
acid or intravenous 5-fluorouracil/folinic acid/irinotecan. Avastin received approval by the US Food
and Drug Administration (FDA) in February 2004. In addition, filing occurred in the US on April 10,
2006, for use of Avastin in previously untreated advanced non-squamous, non-small cell lung cancer,
on May 26 for treatment of women with advanced breast cancer and in Japan on April 21, 2006 for use
of Avastin in patients with advanced or recurrent colorectal cancer.
Roche
and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in various
tumour types (including colorectal, breast, lung, pancreatic cancer, ovarian cancer, renal cell carcinoma
and others) and different settings (advanced and adjuvant i.e. post-operative). The total development
programme is expected to include over 25,000 patients worldwide.
Roche
in Oncology
The Roche Group, including its members Genentech in the United States
and Chugai in Japan, is the world’s leading provider of cancer care products, including anti-cancer
treatments, supportive care products and diagnostics. Its oncology business includes an unprecedented
five products proven to provide survival benefit in different major tumour indications: Avastin, Herceptin,
and Xeloda in advanced-stage breast cancer, Herceptin in early-stage HER2-positive breast cancer, MabThera
in non-Hodgkin’s lymphoma, Avastin and Xeloda in colorectal cancer, Avastin and Tarceva in non-small
cell lung cancer and Tarceva in pancreatic cancer.
In addition to these
anti-cancer agents, the Roche oncology portfolio includes a comprehensive collection of medicines that
can help improve the quality of life of cancer patients: Bondronat (for prevention of skeletal events
in patients with breast cancer and bone metastases, hypercalcaemia of malignancy), Kytril (for chemotherapy
and radiotherapy-induced nausea and vomiting), Neupogen (for cancer-related neutropenia), and NeoRecormon
(for anaemia in various cancer settings). CERA is the most recent demonstration of Roche’s commitment
to anaemia management. Other oncology products include Furtulon (for colorectal cancer) and Roferon-A
(for hairy cell and chronic myeloid leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell carcinoma).
In addition to the medicines, Roche is developing new diagnostic
tests that will have a significant impact on disease management for cancer patients in the future. With
a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas
and lung cancer, as well as a range of molecular oncology tests, Roche will continue to be the leader
in providing cancer-focused treatments and diagnostics.
The unmatched
Roche oncology portfolio as well as an extensive external innovation base through collaborations with
companies and academia is what makes it possible for Roche to provide more effective cancer therapies.
In the United States Herceptin, MabThera (Rituxan), Avastin and Tarceva
are marketed either by Genentech alone or together with its partners Biogen Idec Inc. (MabThera) and
OSI (Tarceva). Outside of the United States, Roche and its Japanese partner Chugai are responsible for
the marketing of these medicines.
About Roche
Headquartered
in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the
fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the
early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range
of fronts to improve people’s health and quality of life. Roche is a world leader in diagnostics, the
leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2005
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss francs, and the Diagnostics Division
posted sales of 8.2 billion Swiss francs. Roche employs roughly 70,000 people in 150 countries and has
R&D agreements and strategic alliances with numerous partners, including majority ownership interests
in Genentech and Chugai. Additional information about the Roche Group is available on the Internet (www.roche.com).
All
trademarks used or mentioned in this release are legally protected.
Reference:
1.
Fehrenbacher, C et al, A phase II, multicenter, randomized clinical trial to evaluate the efficacy and
safety of Avastin (bevacizumab) in combination with either chemotherapy (docetaxel or pemetrexed) or
Tarceva (erlotinib hydrochloride) compared with chemotherapy alone for treatment of recurrent or refractory
non–small cell lung cancer, Abstract #7062, presented at the 42nd Annual Meeting of the American Society
of Clinical Oncology (ASCO) 2006.