MEDIA RELEASE PR38071
Herceptin Now Approved in the EU for Patients With HER2-Positive Advanced Stomach Cancer
BASEL, Jan. 28/PRNewswire-AsiaNet/ --
- First Targeted Biological Therapy to Show Survival Benefit in Stomach
Cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European
Commission has approved Herceptin (trastuzumab) in combination with
chemotherapy for use in patients with HER2-positive metastatic stomach
(gastric) cancer. The approval is based on the impressive results from the
international ToGA trial, which showed that treatment with Herceptin
significantly prolongs the lives of patients with this aggressive cancer.
Overall survival for patients with high levels of HER2 in the ToGA study was
16 months versus 11.8 months (on average) for patients receiving chemotherapy
alone.(i)
"Herceptin is the first targeted biological therapy to show a survival
benefit in advanced stomach cancer and represents a significant advance in
the treatment of this devastating disease," said Pascal Soriot, Chief
Operating Officer (COO), Roche Pharmaceutical Division. "We believe that
Herceptin will help patients with HER2-positive stomach cancer, as much as it
has helped so many women with HER2-positive breast cancer."
Based on the strong results from the phase III ToGA study, the submission
for the label extension was reviewed in an accelerated process by the
European Health Authorities, allowing patients to benefit sooner from this
life-extending treatment. This marketing authorisation is valid with
immediate effect in all European Union (EU) and EEA-EFTA states (Iceland,
Liechtenstein and Norway). Following approval in the European Union,
approvals for a label extension for Herceptin in other regions of the world
are expected to follow soon.
"I am delighted that today's approval will make Herceptin available to
patients with HER2-positive metastatic stomach cancer across Europe," said
Professor Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium,
one of the lead investigators of the ToGA trial. "The approval of Herceptin
for HER2-positive stomach cancer represents an important advance for the
treatment of these patients. Clinicians will need to ensure that patients
with metastatic stomach cancer are accurately tested for HER2 expression."
Stomach cancer is the second most common cause of cancer-related death in
the world and is the fourth most commonly diagnosed cancer, with over
1,000,000 cases of stomach cancer diagnosed each year.(ii) Advanced stomach
cancer is associated with a poor prognosis; the median survival time after
diagnosis is approximately 10-11 months with currently available
therapies.(iii) Approximately 15 - 18% of stomach tumours show high levels of
HER2(iv,v) Early diagnosis of this disease is challenging because most patients do not show symptoms in the
early stage.
About ToGA
ToGA is the first randomised Phase III trial investigating the use of
Herceptin in patients with inoperable locally advanced, recurrent and/or
metastatic HER2-positive stomach cancer. Approximately 3,800 patients were
tested for HER2-positive tumours and 594 patients with HER2-positive disease
were enrolled into the study. The rationale for conducting this trial was
based on the knowledge that the targeted therapy Herceptin has demonstrated
unprecedented efficacy in the treatment of HER2-positive breast cancer. In
addition, the overexpression of HER2 was also observed in stomach cancer.
Targeted cancer therapies are drugs or other substances that block the growth
and spread of cancer by interfering with specific molecules involved in
tumour growth and progression.
In the ToGA study, patients were randomised to receive one of the
following regimens as their first line of treatment:
- A fluoropyrimidine (Xeloda or intravenous 5-FU) and cisplatin
every 3 weeks for 6 cycles. Most patients were receiving Xeloda and
cisplatin as chemotherapy
- Herceptin 6mg/kg every 3 weeks until progression in combination
with a fluoropyrimidine and cisplatin for 6 cycles
The primary objective of the study was to demonstrate superiority in
overall survival of the Herceptin-containing treatment arm compared to the
chemotherapy alone arm. The pre-planned interim analysis was triggered by the
occurrence of 347 events. Secondary endpoints for the study included
progression-free survival, overall response rate, duration of response,
safety and quality of life. In the ToGA study, no new or unexpected side
effects were observed. For overall survival, the Hazard Ratio was 0.74 (CI
0.60, 0.91) with a highly significant p-value of p=0,0046. Herceptin
increased the median overall survival time by 2.7 months to 13.8 months
(intent to treat patient group, defined as IHC3+ or FISH-positive,
represented 22% of patients tested for HER2 in the ToGA study). The response
rate was increased with Herceptin from 34.5 % to 47.3%. Patients with tumours
exhibiting high levels of HER2 (IHC3+ or IHC2+/FISH-positive, 16% of patients
tested for HER2 in the ToGA study) experienced even greater benefit from the
addition of Herceptin. For these patients, overall survival in the study was
16 months on average versus 11.8 months for patients receiving chemotherapy
alone. The EU label recommends Herceptin for patients expressing high levels
of HER2.
About Herceptin
Herceptin is a humanised antibody, designed to target and block the
function of HER2, a protein produced by a specific gene with cancer-causing
potential. The mode of action of Herceptin is unique in that it activates the
body's immune system and suppresses HER2 to target and destroy the tumour.
Herceptin has demonstrated unprecedented efficacy in treating both early and
advanced (metastatic) HER2-positive breast cancer. Given on its own as
monotherapy as well as in combination with or following standard
chemotherapy, Herceptin has been shown to improve response rates,
disease-free survival and overall survival while maintaining quality of life
in women with HER2-positive breast cancer.
Herceptin is marketed in the United States by Genentech, in Japan by
Chugai and internationally by Roche. Since 1998, Herceptin has been used to
treat more than 740,000 patients with HER2-positive breast cancer worldwide.
About Xeloda
Xeloda (capecitabine) is a highly effective targeted oral chemotherapy
offering patients a survival advantage when taken on its own or in
combination with other anticancer drugs. Xeloda uniquely activates the
cancer-killing agent 5-FU (5-fluorouracil) directly inside the cancer cells
so avoiding damage to healthy cells. Xeloda tablets can be taken by patients
in their own home, reducing the number of hospital visits.
Licensed and marketed by Roche in more than 100 countries worldwide,
Xeloda has more than ten years of proven clinical experience providing an
effective and flexible treatment option to over 1.8 million people with
cancer. Xeloda is currently approved in metastatic colorectal, breast and
pancreatic cancer; advanced gastric cancer and adjuvant colon cancer.
Roche Personalised Healthcare: Fitting treatments to patients
Different people respond differently to medicines. The aim of Roche
Personalised Healthcare (PHC) is to target treatments to the patients most
likely to benefit. This means tailoring treatments to specific patient
sub-groups who share similar characteristics in their genetic makeup or in
the molecular nature of their disease. This approach has enormous potential
to make healthcare better, safer and more effective, with benefits for
patients, physicians, payers, and society at large.
Herceptin treatment in breast cancer is a case in point: Measuring the
levels of the protein HER2 in breast cancer cells with specific tests such as
the assays from Roche Tissue Diagnostics (Ventana) reliably identifies
patients who are likely to respond to Herceptin, a medicine that specifically
targets HER2. Roche is also applying this approach to the diagnosis and the
treatment of HER2-positive metastatic gastric cancer with Herceptin.
About Roche
Headquartered in Basel, Switzerland, Roche is a leader in
research-focused healthcare with combined strengths in pharmaceuticals and
diagnostics. Roche is the world's largest biotech company with truly
differentiated medicines in oncology, virology, inflammation, metabolism and
CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based
cancer diagnostics and a pioneer in diabetes management. Roche's personalised
healthcare strategy aims at providing medicines and diagnostic tools that
enable tangible improvements in the health, quality of life and survival of
patients. In 2008, Roche had over 80,000 employees worldwide and invested almost 9 billion Swiss francs in
R&D. The Group posted sales of 45.6 billion Swiss francs. Genentech, United States, is a wholly owned
member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more
All trademarks used or mentioned in this release are protected by law.
References
(i) Van Cutsem et al. Abstract #7BA ECCO/ESMO 2009
(ii) American Cancer Society. Global Cancer Facts & Figures 2007
(iii) Ohtsu A. J Gastroenterol 2008;43:256-264
(iv) Hofmann M, Stoss O, Shi D, Buttner R, van d, V, Kim W et al.
Assessment of a HER2 scoring system for gastric cancer: results from a
validation study. Histopathology 2008; 52(7):797-805.
(v) Park DI, Yun JW, Park JH, Oh SJ, Kim HJ, Cho YK et al. HER-2/neu
amplification is an independent prognostic factor in gastric cancer. Dig Dis
Sci 2006; 51(8):1371-1379.
SOURCE: Roche
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