Herceptin Now Approved In The Eu For Patients With Her2-positive Advanced Stomach Cancer

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28th January 2010, 10:21pm - Views: 1297

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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



    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


    "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

People Feature Roche 3 image

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.


    (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.


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