Tarceva Helps Patients With Genetically Distinct Form of Lung Cancer Live Longer

Chicago, June 8, 2010 (ots/PRNewswire) - New data show that first-line
treatment with Tarceva(R)(erlotinib) delivered exceptional survival
benefits in patients with advanced lung adenocarcinoma (a form of non
small cell lung cancer) with epidermal growth factor receptor (EGFR)
activating mutations.[1] The phase II data show that Tarceva plus
chemotherapy resulted in median overall survival of 39 months and
Tarceva alone gave a median survival of 31.3 months. Patients with
advanced lung cancer typically survive for only about 12 months with
chemotherapy alone[2]. The data are from CALGB 30406, a study led by
the US Cancer and Leukemia Group B and were presented at the American
Society of Clinical Oncology (ASCO) meeting in Chicago, USA.

Non small cell lung cancer (NSCLC) with EGFR activating mutations
is considered to be a genetically distinct form of lung cancer which
is most common in patients who have never smoked, patients with
adenocarcinoma, people of Asian origin and females.[3],[4]

"The exceptional survival benefits seen when Tarceva is given to
patients with advanced lung cancer that has EGFR activating mutations
suggest that we may be able to make further progress against this
devastating disease," said Dr. Luis Paz-Ares, M.D., Hospital
Universitario Virgen del Rocío, Seville, Spain and lead author of a
recent pooled analysis of clinical outcomes in patients with NSCLC
with EGFR activating mutations.[3]

Two prospective phase III studies of Tarceva in NSCLC with EGFR
activating mutations are ongoing. The EURTAC trial involves patients
in Spain, Italy and France and the OPTIMAL trial involves patients in
China. Both EURTAC and OPTIMAL are evaluating the efficacy of
first-line Tarceva versus chemotherapy (platinum-based and
gemcitabine/carboplatin, respectively) in patients with advanced
NSCLC with EGFR activating mutations who have not received prior
chemotherapy. Efficacy results from the OPTIMAL trial are expected in
the second half of 2010 and final results of the EURTAC trial in
2011.

About CALGB 30406
- CALGB 30406 was a randomised, prospective phase II trial designed to
evaluate Tarceva alone or in combination with chemotherapy
(carboplatin and paclitaxel) and the impact of EGFR activating
mutations on outcomes in never or light former smokers diagnosed with
advanced lung adenocarcinoma (a form of NSCLC). The study involved 181
patients and the primary endpoint was progression free survival (PFS).
- Overall people who received Tarceva plus chemotherapy lived a median of
19.6 months and those who received Tarceva alone lived a median of 24.3
months (median PFS 6.6 months and 6.7 months, respectively).
- The group of people whose tumours had EGFR activating mutations who
received Tarceva plus chemotherapy lived a median of 39.0 months.
Those who received Tarceva alone lived a median of 31.3 months.
- The group of people whose tumours did not have EGFR activating
mutations who received Tarceva plus chemotherapy alone lived a median
of 13.7 months. Those who received Tarceva alone lived a median of
18.1 months.
- Fewer severe (grade 3 or 4) adverse events were observed with Tarceva
alone compared to Tarceva plus chemotherapy.

CALGB 30406 data presentation: 15:00 CDT Monday 7 June, Lung
Cancer - Metastatic Oral Abstract Session, E Hall D2: Randomized
Phase II trial of erlotinib (E) alone or in combination with
carboplatin/paclitaxel (CP) in never or light former smokers with
advanced lung adenocarcinoma; P.A. Jänne, et al. J Clin Oncol 28:7s,
2010 (suppl; abstr 7503).

About EGFR in lung cancer

EGFR is a protein which sits across the cell membrane to which
epidermal growth factor (EGF) binds.[5] When binding happens it
activates an enzyme called tyrosine kinase which triggers a complex
signalling cascade that leads to events including accelerated cell
growth and division, development of metastasis and
angiogenesis.[6],[7] Some NSCLC tumours possess activating mutations
in the EGFR gene, changing the structure of the EGFR proteins that
they code for such that they have increased activity.

About Tarceva

Tarceva is a once-daily, oral non-chemotherapy treatment for the
treatment of advanced or metastatic NSCLC. It has been shown to
potently inhibit (epidermal growth factor) EGFR, a protein involved
in the growth and development of cancers. Tarceva is the first and
only EGFR inhibitor to be approved for use in maintenance and
second-line treatment settings in patients with advanced or
metastatic NSCLC. It is also the only EGFR inhibitor to have shown
activity in patients irrespective of EGFR activating mutation status.
In both maintenance and second-line settings, Tarceva has a proven
and significant survival and symptom benefit without the side effects
associated with chemotherapy. In addition, Tarceva in combination
with chemotherapy is the first treatment in over a decade to have
shown a significant survival benefit in treating patients with
pancreatic cancer. Since initial launch Tarceva has been used to
treat more than 400,000 patients worldwide and is now approved in
more than 100 countries.

About Roche

Information about the Roche Group is available on the Internet at
http://www.roche.com.

References
---------------------------------
[1] Randomized Phase II trial of erlotinib (E) alone or in combination
with carboplatin/paclitaxel (CP) in never or light former smokers
with advanced lung adenocarcinoma: CALGB-30406. Jänne, PA et al.
Oral abstract presentation at ASCO, Chicago, USA, June 2010.
[2] Earle, CC. Chest 2000; 117: 1239-46.
[3] Paz-Ares, et al; J. Cell. Mol. Med, 2010.
[4] Mitsudomi T, Yatabe Y. Cancer Sci 2007;98:1817-24.

[5] http://www.cancer.gov/ncicancerbulletin/NCI_Cancer_Bulletin_0
51308/page3. Accessed 25.03.10

[6] Prenzel N et al. Endocrine-Related Cancer. (2001). 8:11-31.
[7] Britten CD. Mol Cancer Ther; 2004. 3 1335-42.

ots Originaltext: Roche Tarceva
Im Internet recherchierbar: http://www.presseportal.de

Contact:
CONTACT: For further information please contact: Federico Maiardi,
Roche,Tel: +41-61-688-7946, Mobile: +41-79-264-3978,
email:federico.maiardi@roche.com; Rosemary Hennings, Galliard,
Tel:+44-20-7663-2253, Mobile: +44-7799-411-325
email:rhennings@galliardhealth.com