Astrazeneca Completes Enrolment In Second Pivotal Study For Vandetanib (Zactima (Tm) ) In Non-Small Cell Lung Cancer (NSCLC)

Main Category: Lung Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 13 Mar 2008 - 1:00 PDT

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AstraZeneca announced that it has completed enrolment in a further two pivotal Phase III trials for investigational once-daily oral anti-cancer drug, vandetanib. Results from these two Phase III studies, ZODIAC and ZEAL, are expected later this year.

ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer) is a randomised, double-blind, multi-centre Phase III study to assess the efficacy of vandetanib 100mg once daily plus docetaxel versus docetaxel alone in 1,380 patients with locally advanced or metastatic NSCLC after failure of first-line anti-cancer therapy.

ZEAL (ZACTIMA Efficacy with Alimta in Lung cancer) is a randomised, double-blind, multi-centre Phase III study to assess the efficacy of vandetanib100mg once daily plus pemetrexed versus pemetrexed alone in 510 patients with locally advanced or metastatic NSCLC, after failure of first-line anti-cancer therapy.

ZEST (ZACTIMA Efficacy Study versus Tarceva), which is investigating vandetanib versus erlotinib, was the first Phase III study to complete enrollment in November 2007.

" NSCLC is an area of high unmet medical need, and we hope vandetanib will offer a beneficial new treatment option that will improve the lives of people with lung cancer, " said Dr Peter Langmuir, Medical Science Director at AstraZeneca.

ZODIAC and ZEAL are part of a comprehensive Phase III clinical trial programme to gain a broad understanding of how vandetanib may benefit people with lung cancer. The other study (currently recruiting) is ZEPHYR (vandetanib + best supportive care [BSC] versus BSC).

The extensive Phase III programme in NSCLC follows promising results from two Phase II trials where vandetanib demonstrated encouraging anti-tumour activity when used alone or in combination with standard chemotherapy (docetaxel).1;2 Vandetanib has also shown promising early data in hereditary medullary thyroid cancer and has been given FDA and EU orphan drug status, and FDA fast track designation for this indication.

Vandetanib (ZACTIMA (tm) )

* Vandetanib is a new oral anti-cancer drug being investigated in clinical trials to assess its impact on the lives of patients with lung and thyroid cancer.

* Studies have already shown that use of vandetanib both on its own and in combination with chemotherapy gives additional time to patients before their disease progresses.1-3

* Vandetanib has a unique profile that fights cancer through two clinically proven mechanisms - by blocking the development of tumour blood supply, and by blocking the growth and survival of the tumour itself.4;5

* Studies to date have shown that ZACTIMA has a manageable side effect profile.1-3,5

* Vandetanib ' s potential benefits in other cancers are also being explored.

ZACTIMA (tm) is a trademark of the AstraZeneca group of companies.

About lung cancer in the UK

In 2006 in Europe, lung cancer with an estimated 334, 800 deaths, was the most common cause of death from cancer, representing 19.7 per cent of all nonmelanoma skin cancers 6

Until the late 1990s, lung cancer was the most frequently occurring cancer in the UK; it has now been overtaken by breast cancer, but still accounts for around 1 in 7 new cancer cases, that is, 38,313 new patients diagnosed in 20047 Overall, of all those people diagnosed with all types of lung cancer, non-small cell lung cancer and small cell lung cancer, at all stages:

* only 20% will live for at least one year post diagnosis.
* 6 % will live for at least five years after diagnosis
* 5 % will live for at least 10 years. 8
For those who are able to have surgery to remove their cancer, about 20 per cent are alive five years later.

About thyroid cancer in the UK

Every year in the UK nearly 1,650 cases of thyroid cancer are diagnosed in the UK. Thyroid cancer causes nearly 350 deaths in the UK each year. 9

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in research, development, manufacturing and marketing of prescription pharmaceuticals and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US $29.55 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection product sales. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

References

(1) Natale RB et al. ZD6474 versus gefitinib in patients with advanced NSCLC: Final results from two-part, double-blind randomized phase II trial. Journal of Clinical Oncology, Vol 24, No. 18S: Abs 7000. 2006

(2) Heymach JV et al. Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer.Journal of Clinical Oncology, Vol 25, No 27, 2007: 4270-4277.

(3) Johnson, B. et al.Randomized Phase II study of vandetanib alone or in combination with carboplatin and paclitaxel as 1st-line treatment for advanced NSCLC. J Thoracic Oncol 2007;2(8 Suppl S):S358-9, Abs C1-02.

(4) Wedge. S.R et al. ZD6474 inhibits vascular endothelial growth factor signaling, angiogenesis, and tumor growth following oral administration. Cancer Res 2002;62(16):4645-55.

(5) Holden SN, Eckhardt SG, Basser R et al. Clinical evaluation of ZD6474, an orally active inhibitor of VEGF and EGF receptor signaling, in patients with solid, malignant tumors. Ann Oncol 2005; 16(8):1391-1397.

(6) J. Ferlay, P. Autier, M. Boniol, M. Heanue, M. Colombet, P. Boyle. Estimates of the cancer incidence and mortality in Europe in 2006. See here. 2007 Mar;18(3):581-92.

(7) London. Cancer Research UK .. Accessed March 2008

(8) http://www.cancerhelp.org.uk/help/default.asp?page=6747. accessed March 2008

(9) London. Cancer Research UK. accessed March 2008

http://www.astrazeneca.co.uk

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