Vandetanib Increases Progression-Free Survival In Patients With Advanced Non Small Cell Lung Cancer - Phase II Study

Main Category: Lung Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 21 Sep 2007 - 16:00 PDT

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Results published in the Journal of Clinical Oncology1 show that AstraZeneca's investigational once-daily oral anti-cancer drug vandetanib in combination with docetaxel, increased progression free survival (PFS) compared with docetaxel alone in a phase II study of 127 patients with pre-treated advanced Non-Small Cell Lung Cancer (NSCLC).

The trial, study 6 demonstrated that adding vandetanib 100mg to standard docetaxel therapy improved median PFS to 18.7 weeks (HR=0.64, 95% CI 0.38-1.05; p=0.074), compared to 12 weeks with docetaxel alone. The combination of vandetanib (100 mg) plus docetaxel was generally well-tolerated; common adverse events included rash, diarrhea and asymptomatic QTc prolongation, all of which responded to standard management.

"Given the poor prognosis in advanced non-small cell lung cancer, an increase in time to disease progression can be meaningful for these patients," said Study 6 lead author John Heymach, Assistant Professor of Thoracic Head/Neck Medical Oncology at the University of Texas MD Anderson Cancer Centre. "The results of Study 6 provide encouraging support, and reinforce further investigation with vandetanib in combination with chemotherapy in Phase III trials."

AstraZeneca is investigating vandetanib in an extensive Phase III NSCLC clinical trial programme to gain a broad understanding of how the compound may benefit people with lung cancer. AstraZeneca's current Phase III vandetanib studies include ZODIAC (ZACTIMA in cOmbination with Docetaxel In non-smAll cell lung Cancer), a randomised, double-blind study comparing vandetanib (100mg) in combination with docetaxel vs. docetaxel alone, in patients with locally advanced or metastatic NSCLC after failure of first-line anticancer treatment.

The study is recruiting and aims to enrol approximately 1400 patients throughout Europe, North America, South America and Asia Pacific. The primary end point of the study is PFS. Response rates and overall survival will be evaluated as secondary endpoints in the study.

Other studies currently recruiting within vandetanib's NSCLC Phase III clinical development programme are:

- ZEAL (ZACTIMA Efficacy with Alimta® (pemetrexed) in Lung cancer)
- ZEST (ZACTIMA Efficacy Study versus Tarceva® (erlotinib))
- ZEPHYR Zactima Efficacy Study for NSCLC Patients with History of EGFR-TKI and Chemo-Resistance ZACTIMA(tm) is a trademark of the AstraZeneca group of companies.

Study 6

The study was a randomized, double-blind, placebo controlled Phase II trial that evaluated the activity of vandetanib (100mg and 300mg) in combination with standard docetaxel therapy vs docetaxel alone in 127 patients with locally advanced or advanced NSCLC (stage IIIB/IV), including patients with squamous cell lung carcinoma, after failure of first-line platinum-based chemotherapy.

Non-small cell lung cancer (NSCLC)

Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. Around 80% of lung cancer is NSCLC. It usually grows and spreads more slowly than small cell lung cancer (SCLC).

There are three forms of NSCLC:

- Adenocarcinomas are often found in an outer area of the lung.
- Squamous cell carcinomas are usually found in the center of the lung by an air tube (bronchus).
- Large cell carcinomas can occur in any part of the lung. They tend to grow and spread faster than the other two types.

About lung cancer in the UK

Lung cancer is the most common cancer in the world with 1.3 million new cases diagnosed every year.2

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 2004.3

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.4

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4 Good Index.

For more information about AstraZeneca, please visit: http://www.astrazeneca.co.uk

References

1. John V. Heymach et al.(2007) Randomized, Placebo-Controlled Phase II Study of Vandetanib Plus Docetaxel in Previously Treated Non-Small-Cell Lung Cancer. J Clin Oncol 25: 27. 20 September 2007

2. J. Ferlay, P. Autier, M. Boniol, M. Heanue, M. Colombet, P. Boyle. Estimates of the cancer incidence and mortality in Europe in 2006. Click here Oncol. 2007 Mar;18(3):581-92.http://info.cancerresearchuk.org/cancerstats/types/lung/

3. Office for National Statistics, Cancer Statistics registrations: Registrations of cancer diagnosed in 2004, England. See here Series MB1 no.33. 2005, National Statistics: London. ISD Online. 2007 See here & Information and Statistics Division, NHS Scotland. Welsh Cancer Intelligence and Surveillance Unit, 2007. http://www.wcisu.wales.nhs.uk/http://info.cancerresearchuk.org/cancerstats/types/lung/

4. Click here . accessed 20 August 2007

http://www.astrazeneca.co.uk