Navigation Links
Video: Phase III Study Data With Vandetanib (Zactima(TM)) in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) Presented at American Society of Clinical Oncology

ORLANDO, Fla., May 30 Data from the Phase III ZODIAC study in advanced non-small cell lung cancer patients, with the investigational drug vandetanib, were presented today at the American Society of Clinical Oncology (ASCO) meeting in Orlando. Results show that the study met its primary endpoint, demonstrating that the addition of vandetanib to docetaxel resulted in a statistically significant improvement in progression-free survival (PFS), the length of time a patient lives without their cancer growing (hazard ratio [HR] 0.79, 97.58% CI 0.70-0.90; P<0.001. Median PFS: 14.0 weeks vs. 17.3 weeks, favoring vandetanib). Vandetanib is the first oral targeted therapy to show evidence of clinical benefits when added to chemotherapy in a Phase III study in second line advanced NSCLC(1).

To view the Multimedia News Release, go to:

ZODIAC is a randomized, double-blind, placebo-controlled Phase III study evaluating the combination of vandetanib 100mg with docetaxel versus docetaxel alone. The study enrolled 1391 patients previously treated with one prior anti-cancer therapy for advanced NSCLC.

Data from ZEAL(2), a smaller Phase III study also featured on this year's ASCO program, are supportive of ZODIAC although the primary endpoint did not reach statistical significance in the ZEAL study (hazard ratio [HR] 0.86, 97.58% CI 0.69-1.06; P=0.108. Median PFS: 11.9 weeks vs. 17.6 weeks, favouring vandetanib). The combination of vandetanib plus pemetrexed did show a positive trend in prolongation of PFS compared with pemetrexed alone.

ZEAL is a randomized, double-blind, placebo-controlled Phase III study evaluating vandetanib 100mg plus pemetrexed versus pemetrexed alone. The study enrolled 534 patients previously treated with one prior anti-cancer therapy for advanced NSCLC.

Evaluation of secondary endpoints in the ZODIAC and ZEAL studies showed that the addition of vandetanib to chemotherapy significantly improved objective response rate, which is a measurement of tumor shrinkage (ZODIAC: 17% vs. 10%, P<0.001; ZEAL: 19.1% vs. 7.9%, P<0.001), the studies also showed that adding vandetanib to chemotherapy resulted in a significantly longer time to deterioration of disease related symptoms (ZODIAC: HR 0.78, P=0.002, FACT-L Lung Cancer Subscale; ZEAL: HR 0.61, P=0.004, Lung Cancer Symptom Scale). Overall survival in both studies showed a positive trend, although they did not reach statistical significance (ZODIAC Study: HR 0.91, 97.52% CI 0.78-1.07: P=0.196; ZEAL Study: HR 0.86, 97.54% CI 0.65-1.13; p=0.219).

The observed safety profile in both studies was consistent with previous studies with vandetanib in NSCLC. The most common adverse events associated with vandetanib included rash, diarrhea and hypertension (ZEAL); rash, diarrhea and neutropenia (low white blood cell count) (ZODIAC). Incidence of protocol-defined QTc prolongation was <2.0 percent in both studies and was not associated with symptoms.

"There are more deaths from lung cancer alone than from breast, colon, and prostate cancers combined - and it's extremely difficult to treat," said Professor Roy Herbst, M.D., Ph.D., The University of Texas M. D. Anderson Cancer Center, Texas, Principal Investigator on the ZODIAC study. "The ZODIAC study showed adding vandetanib to chemotherapy improved progression-free survival, in patients who have few, if any options for treatment."

Results from a third Phase III study, ZEST(3), were also presented at this year's ASCO. While the primary objective of demonstrating a statistically significant prolongation of PFS for vandetanib was not met in this study, in a pre-planned non-inferiority analysis, vandetanib was shown to have similar efficacy to erlotinib for PFS and OS (PFS: hazard ratio [HR] 0.98, 95.22% CI 0.87-1.10; P=0.721; OS: HR 1.01, 95.08% CI 0.89-1.16; P=0.830). Objective response rate and symptom control were also similar for both treatments (ORR: both 12%; symptoms: pain, HR 0.96, P=0.583; dyspnea, HR 1.08, P=0.333; cough, HR 0.94, P=0.403).

The ZEST study was a randomized, double-blind, Phase III study evaluating the efficacy of vandetanib 300mg versus erlotinib 150mg. The study enrolled 1240 patients with locally advanced or metastatic NSCLC after failure of at least one prior anti-cancer therapy.

The most common adverse events observed in the ZEST study were rash, diarrhea and hypertension. Incidence of protocol-defined QTc prolongation was 5.1 percent in the vandetanib arm.

AstraZeneca plans to submit a regulatory submission for the use of vandetanib 100mg in combination with chemotherapy for patients with advanced NSCLC in the first half of 2009.

Evaluation of vandetanib is ongoing, as monotherapy or in combination with other anti-cancer therapies in a range of tumor types, including thyroid cancer.

Results from the ZEPHYR (300mg monotherapy study in EGFR failures in advanced NSCLC, Phase III) and ZETA (300 mg monotherapy in advanced medullary thyroid cancer, Phase III) studies will be available during the second half of 2009.

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

About lung cancer

  • Over 1.35 million new cases of lung cancer are diagnosed every year and nearly 1.2 million people die as a result of this devastating disease - more than breast, colon and prostate cancer combined(4).
  • Non-small cell lung cancer accounts for around 85% of all lung cancers(5).
  • If lung cancer is detected at early stages, before it has spread to other organs or lymph nodes, around half of patients can survive for five years or more. However, few lung cancers are found at this early stage and it is normally diagnosed at the advanced stage, when five year survival falls to approximately 15%(6).

About AstraZeneca

AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit:

The statements contained herein include forward-looking statements. Although we believe our expectations are based on reasonable assumptions, any forward-looking statements, by their very nature, involve risks and uncertainties and may be influenced by factors that could cause actual outcomes and results to be materially different from those predicted. The forward-looking statements reflect knowledge and information available at the date of the preparation of this press release and the Company undertakes no obligation to update these forward-looking statements. Important factors that could cause actual results to differ materially from those contained in forward-looking statements, certain of which are beyond our control, include, among other things, those risk factors identified in the Company's Annual Report/Form 20-F for 2008. Nothing contained herein should be construed as a profit forecast.

Reference List

(1) Herbst, R. et al. Vandetanib plus docetaxel vs docetaxel as 2nd-line treatment for patients with advanced non-small-cell lung cancer (NSCLC): a randomized, double-blind phase III trial (ZODIAC). ABS 31495. ASCO. 2009.

(2) De Boer, R. et al. Vandetanib plus pemetrexed vs pemetrexed as 2nd-line therapy in patients with advanced non-small-cell lung cancer (NSCLC): a randomized, double-blind phase III trial (ZEAL). ABS 31867, ASCO. 2009.

(3) Natale, R. et al. Vandetanib versus erlotinib in patients with advanced non-small-cell lung cancer (NSCLC) after failure of at least 1 prior cytotoxic chemotherapy: a randomized, double-blind phase III trial (ZEST). ABS 31610. ASCO. 2009.

(4) Ferlay, J. et al. GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5. version 2.0. Lyon: IARC Press, 2004.

(5) Ginsberg RJ. et al. Cancer: Principles and Practices of Oncology. 5th ed; 858-911. 1997. 6th ed. 925-983. 2001.

(6) Bepler G. Lung cancer epidemiology and genetics. J Thorac Imaging 1999; 14(4):228-234.

SOURCE AstraZeneca Pharmaceuticals
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Video: Data on More Than 15 Novartis Oncology Compounds at ASCO Highlight Progress Toward Targeted Therapies for Diverse Tumor Types
2. Video: UCB Launches Vimpat(R) in the U.S. for Add-On Treatment of Epilepsy in Adults
3. Video: Partnership Unites UCB with Consumer Product Innovator OXO(R)
4. Video: ev3 Inc. Announces First Patient Enrollments in DEFINITIVE LE Post-Market Study
5. Video: Afinitor(R) Approved in US as First Treatment for Patients With Advanced Kidney Cancer After Failure of Either Sunitinib or Sorafenib
6. Video: Provectus PV-10 Interim Phase 2 Safety and Efficacy Results are as Good as or Better than Phase 1 Results
7. Video: Zometa(R) Reduces Risk of Breast Cancer Recurrence in Premenopausal Women, Study in The New England Journal of Medicine Reports
8. Video: Femara(R) First Aromatase Inhibitor to Indicate Survival Benefit Versus Tamoxifen When Taken for Five Years After Breast Cancer Surgery
9. Video: Tasigna(R) Demonstrates Rapid Response as Initial Therapy in Life-Threatening Form of Leukemia
10. Video: New Survey Finds Mothers See Influenza as a Serious Health Threat, but Often Dont Get Their Families Vaccinated
11. Video: Novartis Vaccines and PTA Battle Flu: Public Health Vaccination Initiative Urges Families Lets Fight Flu Together!
Post Your Comments:
(Date:4/27/2016)... 27, 2016 Transparency Market Research ... Market - Global Industry Analysis, Size, Share, Growth, Trends, ... the global skincare devices market was valued at US$ ... at a CAGR of 10.1% from 2015 to 2023 ... Browse the full Skincare Devices Market (Treatment Device - LED ...
(Date:4/27/2016)... 27, 2016  Bayer Animal Health today announced ... the University of Florida College of Veterinary Medicine, ... in Communication Award (BECA). Brittany was selected from ... a total of $70,000 in scholarship funds through ... Bayer has provided a total of $232,500 in ...
(Date:4/27/2016)... , April 27, 2016 ... ), a developer of a new generation of ... positive overall survival results for Paclical/Apealea in the ... 789 patients with epithelial ovarian cancer. These preliminary ... Paclical/Apealea in combination with carboplatin versus Taxol in ...
Breaking Medicine Technology:
(Date:4/29/2016)... San Francisco, CA (PRWEB) , ... April 29, ... ... recently released fertility clinic data for 2014. Each year, reproductive endocrinologists are required ... CDC and SART, the main organization of professionals dedicated to the practice of ...
(Date:4/29/2016)... Los Angeles, California (PRWEB) , ... April 29, 2016 , ... ... all across USA, 1Heart Caregiver Services continues its successful franchise development and expansion as ... Ferdie has an extensive managerial and administrative experience in his 32 years of working ...
(Date:4/28/2016)... ... April 28, 2016 , ... The ... announced it has signed a letter of intent with Moda to ... Insurance Company (NORDIC). , Started by dentists 36 years ago, TDIC focuses exclusively ...
(Date:4/28/2016)... ... April 28, 2016 , ... CastCoverz!, America’s ... with AquaShieldUSA, the country's oldest waterproof cast protector . As the largest ... the largest selection of daily, night, weatherproof and waterproof covers for most orthopedic ...
(Date:4/28/2016)... (PRWEB) , ... April 28, 2016 , ... ... was among the organization’s most successful events, attracting medical professionals from around the ... and stimulating networking events. , Opening Ceremonies Sunday, April 17 included the introduction ...
Breaking Medicine News(10 mins):