Avastin Gives an Additional Four Months of Life to Patients with One of the Most Common Types of Lung Cancer
Phase III trial shows patients with advanced adenocarcinoma of the lung have a 45% better chance of survival with Avastin
BASEL, Switzerland, 13 November 2008--Roche announced today that an exploratory analysis of the pivotal phase III E4599 study demonstrated that Avastin (bevacizumab) in combination with paclitaxel and carboplatin chemotherapy led to an increase in overall survival of 4 months over chemotherapy alone in patients with advanced adenocarcinoma, the most common form of non-small cell lung cancer (NSCLC). Avastin gives these patients a 45% better chance of survival compared to chemotherapy alone.
The E4599 study previously reported a significant increase in median overall survival in advanced NSCLC and was the first time a treatment was proven to extend overall survival beyond one year in these difficult to treat patients. This new analysis looked at different histologic sub-groups of non-squamous NSCLC patients and assessed the benefits seen with Avastin. The analysis demonstrated that patients with adenocarcinoma achieved a median overall survival of 14.2 months when treated with an Avastin-based therapy compared to 10.3 months seen with chemotherapy alone.
This is the first time a benefit of this magnitude, an overall survival beyond 14 months, has been reported in patients with adenocarcinoma.
“Earlier results from E4599 showed that bevacizumab in combination with chemotherapy significantly increased overall survival in patients with non-squamous non-small cell lung cancer,” said Alan Sandler, Associate Professor of Medicine, Medical Director and Thoracic Oncology Director at Vanderbilt-Ingram Cancer Centre and lead investigator of the E4599 study. “This additional analysis further defines the magnitude of benefit for patients with the most common type of NSCLC, adenocarcinoma.”
Data from the E4599 and AVAiL studies formed the basis of Avastin’s European approval in lung cancer in August 2007. Avastin-based treatment is proven to help patients with advanced lung cancer live longer than ever before and also increase the time patients live without their cancer getting worse (progression-free survival). The majority of patients (79%) with non-squamous NSCLC are eligible for Avastin-based therapy.1 Safety of Avastin in advanced NSCLC has been confirmed in data from these two phase III trials and show that Avastin-specific side effects are limited and manageable compared to those of chemotherapy. 2,3
The results of the randomised, controlled, multicentre phase III E4599 study of 878 patients with locally advanced, metastatic or recurrent NSCLC, with histology other than predominant squamous cell, show that median survival of patients treated with Avastin at a dose of 15 mg/kg every three weeks plus paclitaxel and carboplatin chemotherapy was 12.3 months, compared to 10.3 months for patients treated with chemotherapy alone. Patients receiving Avastin in combination with paclitaxel and carboplatin had a 25% improvement in overall survival compared to patients who received chemotherapy alone. An analysis of patients with the most common type of NSCLC, adenocarcinoma showed that the benefit was of even greater magnitude in this particular sub-group of patients – 14.2 months of overall survival when Avastin was used in conjunction with chemotherapy versus 10.3 months in patients who received chemotherapy alone. In the E4599 study, adenocarcinoma patients represented 69% of the total study group. The majority (approx 79%) of non-squamous NSCLC patients are eligible for Avastin-based therapy.1 The safety profile of Avastin in combination with chemotherapy reported in this trial was consistent with that reported in other clinical trials in other solid tumours. The most common adverse events associated with Avastin therapy were: hypertension (5.6%), proteinuria (4.2%), fatigue (5.1%) and dyspnoea (5.6%).2 Pulmonary haemorrhage/ haemoptysis cases (grade 3-5) have been observed in up to 2.3% of the patients treated with Avastin plus chemotherapy as compared with < 1% with chemotherapy alone.
About Lung Cancer
Lung cancer is the single biggest cancer killer in Europe, claiming 334,800 lives in 2006. Unfortunately, the majority of NSCLC cases are still diagnosed at an advanced stage when the cancer is inoperable or has already spread to another part of the body. In spite of the use of chemotherapy as the first-line treatment option, less than five percent of people with advanced NSCLC survive for five years after diagnosis and most die within twelve months.
1. Market Research – Synovate Cancer Therapy Monitor, Top 5 EU (MAT Q4 2006)
2. Sandler A, et al. Paclitaxel-Carboplatin Alone or with Bevacizumab for Non-Small-Cell Lung Cancer. N Engl J Med. 2006:355; 2542-50
3. Manegold, C et al. BO17704 (AVAIL): A phase III randomised study of first-line bevacizumab combined with cisplatin/gemcitabine (CG) in patients with advanced or recurrent non-squamous, non-small cell lung cancer (NSCLC). ESMO 2008
Posted: November 2008