Millennium and Johnson & Johnson Pharmaceutical Research & Development Initiate Randomized Phase II Trial of VELCADE(R) (Bortezomib) for Injection in Non-Small Cell Lung Cancer
Monday March 6, 8:01 am ET
Building on positive single-agent activity, companies advance clinical development program
CAMBRIDGE, Mass., March 6 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced together with co-development partner Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (J&JPRD), the initiation of a three-arm, randomized, Phase II study of VELCADE and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have failed prior chemotherapy treatment. The study will assess the potentially additive benefits of combining the activity of two targeted therapies with different mechanisms of action. Also already underway is a two-arm, randomized, Phase II study of VELCADE in combination with erlotinib for patients with locally advanced or metastatic NSCLC and a study of single-agent VELCADE in relapsed bronchioalveolar carcinoma and adenocarcinoma of the lung. In newly diagnosed patients with NSCLC, a study to evaluate VELCADE in combination with other agents has recently been completed.
"Based on promising, single-agent response rates, we are moving forward with our clinical program to evaluate the benefits of VELCADE based regimens in treating non-small cell lung cancer," said David Schenkein, M.D., Senior Vice President, Clinical Development. "We hope to demonstrate that these approaches may offer additional efficacy and safety benefits and may help patients with this advanced disease."
The Phase II randomized, open-label, multi-center study will enroll approximately 135 patients. The primary endpoint is objective response rate (complete and partial response) as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Secondary endpoints of the study include disease control rates (complete response, partial response and stable disease), time to progression, progression-free survival and safety. Patients will be assigned to one of three treatment groups: VELCADE in combination with pemetrexed, pemetrexed alone or VELCADE alone. VELCADE will be administered on a weekly schedule in both arms. The weekly dose of VELCADE in this study is 1.6 mg/m2 and pemetrexed will be administered at the standard registered dose of 500 mg/m2.
Previous clinical trial results of VELCADE in NSCLC include:
* Interim survival data from a Phase II study of VELCADE in combination with gemcitabine and carboplatin in newly diagnosed patients with NSCLC was recently provided by the Southwest Oncology Group. The analysis of the combination therapy showed a median five-month, progression-free survival and a median 11-month overall survival. The side effects observed in this trial were manageable and similar to those seen in other trials of VELCADE including gastrointestinal events, hematologic events, fatigue and peripheral neuropathy.
* Final data from the single-agent arm of a multi-center, Phase II trial of VELCADE in second-line NSCLC was presented in May 2005 at the 41st Annual Meeting of the American Society of Clinical Oncology. Data from the trial of VELCADE as a single agent showed a median survival of 7.4 months and a one-year survival of 39 percent. The most common adverse events in this trial were gastrointestinal events, fatigue and peripheral neuropathy.
About Non-Small Cell Lung Cancer
According to the American Cancer Society, lung cancer is the leading cause of cancer death among both men and women in the United States. Approximately 163,500 deaths will be attributed to lung cancer and 172,570 new cases will be diagnosed in 2005. Of those, 87 percent will be NSCLC. There are three sub- types of NSCLC, including squamous cell carcinoma, adenocarcinoma, and large- cell undifferentiated carcinoma. The five-year survival rate for all stages of NSCLC combined is 15 percent. If NSCLC is diagnosed and treated early with surgery before spreading to the lymph nodes or other organs, the average five- year survival rate improves to 50 percent. However, it is estimated that only 15 percent of people with lung cancer are diagnosed at an early stage.(1) |
