Company-sponsored trial in patients with either brochioloalveolar carcinoma (BAC) or adenocarcinoma with BAC features reinforces commitment to strategic development --
CAMBRIDGE, Mass., April 25 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc. (Nasdaq: MLNM - News) today announced, in collaboration with Johnson & Johnson Pharmaceutical Research & Development, LLC, the initiation of PEAK (Prospective Evaluation of bortezomib in Adenocarcinoma with bronchioalveolar features as a Keystone of therapy). This is a multicenter phase II clinical trial of VELCADE in patients with either advanced BAC or adenocarcinoma with BAC features that have progressed on or after receiving one to two lines of chemotherapy, one of which must have been an epidermal growth factor receptor tyrosine kinase inhibitor (EGRF TKI). The open-label study will assess efficacy in terms of tumor response rate measured by Response Evaluation Criteria in Solid Tumors (RECIST) guidelines.
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"Millennium, and our partner Johnson and Johnson, are committed to investigating VELCADE as a therapy for lung cancer and this trial is an integral component of our global development plan," said David Schenkein, M.D., senior vice president, clinical research, Millennium. "In reviewing previous VELCADE experiences, we saw several dramatic single-agent responses in patients with BAC and we are eager to explore the potential of VELCADE so that we may be able to offer new options for patients in need."
VELCADE is approved in the U.S. for the treatment of patients who have received at least one prior therapy. Millennium and Johnson & Johnson continue to investigate VELCADE globally in phase I, II and III clinical trials in both hematologic and solid tumors, including frontline MM, non-Hodgkin's lymphoma and lung, prostate and ovarian cancers.
About BAC
Patients with BAC or adenocarcinoma with BAC features comprise a 30,000- patient group representing approximately 20% of the overall non-small cell lung population. These patients tend to have a unique histology and have typically responded poorly to cytotoxic drugs used for non-small cell lung cancer. Data suggest that the incidence of BAC is increasing, notably in younger non-smoking women. Despite reports of prolonged survival, BAC remains incurable with the vast majority of patients dying of respiratory failure or pneumonia within five years of diagnosis.
About VELCADE® (bortezomib) for Injection
VELCADE is indicated for the treatment of multiple myeloma patients who have received at least one prior therapy. VELCADE is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol.
Risks associated with VELCADE therapy include new or worsening peripheral neuropathy, hypotension, cardiac disorders, gastrointestinal adverse events, thrombocytopenia and tumor lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with VELCADE.
In 331 patients who were treated with VELCADE 1.3 mg/m2 dose in the phase III APEX study, the most commonly reported adverse events were asthenic conditions (61%), diarrhea (57%), nausea (57%), constipation (42%), peripheral neuropathy (36%), vomiting (35%), pyrexia (35%), thrombocytopenia (35%), psychiatric disorders (35%) and anorexia and appetite decreased (34%). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4%), neutropenia (2%) and hypercalcemia (2%). A total of 144 patients on VELCADE (44%) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6%), diarrhea (5%), dyspnea and pneumonia (4%) and vomiting (3%).
VELCADE is being co-developed by Millennium and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of VELCADE in the U.S.; Ortho Biotech and Janssen-Cilag are responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for Japan. VELCADE is approved in more than 40 countries worldwide including the U.S., European Union members, and a number of countries within Latin America and South-East Asia such as Argentina, China, Korea, Singapore and Thailand. |
