Addition of VELCADE(R) (Bortezomib) for Injection Improved survival in Front-Line Advanced Lung Cancer
-- 11-month Survival Compared to 9-Month Historic Results with a Standard of Care --
ATLANTA, June 4 /PRNewswire-FirstCall/ -- Millennium Pharmaceuticals, Inc.
(Nasdaq: MLNM) today announced the final results from a Phase II study
conducted by the Southwest Oncology Group (SWOG) that showed a median survival
of 11 months for patients with non-small cell lung cancer (NSCLC) treated with
a VELCADE based regimen. This compared favorably to the historic 9-month
survival seen in past SWOG studies with a 2-drug platin-based regimen, a
current standard of care, in patients with non-small cell lung cancer (NSCLC).
These data were reported at the American Society of Clinical Oncology (ASCO)
42nd Annual Meeting in Atlanta, June 2-6, 2006.
"These survival results are among the best our group has seen in this
newly diagnosed patient population," said Angela Davies, M.D., Assistant
Professor, University of California Davis Cancer Center. "Given the current
lack of options for treating lung cancer, we look forward to additional
studies which may support the use of bortezomib."
VELCADE in Combination in Advanced NSCLC: A SWOG Phase II Trial (Abstract
7017)
The Phase II single-arm, multi-institutional study led by Dr. Davies
assessed the safety and efficacy of VELCADE in combination with gemcitabine
(GEM) and carboplatin (CARBO) in 114 chemo-naive patients with stage IV and
selected stage IIIB NSCLC. Patients received GEM 1000 mg/m2 days 1 and 8, and
CARBO AUC 5 on day 1, followed one hour later by VELCADE 1.0mg/m2 days 1, 4, 8
and 11. Patients without disease progression after four cycles were able to
continue with VELCADE alone. Response rate was measured using the RECIST
(Response Evaluation Criteria in Solid Tumors) guidelines. Median follow up
was 13 months. Key findings include:
-- Median overall survival of 11 months
-- One-year survival of 47 percent with five-month progression-free
survival
-- Overall response rate of 20 percent; stable disease of 66 percent
-- Therapy well tolerated. The most common hematological toxicities were
neutropenia and thrombocytopenia and the most common non-hematological
adverse events were fatigue and gastrointestinal events.
NSCLC accounts for about 85 percent of all lung cancer cases(1) with an
estimated prevalence of more than 170,000 new cases per year.(2) Drug choices
are limited while resistance to standard treatments is common. Nearly 60
percent of those diagnosed with advanced lung cancer die within one year of
diagnosis and only 15 percent of patients diagnosed with all stages of lung
cancer survive after five years with the disease.(2)
"This study highlights the potential survival benefit of VELCADE in solid
tumors beyond hematological cancers," said Robert Tepper, M.D., President,
Research & Development, Millennium. "It also aligns with our aggressive
strategy to pursue the benefits of VELCADE in lung cancer."
Based on these results and other positive response rates in ongoing
trials, Millennium and co-development partner Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. (J&JPRD) are moving forward with a clinical
program to evaluate the benefits of VELCADE based regimens in treating NSCLC.
The companies recently initiated two randomized Phase II studies of VELCADE,
one in combination with pemetrexed and the other in combination with
erlotinib, in patients with advanced or metastatic NSCLC who have failed prior
chemotherapy treatment.
About Non-Small Cell Lung Cancer
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