Millennium Pharmaceuticals, Inc. 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 favourably 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 was reported at the American Society of Clinical Oncology (ASCO) 42nd Annual Meeting in Atlanta.

"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."

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-naïve 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 Tumours) guidelines. Median follow up was 13 months.

Key findings include: Median overall survival of 11 months; One-year survival of 47 per cent with five-month progression-free survival; Overall response rate of 20 per cent; stable disease of 66 per cent; Therapy well tolerated. The most common haematological toxicities were neutropenia and thrombocytopenia and the most common non-haematological adverse events were fatigue and gastrointestinal events.

NSCLC accounts for about 85 per cent of all lung cancer cases with an estimated prevalence of more than 170,000 new cases per year. Drug choices are limited while resistance to standard treatments is common. Nearly 60 per cent of those diagnosed with advanced lung cancer die within one year of diagnosis and only 15 per cent of patients diagnosed with all stages of lung cancer survive after five years with the disease.

"This study highlights the potential survival benefit of Velcade in solid tumours beyond haematological 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.

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 174,470 new cases will be diagnosed in 2006. Of those, 87 per cent will be NSCLC cases. 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 60 per cent. However, it is estimated that only 15 percent of people with lung cancer are diagnosed at an early stage.

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. Velcade should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.

Risks associated with Velcade therapy include new or worsening peripheral neuropathy, hypotension observed throughout therapy, cardiac and pulmonary disorders, gastrointestinal adverse events, thrombocytopenia, neutropenia and tumour lysis syndrome. Women of childbearing potential should avoid becoming pregnant while being treated with Velcade.

In 331 patients who were treated with Velcade in a phase III multiple myeloma study, the most commonly reported adverse events were asthenic conditions (61 per cent), diarrhoea (57 per cent), nausea (57 per cent), constipation (42 per cent), peripheral neuropathy (36 per cent), vomiting (35 per cent), pyrexia (35 per cent), thrombocytopenia (35 per cent), psychiatric disorders (35 per cent), anorexia and appetite decrease (34 per cent), parasthesia (27 per cent), dysesthesia (27 per cent), anaemia and headache (26 per cent), and cough (21 per cent). Fourteen percent of patients reported at least one episode of grade 4 toxicity; the most common grade 4 toxicities were thrombocytopenia (4 per cent), neutropenia (2 per cent), and hypercalcemia (2 per cent). A total of 144 patients on Velcade (44 per cent) reported serious adverse events (SAEs) during the study. The most commonly reported SAEs were pyrexia (6 per cent), diarrhoea (5 per cent), dyspnoea, pneumonia (4 per cent), and vomiting (3 per cent).

Velcade is being co-developed by Millennium Pharmaceuticals, Inc. and Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Millennium is responsible for commercialization of Velcade in the US; Janssen-Cilag is responsible for commercialization in Europe and the rest of the world. Janssen Pharmaceutical K.K. is responsible for commercialization in Japan. Velcade is approved in more than 65 countries worldwide. Velcade is also approved in the European Union as a treatment at first relapse.