My good friend at Millennium, Manisha Pai, forwarded me this press release about the new VISTA/Velcade study results last evening:
— Front-line use of VELCADE with melphalan and prednisone improves clinical benefit compared to conventional treatment —
CAMBRIDGE, Mass., April 29, 2010 — Millennium: The Takeda Oncology Company today announced the publication of results from the 682-patient, randomized, international Phase III VISTA1 trial in the Journal of Clinical Oncology (JCO). The results continue to show an extension in the length of life for patients taking VELCADE, melphalan and prednisone (VcMP) in the front-line setting compared to MP alone.
The VISTA study is the largest Phase III registration trial in previously untreated multiple myeloma patients ineligible for stem cell transplantation. These data were the basis for the approval of VELCADE in the front-line setting in June 2008 and were subsequently published in the New England Journal of Medicine. The JCO article contains updated data from the VISTA trial presented at the 2009 Annual Meeting of the American Society of Hematology.
The published data showed a 35 percent reduced risk of death with VcMP versus MP alone (hazard ratio 0.65), demonstrating a significant survival benefit for patients in the VcMP arm.
Based on these updated positive trial results, the U.S. Food and Drug Administration (FDA) approved a supplemental new drug application (sNDA) for VELCADE in December 2009, expanding the label to include long-term Overall Survival (OS) data (at a median follow-up of 36.7 months). VELCADE remains the only front-line multiple myeloma treatment that has demonstrated this type of significant survival advantage for patients and that includes data supporting an OS advantage in its label across all lines of therapy.
“Prolonging the patient’s overall survival is the ultimate goal in multiple myeloma treatment,” said Maria-Victoria Mateos, M.D., Ph.D., Hospital Universitario de Salamanca, lead author of the study. “For the first time in the front-line setting, we have data from a long enough follow-up, confirming that VcMP results in a significantly longer overall survival than a standard of care, both overall and in patients who received subsequent therapy. This supports the addition of VELCADE to MP in the front line setting, rather than the use of MP followed by novel agents.”
“These data underscore the importance of using VELCADE upfront, as it provides a long-term improvement in overall survival,” said Nancy Simonian, M.D., Chief Medical Officer, Millennium.
Patients in the VcMP arm of the VISTA study received nine 6-week cycles of VELCADE at 1.3 mg/m2 (days 1, 4, 8, 11, 22, 25, 29 and 32 in cycles 1 through 4 and days 1, 8, 22 and 29 in cycles 5 through 9) with melphalan 9 mg/m2 and prednisone 60 mg/m2 (days 1 through 4 in cycles 1 through 9), or melphalan plus prednisone, in the same dose and schedule administered to the patients in the VcMP arm. Patients remained on VcMP therapy for a median of 46 weeks (eight cycles) out of the planned nine cycles versus 39 weeks (seven cycles) with melphalan and prednisone.
About Multiple Myeloma
Multiple myeloma is the second most common hematologic malignancy. In the U.S., more than 60,000 individuals have MM and 20,000 new cases are diagnosed each year. Worldwide there are approximately 74,000 new cases and over 45,000 deaths annually.
The international Phase III VISTA trial was conducted by Millennium and its co-development partner Johnson & Johnson Pharmaceutical Research & Development (JJPRD). The trial randomized 682 patients with newly diagnosed multiple myeloma, ineligible for stem cell transplantation, to receive either VELCADE, melphalan and prednisone (VcMP) or melphalan and prednisone (MP) alone. The primary end point of the trial was time-to-disease progression, with secondary endpoints including overall survival, progression-free survival, response rates, and safety.
No real surprises here. But this VISTA study is an important step toward confirming what we already know: that novel therapy agents like Velcade, Thalomid and Revlimid are extending the lives of many multiple myeloma patients by several years. Thanks, Manisha!
Feel good and keep smiling! Pat