Please Subscribe to get a daily link to Pat's blog via email

Subscribe!

Your privacy is important to us. We will never spam you and keep your personal data secure.

Categorized | Uncategorized

JOURNAL OF CLINICAL ONCOLOGY PUBLISHES DATA ON OVERALL SURVIVAL BENEFIT OF VELCADE® (BORTEZOMIB) FOR INJECTION IN PATIENTS WITH PREVIOUSLY UNTREATED MULTIPLE MYELOMA

Posted on May 01 2010 by Pat Killingsworth | 1,344 views

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.


About VISTA


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

4 Comments For This Post

  1. whiteandmissing Says:

    That’s great but what about quality of life while taking this standard of care. My quality has greatly diminished since diagnosis and transplant and with no current treatment I am still good for not even 50% of normal work and activities. There has to be other alternatives and I would personally like to see more experiences from others that highlight their overall health improvements while going through this short term condition know as multiple myeloma.

  2. Pat and Pattie Killingsworth Says:

    I understand! Most of these treatments were developed with killing myeloma cells in mind–not quality of life. I relate it to my difficulty maintaining muscle mass while using Revlimid. No one seems to care about that. Everyone uses words like "tolerate." It isn't yet about improving quality of life for long suffering patients. After all, no one anticipated mm patients living so long or using these meds over such an extended period of time. Even over the counter meds like Tylenol can be dangerous when used continually over long periods. My hope is, as time goes on, more thought will go into improving the long term side effects of using these drugs. I'm sorry you haven't bounced back after your transplant. I appreciate your reading and your great suggestion! I will try to note and document more alternatives and experiences from fellow patients, with an eye on improving our quality of life. Thank you! Pat

  3. Jerry Says:

    This study seems to be biased towards Velcade. The patients taking VcMP went 46 weeks and the patients taking MP only went 39 weeks. Why the difference. This affects the results. Not a good comparison. No mention of the quality of life. My wife is on this treatment plan of VcMP. She is in cycle 6. The blood marker for the myeloma cell is normal but she has significant peripheral neuropathy. It has gotten worse in the last 4 weeks. I find her crying due to the PN pain, but she is afraid if she stops the velcade the cancer will come back.

  4. Pat and Pattie Killingsworth Says:

    Jerry-
    The study may, indeed be biased. Afterall, like most drug studies, it was paid for by the maker, Millennium. I understand your wife's fear of letting go of the Velcade. Remind her that if the cancer comes back she can always resume treatment–and it should still work. If it doesn't, the new drug, carbilzomib, should be waiting on the other side and may also work–without the PN. Hopefully, as soon as she stops using the Velcade, her PN should improve. Get her off that stuff! Like so many other mm patients, she has responded well to novel therapy. No reason to believe other drugs may not work as well–without the PN.
    Good luck- Pat

Leave a Reply


Follow On Twitter!

Follow HelpWithMyeloma on Twitter

Archives