I need to be honest with you. I am underwhelmed by multiple myeloma related news coming out of Chicago this week ahead of the American Society of Oncology (ASCO) meetings Friday.
Most years my inbox would be flooded with press releases, touting when and where results from any number of different myeloma related studies can be found. There would be hints and teases about things to come.
This year, almost nothing!
There are several reasons for this. First, Celgene, one of the top two anti-myeloma drug companies, needed to release some of their most important trial data early.
WHY? Why would Celgene release key maintenance data involving Revlimid two weeks before their data is presented at ASCO
In my opinion, it was to blunt negative publicity associated with the FDA’s decision that Celgene needed to include a secondary cancer warning on their Revlimid label.
So like any major corporation, the best way to combat negative news is with other, more positive news.
Here is a copy of the press release that Celgene officials sent me on May 1oth:
NEW ENGLAND JOURNAL OF MEDICINE REPORTS ON THREE PHASE III REVLIMID® (LENALIDOMIDE) TRIALS IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
Consistent progression-free survival improvement shown with continuous lenalidomide therapy in elderly patients not eligible for transplant and as maintenance therapy in patients following autologous stem cell transplant
BOUDRY, Switzerland – (May 9, 2012) – Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that results from three phase III studies evaluating the use of continuous REVLIMID® (lenalidomide) treatment in newly diagnosed multiple myeloma (MM) patients or maintenance treatment with lenalidomide following autologous stem cell transplant were published online in the May 10, 2012 edition of the New England Journal of Medicine. All three publications highlight the expanding body of clinical evidence supporting lenalidomide treatment in these areas.
Continuous Lenalidomide Therapy (non-transplant eligible population):
The first article highlights a Celgene-sponsored study of continuous lenalidomide treatment in elderly patients newly diagnosed with multiple myeloma.
Continuous Lenalidomide Treatment for Newly Diagnosed Multiple Myeloma (MM-015)
This double-blind, phase III, multicenter, randomized study conducted by Celgene compared melphalan–prednisone–
The two additional articles published in the edition highlighted cooperative group studies that evaluated the use of lenalidomide maintenance following autologous stem cell transplant (ASCT).
In each of the studies, one funded by the National Cancer Institute and conducted by the Cancer and Leukemia Group B (CALGB) and one by the Intergroupe Francophone du Myelome (IFM), maintenance treatment with lenalidomide following ASCT resulted in delayed time to disease progression or death compared to placebo.
Lenalidomide after Stem-Cell Transplantation for Multiple Myeloma (CALGB 100104)
The phase III CALGB study assessed 460 newly-diagnosed patients who received either lenalidomide or placebo following ASCT until disease progression.
Lenalidomide Maintenance after Stem-Cell Transplantation for Multiple Myeloma
IFM 2005-02 is a phase III, placebo-controlled trial investigating the efficacy of lenalidomide maintenance after transplantation in 614 myeloma patients.
REVLIMID® is not approved for use in newly diagnosed multiple myeloma.
REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.
REVLIMID is also approved in theUnited States,Canada,Switzerland,
Since 1998, Celgene continues to be a pioneer in creating environments in which patients can benefit from our disease-altering therapies safely. As a result, hundreds of thousands of patients worldwide have accessed the clinical benefits of our therapies through our performance-based risk management programs including, S.T.E.P.S.®, RevAssist® and RevMate®, which form the foundation of our commitment to patient safety.
U.S. Regulatory Information for Revlimid
REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of multiple myeloma (MM) patients who have received at least one prior therapy.
REVLIMID® (lenalidomide) is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1–risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
That’s a lot to digest! Instead of plowing-through all of that, click-on the headline link below to access a post I did about this on MyelomaNews.com last week, which includes access to an excellent summary of these three maintenance trials in Science Daily:
You do know that you can follow research related multiple myeloma, amyloidosis and MDS news on MyelomaNews.com, right?
The bottom line is this: I’m not sure that the FDA’s pronouncement was all that bad–or that any of the three maintenance study results were all that good. Nothing unexpected. No game changers here.
Yes, Revlimid maintenance extends progression free survival (PFS) by nearly two years among a majority of post transplant patients. This would be bigger news if it also extended patient’s lives (OS) just as long. But alas, the OS numbers barely crept-up.
And the secondary cancer issue? What choice do we have? Like my melanoma, if a myeloma patients develops a secondary cancer, we will have to deal with it. At least our blood counts and overall health is being monitored constantly–so any additional cancers should be caught early.
There will be some other Celgene related news at ASCO. Revlimid is on the way to finally gaining FDA approval for use in newly diagnosed patients, even though it has been used that way off-label for over five years. And pomalidomide may get preliminary approval for use in relapsed/refractory patients by year’s end.
Meanwhile, my good friends at Millennium continue to do back flips over MLN9708, their new, oral proteasome inhibitor. And I would personally like to see more data about when and how much Velcade a relapsed patient (like me!) should use as maintenance.
Onyx (Carfilzomib) is holding a number of sessions. But they don’t seem to by hyping them as much as they have prior to other meetings. Maybe they don’t want to jinx their second opportunity to obtain the FDA’s favor in July.
Patrys’ new U.S. patent covering its lead product, PAT-SM6, has piqued lots of interest. PAT SM6 is an anti-tumor antibody that has shown promise as a potential treatment for several different types of cancer, including multiple myeloma.
Maybe no news is good news? Let’s hope the eerie quiet I sense in my empty email inbox means nothing is going wrong with ongoing studies for a number of different therapies. It’s that, or I’m being forced to remember how slow myeloma research moves in real time–at least for a patient living day by day on accelerated myeloma time!
I will be posting two or more times a day with news from ASCO starting Friday. And don’t forget to follow multiple posts and links back to relevant myeloma research on MyelomaNews.com as well.
Time to pack! I always prepare to leave for ASH and ASCO feeling such a sense of hope and anticipation…
Feel good and keep smiling! Pat