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Has bad timing left ASH irrelevant?

Home/News, Research/Has bad timing left ASH irrelevant?

Has bad timing left ASH irrelevant?

I’m almost packed. Tomorrow I’ll be driving three hours south to Orlando to attend my 7th American Society of Hematology (ASH) annual meeting. Seven years! How the multiple myeloma therapy landscape has changed. Heck, things have been turned upside down in three short weeks.

The Washington Post ran an impressive article about it on Wednesday:

For multiple myeloma community, a November to remember


Here’s an excerpt from Brady Dennis’ article, leading into a detailed interview with MMRF President, Walter Capone:

During a two-week span in November, the Food and Drug Administration approved three new drugs to treat multiple myeloma, a rare form of blood cancer that kills an estimated 11,000 Americans a year. The approvals, along with others in recent years, are beginning to alter the prognosis of a disease that once amounted to a death sentence for many patients.

Until last month, seven drugs had been approved for multiple myeloma, which causes malignant plasma cells to build up in bone marrow, where they crowd out healthy cells, hinder the body’s ability to fight infection, and lead to problems, such as tumors and kidney damage. Now there are 10 treatments available, some unlike any that have come before.

On Nov. 16, the FDA approved Darzalex, the first “monoclonal antibody” for multiple myeloma, which works by helping certain immune systems cells identify and attack cancer cells. Days later came an approval for Ninlaro, a “proteasome inhibitor” aimed at hindering the ability of cancer cells to grow and survive; it is taken as a once-a-week pill. Finally, on Nov. 30, came the approval of Empliciti, another drug intended to harness the body’s immune system to attack and kill malignant cells. Each of the drugs were approved for patients who already have tried other treatments, only to see their cancer persist.

The FDA granted Darzalex and Emplicitie its “breakthrough” designation, a process designed to expedite the development and review of drugs that demonstrate substantial improvement over existing therapies for serious conditions. All three of the new drugs received “priority review,” meaning the FDA evaluated them much faster in order to speed them to patients in need.
Despite the understandable excitement in the multiple myeloma community, the new drugs are not a panacea. As with many cancer treatments, some patients showed a dramatic response to the new therapies, but data showed many others did not. Even in those patients who did respond, the benefits were not necessarily indefinite. In addition, as with other promising treatments approved in recent years, the new myeloma drugs are expensive — in some cases, the cost exceeds $10,000 a month…

A “November to remember” is an understatement. Consider the magnitude of three new myeloma therapies all being approved in the same month; just weeks before what should be the year’s biggest multiple myeloma news event.

This all begs the question: Does a blockbuster November leave mean the ASH meetings are anticlimactic?

While it is true that much of the time focused on myeloma therapy will be spent justifying the approval of elotuzumab, daratumumab and ixazomib, these approvals doesn’t mean the myeloma research cupboard is bare. On the contrary, there is going to be data presented on a series of drugs and experimental compounds that I haven’t even heard of yet. Several are crossover drugs–drugs already FDA approved for use against other cancers that may work against myeloma, too.

JanssenFor example, Sunday I’m interviewing one of the head researchers responsible for bringing daratumumab to market. But there’s another angle here. Apparently the partnership between Janssen and Pharmacyclics has been successfully testing their lymphoma and leukemia drug, Imbruvica, in combination with Kyprolis. This is exciting on so many levels. One, the drug is already tested and approved, so side effects can be anticipated. Second, Imbruvica is an entirely different class of drug. It isn’t easy, but attacking myeloma through different pathways is something myeloma researchers strive for. Using an existing drug by combining it with another would save everyone a lot of time and money–and potentially help save lives.

There are a dozen ongoing projects like this one. And dozens more far out approaches being tested that might help, too.

A let down? Anticlimactic? Maybe to the untrained eye. I’m overwhelmed by the options.

Want to know my biggest concern? As more and more approaches bull their way forward, how are our doctors to know which ones to try and when?

Monday is often called “myeloma Monday” at ASH; that’s when the most myeloma related news breaks. As you follow news from ASH the next four or five days, try and read between the lines. I’m hoping one or more obscure drugs like Imbruvica end up being real difference makers in a year or two, not five years down the line.

I’m fatigued and a bit concerned about how well I’ll hold up this year. After all, its only been 45 days since Day Zero of my second transplant. But I’m pumped! So much to learn, old friends to see. Then I’m off to Iowa City for confirmation that our tandem approach worked as well as Dr. Tricot hopes. I’d better get packing.

Feel good and keep smiling! Pat