After a hectic 2018, early indications are that changes and challenges may face us in 2019. On the same day we learned that Celgene, the dominant pharmaceutical company in the myeloma field for over two decades, will be bought by Bristol-Myers Squibb (BMS), the price of Celgene’s myeloma drug, Revlimid, was increased yet again. The future landscape in the myeloma space will emerge in the coming months as the takeover by BMS is finalized in the third quarter of 2019.
The very good news is that the commitment to myeloma research and new drug development is at an all-time high around the world. But the challenges of high drug costs and global access remain. It will require all the tools of resilience to handle these and broader concerns for myeloma patients everywhere.
What is resilience?
In a previous blog, I introduced the concept of resilience. Additional studies indicate that everyone’s ability to deal with stress is partly “hardwired” from birth, but can definitely be improved using positive strategies to focus on ideal outcomes. So, when change occurs, and challenges come out of left field, resilience is the ability to calmly recalibrate your personal navigation systems and chart a new way forward. Easier said than done – but it is becoming the name of the game!
Early 2019 news
The early news this year is a mixture of good and bad:
- New therapies Let’s start with the good news that several important new therapies will be moving forward towards FDA approval. There should be word about selinexor within the next two to three months. Other agents, such as venetoclax, melflufen plus BiTEs (bispecific T-cell engagers), and CAR T-therapies, will continue in trials in 2019. Exciting trials with approved agents will also continue – such as the ASCENT trial in high-risk smoldering multiple myeloma (HR SMM), in which Kyprolis + Revlimid + dexamethasone + Darzalex is already producing deep responses.
The disconcerting news is that there is no new plan to make all these new therapies truly affordable. With costs that exceed the mortgage on the most luxurious home, you can imagine any solution will certainly be elusive this year.
But one piece of good news is that a team of myeloma specialists (including myself) seeking approval for minimal residual disease (MRD) as an endpoint in myeloma met with the U.S. Food and Drug Administration (FDA) on December 11, 2018, and has clear plans to submit data for potential approval in 2019. This means that clinical trials can be much shorter and cheaper using undetected MRD (“MRD negative”) as an early indicator of treatment benefit with new treatments or combinations.
- What to eat The good news is that for 2019, the Mediterranean Diet has won gold as the top-ranked diet by U.S. News & World Report! This is something I have been recommending for several years – the diet eaten in healthy, so-called Blue Zones, where residents have an increased likelihood of living to over 100 years old. (See my previous blogs for more details: “Investing in health is the best way to achieve longevity,”
The not-so-good news is that consumers in the U.S. need to select foods with caution since (because of bad health consequences) are NOT banned here. The food additives and various drugs that are of concern include potassium bromate and azodicarbonamide (ADA) (found in baked goods, such as American-made bread, cookies, buns and pizzas). These are possible cancer-causing agents, as are the flavor enhancers and preservatives butylated hydroxyanisole (BHA) and butylated hydroxytoluene (BHT), used widely in American food products. Brominated vegetable oil (BVO) and dyes (yellow dyes #5 and #6; red dye #40) can cause a variety of medical problems.
This is one area where resilience comes into play. Be informed, stick with the “Real Food” which is a key part of the Mediterranean diet!
What causes myeloma?
An ongoing development in 2019 is the IMF-supported iStopMM project in Iceland. An important part of iStopMM is to determine which patients in Iceland are developing MGUS (monoclonal gammopathy of undetermined significance), SMM (smoldering multiple myeloma), and MM (multiple myeloma), and why. The expectation is that multiple factors are involved, including age (likelihood increases with age), diet (Mediterranean-type diet is beneficial), and potential exposures to infectious agents or toxins of types to be assessed/determined. It is truly exciting to see the start of this exploratory process.
On the negative side, the activities of the U.S. Environmental Protection Agency (EPA) continue to be very distressing. A recent report indicates a rollback of mercury emissions restrictions from coal-burning power plants. Cumulative emissions and toxic leaks of various types are well known to impact the health of everyone through both air and water pollution. Again, personal resilience is needed to be aware and protect yourself and family members to the extent possible.
Another turbulent year is off and running. With so much positive happening, it is important to be alert for the best opportunities and avoid potential negatives along the way. Resilience will definitely be an asset worth cultivating for all!
Dr. Brian G.M. Durie serves as Chairman of the International Myeloma Foundation and serves on its Scientific Advisory Board. Additionally, he is Chairman of the IMF's International Myeloma Working Group, a consortium of nearly 200 myeloma experts from around the world. Dr. Durie also leads the IMF’s Black Swan Research Initiative®.