What a year it has been for the myeloma community. The collaborative effort of the myeloma family was rewarded with four new drugs approved for multiple myeloma (MM) in 2015—three of them in November. My friend Dr. Jim Omel called it a November to Remember. Sponsored by the International Myeloma Foundation, 15 support group leaders attended the 57th American Society of Hematology conference and reported the news, provided patients’ points of view and opinions, and brought attention to the need to continue to push the envelope for research and development—all because the war is not yet won against myeloma. As Dr. Richardson explained, there were many paradigm-shifting things to report from the conference.
- There was consensus that a triplet that contains an immunomodulatory drug and a proteasome inhibitor should be the standard of care.
- While there was evidence that early transplant resulted in longer progression free survival, the overall survival was similar with that of a late transplant. Some investigators believe the choice, therefore, needs to be patient-preference-driven without compromising future treatability of the patient. What does that mean? Collect stems cells if the patient is a transplant candidate, and even for transplant ineligible patients, use the combination treatment of melphalan and prednisone (MP) with discretion. This is because patients are living longer, and more non- marrow-compromising agents are available today.
- With the approval of both Empliciti (elotuzumab) and Darzalex (daratumumab), the era of the antibodies is here to stay. Now comes the hard part, how do you translate the approval and success of the clinical trials to clinical practice?
- I loved the FDA ASH collaborative session during which Drs. Vincent Rajkumar and Paul Richardson outlined their points of view on how to position these drugs in the clinic for newly diagnosed, smoldering, relapsed, and refractory MM patients. Dr. Rajkumar pushed the envelope: he suggested that while OS may not be an easy clinical trial end point to target, colleagues and pharma companies should be challenged to go beyond progression free survival as an end point.
- It was also clear that more antibody drugs are primed for prime time and are making progress through various clinical trials.
- When there is no definitive data to be absolute in treatment, most multiple myeloma practitioners are now including patient preference in their clinical decision-making process.
- During the late-breaking abstract session on Tuesday morning, a National Cancer Institute investigator presented an early read-out of the results of a CAR-T cell therapy. Even though the follow-up was about 12 weeks, the results were very encouraging.
- Although there are as many new questions as there are answers, and the doctors urged each other and us to exercise judgment, they are driven by progress and choice enabled by the collaborative effort of the myeloma community—the myeloma family.
- Progress has been made with the investigation of minimum residual disease (MRD) to make it part of the prognosis and treatment analytics equation. Most interesting was the use of MRD testing in the blood, which both Drs. Palumbo and Paiva indicated will make MRD testing mainstream. Imaging, including PET-CT, should continue to be part of patient tests.
- 20 years post diagnosis, I am more hopeful than ever for the future of the myeloma family!!
Dr. Rafael Fonseca summarized the meeting as follows: