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As new scientific advancements occur at the genetic and protein levels, more strategies have been developed to identify and combat multiple myeloma.
Major advances have occurred over the past two decades in treating multiple myeloma, and these advances are progressing rapidly today, says Gerry Messerschmidt, MD, FACP, chief medical officer of Precision Oncology. Many innovative strategies and combinations of approved and experimental therapies have a high likelihood of gaining approval and becoming standard use. “This means more therapy, more often, and thus, potential financial ramifications for payers of myeloma treatment,” Messerschmidt said.
As a clinical oncologist and an executive with a leading oncology development provider specializing in clinical trial execution, biomarker services, and analytics, Messerschmidt is tuned into the changes in the myeloma landscape.
Managed Healthcare Executive (MHE) recently spoke with Messerschmidt about new therapies on the radar, and how they could impact treatment.
MHE: What are healthcare executives’ major challenges in the area of multiple myeloma?
MesserschmidtMesserschmidt: The main challenge for healthcare executives is maintaining a working understanding of approved therapy and standard therapy versus experimental therapy. Today, proteasome inhibitors (PIs), immune modulators (IMiDs), and a steroid are standard and approved therapies, as are many chemotherapies. First-line therapy is usually 2 or 3 drugs and, if possible, many recommend autologous hematopoietic stem cell transplant, once or more than once. Transplants are neither approved by regulatory agencies nor reviewed; however, one transplant is clear standard therapy in many institutions and more than one is often standard in select institutions. Data support both positions.
Many newer drugs are also in development to treat multiple myeloma and will be arriving on the market this year and over the next several years. Maintaining a working knowledge of these products and their pros and cons compared with other drugs requires examining information from the drug developer, the literature and the providers.
The healthcare executive must rely on hematologists and pharmacists to review, discuss, and recommend the drugs and procedures for newly diagnosed multiple myeloma through last therapy. All will need to recognize that an algorithm designed today could be outdated in several months. Rapid additions of new therapies and clinical data measuring interventions will continually occur over the next decade.
MHE: How can these challenges be met or avoided?
Messerschmidt: Decisions to incorporate therapies into a standard treatment design can be based on the literature, experiencing meeting presentations by experts, FDA approval, and other data reviews available. However, direct experience by the site with these new drugs and procedures can also provide physicians, pharmacists, and healthcare specialists with invaluable experience. Participating in many clinical trials allows hospitals and clinics to understand these new therapies more closely and assess based on prior experience.
This often occurs in private practice groups by actually using a newly approved drug on several appropriate patients and assessing the efficacy and toxicity with their patients. This is not possible in many treatment situations where only formulary or approved and paid-for cancer products are available.
Clinical trials often provide cancer patients with new, cutting-edge therapies while offering healthcare experts the firsthand experience that can expedite data review and formulary selection when approved.
MHE: What are some promising developments in multiple myeloma?
Messerschmidt: Multiple myeloma has been demonstrated to clonal progress with time and each clone can have new, varied and more difficult-to-treat genetic mutations. Thus, first-line therapy with intensive anti–multiple myeloma therapy is the proposed method of new therapy integration as the data evolve. On April 6, 2017, the NEJM (Attal et al, 376(14):1311-20) published a 700 multiple myeloma patient trial of three-drug induction therapy plus transplantation demonstrating a significantly higher complete remission rate (59% versus 48%, p=0.03) and an increase of 35% [1 year and 2 months] in time to relapse of myeloma (longer progression free survival of 50 months versus 36 months Hazard ratio 0.65; p<0.001) versus the 3-drug regimen without transplantation. More effective early combination therapies are anticipated to increase over the next 5 to 10 years, with the goal of prolonging survival.
Therapies approved for use at time of relapse of multiple myeloma are anticipated to help patients prolong time between start of therapy and subsequent resistance and may also prolong some survival measures. However, this population can be anticipated to have more clonal mutations and thus require even more intensive multi-modality/drug therapy and may not have as much benefit as those treated intensively up front. Drug developers can be expected, if their products are demonstrated beneficial in second- or subsequent-line therapy, addition to first line clinical trials will rapidly follow increasing the number of drugs in combination first line.
In parallel, new precision measures are being developed to make individualized treatment decisions for patients. This precision medicine or precision oncology approach is moving rapidly to find abnormalities in patients that can suggest specific targeted therapies and more careful selection of appropriate treatment for patients. Payers need to have the medical knowledge that measuring individual patient abnormalities in genomics, proteomics and antigens will soon be used to prescribe combinations of therapies. These biopsy and blood (liquid biopsy) results are expected to advise the oncology of the specific abnormalities in that specific patient and then choses specific and non-specific known effective therapies for that individual. This is precision oncology and is rapidly progressing in the treatment of myeloma and other malignant diseases.
As new scientific advancements occur at the genetic and protein levels, more strategies have been developed to identify and combat multiple myeloma. Today, these range from new PIs and IMiDs to specifically targeted small molecules that target abnormal functions within the myeloma cells, such as metabolic and internal systems-specifically, targeted anti-myeloma vaccines, other immune therapies, and CAR-T cells targeted to myeloma.
Today, triple therapy initially, followed by transplant, is very standard and common, which is followed by maintenance therapy. It is certainly possible that many of the experimental therapies mentioned above could be commonly used in addition to today’s triplet therapies up front, during transplant, or as maintenance, second-, third-line, and so on. Therapies will also increase in number, most likely extending life and, hopefully, quality of life for these patients as well.