Evolving Treatment Strategies in Multiple Myeloma: Janssen's Darzalex Leads a Host of Novel Agents in Redefining Treatment Strategies and Approaches
EXTON, Pa., June 7, 2018 /PRNewswire/ -- Multiple classes of agents with distinct mechanisms of action are creating new treatment options with more favorable toxicity profiles and improved efficacy and outcomes of combination therapy with existing backbone agents. Based on the recently completed research conducted by Spherix Global Insights with 107 US hematology-oncology specialists, the availability of such a wide range of new classes of agents and a developing use of genomic profiles presents both a great opportunity and a great challenge for providers: how to identify the optimal use of novel therapies to maximize survival while balancing the patient's quality of life desires and financial concerns associated with the continued trend in triplet (and even quad) treatment regimens.
In 2015, the multiple myeloma (MM) market exploded with the approval of Novartis' Farydak (panobinostat), Takeda 's Ninlaro (ixazomib), BMS's Empliciti (elotuzumab), and Janssen's Darzalex (daratumumab). Among these relatively recent approvals, surveyed physicians appear to be enchanted with Darzalex, which rivals Celgene's backbone MM treatment, Revlimid (lenolidomide) in satisfaction and value perception. Virtually all of the survey respondents report use of Darzalex, with a large majority preferring to introduce it earlier in the disease course (e.g. first relapse). With its new indication in combo with Velcade-melphalan-dexamethasone (a quad regimen) for the treatment of newly diagnosed MM patients ineligible for autologous stem cell transplant (SCT) and ongoing trials looking at new combinations with immunotherapy and use in pre-symptomatic MM, it appears that Darzalex is well-poised for continued growth. Indeed, more than half of the respondents anticipate increasing their use of the brand in the next three months.
There is less enthusiasm for other MM treatments, all of which were rated significantly lower than Darzalex on the all-important efficacy parameters (improvement in overall survival, overall relapse rate, and progression free survival). Amgen's Kyprolis rates somewhere between Darzalex and the other newly introduced agents - outperforming Farydak, Ninlaro, and Empliciti on efficacy parameters but significantly trailing Darzalex.
Amgen may have additional facetime and leverage in the MM space however, as they promote the expanded label for Xgeva (denosumab) to prevent fracture, spinal cord compression, or the need for radiation or surgery to bone in patients with multiple myeloma. While market access issues are placing some pressure on Xgeva, the surveyed respondents project significant gains for Xgeva in MM patients in the next three months, with emphasis in patients with renal insufficiency and lytic bone lesions.
In the near term, growth of nearly all brands can be expected, as a move to combination therapy earlier in the treatment course continues, but the most favorable growth is expected for Darzalex. Slightly further out, a robust MM pipeline exists, including products currently available for other indications (such as BMS' Opdivo and AbbVie/Genentech's Venclexta) as well as novel new MOAs such as Karyopharm Therapeutic's selinexor and Sanofi-Genyzme's isatuximab. Familiarity is highest for products already commercially available, but more than one-third of the survey respondents selected selinexor as one of the top two agents in the pipeline that would have the greatest impact on the MM marketplace.
The next survey, with scheduled fielding in June, will continue to track key metrics and brand/company performance in this market, including the multiple variables influencing choice, composition, sequencing, and duration of current therapies. Further exploration into the evolving role of stem cell transplant (SCT), the impact of economics upon therapeutic selection, and the current and future implications of minimal residual disease (MRD) as a surrogate marker and clinical endpoint will be newly introduced topics. Lastly, the survey will solicit feedback from those who attended ASCO on notable new and compelling data and how it will influence practice patterns.
The RealTime Dynamix™: Multiple Myeloma (US) series provides a detailed and timely look at current and future trends in the MM market and the impact to leading brands related to the rapidly evolving landscape. The independent study features quarterly releases, allowing for close monitoring and trending of key performance metrics.
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