Spherix Global Insights

October 30, 2019

Janssen’s Darzalex Continues to Impress in Multiple Myeloma and New Indications Are Expected to Fuel Additional Growth

According to a recent survey conducted by Spherix Global Insights with 150 hematology-oncology specialists, the majority anticipate increasing their use of Darzalex as a result of the recent first-line approval of Darzalex/lenalidomide/dexamethasone (DRd) in transplant ineligible patients with multiple myeloma, and the group is largely optimistic about the potential approval of a subcutaneous formulation of the agent.

EXTON, Pa., / October 30, 2019 / PRNewswire – In late June 2019, Darzalex, in combination with lenalidomide and dexamethasone (DRd), was approved for the first-line treatment of patients with newly diagnosed multiple myeloma (MM) who are transplant ineligible. A few weeks later, Janssen submitted a BLA to the FDA for their subcutaneous formulation of Darzalex (Darzalex SC). In the most recent RealTime Dynamix™: Multiple Myeloma (US) report, Spherix explored the recent DRd approval and the potential launch of Darzalex SC to gain insights on the overall impact on Darzalex use by hematologists and oncologists (heme/oncs).

According to the report, the vast majority of heme/oncs were aware of the recent DRd approval, and as a result, most anticipate increasing their use of Darzalex. Among heme/oncs not planning to increase use of Darzalex, they cite satisfaction with current options and their preferred use of Darzalex as a subsequent therapy in patients with MM. Heme/oncs are also optimistic about Darzalex SC; nearly all respondents surveyed were moderately to highly familiar with the clinical studies supporting Janssen’s recent BLA submission, and almost three quarters anticipate increasing their use of Darzalex if the new formulation is approved.

Projections for Darzalex SC suggest that heme/oncs are more inclined to start Darzalex-naïve patients on the SC formulation, while over half of the heme/oncs would be willing to switch patients currently being treated with IV Darzalex to its SC formulation. The new formulation could give Janssen a competitive advantage over pending competitor, isatuximab, another CD38-directed antibody which is being developed by Sanofi-Genzyme. Isatuximab, with an expected approval date in early 2020, will be available only in the IV formulation.

Genzyme’s BLA was based on strong evidence from the Phase 3 ICARIA-MM trial which evaluated isatuximab in combination with pomalidomide and dexamethasone (IsaPd) versus Pd. Results of the trial demonstrated greater efficacy of IsaPd compared to Pd in patients with relapsed / refractory MM (R/R MM); and based on these positive results, over half of the heme/oncs surveyed in the Spherix study believe they would be very likely to alter their treatment paradigm. How the future launch of isatuximab will affect Darzalex remains to be seen.

Another development in the MM market is the recent FDA approval of Karyopharm’s Xpovio (selinexor) in combination with dexamethasone for the treatment of patients with R/R MM who have received at least four prior therapies. Approval was based on the results of the Phase 2b STORM trial, providing an additional option for a difficult to treat R/R MM population.

Compared to other agents used to treat patients with MM, familiarity of Xpovio was generally low, with only about one-third of heme/oncs reporting high familiarity at roughly one month post launch. Even so, most respondents plan on changing their treatment approach as a result of the Xpovio approval. Indeed, nearly one in five heme/oncs reported already using the agent, and over half of the heme/oncs anticipate using the agent within the next three months.

Consistent with the label, most heme/oncs will use Xpovio as a later line therapy in patients with R/R MM. The greatest drivers for Xpovio use include patients being refractory to prior therapies and Xpovio’s novel mechanism of action. Concerns about insurance, potential safety issues, and low familiarity topped the list of barriers preventing heme/oncs from using the agent. By next quarter, familiarity will likely improve as Karyopharm begins to establish itself as a respected partner in MM.

 About RealTime Dynamix™
The ongoing quarterly series included in Spherix’s RealTime Dynamix™: Multiple Myeloma (US) service provides an independent perspective on the evolution of the MM market and highlights areas of unmet need upon which new competitors may be able to capitalize. The series also tracks performance of other key inline products (including Amgen’s Kyprolis, BMS’ Empliciti, Takeda’s Ninlaro, Celgene’s Revlimid / Pomalyst / Thalomid, and Novartis’ Farydak) as well as advanced pipeline agents (including Sanofi Genzyme’s isatuximab, bluebird bio and Celgene’s bb2121, GlaxoSmithKline’s belantamab mafodotin, and Oncopeptides’ melflufen).  The next wave of the report is scheduled to publish in December 2019.

 About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, neurology, and oncology markets.

Spherix was recently recognized by Philadelphia Business Journal as a 2019 Soaring 76 recipient for the fastest growing companies in the Greater Philadelphia area and by The Philadelphia Inquirer as an Entrepreneurs’ Forum 2019 Philadelphia 100® Winner for the fastest growing privately-held companies in the Greater Philadelphia area.

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For more information contact:
Jake B. Guinto, PhD, Insights Director
Phone: (484) 879-4284
Email: info@spherixglobalinsights.com

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