Use of Darzalez and Xpovio Expected to Increase Due to New Approvals, Spherix Survey Shows

U.S. blood cancer specialists are aware of recent approvals for multiple myeloma patients and expect to increase their use of Darzalex (daratumumab) as first-line combination therapy, as well as Xpovio (selinexor) as a fifth-line combination therapy, according to a survey conducted by market research firm Spherix Global Insights.

The data also highlighted a general optimism regarding the potential approval of Darzalex’s subcutaneous (under-the-skin) formulation by the U.S. Food and Drug administration (FDA), which would be the preferred formulation among specialists.

Spherix’s quarterly reports, called “RealTime Dynamix: Multiple Myeloma (US),” are based on online surveys of about 100 U.S. blood cancer specialists. They provide 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,” according to the company’s website.

The current report, whose data were announced in a press release, relied on 150 blood cancer specialists and focused on recently approved treatments and promising experimental therapies. These included Janssen Pharmaceuticals’ Darzalex, Sanofi-Genzyme’s isatuximab, and Karyopharm’s Xpovio, among others.

The late June FDA approval of Darzalex, combined with Revlimid (lenalidomide) and dexamethasone (collectively known as DRd), as first-line treatment for myeloma patients who are ineligible for transplant, was based on data from the MAIA Phase 3 trial (NCT02252172). Darzalex is given intravenously (directly into the patient’s bloodstream).

Jansen’s recent application to the FDA for Darzalex’s new subcutaneous formulation was supported by positive results from two ongoing clinical trials — the COLUMBA Phase 3 trial (NCT03277105) and the PLEIADES Phase 2 trial (NCT03412565). Those are evaluating the new formulation, alone or in combination with standard treatment, in newly diagnosed patients or in those with relapsed or refractory disease.

According to Spherix’s report, most specialists were aware of the recent approval of first-line DRd combo and anticipated increasing their use of Darzalex as a result. Those reporting no plans of increasing Darzalex use stated they were satisfied with current therapeutic options and preferred to use Darzalex as a later line therapy.

Darzalex, alone or in combination with other therapies, also is approved for the treatment of patients who failed to respond to prior therapies.

Also, nearly all responders were moderately to highly familiar with the COLUMBA and PLEIADES studies, and almost 75% of them anticipated increasing Darzalex use in case the new formulation is approved.

Specialists showed a preference for Darzalex’s subcutaneous formulation, as they were more prone to use it, over the intravenous formulation, in patients never treated with Darzalex. More than half of them said they would switch patients’ current Darzalez treatment to the new formulation.

Darzalex’s subcutaneous formulation likely would be an advantage over Sanofi-Genzyme’s investigational isatuximab, an immunotherapy that targets the same molecular mechanism as Darzalex.

In July, the FDA agreed to review isatuximab’s application as a potential therapy for patients with relapsed or refractory myeloma, and an approval is expected in early 2020, according to the press release.

Based on data from the ICARIA-MM Phase 3 study (NCT02990338), which showed significant clinical benefits in adding isatuximab to Pomalyst (pomalidomide) and dexamethasone standard therapy, more than half of the specialists reported they very likely would alter their treatment model.

Also in July, adults with relapsed or refractory disease who received and failed to respond to at least four prior therapies had a new therapeutic option: a combination of Xpovio with dexamethasone. FDA’s approval was based on findings from the STORM Phase 2b trial (NCT02336815).

Spherix’s report showed that only around 33% of specialists reported high familiarity with Xpovio roughly one month after its launch, suggesting that Xpovio awareness was generally low. However, familiarity with Xpovio is expected to improve in the next months.

Most responders stated they planned to change their treatment approach based on this new approval. Nearly 20% of them reported already treating patients with Xpovio and more than half predicted using it within the following three months.

Specialists cited Xpovio’s indication as an additional therapeutic option for patients with hard-to-treat multiple myeloma and its new mechanism of action as the main reasons for its use. While immunotherapies rely on the modulation of immune responses against cancer cells, Xpovio leads to the accumulation of tumor suppressor proteins inside the cell’s nucleus, inducing the selective death of cancer cells.

Main reasons preventing Xpovio use included concerns about insurance, potential safety issues, and low familiarity.

The next Spherix report is scheduled to be published in December.