Spherix Global Insights

February 11, 2021

Biogen’s Vumerity and Bristol Myers Squibb’s Zeposia Show Signs of Early First-Line Success Among Multiple Sclerosis Patients Due to Tolerability and Onboarding Advantages Over Established Agents

According to Spherix Global Insights, the emerging Bruton’s tyrosine kinase inhibitors, including EMD Serono’s evobrutinib, Sanofi Genzyme’s tolebrutinib, and Genentech’s fenebrutinib, may disrupt current first-line treatment patterns, particularly in progressive multiple sclerosis

EXTON, Pa., February 11, 2021/PRNewswire/ —With the recent additions of Novartis’ Mayzent, Bristol Myers Squibb’s Zeposia, and Biogen’s Vumerity to the multiple sclerosis (MS) market in the United States, neurologists increasingly choose to initiate treatment by prescribing an oral disease-modifying therapy (DMT). Data from 1,018 charts of MS patients initiated on their first DMT within the prior three months, provided by 205 neurologists as part of Spherix’s RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) service, indicate that the oral DMT class now accounts for close to half of all recent first-line DMT initiations (up from just over one-third only four years ago).

The diversity of the oral class drives its popularity for first-line treatment; neurologists consider standard- or moderate-efficacy options (such as Sanofi Genzyme’s Aubagio or fumarate DMTs) appropriate for a wide breadth of MS patients beginning their DMT treatment. However, for patients with unfavorable prognoses, S1P receptor modulators (particularly the next-generation Mayzent or Zeposia) are frequently considered optimal first-line choices.

The plethora of new competition for Biogen’s Tecfidera from recently launched fumarate DMTs (including generic dimethyl fumarate, Banner Life Sciences’ Bafiertam, and Biogen’s own Vumerity) has done little to blunt Tecfidera share among recent new starts. The brand is still one of the most frequently prescribed DMTs for this MS patient segment, together with Teva’s Copaxone and Genentech’s Ocrevus.

In fact, uptake of the new fumarates underlies much of the overall growth in the oral DMT class over the past year; total first-line share of the fumarate DMTs has increased by more than 65% since early 2020. With tolerability driving almost half of Vumerity selections in the first line of therapy, share of Vumerity is outpacing even that of generic dimethyl fumarate.

In contrast to the fumarate class, dynamics within the S1P receptor modulator class have shifted since the availability of Zeposia beginning in June 2020, and Novartis’ Gilenya appears to have borne the brunt of Zeposia’s early success. With neurologists reporting a much lower rate of required first-dose observation for patients recently initiated on Zeposia than other S1P receptor modulators, and more neurologists choosing Zeposia than Gilenya because of favorable tolerability perceptions, Zeposia has quickly emerged as an attractive first-line option successfully competing with both S1P receptor modulators and anti-CD20 monoclonal antibodies.

However, to achieve further growth in this segment, Zeposia will have to contend with the resilient and trusted fumarate class. Consistent use of Zeposia among patients with both favorable and unfavorable long-term prognoses may help broaden its appeal.

Expected to launch within the next few years, the Bruton’s tyrosine kinase (BTK) inhibitors, including EMD Serono’s evobrutinib, Sanofi Genzyme’s tolebrutinib, and Genentech’s fenebrutinib, will further expand the mechanistic options within the oral DMT class. Just over one in ten audited patients would have been considered a very likely candidate for evobrutinib had it been available for prescribing at the time of first-line DMT selection.

The profile of these theoretical candidates suggests that neurologists may consider evobrutinib treatment for a wide variety of treatment-naïve patients; evobrutinib (and the BTK inhibitor class) may have the ability to disrupt usage patterns not only among oral DMTs but also across other classes, including platform injectable agents and monoclonal antibody DMTs. Furthermore, neurologists considered higher percentages of patients with primary progressive MS (PPMS) than relapsing MS very likely candidates for BTK inhibitors, especially for tolebrutinib and fenebrutinib – both of which are currently undergoing Phase III trials for progressive MS. Assuming successful clinical development of this novel class, Ocrevus may finally feel some pressure for first-line initiations in PPMS.

About RealWorld Dynamix™
RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

The fifth annual audit included in the RealWorld Dynamix™: DMT New Starts in Multiple Sclerosis (US) service published last week.

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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, and neurology markets.

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