Data Provide Further Insight into Consistent Efficacy Benefits of Mavenclad in Relapsing MS

Merck, a leading science and technology company, announced the presentation of new efficacy and benefit-risk assessment data for MAVENCLAD (Cladribine Tablets) at the 4th Congress of the European Academy of Neurology (EAN), in Lisbon, Portugal. Results of a retrospective analysis of the Phase III CLARITY study showed benefits in patients with relapsing remitting MS (RRMS) aged ≤50 and >50 years and treated with MAVENCLAD, with improvements observed in both relapse rate and Magnetic Resonance Imaging (MRI) outcomes when compared with placebo. The aim of the post-hoc analysis of the Phase III CLARITY study was to investigate whether the beneficial clinical and MRI effects of MAVENCLAD are consistent in both older and younger adult patients. The results highlight the improvements observed in annualized relapse rate (ARR) and MRI outcomes versus placebo in both subgroups of RRMS patients, ≤50 and >50 years; MAVENCLAD reduced relapse risk compared to placebo by 59 percent and 52 percent, respectively. In placebo treated patients, there were higher mean numbers of new T1 Gd+ and active T2 lesions for those aged ≤50 years compared to patients aged >50. Despite this, MAVENCLAD treatment demonstrated significant effects on MRI measures in both age groups (P<0.0001). These data have the potential to differentiate the efficacy of MAVENCLAD from that of other high efficacy disease-modifying drugs (DMDs) in the treatment of older patients with MS.

“These data have provided further evidence, which confirms Mavenclad as an effective treatment for younger and older adults,” said Prof. Gavin Giovannoni, a lead investigator in the CLARITY studies and Chair of Neurology, Barts and The London School of Medicine and Dentistry, UK. “This is something that we have not seen consistently across all clinical endpoints with some of the newer high-efficacy RRMS treatments and so provides a valuable insight into the treatment options available.” Additional data presented at EAN 2018 provide the results of the first application of the EMA-recommended Multi-Criteria Decision Analysis (MCDA) methodology to assess the benefit-risk profile of MAVENCLAD versus other recently approved DMDs in MS patients with high disease activity. Results of this systematic application of MCDA methodology indicate either comparable or more favorable benefit-risk profile for MAVENCLAD in patients with high disease activity when compared to that of other DMDs. Specifically, in patients with high disease activity, MAVENCLAD had the highest overall weighted preference value compared to the other DMDs evaluated, followed by alemtuzumab and natalizumab. In the overall RRMS population MAVENCLAD was very close to dimethyl fumarate in being ranked as having the best benefit-risk balance, with an overall weighted preference value of 62 versus 63, respectively.

“The presentation of these data highlight our ongoing commitment to understanding the full benefit-risk profile of Mavenclad in a broad range of patients. Post hoc data from the CLARITY study, coupled with results from a Multi-Criteria Decision Analysis, which are based on expert physician assessment and practice-relevant treatment considerations, form a potentially useful tool for physicians considering therapy options for patients with high disease activity,” said Luciano Rossetti, Head of Global R&D for the Biopharma business of Merck. “The MCDA methodology is one that is recommended by EMA, and we are pleased that Mavenclad performed well using this approach, compared with other disease-modifying therapies.” Furthermore, additional post hoc data from clinical studies of patients treated with Rebif (subcutaneous interferon beta-1a) showed that the MAGNIMS score at Year 1 reliably predicted long-term clinical disease activity (CDA)-free status and disability progression. At Year 1 the median time to a CDA event was longer in patients with a MAGNIMS score of 0, versus those with score 1 or 2. Additionally, median time to Expanded Disability Status Scale (EDSS) progression was found to be longer in patients with a year 1 MAGNIMS score of 0 (7.5 years), versus those with 1 (4.0 years) or 2 (2.5 years).

Additionally, a presentation from the Merck-sponsored MS in the 21st Century joint patient-physician steering group highlighted the results of an international unmet needs survey, suggesting a disconnect between patients’ and physicians’ perspectives of MS treatment decisions. The results of this survey indicate that MS patients have different perceptions of the current unmet needs in the disease area compared to healthcare professionals (HCPs). Whilst 87.7 percent of HCPs considered that they involved their patients in the decision-making process, only 38.9 percent of patients reported that they felt involved in that process. Addressing this disconnect between patients’ and physicians’ perspectives during treatment discussions could lead to an improved dialogue between HCPs and patients, an integral step towards finding appropriate individualized treatment approaches for each patient. – Medical Buyer Bureau