AUGUST 2, 2021 •
- Results show that every six-week natalizumab IV administration provides a high level of efficacy in controlling MS disease activity in patients who switched from the approved every four-week dosing regimen
- Data from the first prospective, randomized, controlled study of an extended dosing schedule for natalizumab offer valuable insights and build on positive real-world effectiveness findings1,2,3
- Updated analyses from the TOUCH® Prescribing Program indicate an average six-week dosing schedule is associated with an 88 percent reduction in the probability of developing PML4
CAMBRIDGE, Mass., Aug. 02, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced results from the two-year prospective, randomized, interventional, controlled, open-label Phase 3b NOVA study (NCT03689972). NOVA was designed to estimate a potential difference between the efficacy of every six-week (Q6W) 300mg natalizumab intravenous (IV) administration compared to the efficacy of the approved every four-week (Q4W) dose in people treated with TYSABRI® (natalizumab) (n=499) for relapsing-remitting multiple sclerosis (MS) after at least one year of disease stability on a Q4W IV dosing schedule.
The primary endpoint showed a numerical difference between the mean number of new or newly enlarging T2 hyperintense lesions at week 72 of 0.05 (Q4W) and 0.20 (Q6W) (p=0.0755), which based on the full trial results is not clinically meaningful. The numerical difference was driven by a high number of lesions occurring in two participants in the Q6W arm – one patient who developed lesions three months after treatment discontinuation and a second patient who developed asymptomatic progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection. The proportion of patients that developed new or newly enlarging T2 lesions in each arm was 4.1 percent (Q4W) and 4.3 percent (Q6W).
There were no statistically significant or clinically meaningful differences in secondary endpoints at week 72 between the Q4W and Q6W treatment arms, and disease activity was well-controlled in both arms:
- Annualized relapse rates were low at 0.00010 (Q4W) and 0.00013 (Q6W), with 97.9 percent patients in the Q4W arm remaining relapse-free compared to 97.2 percent of patients in the Q6W arm.
- The proportion of patients that developed T1 hypointense lesions in each arm was 1.1 percent (Q4W) and 1.4 percent (Q6W).
- Both arms demonstrated 0.5 percent of participants with gadolinium (Gd) enhancing T1 lesions.
“The NOVA study provides the first prospective, randomized efficacy data of every six-week dosing with natalizumab, building on its well-established clinical profile and the real-world findings1,2,3,” said Maha Radhakrishnan, M.D., Chief Medical Officer at Biogen. “In addition to the safety analyses from the TOUCH Prescribing Program, which showed significant reduction in the probability of PML, the results from NOVA deliver a more comprehensive understanding of the six-week dosing regimen of natalizumab.”
The NOVA study was initiated to assess the efficacy of Q6W dosing with natalizumab IV administration following analyses from the TOUCH (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program, which showed that extended interval dosing was associated with a significant reduction in the probability of PML. An updated analysis of data from TOUCH showed that an average Q6W dosing regimen is associated with an 88 percent reduction (hazard ratio 0.118, p<0.0001) in the probability of PML in comparison to the approved Q4W dose.4
The safety findings in the NOVA study were consistent with the known safety profile of IV natalizumab and the incidence of adverse events and serious adverse events were similar between the two treatment arms. One patient with asymptomatic PML in the Q6W arm was high-risk based on the known risk factors (anti-JCV antibody index >1.5, and >2 years of TYSABRI treatment), underlying the importance of PML monitoring and risk factor considerations in patients treated with natalizumab.
A complete analysis of the study data is ongoing and detailed results will be shared in a future scientific forum. Natalizumab is available commercially under the brand name TYSABRI and the only approved dose is 300mg on a Q4W regimen.
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