- A little-used cancer drug from Novartis could pose a challenge to the company's cross-town rival Roche in multiple sclerosis, following study results showing the therapy convincingly reduced relapses and slowed disability progression in patients with the neurological disorder.
- In two Phase 3 trials, Novartis pitted ofatumumab, sold as Arzerra for cancer treatment, against Sanofi's seven-year old Aubagio in relapsing MS. While comparing results across trials can mislead, the annualized relapse rate posted by patients in the ofatumumab arms look on par with what Roche's Ocrevus yielded in the trials that led to its approval for the condition.
- Novartis hinted at ofatumumab's potential competitiveness in its statement on the data, highlighting the drug's injectable delivery and low need for patient monitoring. Ocrevus is infused and requires patients be monitored for at least an hour after treatment.
Novartis won't readily cede its long-time leading position in MS, a disease that's seen more than half a dozen new treatments arrive since approval of the Swiss pharma's Gilenya (fingolimod) in 2010.
As a leukemia treatment, ofatumumab has been rapidly eclipsed by drugs like AbbVie's Imbruvica (ibrutinib), leading Novartis to stop marketing the medicine outside the U.S.
But its future looks brighter in MS following results from the ASCLEPIOS 1 and 2 studies, which tested the drug head to head against Aubagio (teriflunomide) in more than 1,800 patients. Like Roche's Ocrevus (ocrelizumab), ofatumumab targets a protein called CD20 that's present on the surface of immunological B cells.
On the trials' primary goal, reducing the number of confirmed relapses, ofatumumab handily surpassed Aubagio, cutting annualized relapse rates by 51% and 59%, respectively.
Trial results for ofatumumab in relapsing multiple sclerosis
|Study||ofatumumab ARR||Aubagio ARR||% reduction in ARR|
|ASCLEPIOS 1||0.11||0.22||-50.5% (p<0.001)|
|ASCLEPIOS 2||0.10||0.25||-58.8% (p<0.001)|
SOURCE: Company release
Investigators also found ofatumumab suppressed the brain lesions characteristic of MS and slowed disease progression by roughly a third versus Aubagio at three and six months.
By annualized relapse rates, the numbers for ofatumumab are in a similar range, if not better, than the 0.156 and 0.155 figures that Ocrevus posted in two Roche studies of relapsing MS patients. Those trials compared Ocrevus to Merck KGaA's interferon beta therapy Rebif rather than Aubagio, however.
"The impressive 0.10-0.11 ARR with ofa[tumumab] does suggest a very competitive profile in RRMS, where ofa[tumumab]'s potentially more convenient sub[cutaneous] delivery and shorter B-cell depletion could help offset Ocrevus's longer duration of action and entrenchment," wrote RBC Capital Markets analyst Brian Abrahams in a note to clients, although he acknowledged cross-trial comparisons can be difficult.
Novartis said it plans to submit the data to regulators by the end of 2019, potentially setting up decisions on approval for late in 2020.
That's a timeline that Johnson & Johnson might also be eyeing, after seeing positive results for its oral MS drug ponesimod. In a head-to-head study also against Aubagio, results of which were disclosed Thursday, treatment with ponesimod resulted in an annualized relapse rate of 0.202.
J&J said data from the study would form the basis of regulatory submissions to U.S. and EU regulators for approval in relapsing MS.
Catching Ocrevus won't be an easy task, if either drug is eventually cleared for commercial sale. The drug has steadily gained market share and, as of the second quarter, was prescribed to close to four out of every 10 patients starting MS treatment, according to Roche. Sales totaled 1.7 billion Swiss francs, or about $1.72 billion, over the first six months of 2019.
Perhaps with an eye to new competitive threats, Roche this week presented new analyses showing earlier treatment with Ocrevus leds to reduced disability progression.