Mirikizumab scores an easy win over Cosentyx

Snippets

Given how much Lilly has invested in mirikizumab, a likely late entrant in psoriasis, it is vital for this anti-IL-23 MAb to record clinical knockouts. And its first pivotal study against an active comparator, the Oasis-2 trial versus Novartis’s Cosentyx, appears to have delivered just that. Acing Oasis-2’s primary endpoints versus placebo at four months is pretty meaningless; the real-world relevance lies in the trial’s secondary measures, at 12 months, where the clear win against Cosentyx becomes evident. Critics will complain that it is difficult to estimate whether the Novartis drug over- or underperformed the data on its US label, as these relate to different measures – IGA clear or almost clear status and Pasi 75 improvement – to Oasis-2, and use a 12-week time point. Moreover, in Cosentyx Lilly had set itself a low bar; cross-trial comparisons suggest that two rival anti-IL-23s, Abbvie’s Skyrizi and Johnson & Johnson’s Tremfya, would have been harder for mirikizumab to beat (Lilly spends big on mirikizumab, February 12, 2020). Still, a win is a win, and Lilly now has ammunition to help mirikizumab meet its 2026 sellside consensus revenue forecast, which EvaluatePharma calculates as $1.3bn.

Summary of Lilly's Oasis-2 trial result
  Mirikizumab Cosentyx
Primary efficacy endpoints, placebo adjusted*
sPGA (0,1) at 4 months 73.4% 70.0%
Pasi 90 at 4 months 68.1% 66.5%
Selected secondary efficacy endpoints, not placebo adjusted**
sPGA (0,1) at 12 months 83.1-83.3% 68.5%
Pasi 90 at 12 months 81.4-82.4% 69.4%
Note: placebo dosing was stopped after 4 months *statistically significant versus placebo; **statistically significant versus Cosentyx. sPGA; static physician's global assessment of (0,1) with at least a 2-point improvement.

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