Roche has announced positive results from its phase 3 study of crovalimab in patients with paroxysmal nocturnal haemoglobinuria (PNH), a rare and life threatening blood condition.
PNH causes a patient’s red blood cells to break apart, resulting in a range of debilitating symptoms such as anaemia, fatigue, blood clots and kidney disease.
C5 inhibitors can be effective in treating the condition. This includes AstraZeneca/Alexion’s Soliris (eculizumab), which was approved by the US Food and Drug Administration in 2007 and has subsequently become a standard of care for patients with the disorder.
Like Soliris, crovalimab is also a C5 inhibitor, but only needs to be given as a subcutaneous injection every four weeks, compared to an intravenous infusion and clinic visit every two weeks with Soliris.
“People with PNH may benefit from more options to achieve robust disease control with less frequent treatment intervals,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
Roche’s COMMODORE 2 study met its two efficacy primary endpoints of transfusion avoidance and control of haemolysis – the ongoing destruction of red blood cells – with results showing the drug was as effective as Soliris.
In addition to the results from COMMODORE 2 that enrolled patients who had not been previously treated with C5 inhibitors, the company also reported positive outcomes from its COMMODORE 1 study for PNH patients switching from currently approved C5 inhibitors to crovalimab, which it said ‘supported the favourable benefit-risk profile’ of the drug.
The company said it will now be submitting data from both studies to regulatory authorities around the world.
“As the first global phase 3 data for crovalimab, these results emphasise its potential to address these needs. We look forward to submitting this data to regulatory authorities, bringing us one step closer to making crovalimab available for people with PNH around the world,” Garraway said.
Earlier this month, Roche announced that its antibody drug conjugate, Polivy (polatuzumab vedotin), had been recommended by the National Institute for Health and Care Excellence (NICE) as part of a drug combination to treat adults with an aggressive form of blood cancer.
In final draft guidance, NICE recommended Polivy be used in combination with rituximab, cyclophosphamide, doxorubicin and prednisolone (R-CHP) for untreated diffuse large B-cell lymphoma (DLBCL).