Roche has reported positive findings from the Phase III COMMODORE 3 clinical trial, in which its antibody crovalimab achieved disease control in paroxysmal nocturnal haemoglobinuria (PNH) patients.
Carried out in China, the single-arm trial is designed to analyse the safety, efficacy, pharmacokinetics, and pharmacodynamics of crovalimab in PNH patients.
It enrolled 51 such subjects who were not previously treated with complement inhibitors.
According to the new data, the trial met the co-primary efficacy endpoints of haemolysis control and transfusion avoidance (TA), which are disease control indicators.
From week five to 25, the mean proportion of subjects with haemolysis control was reported to be 78.7%.
A statistically significant difference between the proportion of subjects with TA in 24 weeks before screening and those with TA from baseline through to week 25 was seen.
In addition, the proportion of subjects with breakthrough haemolysis from baseline to week 25 and haemoglobin stabilisation were 3.9% and 51%, respectively.
Crovalimab’s overall safety data were in line with those already reported with C5 inhibitors and underlying diseases.
It was also found to be well-tolerated, without any new safety signals detected.
China’s National Medical Products Administration has accepted the trial data submitted seeking approval in PNH, under Priority Review.
The company anticipates findings from the international trials of COMMODORE 1 and COMMODORE 2 of crovalimab in PNH patients next year.
An investigational, new, anti-C5 recycling monoclonal antibody, crovalimab can hinder the complement system.
Roche Global Product Development chief medical officer and head Levi Garraway said: “We are pleased with the strength of these first Phase III data for crovalimab, which we hope will address the urgent need for efficacious and well-tolerated treatment options for this life-threatening condition in China.
“As crovalimab has been developed to be taken subcutaneously and infrequently, with the option to self-administer, it has the potential to become an important treatment option for people everywhere living with paroxysmal nocturnal haemoglobinuria.”
In November this year, the company reported that the Phase III GRADUATE I and II trials of gantenerumab in early Alzheimer’s disease failed to meet the primary endpoint of a reduction in clinical decline.