Roche, new data on therapies for haemophilia A and lymphomas

Positive results for two clinical trials on the treatment of haemophilia A and previously untreated diffuse large B cell lymphoma (Dlbcl) were presented by Roche at the recently concluded 63rd American Society of Hematology (ASH) congress. . Data from the interim analysis of the phase III ‘Haven 6’ study indicate that emicizumab has a favorable safety profile in patients with mild or moderate haemophilia A without factor VIII inhibitors. Emicizumab also allowed for clinically meaningful bleeding control: 80.3% of study participants did not experience any bleeding episodes that required treatment, while 90.1% did not experience joint bleeding that required treatment. treatment. No new elements to report regarding safety. “We are pleased to see that emicizumab continues to demonstrate benefits in other populations with haemophilia A, regardless of disease severity,” said Levi Garraway, chief medical officer and head of global product development at Roche. “The clinical evidence for emicizumab comes from one of the largest pivotal clinical trial programs in haemophilia A with and without factor VIII inhibitors. We reaffirm our commitment to collaborate with the haemophilia community to deepen efficacy and the safety of emicizumab in larger populations “. In the area of ​​onco-hematology, Roche also presented among the late-breaking abstracts – and simultaneously published in the Nejm – the results of the phase 3 study ‘Polarix’ on the combination of polatuzumab vedotin with the R-Chp immuno-chemotherapy regimen. The first treatment in more than 20 years to demonstrate significant additional clinical benefits over the current standard of therapy – with a 27% reduction in the risk of disease progression or death – in patients with previously diffuse large B cell lymphoma (Dlbcl) untreated, potentially transforming the prognosis of the disease. “About 40% of patients with this aggressive lymphoma experience a relapse or show refractoriness to first-line treatment and, at that point, face a poor prognosis, with limited treatment options. The still unmet need is therefore still high,” Garraway pointed out again. “With this regimen, we will have the ability to change the course of the disease for people with Dlbcl, so we are working with health authorities around the world to make this important new treatment option available as soon as possible,” he concluded. And again: at the congress (Ash) data were presented for the first time showing how mosunetuzumab is able – in patients with relapsed / refractory follicular lymphoma, a form of indolent non-Hodgkin’s lymphoma but subject to multiple relapses – to induce rates high complete remission and long-lasting responses. In particular, the pivotal phase I / II study ‘Go29781’ demonstrated that the molecule induces complete and lasting responses that are maintained for at least 18 months in heavily pretreated patients who have received at least two previous systemic treatments. With a complete response rate of 60%, the median duration of response is 22.8 months; the median progression-free survival was 17.9 months, while the most frequent adverse event was cytokine release syndrome which was mild or moderate in most cases.