“Important new data” related to the portfolio of leading treatments in the hematology field were presented by the Swiss Roche on the occasion of the 64° Congresso dell’American Society of Hematology (Ash), which ended yesterday in New Orleans, Louisiana (USA). The data – reads a note released by the company – concern the treatment of numerous blood disorders, including haemophilia A, some types of blood cancers such as non-Hodgkin’s lymphoma (NHL) and multiple myeloma, and other conditions such as paroxysmal nocturnal hemoglobinuria (PNH).
In infants (up to 12 months) with haemophilia a severe, without factor VIII inhibitors, interim results from the Phase 3 Haven 7 study demonstrate that emicizumab provided significant bleeding control with a favorable safety profile. 77.8% of participants had no bleeds requiring treatment, and 42.6% had no bleeds, treated or untreated.
“The study was designed taking into consideration what is reported in the WFH (World Federation of Haemophilia) guidelines: regular prophylaxis started at a young age should be considered the standard of care for the treatment of haemophilia, as studies have shown that early prophylaxis improves long-term outcomes, such as joint health, while reducing the risk of Ich at the same time”, declares Flora Peyvandi, Director of Angelo Bianchi Bonomi Hemophilia and Thrombosis Center Fondazione Irccs Cà Granda Ospedale Maggiore Policlinico, Department of Medical Pathophysiology – surgery and transplants University of Milan. “Emicizumab offers the opportunity to start prophylaxis more easily even in the first few months of life to provide protection for newborns and newly diagnosed infants, while prophylaxis with factor VIII replacement therapy often starts after the first year of life for problems related to venous access”, adds Antonio Coppola, medical director at the Haemophilia and Congenital Hemorrhagic Diseases Hub Center of the Parma University Hospital.
A second result presented by Roche at the Ash meeting concerns new data and updates on the anti-CD79b drug conjugate antibody, the progenitor of its class, polatuzumab vedotin. Data from the Polarix study support the potential benefit of the drug in combination with rituxime, cyclophosphamide, doxorubicin and prednisone (R-Chp) in improving outcomes for patients with previously untreated diffuse large B-cell lymphoma (Dlbcl).
“Too many Dlbcl patients still experience tumor recurrence or progression after initial treatment. This highlights the need to improve a standard of care that has remained unchanged for the past 2 decades,” said Levi Garraway, Roche Chief Medical Officer and Head of Global Product Development – Updated data from Polarix indicate the potential benefits that a treatment with polatuzumab vedotin could bring to patients with this type of lymphoma, while also demonstrating our commitment to developing new treatment options.”
An analysis of the Polarix study, also presented at the Ash Congress, showed that over the next 10 years, polatuzumab vedotin plus R-Chp has the potential to reduce the number of patients receiving treatment by 27% compared with R-Chop. second-line, improving the chances of a successful outcome for more patients and significantly reducing the overall treatment burden of Dlbcl. Based on pivotal data from the Polarix study, more than 50 countries have approved polatuzumab vedotin in combination with R-Chp for the treatment of adult patients with previously untreated Dlbcl, including the EU, Japan and most recently Canada.
During the summit Ash Roche also presented the updated clinical data of its CD20xCD3 bispecific antibodies, the largest and most advanced development program in lymphomas – the note points out – which includes five oral presentations. Updated results from the investigational bispecific glofitamab antibody suggest it has the potential to be the first in this new class to be administered for a fixed time period to heavily pretreated relapsed or refractory (R/R) Dlbcl patients. Updated data from the bispecific antibody mosunetuzumab also continued to demonstrate a clinically meaningful impact in multi-drug patients with follicular lymphoma. Mosunetuzumab, which was approved by the European Commission as a first-in-class bispecific antibody, is a fixed-duration treatment that can be administered on an outpatient basis and could offer patients the potential to achieve durable remission with a treatment-free period .
Finally, data from the Phase 3 Commodore 3 study conducted in China were also presented showing that crovalimab – a novel anti-C5 recycler monoclonal antibody – is effective and well tolerated in people with paroxysmal nocturnal hemoglobinuria. The study met its co-primary efficacy endpoints (transfusion avoidance-ET and hemolysis control), demonstrating that subjects with PNH who had not been previously treated with complement inhibitors and who received subcutaneous injections of crovalimab every 4 weeks they achieved disease control.