Roche announced today, on the occasion of the 2022 Congress of the European Hematology Association in Vienna, the new long-term follow-up results and sub-analyzes of clinical trials on already approved or investigational therapies from its extensive hematology portfolio. The data includes those of the final analysis of the study di phase III Gallium, diobinutuzumab in combination with chemotherapy in patients with previously untreated advanced follicular lymphoma, and some under analysis of the phase III study Polarix dipolatuzumab vedotin in combination with arituximab plus cyclophosphamide, doxorubicin and prednisone (R-Chp) in patients with previously untreated diffuse large B cell lymphoma (Dlbcl). Roche also presented its data bispecific antibody development programs T-cell engaging, mosunetuzumab and glofitamab in patients on advanced lines of therapy for non-Hodgkin lymphoma (Nhl, non-Hodgkin lymphoma), and cevostamab e RG6234 in relapsed or refractory multiple myeloma.
“Hematological cancers – said Levi Garraway, Md, Phd, Chief Medical Officer and Head of Global Product Development – are difficult to treat at all stages. However, by improving frontline treatment options, we aim to increase the likelihood of significant clinical benefits for patients. With these new data, and with the long-term studies on other fixed-duration therapies in our portfolio – he explains – we strengthen our commitment to the development of innovative therapeutic solutions, which can not only decrease patients’ need for long-term treatments. , but also to reduce the repercussions associated with them “.
After eight years of follow-up in previously untreated follicular lymphoma patients, obinutuzumab in combination with chemotherapy was a significant improvement of the PFS maintained (Progression free survival), confirming its role as a standard of care for first-line treatment. Seven-year Pfs was significantly improved with obinutuzumab in combination with chemotherapy (63.4%) compared with arituximab plus chemotherapy (55.7%). This translated into a longer time to subsequent anti-lymphoma treatment: at seven years, 74.1% of patients treated with obinutuzumab plus chemotherapy had not yet started a new therapy compared with 65.4% of those treated with rituximab plus. chemotherapy. The incidence of serious adverse events was 48.9% with obinutuzumab plus chemotherapy and 43.4% with rituximab plus chemotherapy.
Exploratory subgroup analyzes of the phase III Polarix study – conducted with polatuzumab vedotin in combination with R-Chp versus current standard of care rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated Dlbcl – further support the dipolatuzumab vedotin potential to change the standard of care for this aggressive lymphoma.
Among the data presented – reads a note – an analysis of the study participants from Asia (China, Hong Kong, Japan, South Korea and Taiwan). In this subgroup, the results demonstrated a significant improvement in Pfs with polatuzumab vedotin plus R-Chp compared to R-Chop, with a 36% reduction in the risk of disease progression, recurrence or death. The safety profile was generally comparable for both regimens. Based on the positive Polarix results of the overall study patient population, the European Commission approved polatuzumab vedotin plus R-Chp in May 2022 for the treatment of adult patients with previously untreated Dlbcl. In Italy, an evaluation by the national regulatory body for polatuzumab vedotin on the front line is expected in the coming months, while the therapy is already available to adult patients with relapsed or refractory form, not eligible for transplantation.
Not only. The pivotal phase II study Np30179 – which included heavily pre-treated and refractory Dlbcl patients – demonstrated that fixed-duration treatment withglofitamab, an investigational bispecific Cd20xCd3 antibody, induced high and long-lasting complete response rates. After a median follow-up of 12.6 months – the note continues – 39.4% of patients (n = 61/155) achieved a primary efficacy endpoint, and half (51.6%) achieved a overall response (percentage of patients with complete or partial response; secondary efficacy endpoint) as assessed by an independent review committee. Occurring in 63% of patients, cytokine release syndrome was the most common adverse event. These data were recently presented at the American Society of Clinical Oncology Annual Meeting 2022 and have been submitted for approval by the EMA. Submissions to other health authorities around the world, including the FDA, are expected this year.
An exploratory subgroup analysis showed that mosunetuzumab it could be aeffective tolerability option in patients aged <65 and ≥65 years with relapsed or refractory follicular lymphoma who have received two or more previous therapies. Patients ≥65 years of age achieved a higher objective response rate than those <65 years of age (87.0% vs 77%, respectively). Lower rates of cytokine release syndrome and serious adverse events were observed in patients aged ≥65 years (37%) compared to those aged <65 years (52%). Additional data from Go29781 demonstrated that re-treatment with mosunetuzumab in patients who achieved a complete response but whose disease subsequently progressed was effective, and that the safety of re-treatment was consistent with that of initial treatment.
The European Community recently approved mosunetuzumab for the treatment of patients with R / R follicular lymphoma who have received at least two previous systemic therapies. The FDA has granted mosunetuzumab the breakthrough therapy and orphan drug designation for this same group of patients. The data presented at the Ehaas well as the phase III studies currently underway, will broaden knowledge of glofitamab and mosunetuzumab and their impact in both first and subsequent lines of treatmentwith the aim of obtaining significant and lasting clinical benefits for people with different types of lymphomas.
In line with its commitment to improving clinical benefits and personalization of care for people with hematological cancers, Roche – concludes the note – has expanded its trials beyond lymphomas and leukemias, including multiple myeloma. It is the third most common type of haematological cancer – it is diagnosed in over 170,000 people globally every year – and involves plasma cells (cells that produce antibodies in the bone marrow).
Although scientific advances have improved prognosis, multiple myeloma remains an incurable disease characterized by multiple relapses, with an overall five-year survival rate of approximately 55%. Roche presented at the Eha i data on cevostamab, an experimental bispecific T-cell engaging FcRH5xCD3 antibody, which is evaluated alone and in combination with other drugs for the treatment of subjects with Mm R / R, and on RG6234, a new bispecific antibody T-cell engagingGPRC5DxCD3, which is the subject of a phase I study conducted on patients with Mm R / R. Although the trials are only at the beginning, theclinical activity and the safety profiles observed with these molecules appear encouragingand support further investigation.