Glofitamab, a CD20 x CD3 T-cell engaging bispecific antibody treatment, is a promising new therapy for patients with heavily pretreated and/or highly refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL), a study led by Peter Mac researchers has shown.
Findings presented at the ASCO 2022 meeting by Associate Professor Michael Dickinson showed that glofitamab induced durable complete remissions and had favourable safety profile in patients with R/R DLBCL and two or more prior therapies, including those with prior exposure to CAR T-Cell therapy.
The results are from the phase II NP30179 expansion study, which involved 155 patients with R/R DLBCL who were followed-up more than a year (median 12.6 months) after treatment with the investigational drug being developed by Roche.
It found that more than a third of the patients (39.4%) achieved a complete response (CR) of their disease, while the overall response rate (ORR) to glofitamab was 51.6%.
Associate Professor Dickinson said these effects were durable, as for most (77.6%) patients with a complete response this was ongoing at 12 months.
“At data cut, the projected 12-month OS [overall survival] rate was 48%, and 92% of complete responders were alive” the abstract noted.
The study also showed that CR rates were consistent in patients with and without prior CAR-Ts, with a median time to CR of 42 days.
The main adverse effect was cytokine release syndrome (CRS), occurring in 63% of patients. Most CRS events were associated with initial doses and were predominatly Grade 1 (51%) or 2 (12%), whereas Grade 3 (3%) and 4 (2%) were uncommon and only one patient discontinued glofitamab due to CRS.
“I’m encouraged by these data as they signify new hope for these patients who otherwise have limited effective treatment options and have faced disappointment from their disease not responding to multiple prior rounds of treatments,” said Associate Professor Dickinson, who is Lead of the Aggressive Lymphoma Disease Group within Clinical Haematology Department at Peter Mac and Royal Melbourne Hospital.
“These glofitamab data suggest that patients may be able to achieve durable control of their disease with a set course of treatment that they don’t have to take continuously until disease progression.”
The first-in-human trials of this investigational drug were conducted at Peter Mac, and recruitment is also underway for several further trials of glofitamab.
One these is the Peter-Mac led COALITION trial, which combines glofitamab with chemotherapy in younger patients with higher risk blood cancers as a front line therapy for large B-cell lymphoma.
In a statement, Roche said the data from the study was being submitted to regulatory authorities in Europe and the US to apply for registration of glofitamab to be used in lymphoma.