Roche’s Glofitamab: ASCO 2022

Roche revealed the impressive findings from the Phase II expansion study of Glofitamab in the patients with R/R DLBCL (Abstract # 7500)

Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. Moreover, glofitamab is a part of Roche's larger bispecific antibody development program, which could lead to a new immunotherapy-based treatment for a variety of blood malignancies. According to the results presented at the ASCO 2022 conference, as of 14 March 2022, a total of 155 patients were evaluable, with a median follow-up of 12.6 months. The elicited complete response (CR) was 39.4%, followed by an overall response rate (ORR) of 51.6%. Moreover, these data were more impressive since 34% of patients were after receiving CAR-T therapy, and the CR rate in these patients was 35%.

Most importantly, the impact of the CR rate sets the bar for other rival competitors like AbbVie, Genmab, etc. As per the independent review committee, the median duration of response (DoR) in the trial was 10.6 months, and the median progression-free survival (PFS) was 12.6 months. In addition to that, the median OS (Overall Survival) was 11.5 months. In terms of safety, glofitamab was well tolerated with low-grade CRS (Cytokine release syndrome).

KOL insights

“These glofitamab data suggest that patients may be able to achieve durable responses with a set course of treatment that they don’t have to take continuously until disease progression.” –Expert Opinion.

“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”–Expert Opinion.


The recent data on glofitamab brings it one step closer to the goal of finding solutions for people with heavily pretreated diffuse large B-cell lymphoma, which often relapses and becomes more aggressive. Moreover, the potential of glofitamab as a new fixed-duration, readily available treatment could be instrumental to improving outcomes for people with this difficult-to-treat cancer who otherwise have limited options. The consistent CR rate was achieved early and durable after the fixed treatment duration. Based on these findings, the Phase II expansion study data have been submitted for approval to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including the US FDA, are also planned this year. Additionally,  glofitamab could be an effective companion to Roche’s CD79b-directed ADC Polivy (Polatuzumab Vedotin), which was approved in the EU earlier this week for previously untreated DLBCL.

Companies-  AbbVie, Roche (Genentech), Bristol Myers Squibb, Regeneron Pharmaceuticals, Amgen, Incyte Corporation,  Merck Sharp & Dohme LLC,  Sanofi, IGM Biosciences, Gilead Sciences, Allogene Therapeutics, Sorrento Therapeutics, Novartis, MorphoSys, Kite Therapeutics, Beigene, Seagen, Curocell, TG Therapeutics, and others.