ASH 2024 | Glofitamab plus R-ICE chemotherapy in R/R DLBCL: a Phase Ib study

This study, which I think we can shorten and just call the G-RICE study, which is glofitimab plus rituxan and ICE chemotherapy, is a second-line study. So the second line is for patients who have relapsed after initial chemotherapy. And the question is really how do you cure the most patients in this space? Because these are the patients we didn’t cure in front-line chemotherapy, and it’s a high priority for me to cure as many lymphoma patients as possible. So we know that if you go to auto transplant and you go to CAR-T, the less disease you have the better you’re going to do. And sure, CAR T can cure some patients with some disease, but auto transplant almost never can. And the less disease you have going into CAR, the less risk you have for toxicity and the higher chance you have of cure. So how do you take someone who has significant burden of disease and get them optimally prepared for CAR-T? So we know that ICE chemotherapy has a CR rate of about 35%. And in this study, we hypothesized that combining the bispecific antibody, glofitimab, which is approved in the third line and which has a CR rate of about 50%, was going to augment the efficacy of ICE or RICE because you add rituxan to the ICE and get more patients to transplant. So patients in this study got obinutuzumab with ICE and glofit in cycle one and glofit was given in step-up dosing. Option of having a cycle three where they got glofitimab plus ICE, then they could go on to have up to four additional cycles of glofitimab while they got ready for their auto or their CAR. What we found, first of all, is that there were no new or concerning safety signals that we saw in this study. There was a significant number of grade three AEs, but this was almost all hematologic, which were expected toxicities of ICE, so neutropenia, anemia, thrombocytopenia, and these are known toxicities of the ICE chemotherapy. What was really exciting is that the CRS was extremely low in this study, so no patients had grade 3 or 4 CRS. The CRS was all grade 1 to 2, and all of the CRS occurred in the first or second dose of glofitimab, and then patients really tolerated the glofitimab without any additional toxicity or side effects subsequently. We were also extremely encouraged by our overall response rate and complete response rate. So we had an overall response rate of, we had a complete response rate that was higher than 75% with an overall response rate that was higher than 80%, which, you know, for this patient population that even to bispecifics, you know, has this, this is, this overall response rate, complete response rate is better than either agent alone. And it’s astoundingly good. And we were very excited that we had this across the board for patients with even primary refractory disease who are thought not to be chemotherapy sensitive. We had very high response rates and very high CR rates. We’re going to be following patients for up to two years after their auto or CAR, but that data isn’t mature yet, so I won’t be presenting that today. But I hope to be presenting that sometime in 2025 at another meeting, and I look very much forward to that. And we think this potentially has a bright future as a drug therapy combination in the second line space where there really isn’t at this point a good standard of care to get patients optimally prepared for auto transplant or CAR.

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