Abstract 97P
Background
Anti CD20/CD3 bispecific antibody glofitamab (G) demonstrated high efficacy and acceptable toxicity profile in patients with aggressive r/r B-NHL. Nevertheless, the number of patients and conditions in clinical trials is limited, which requires further study of the G safety in real clinical practice.
Methods
This study included 28 pts with r/r B-NHL who were treated with G from May 2021 to August 2022 within the Russian Named Patient Program. G was prescribed in escalated regimen: 2.5 mg D8C1, 10 mg D15C1, 30 mg D1C2-12. Anti-CD20 antibody was administrated in D1C1. Efficacy was analyzed by PET-CT (Lugano criteria). Adverse events (AEs) were graded according to NCI CTCAE 5.0.
Results
Median age at G initiation was 50 (21-83), male/female ratio - 11/17 (39/61%). Median number of therapy lines before G was 3 (2-8). ECOG>1 at G initiation was in 7 (25%), B symptoms in 6 (21%) and bulky disease in 8 (29%) pts. Median follow-up was 6 (1-16) mo. At analysis 22 (79%) pts discontinued therapy due to PD (n=10, 36%), severe COVID-19 (n=5, 18%), therapy completion (n=5, 18%), other reason (n=2, 7%). Median number of cycles was 6 (1-12). ORR was 67% (56% CR, 11% PR). Eight pts died during G therapy including 5 (18%) pts due to PD. AEs were present in 27 (96%) pts including gr 3-4 in 14 (43%) and gr 5 in 3 (11%) pts (Table). Any grade COVID-19 was revealed in 9 (32%) pts. Three (11%) pts died due to severe COVID-19. Anti-SARS-CoV-2 antibodies were introduced in 14 (50%) pts: in 6 (21%) pts after Covid-19 and in 8 (29%) pts as a Covid-19 prophylaxis. There were no cases of severe Covid-19 after prophylaxis with antibodies. Other viral infections have also been observed: gr 1-2 VZV in 3 (11%), gr 4 CMV pneumonia in 1 (4%) pts. Table: 97P
| All AEs | 27 (96%) | ||
| Any grade | Grade 3-4 | Grade 5 | |
| Hematologic AEs | |||
| Neutropenia | 17 (61%) | 8 (29%) | no |
| Anemia | 14 (50%) | 3 (11%) | no |
| Thrombocytopenia | 7 (25%) | 1 (4%) | no |
| Infection | |||
| Covid-19 | 10 (36%) | 4 (14%) | 3 (11%) |
| VZV | 3 (11%) | no | no |
| CMV pneumonia | 1 (4%) | 1 (4%) | no |
| Immunological | |||
| CRS | 15 (54%) | 1 (4%) | no |
| Tumor flare | 6 (21%) | 2 (8%) | no |
| Other | |||
| Headache | 1 (4%) | 1 (4%) | no |
Conclusions
G demonstrated high efficacy in patients with r/r B-NHL. However, the wide range of toxicities has also been demonstrated including a high rate of viral infections. Anti-SARS-CoV-2 antibodies and standard viral prophylaxis should be considered in this patient group.
Legal entity responsible for the study
Liudmila Fedorova, Kirill Lepik, Olesya Smykova, Natalia Mikhailova, Marina Popova, Vladislav Markelov, Elena Kondakova, Ivan Moiseev, Alexander Kulagin.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.