ASH 2021 report: new CAR T data, and more

This week on DocWire, we covered the latest cutting-edge research from the 2021 American Society of Hematology (ASH) annual meeting, covering advances in CAR T cell immunotherapies, new treatments for major blood cancers, and more.

The latest cover of ASH 2021

Read on for a breakdown of these top stories from the ASH Annual Meeting.

Updated Results of the MajesTEC-1 Trial of Teclistamab

The results of Phase II of the MajesTEC-1 teclistamab study were first presented to ASH. According to the researchers, teclistamab displayed a manageable safety profile at the recommended Phase II dose and continued to produce significant and lasting responses in patients with relapsed or refractory, heavily pretreated multiple myeloma (MM).

Of 40 patients treated with the Phase II dose, the overall response rate (ORR) was 65%, with a very good partial response rate or better (≥VGPR) of 60% and a complete response rate or better ( ≥CR) by 40%.

The most common non-haematologic adverse events (AEs) in the entire cohort (phase I / II) were cytokine release syndrome (CRS, 67%; grade ≥ 3, 1%). The most common haematologic AEs were neutropenia (53%; grade ≥ 3, 45%), anemia (41%; grade ≥ 3, 27%) and thrombocytopenia (33%; grade ≥ 3, 18%). Four patients developed grade I or II immune effector cell-associated neurotoxicity syndrome (ICANS), which resolved.

Related Video: Shaji Kumar on the Changing Landscape of Immunotherapy in Myeloma

Updated Results of the MajesTEC-1 Trial of Teclistamab

Real-world CAR T data in MCL

Following its approval by the FDA in 2020 based on the results of the ZUMA-2 trial, brexucabtagene autoleucel (brexu-cel), a chimeric antigen receptor (CAR) T cell therapy targeted against CD19, has been implemented in standard care for patients with relapsed / refractory mantle cell lymphoma (MCL). In a subsequent study assessing data on the use of brexu-cel in real-world practice, presented at ASH 2021, researchers found the treatment to have “encouraging” safety and efficacy profiles in routine care.

At a median follow-up of 3 months, the CRS rate was 88%, with 8% considered grade 3 or higher. The ICANS rate was 58%, with 33% considered level 3 or above. No fatal cases of CRS or ICANS have been reported. On day 30 of the response assessment in 81 evaluable patients, the ORR was 86%, with a complete remission rate of 64%. Among patients who responded by day 30, the three-month continuous response rate was 83.7%. =

Even though 73% of real-world patients would not have been eligible for enrollment in ZUMA-2, their rates of TRG and CR were comparable to those reported in the study cohort, which led the authors to consider brexu-cel to be generally safe and effective. However, they recognized that “longer follow-up is needed to confirm safety and long-term efficacy.”

Learn more about ASH: First-line R-BAC shows sustained efficacy in elderly patients with MCL

Real experience with Brexucabtagene Autoleucel for relapsed / refractory mantle cell lymphoma

Targeted therapy for CLL in elderly patients

Although people over the age of 80 account for over 20% of chronic lymphocytic leukemia (CLL) cases, this population is under-represented in clinical drug trials, and treatment outcome data is limited. In a pooled analysis, the researchers found that very old patients treated with targeted agents exhibited comparable survival to their younger counterparts.

The most common first-line treatment regimens were venetoclax plus obinutzumab (82%), demystification of bendamustine with ibrutinib plus obinutuzumab (9%), venetoclax plus obinutuzumab and ibrutinib (6% ), and bendamustine with ibrutinib plus ofatumumab (3%). ORR was 73%, with 36% of patients achieving CR. The rates of measurable, undetectable residual disease in this subgroup were 73% in peripheral blood and 39% in bone marrow.

Based on the mean death rate in the ≥80 years age group, the standardized death ratio was 0.78 (95% confidence interval 0.39-1.4), with 11 deaths observed versus 14 expected deaths.

“Very elderly patients treated with targeted agents have a survival comparable to that of a population of the same age and the same sex, which suggests that the initiation of treatment in elderly and potentially frail patients is beneficial”, the authors concluded. “Dedicated studies are warranted for this clinical context. “

More ASH: High level of undetectable MRD with venetoclax diet in CLL

First-Line Targeted Treatment for CLL Benefits in Elderly Patients, Study Finds

Prognostic factors for ruxolitinib failure in chronic GVHD

A poster presented at ASH 2021 reported several factors associated with ruxolitinib failure in patients with chronic graft-versus-host disease (GVHD), including the severity of GVHD and the type of organ damage.

In addition, the researchers conducted an analysis of real-world data regarding the effectiveness of ruxolitinib in 47 patients with chronic GVHD. The ORR was 46.8%, 61.8% and 62.3% at three, six and 12 months. However, patients with severe grade cGVHD showed less than six months FIT rate compared to those with moderate / mild grade cGVHD (46.6% vs. 81.1%).

The researchers observed a treatment failure rate of 33.4%. At 12 months, the failure-free survival rate in the general population was 64.6%, while the overall survival rate was 83.3%. The authors found no difference in ORR between patients with steroid-resistant and steroid-dependent cGVHD, or according to previous treatment with a tyrosine kinase inhibitor for GVHD.

Learn more about ASH: Evaluating adoptive immunotherapy to prevent acute GVHD

Analysis identifies prognostic factors for ruxolitinib failure in chronic GVHD

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