EHA2024: Industry shares latest drug research in blood cancers

Blood cancer

A number of key findings in haematological malignancies were revealed at this year’s European Hematology Association (EHA) Congress, which was held in Madrid, Spain 13-16 June.

Ibrutinib and talquetamab, Johnson & Johnson

Johnson & Johnson shared clinical trial results for its drug candidates Talvey (talquetamab) and Imbruvica (ibrutinib).

CAPTIVATE Phase II trial: At five years, the clinical benefit of fixed-duration (FD) ibrutinib plus venetoclax was sustained in the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL). Sixty-seven percent of patients receiving the FD regimen were progression-free and overall survival (OS) was 96% for all treated patients. In patients relapsing after FD I+V, subsequent treatment with ibrutinib-based regimens yielded durable responses.

GLOW2: Time to next treatment (TTNT) extrapolation indicate that at six years, approximately 87% of FD I+V patients are unlikely to need second line treatment.

RESONATE-2 Phase III study: The results demonstrated a significant and sustained progression-free and overall survival benefit in patients with previously untreated CLL receiving ibrutinib monotherapy versus chlorambucil, at up to 10 years of follow-up.

MonumenTAL-13 Phase I/II study: Long-term follow-up data for talquetamab show high overall response rates and continued durable responses in multiple myeloma (MM) patients naïve and exposed to prior T-cell redirection therapy.

MonumenTAL-24: Phase Ib results show rapid, deep responses with talquetamab in combination with pomalidomide in relapsed and refractory MM, supporting combination of talquetamab with other anti-myeloma therapies.

Axicabtagene ciloleucel, Kite Pharma

Kite announced results from three new analyses for Yescarta (axicabtagene ciloleucel) in relapsed/refractory (R/R) Large B-cell Lymphoma (LBCL), including both new clinical research and real-world evidence, highlighting manufacturing, product characteristics, and outpatient administration of axicabtagene ciloleucel.

A comparative analysis of real-world and clinical trial data show higher manufacturing success rate and improved T-cell performance for axicabtagene ciloleucel in second-line versus third-line plus treatment of R/R LBCL CAR T-cell therapy.

Preliminary findings, including safety data, from the ZUMA-24 Phase II study suggest that outpatient administration of axicabtagene ciloleucel is feasible, when administered at a qualified treatment centre, at the physician’s discretion with appropriate monitoring.

 A real-world outpatient study also assessed trends in safety and hospitalisation for patients with R/R Non-Hodgkin lymphoma (NHL) who received axicabtagene ciloleucel and brexucabtagene autoleucel at Mayo Clinic. Analysis of safety trends reported that outpatient administration of axicabtagene ciloleucel and brexucabtagene autoleucel was possible without added toxicity.

Exagamglogene autotemcel, Vertex

Longer-term data for Casgevy (exagamglogene autotemcel [exa-cel]) from global clinical trials in people with severe sickle cell disease (SCD) or transfusion-dependent beta thalassemia (TDT) confirm the transformative, consistent and durable clinical benefits of exagamglogene autotemcel over time.

In SCD 92.3% evaluable patients (those with at least 16 months of follow-up) were free from vaso-occlusive crises (VOCs) for at least 12 consecutive months (VF12), consistent with the previously reported primary endpoint data. Mean duration of VOC-free was 27.9 months, with a maximum of 54.8 months.

In TDT 94.2% evaluable patients (those with at least 16 months of follow-up) were transfusion-independent for at least 12 consecutive months with a mean weighted haemoglobin of at least 9 g/dL (TI12), consistent with the previously reported primary endpoint data. Mean duration of transfusion independence was 31.0 months, with a maximum of 59.4 months.

Both SCD and TDT patients reported sustained and clinically meaningful improvements in their quality of life, including physical, emotional, social/family and functional well-being, and overall health status.

In both SCD and TDT patients, edited levels of BCL11A alleles were stable over time in bone marrow and peripheral blood indicating successful editing in the long-term haematopoietic stem cells. All patients engrafted neutrophils and platelets after exa-cel infusion. The safety profile of exa-cel was generally consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant.

Epcoritamab, AbbVie and Genmab

New data evaluating epcoritamab (Epkinly/Tepkinly) in patients with diffuse large B-cell lymphoma (DLBCL) and Richter’s transformation (RT) were presented.

EPCORE NHL-5 study: Results of epcoritamab in combination with Pola-R-CHOP in patients with first-line DLBCL showed strong responses with an overall response rate (ORR) of 100%, with 89% of patients achieving a complete response (CR).

Median follow-up was 5.8 months, with median time to response and time to CR were 2.7 months and 2.8 months, respectively.

EPCORE CLL-​1 trial: Results showed an ORR of 50% for patients treated with epcoritamab in a high-risk population of patients with RT (the transformation of CLL into an aggressive lymphoma, most commonly CD20+ DLBCL)

Median times to response and CR were short (1.4 months and 2.4 months, respectively), and an estimated 53% of patients with CR remained in CR at nine months.

Higher response rates were observed in previously untreated RT, with an ORR of 62% and a CR rate of 54%.

Acalabrutinib, AstraZeneca

Results from the ECHO Phase III trial showed AstraZeneca’s Calquence (acalabrutinib) in combination with bendamustine and rituximab demonstrated a statistically significant and clinically meaningful improvement in PFS and showed a favourable trend in OS compared to standard-of-care chemoimmunotherapy (bendamustine plus rituximab) in previously untreated patients with mantle cell lymphoma (MCL).

The acalabrutinib combination regimen reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy. Median PFS was 66.4 months for patients treated with the acalabrutinib combination versus 49.6 months with standard-of-care chemoimmunotherapy.

The secondary endpoint of OS showed a favourable trend for the acalabrutinib combination compared to standard-of-care chemoimmunotherapy.

Diana Spencer, Senior Digital Content Editor, DDW

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