Highlighted Abstract Summaries

Safety Outcomes in Adult Patients with AML Who Achieved Their First Complete Remission with Gemtuzumab Ozogamicin (GO) Prior to HSCT

Authors: Nelli Bejanyan, Vincent Ho, Miguel-Angel Perales, et al.

This study explored the safety of GO in AML patients in first complete remission (CR1) undergoing HSCT. Among 84 patients, non-fatal hepatic veno-occlusive disease (VOD) occurred in 7%, with most cases being mild, and no VOD-related deaths. The cumulative incidences of transplant-related mortality (TRM) were 7% at 6 months and 15% at 2 years. The 2-year relapse rate was 26%, and leukemia-free survival (LFS) outcomes at 1 and 2 years were 68% and 59%, respectively. Median follow-up was 23.9 months.

The findings suggest that GO prior to HSCT is safe, with low post-transplant VOD rates and comparable TRM and survival outcomes to historical rates. This study supports the use of GO in AML patients in CR1 before undergoing HSCT.

Relevance: For practicing oncologists, these results provide evidence supporting the safety profile of GO in AML patients achieving CR1 before HSCT, underscoring its potential benefits in clinical practice.

Safety Outcomes in Patients with Acute Myeloid Leukemia Receiving Gemtuzumab Ozogamicin and Proceeding to Allogeneic Hematopoietic Stem Cell Transplantation

Authors: Partow Kebriaei, Vincent Ho, Miguel-Angel Perales, et al.

This study assessed the safety of gemtuzumab ozogamicin (GO) in adult AML patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). The study included 157 patients, with 84 in first complete remission (CR1), 48 in second remission (CR2), and 25 in third or greater remission, relapse, or primary induction failure. Non-fatal hepatic veno-occlusive disease (VOD) was reported in 4% of patients, with no VOD-related deaths. The six-month transplant-related mortality (TRM) was 8%, and the 100-day VOD incidence was 5%. Median follow-up was 12.9 months.

The findings suggest that GO is safe prior to HSCT, with VOD and TRM rates comparable to historical data. No new safety concerns were identified, indicating that GO does not significantly increase the risk of serious adverse events post-HSCT.

Relevance: These findings are significant for oncologists considering GO treatment before HSCT, offering reassurance about its safety and supporting its inclusion in pre-HSCT regimens.

A Phase 1b/2 Study of Pivekimab Sunirine (PVEK, IMGN632) in Combination with Venetoclax/Azacitidine for Patients with Newly Diagnosed CD123-Positive Acute Myeloid Leukemia

Authors: Naval Guastad Daver, Pau Montesinos, Jessica K. Altman, et al.

This phase 1b/2 study investigates the combination of Pivekimab Sunirine (PVEK, IMGN632), Venetoclax (VEN), and Azacitidine (AZA) in newly diagnosed (ND) CD123-positive AML patients. PVEK is an antibody-drug conjugate targeting CD123, which is highly expressed on AML cells. Patients receive PVEK with AZA and VEN in a 28-day cycle. Preliminary data showed a 76% measurable residual disease (MRD)-negative rate among 50 patients, supporting further evaluation of this regimen's antileukemia activity and safety.

The findings suggest that the PVEK+AZA+VEN triplet has promising antileukemia activity, particularly in achieving high MRD negativity rates. This study supports the potential of this combination therapy in treating ND CD123-positive AML patients, indicating a possible registration-enabling trial in the future.

Relevance: These results are crucial for oncologists as they highlight a new potential treatment combination for CD123-positive AML, offering hope for improved patient outcomes in a challenging subset of AML.

Patients with Relapsed/Refractory mIDH1 AML Who Proceeded to Transplant After Olutasidenib Treatment

Authors: Stéphane De Botton, Justin M. Watts, Brian Andrew Jonas, et al.

This study evaluates the outcomes of relapsed/refractory (R/R) mIDH1 AML patients who proceeded to hematopoietic stem cell transplantation (HSCT) after achieving remission with olutasidenib (OLU). Among 153 patients treated with OLU, 16 proceeded to HSCT. The response rate to OLU was 75%, with 69% achieving complete remission (CR) and 6% CR with partial hematologic recovery (CRh). At 100 days post-HSCT, all patients were alive, and the overall survival probability was 94% at 12 months and 61% at 24 months.

The findings suggest that OLU is effective in achieving remission in R/R mIDH1 AML patients, enabling them to proceed to potentially curative HSCT. This study supports the use of OLU as a bridging therapy to HSCT in this patient population.

Relevance: For practicing oncologists, these results highlight the potential of OLU to enable HSCT in R/R mIDH1 AML patients, offering a pathway to improved survival outcomes in a difficult-to-treat population.

Frailty Risk Assessment and Impact on Acute Myeloid Leukemia Outcomes (FRAIL-AML): A Population-Based Study from Ontario, Canada

Authors: Gopila Gupta, Sho Podolsky, Ning Liu, et al.

This population-based study from Ontario, Canada, examined the impact of frailty on AML outcomes using the McIsaac's frailty index (MFI). Among 5,450 patients, 65% received intensive treatment (IT) and 35% received non-intensive treatment (NIT). Frailty was associated with worse overall survival (OS) in both IT and NIT groups. The study identified a mismatch in treatment intensity based on frailty status, with 30% of frail patients receiving IT and over 25% of fit patients receiving NIT.

The findings highlight the importance of frailty assessment in optimizing AML treatment decisions. This study supports the integration of standardized frailty evaluations in clinical practice.

Relevance: For oncologists, these results underscore the need for frailty assessments to guide treatment intensity, improving AML patient outcomes through personalized therapy.

Phase I Study of Functionally Enhanced CD33 CAR-T Cells in Patients with Relapsed or Refractory Acute Myeloid Leukemia

Authors: Jing Pan, Shiyu Zuo, Chuo Li, et al.

This Phase I study evaluated the safety and efficacy of functionally enhanced CD33 CAR-T cells in relapsed/refractory (R/R) AML patients. Four patients, including three post-stem cell transplantation, were treated with an initial dose of CAR-T cells. Cytokine release syndrome (CRS) occurred in 75% of patients, with one experiencing grade 4 CRS. Two patients achieved complete remission with incomplete hematologic recovery (CRi) and were MRD-negative at day 30, while two had no response. The functionally enhanced CD33 CAR-T cells showed potential, with two patients remaining disease-free for over two years.

The findings suggest that functionally enhanced CD33 CAR-T cells can induce remissions in R/R AML patients. However, the depletion of normal CD33-positive cells remains a challenge. This study supports further research to optimize CAR-T cell therapy for AML.

Relevance: These results highlight the potential of enhanced CD33 CAR-T cells in treating R/R AML, providing oncologists with insights into new therapeutic strategies.

Importance of Staying Current with New Data

In the ever-evolving field of oncology, staying abreast of the latest research and clinical developments is paramount. The treatment landscape for AML is rapidly changing, with new therapies and combinations being explored and validated through ongoing clinical trials. Integrating new data into clinical practice is essential to providing the best possible care for patients.

The ASCO Annual Meeting is a crucial venue for disseminating groundbreaking research and clinical insights. By staying informed of the latest findings, you have the potential to effectively implement the most up-to-date treatment strategies for your patients with AML. We encourage you to visit The Practical Hematologist website to review the detailed summaries of more than 20 AML-focused abstracts from the 2024 ASCO meeting, which provide valuable information on novel therapies and their implications for clinical practice.

Staying current with new data not only enhances clinical practice but also contributes to improved patient outcomes. We hope these summaries and insights support you in your efforts to provide cutting-edge care to your patients.

Click here for more detailed summaries and insights into advances in AML as presented at ASCO 2024.

References:

Nelli Bejanyan et al., Safety outcomes in adult patients with AML who achieved their first complete remission with GO prior to HSCT. JCO 42, e18504-e18504(2024). DOI:10.1200/JCO.2024.42.16_suppl.e18504

Partow Kebriaei et al., Safety outcomes in patients with acute myeloid leukemia receiving gemtuzumab ozogamicin and proceeding to allogeneic hematopoietic stem cell transplantation. JCO 42, 6516-6516(2024). DOI:10.1200/JCO.2024.42.16_suppl.6516

Naval Guastad Daver et al., A phase 1b/2 study of pivekimab sunirine (PVEK, IMGN632) in combination with venetoclax/azacitidine for patients with newly diagnosed CD123-positive acute myeloid leukemia. JCO 42, TPS6585-TPS6585(2024). DOI:10.1200/JCO.2024.42.16_suppl.TPS6585

Stéphane De Botton et al., Patients with relapsed/refractory mIDH1 AML who proceeded to transplant after olutasidenib treatment. JCO 42, e18516-e18516(2024). DOI:10.1200/JCO.2024.42.16_suppl.e18516

Gopila Gupta et al., Frailty risk assessment and impact on acute myeloid leukemia outcomes (FRAIL-AML): A population-based study from Ontario, Canada. JCO 42, 6506-6506(2024). DOI:10.1200/JCO.2024.42.16_suppl.6506

Jing Pan et al., Phase I study of functionally enhanced CD33 CAR T cells in patients with relapsed or refractory acute myeloid leukemia. JCO 42, 6518-6518(2024). DOI:10.1200/JCO.2024.42.16_suppl.6518

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