EHA 2023: Key Sessions to Watch Out!
The European Hematology Association (EHA) is a leading organization committed to advancing patient care, research, and education in hematology. As the largest European-based organization connecting hematologists globally, it supports career development, promotes research, harmonizes hematology education, and advocates for hematologists and hematology. With its mission to promote excellence in patient care, research and education in hematology, the EHA annual meeting is back this year from June 8-15, 2023, in Frankfurt, Germany.
Ferma.AI has analyzed all 3,141 abstracts for the upcoming EHA conference, which were released on May 11, 2023 and has identified the sessions that are anticipated to generate the most significant interest among attendees.
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Highly Anticipated Sessions, by Indications
- ASCEMBL, Novartis (Abstract)
- QuANTUM-First, Daiichi Sankyo (Abstract)
- SIERRA, Actinium Pharmaceuticals & Loxo Oncology (Abstract)
- QUIWI, Daiichi Sankyo & Dynamic Science (Abstract)
- MIRAGE, Kyowa Kirin (Abstract)
- LOTIS-2, ADC Therapeutics (Abstract)
- EPCORE NHL-2, AbbVie & Genmab (Abstract)
- POLAR BEAR, Roche (Abstract)
- KarMMa-3,Bristol Myers Squibb & Celgene (Abstract)
- DREAMM-5, GlaxoSmithKline & SpringWorks Therapeutics (Abstract)
- MajesTEC-2, Janssen (Abstract)
Highly Anticipated Sessions in Myeloid Leukemia
Rapid And Deep Responses With Asciminib In Patients (Pts) With Chronic Myeloid Leukemia In Chronic Phase (Cml-Cp) After >=2 Prior Tyrosine Kinase Inhibitors (Tkis) In The Phase 3 Ascembl Study
Ascembl | NCT03106779 | Chronic Phase Chronic Myeloid Leukemia | Novartis | Abstract
The ASCEMBL study compared the efficacy and safety of asciminib (ASC) and bosutinib (BOS) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who had previously failed ≥2 tyrosine kinase inhibitors (TKIs). Overall MMR rates at week 96 were higher with ASC than BOS regardless of the last prior TKI received (imatinib,55.6% vs 14.3%; nilotinib, 40.9% vs 35.7%; dasatinib, 37.1% vs 10.5%; radotinib, 50.0% vs 0%; ponatinib, 20.0% vs11.8%) and reason for its discontinuation. Overall, ASC showed higher MMR rates than BOS regardless of prior TKIs or reasons for discontinuation. These findings support ASC as a new standard of care for CML-CP patients who have failed ≥2 prior TKIs.
Impact Of Allogeneic Hematopoietic Cell Transplantation In First Complete Remission Plus Flt3 Inhibition With Quizartinib In Acute Myeloid Leukemia With Flt3-Itd: Results From Quantum-First
Quantum-First | NCT02668653 | Acute Myeloid Leukemia | Daiichi Sankyo | Abstract
The QuANTUM-First study evaluated the efficacy of quizartinib (Quiz), a selective FLT3 inhibitor, in combination with standard chemotherapy in newly diagnosed acute myeloid leukemia (AML) patients with FLT3-ITD mutations. A multivariable extended Cox regression was conducted in all randomized patients, stratified by region, age, and WBC, including allo-HCT in CR1 as time dependent and adjusted for FLT3-ITD variant allele frequency and sex. This analysis revealed Quiz treatment (hazard ratio [HR], 0.770) and allo-HCT in CR1 (HR, 0.424) as favorable factors to OS. The impact of allo-HCT in CR1 was found to be a favorable factor for OS. Quiz demonstrated superior OS regardless of pre-allo-HCT minimal residual disease (MRD) status.
Sierra Trial Results With A Targeted Radiotherapy, Iomab-B, A Myeloablative Conditioning With Reduced Intensity Tolerability Yields High Cr, Long Term Survival In Hsct Ineligible Active R/R Aml
Sierra | NCT02665065 | Relapsed/Refractory Acute Myeloid Leukemia | Actinium Pharmaceuticals, Loxo Oncology | Abstract
The SIERRA phase 3 study compared the efficacy of Iomab-B-based conditioning with physician's choice of conventional care (CC) in older, relapsed/refractory acute myeloid leukemia patients ineligible for hematopoietic stem cell transplantation (HSCT). Median OS in the CO vs non-CO cohorts on the CC arm was 7.1 vs 3.2 months (HR=0.51). OS in patients receiving Iomab-B and HSCT achieving dCR (n=13) was 92% and 60% at 1 and 2 yrs respectively. Event-free survival (EFS) at 6 mos on Iomab-B vs CC was 26% vs 0.2%. Iomab-B-based conditioning followed by HSCT demonstrated favorable safety and tolerability. These results suggest that Iomab-B could be a promising option for older AML patients who are not candidates for HSCT.
Preliminary Results Of Quiwi: A Double Blinded, Randomized Clinical Trial Comparing Standard Chemotherapy Plus Quizartinib Versus Placebo In Adult Patients With Newly Diagnosed Flt3-Itd Wild-Type Aml
Quiwi | NCT04107727 | Adult Newly Diagnosed Flt3-Itd Wild-Type Acute Myeloid Leukemia | Daiichi Sankyo, Dynamic Science | Abstract
The QUIWI trial aimed to evaluate the efficacy of quizartinib (Quiz), in newly diagnosed FLT3-ITD wild-type acute myeloid leukemia patients. In this double-blind, placebo-controlled phase II trial, Quiz was added to the standard 3+7 chemotherapy regimen. Median EFS was 16.6 months with Quiz vs 10.6 months with PBO (HR, 0.729). Regarding OS, 50 out of 180 patients died in the Quiz arm, and 45 out of 93 in the PBO. Median OS was not reached with Quiz vs 15 months with PBO (HR, 0.558),and the 2-years OS was 63.5% with Quiz vs 47% with PBO. The EFS was also higher in the Quiz arm, although not statistically significant. These findings suggest that Quiz may prolong OS in FLT3-ITD wild-type AML patients, warranting further investigation.
Highly Anticipated Sessions in Lymphoma
Efficacy And Safety Of Zandelisib Administered By Intermittent Dosing In Japanese Patients With Relapsed/Refractory Indolent B-Cell Non-Hodgkin'S Lymphoma: Primary Analysis Of The Phase 2 Study Mirage
Mirage | NCT04533581 | Relapsed/Refractory Indolent B-Cell Non-Hodgkin's Lymphoma | Kyowa Kirin | Abstract
The MIRAGE trial evaluated the efficacy and safety of zandelisib, an oral selective PI3Kδ inhibitor, in Japanese patients with relapsed/refractory indolent B-cell non-Hodgkin's lymphoma (B-NHL). The study included 61 patients with follicular lymphoma (FL) or marginal zone lymphoma (MZL). Zandelisib demonstrated a high objective response rate (ORR) of 75.4%, with 24.6% achieving complete response (CR). The treatment was well-tolerated, with a low discontinuation rate due to adverse events. These findings suggest that zandelisib may be a promising therapeutic option for Japanese patients with relapsed/refractory indolent B-NHL.
Long-Term Responses With Loncastuximab Tesirine: Updated Results From Lotis-2, The Pivotal Phase 2 Study In Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Lotis-2 | NCT03589469 | Relapsed/Refractory Diffuse Large B-Cell Lymphoma | ADC Therapeutics | Abstract
Loncastuximab tesirine (Lonca), showed promising antitumor activity in heavily pretreated patients in the LOTIS-2 phase 2 study. Among all patients, the mDOR was 13.4 months (95% CI: 6.9, -), mPFS 4.9 months (2.9, 8.3), and mOS 9.5 months (6.7, 11.5). Among patients with CR, the mDOR, mPFS, and mOS were NR. Safety profile was manageable, and a subset of patients achieved event-free CR for ≥ 2 years. Further investigation is warranted to identify factors predicting long-term response to Lonca.
High Complete Metabolic Response Rates With Epcoritamab + R-Chop In Previously Untreated (1L) Patients With High-Risk Diffuse Large B-Cell Lymphoma, Including Double/Triple-Hit: Epcore Nhl-2 Update
EPCORE NHL-2 | NCT04663347 | Previously Untreated First-Line High Risk Double/Triple-Hit Diffuse Large B-Cell Lymphoma | AbbVie, Genmab | Abstract
Preliminary results from the phase 1/2 EPCORE NHL-2 trial evaluating epcoritamab plus R-CHOP in 1L DLBCL showed high complete metabolic response (CMR) rates and durable responses, including in double-hit/triple-hit DLBCL patients. The response rates were similar for patients with double-hit/triple-hit DLBCL (overall response rate was 100%; CMR rate was 82%). Responses were durable; at 9 months , an estimated 96%of patients with CMR remained in CMR. Subcutaneous epcoritamab plus R-CHOP exhibited promising outcomes and supports the ongoing phase 3 study in 1L DLBCL.
Initial Safety Data From The Phase 3 Polar Bear Trial In Elderly Or Frail Patients With Diffuse Large Cell Lymphoma, Comparing R-Pola-Mini-Chp And R-Mini-Chop
POLAR BEAR | NCT04332822 | Elderly Diffuse Large Cell Lymphoma | Roche | Abstract
POLAR BEAR trial evaluated pola-R-miniCHP compared to standard R-mini-CHOP in elderly/frail DLBCL patients. Safety data from 127 patients showed both regimens were tolerable. Polatuzumab vedotin substitution did not increase hematological toxicity or infection risk but led to more gastrointestinal adverse events. Vigilance in monitoring side effects is crucial when using this regimen in the elderly population.
Highly Anticipated Sessions in Multiple Myeloma
Idecabtagene Vicleucel (Ide-Cel) Vs Standard Regimens In Patients With Triple-Class-Exposed (Tce) Relapsed And Refractory Multiple Myeloma (Rrmm): A Karmma-3 Analysis In High-Risk Subgroups
KarMMa-3 | NCT03651128 | Relapsed/Refractory High-risk Multiple Myeloma | Bristol Myers Squibb, Celgene | Abstract
The KarMMa-3 study aimed to assess the efficacy and safety of ide-cel in high-risk patients. With a median follow-up of 18.6 months (range: 0.4–35.4), patients treated with ide-cel demonstrated longer median progression-free survival (mPFS) compared to standard regimens across all high-risk subgroups, including cytogenetic abnormalities (mPFS: 11.9 vs. 4.2 months), R-ISS stage 3 disease (mPFS: 5.2 vs. 3.0 months), high tumor burden (mPFS: 11.0 vs. 4.9 months), EMP (mPFS: 7.2 vs. 2.0 months), and TCR disease (mPFS: 11.2 vs. 3.5 months). Additionally, complete response rates (CRRs) were improved with ide-cel compared to standard regimens in all high-risk subgroups: cytogenetic abnormalities (31.8 vs 4.9%), R-ISS stage 3 (16.1 vs 7.1%), high tumor burden (31.0 vs8.8%), EMP (23.0 vs 3.1%), and TCR disease (33.5 vs 1.1%). These findings support the utilization of ide-cel in patients with heavily treated, high-risk multiple myeloma.
Low-Dose Belantamab Mafodotin (Belamaf) In Combination With Nirogacestat Vs Belamaf Monotherapy In Patients With Relapsed/Refractory Multiple Myeloma (Rrmm): Phase 1/2 Dreamm-5 Platform Sub-Study 3
DREAMM 5 | NCT04126200 | Relapsed/Refractory Multiple Myeloma | GlaxoSmithKline, SpringWorks Therapeutics | Abstract
DREAMM-5 is a Phase 1/2 study investigating Belantamab mafodotin (belamaf) combinations. This sub-study compared low-dose belamaf + nirogacestat to belamaf alone in triple-class refractory RRMM patients. For the combination and monotherapy arms, respectively, ORR was 29% and 38%. Incidence of Grade ≥3 adverse events was 76% and 65%. The combination demonstrated an encouraging ORR with reduced high-grade ocular events, suggesting increased BCMA target density. Safety and efficacy data were consistent with previous studies.
Teclistamab (Tec) + Nirogacestat (Niro) In Relapsed/Refractory Multiple Myeloma (Rrmm): The Phase 1B Majestec-2 Study
MajesTEC-2 | NCT04722146 | Relapsed/Refractory Multiple Myeloma | Janssen | Abstract
The MajesTEC-2 trial investigated the combination of the BCMA-directed bispecific antibody teclistamab with the gamma-secretase inhibitor nirogacestat in patients with relapsed/refractory multiple myeloma. Three dose levels were evaluated, and the combination demonstrated response rates ranging from 57% to 92%. The most common treatment-emergent adverse events included neutropenia, cytokine release syndrome, and diarrhea. The combination shows promise in enhancing BCMA-directed therapies with a gamma-secretase inhibitor.
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