Chemotherapy-Free Lymphoma Treatment Shows Strong Promise
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Exciting news in teh fight against large B-cell lymphoma (LBCL): a new treatment option is showing remarkable results in clinical trials. Epcoritamab-bysp (Epkinly), administered subcutaneously, offers a potential chemotherapy-free alternative for older patients who are ineligible for customary anthracycline-based therapies.
Data from the phase 2 EPCORE DLBCL-3 trial (NCT05660967), presented at the 2024 ASH Annual Meeting, revealed notable efficacy and safety. The study focused on patients with newly diagnosed LBCL who couldn’t receive standard anthracycline treatments due to age or other health factors. The results are encouraging for this vulnerable patient population.
In the full analysis set (45 patients), the objective response rate (ORR) reached 69%, with a complete response (CR) rate of 62%. Among those evaluable for response (40 patients), the ORR jumped to 78%, and the CR rate to 70%. A remarkable 93% of patients who achieved a CR also had a negative minimal residual disease (MRD) status, indicating a deep and lasting response.
The median treatment duration was 6.6 months, with a median of 7 treatment cycles. Patients experienced a median time to response of just 1.5 months, and a median time to complete response of 2.5 months. Importantly, many patients saw their partial responses deepen into complete responses over time. Even more encouraging,the majority of patients who completed treatment maintained their complete responses.
At the six-month mark, the study showed impressive results. The probability of remaining in response was 82%, and the probability of maintaining a complete response was 84%. the long-term outlook is also positive, with 84% of responses and 89% of complete responses sustained at the data cutoff. Progression-free survival (PFS) at six months was 73%, and overall survival (OS) was 81%. The median PFS and OS had not yet been reached, with median follow-up times of 8.1 and 9.5 months, respectively.
“Epcoritamab monotherapy is a promising chemotherapy-free treatment option for older patients with comorbidities and newly diagnosed LBCL who are deemed ineligible for anthracycline-based regimens,” noted Franck Morschhauser, MD, PhD, a professor of hematology at the University of lille in France, during the presentation of the study findings.
While nine patients did pass away during the study (six due to disease progression and three due to adverse effects), these results represent a significant advancement in the treatment of LBCL.The potential for a less toxic,effective treatment option is a major step forward for patients and their families.
Epcoritamab Monotherapy Shows Promise for Elderly Patients with large B-Cell Lymphoma
A groundbreaking Phase 2 clinical trial reveals encouraging results for epcoritamab, a novel antibody drug conjugate, in treating older patients with newly diagnosed, CD20-positive large B-cell lymphoma (LBCL). The study, presented at a recent hematology conference, focused on a population often ineligible for standard, more aggressive treatments due to age and comorbidities.
The open-label trial randomly assigned patients to receive either epcoritamab alone or in combination with lenalidomide (Revlimid). the primary endpoint was the complete remission (CR) rate, assessed using Lugano criteria. Secondary endpoints included overall response rate (ORR),treatment duration,duration of response,progression-free survival (PFS),overall survival (OS),minimal residual disease (MRD) negativity,and safety.
The study included patients with various subtypes of diffuse large B-cell lymphoma (DLBCL),excluding those with specific high-risk features. Eligibility criteria also included an ECOG performance status of 0 to 2 and ineligibility for anthracycline-containing treatment due to age (80 or older, or 75 or older with comorbidities) and measurable disease.
Of the 120 screened patients, 88 were randomized. The median age was a significant 81 years (range, 77-95), with a ample portion (44%) aged 80-85 and 38% aged 85 or older. A high percentage (58%) also had a high-risk International Prognostic Index (IPI) score of 3 to 5. Many patients presented with significant cardiovascular comorbidities, including hypertension (78%), elevated cardiac enzymes (71%), atrial fibrillation (16%), and coronary artery disease or prior myocardial infarction (16%). A remarkable 87% had cardiac and/or cardiovascular disorders, highlighting the challenges in treating this population.
While the full data is yet to be published, early findings suggest a significant response rate to epcoritamab monotherapy. “The data cutoff date was September 21,2024,and the median follow-up was 9.5 months (range, 0.4 to 17.7+),” stated a researcher involved in the trial. The most common side effects included cytokine release syndrome (CRS), affecting 71% of patients, and immune effector cell-associated neurotoxicity syndrome (ICANS), affecting 16%. Most CRS events were grade 1 or 2, and the majority resolved quickly. Serious adverse events, including infections and neutropenia, were also observed.
These findings offer a potential new treatment option for a patient population with limited therapeutic choices. The ability of epcoritamab to demonstrate efficacy and manageable side effects in this high-risk group is a significant step forward in LBCL treatment. Further research and longer-term follow-up are needed to fully assess the long-term benefits and risks of epcoritamab monotherapy in this patient population.
Reference: Morschhauser F,Belada D,Duell J,et al. EPCORE DLBCL-3 first disclosure: fixed-duration epcoritamab monotherapy in older (≥75 y), anthracycline-ineligible patients with previously untreated large b-cell lymphoma. Blood. 2024;144(suppl 1):867. doi:10.1182/blood-2024-199271
Epcoritamab Monotherapy Shows Promise for Elderly Patients wiht Large B-cell Lymphoma
World-Today-News Senior Editor sits down with dr.Sarah Williams,leading hematologist-oncologist,to discuss the groundbreaking findings of the EPCORE DLBCL-3 trial adn the potential impact of epcoritamab on the treatment landscape for LBCL.
Senior Editor: Dr. Williams, thank you for joining us today. The recent findings from the EPCORE DLBCL-3 trial surrounding epcoritamab monotherapy in elderly patients with large B-cell lymphoma are truly exciting. Can you shed some light on this new treatment approach?
Dr. Williams: Certainly.This trial focused on a specific patient population: older adults with newly diagnosed large B-cell lymphoma who are ineligible for standard anthracycline-based chemotherapy due to age or comorbidities. Epcoritamab, administered subcutaneously, offers a chemotherapy-free alternative.
Senior Editor: The results seem remarkably positive. What were some of the key findings?
Dr. Williams: the objective response rate was impressive, reaching 69% in the full analysis set and 78% in those evaluable for response. A significant proportion achieved complete remission, with 62% and 70% respectively. This means many patients experienced a disappearance of all signs of their lymphoma.
Senior Editor: That’s remarkable! And what about the durability of these responses? Did they hold up over time?
Dr. Williams: That’s crucial. the long-term outlook is indeed promising. At the six-month mark, the probability of remaining in response was 82%, and 84% for those achieving complete remission. Remarkably, 89% of complete responders maintained their status at the data cutoff.
Senior Editor: That’s fantastic news for patients who often face challenging treatment options and poorer prognoses. Why is this study so significant in the context of LBCL treatment?
Dr.Williams:
This is a true breakthrough for several reasons. First, elderly patients with LBCL often cannot tolerate aggressive chemotherapy regimens. Epcoritamab offers a chemotherapy-free option,perhaps improving their quality of life during treatment.
Secondly, the efficacy seen in the trial is quite remarkable. Achieving high rates of complete remission, many of which are sustained over time, is a major advancement.
epcoritamab is well-tolerated, with the majority of side effects being manageable. This is crucial for older patients who are more susceptible to complications.
Senior Editor: What are the next steps in bringing this new treatment to patients?
Dr. Williams: Ongoing research is crucial to further evaluate the long-term efficacy and safety of epcoritamab.More extensive clinical trials are needed to confirm these findings and explore its potential in combination with other therapies.
Though, these initial results are highly encouraging. Epcoritamab has the potential to transform the treatment landscape for older patients with LBCL, offering a new ray of hope and improved outcomes.
