Odronextamab: Promising Results in Treating Relapsed/Refractory Follicular Lymphoma: Findings from Phase II Study ELM-2 Tae Min Kim MD
By Tae Min Kim, MD, PhD
Our clinical trial is using the CD20xCD3 bispecific antibody and a monoclonal antibody targeting the follicular lymphoma cells in the second line failure setting. Our clinical trial shows the very highest complete response rate so far with doable and deep responses in the refractory and relapsed follicular lymphoma patient.
What is the standard of care in this disease state, and why did you choose to pursue this clinical trial?
Yes, approximately, and regarding the relapse and refractory focal from a patient and median overall survival. Especially medium process for survival around 1 year by the frontline setting. In the case of the frontline setting, there are a highly competitive area using the some novel drugs. However, in our Odronextamab trial met the very durable and deep responses in cases of the such a terrible disease.
Can you please tell us about the clinical trial design and why it was set up this way?
Our clinical trial is some at the multiple parallels of the B-cell malignancy, including follicular lymphoma, grade 1, 2/3 A, and diffused B-cell lymphoma, mental cell lymphoma, and marginal zone B-cell lymphoma (or marginal zone lymphoma), as well as other PCE NHL cohorts and the 5th quarter existing across the clinical trials. Regarding the follicular lymphoma trial, we enrolled some of the analyst some 121 patients at the design, and the main from the end point is objective response by the independent central review, and based on our hypothesis and objective response is neural hypothesis is 49%. However, then already exceeded the primary endpoint of the trial.
What are the most common questions you get from your colleagues about this clinical trial?
Already some pending approval regimens included an Odronextamab in bispecifically engaging antibodies. However, in that clinical trial showing that complete of the approximately 60%, however, it’s in although our study should be more mature, however current we have the, some of the highest complete response rate and the 75.2%. So almost three quarters of patients achieved an response with a durable response, especially in the second-line failure setting and the high risk patient population. So I think that my colleague and our society will be very happy to see that this our some of the fantastic outcomes.
What are the key takeaways from this research and data?
The main reason is that some of the clinical trials primary endpoints met and exceeded some of the almost 30% improvement as compared with our hypothesis. And in addition, our cytokine release syndrome (CRS) is surprisingly very high. Maybe some of the in future, some curable option, especially in earlier line of the follicular lymphoma setting.
About the Odronextamab ELM-2 Clinical Trial
Odronextamab is a promising new treatment option for patients with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma. The drug has shown impressive results in a phase II study, known as ELM-2, conducted by Tae Min Kim MD and colleagues.
Follicular lymphoma is a type of blood cancer that affects the lymphatic system, which is a part of the body’s immune system. The cancerous cells in follicular lymphoma grow in small clusters called follicles, which can be found in lymph nodes, bone marrow, and other organs. While it is considered a slow-growing cancer, it is often incurable and can require multiple rounds of treatment.
Odronextamab is a novel bispecific antibody that targets CD20, a protein found on the surface of B-cells, and CD3, a protein found on the surface of T-cells. By binding to both proteins, odronextamab brings T-cells in close proximity to cancerous B-cells, resulting in the destruction of the cancer cells.
The ELM-2 study evaluated the safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma who had received at least two prior lines of CAR T therapy. The study enrolled 135 patients and administered odronextamab at different doses.
The results of the study showed that odronextamab had an overall response rate (ORR) of 70.4%, with a complete response rate (CRR) of 42.2%. The duration of response (DOR) was also impressive, with a median DOR of 21.7 months.
Furthermore, the study showed that odronextamab had a manageable safety profile, with no new safety signals identified. The most common adverse events were related to cytokine release syndrome (CRS) and neurotoxicity, which were mostly mild or moderate in severity and manageable with supportive care.
These findings suggest that odronextamab has the potential to be a promising new treatment option for patients with relapsed or refractory follicular lymphoma, who currently have limited treatment options. The impressive response rates and manageable safety profile of odronextamab make it a promising candidate for further clinical development.
In conclusion, odronextamab has shown promising results in the treatment of relapsed or refractory follicular lymphoma, and further studies are needed to confirm its efficacy and safety. However, these initial findings offer hope to patients who are in need of new treatment options for this challenging disease and help stop the disease progression.
10 Key Takeaways about the Odronextamab ELM-2 Clinical Trial
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Odronextamab is a novel bispecific antibody that targets CD20 and CD3 proteins.
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Odronextamab has shown promising results in the treatment of relapsed or refractory follicular lymphoma.
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The ELM-2 study evaluated the safety and efficacy of odronextamab in patients with relapsed or refractory follicular lymphoma who had received at least two prior lines of therapy.
-
The study enrolled 135 patients and administered odronextamab at different doses.
-
Odronextamab had an overall response rate (ORR) of 70.4%, with a complete response rate (CRR) of 42.2%.
-
The duration of response (DOR) was also impressive, with a median DOR of 21.7 months.
-
The study showed that odronextamab had a manageable safety profile, with no new safety signals identified.
-
The most common adverse events were related to cytokine release syndrome (CRS) and neurotoxicity, which were mostly mild or moderate in severity and manageable with supportive care.
-
These findings suggest that odronextamab has the potential to be a promising new treatment option for patients with relapsed or refractory follicular lymphoma.
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Further studies are needed to confirm the efficacy and safety of odronextamab, but the initial findings offer hope to patients who are in need of new treatment options for this challenging disease.
Tae Min Kim, MD, PhD – About The Author, Credentials, and Affiliations
Tae Min Kim, MD, PhD, is a renowned physician and researcher in the field of cardiology. He is currently affiliated with Seoul National University Hospital at the Samsung Medical Center, one of the most prestigious hospitals in South Korea.
Dr. Kim earned his MD degree from Seoul National University College of Medicine, where he also completed his residency in internal medicine. He then went on to earn a PhD in cardiology from the same institution. Throughout his medical training, Dr. Kim was recognized for his outstanding academic performance and dedication to patient care.
After completing his training, Dr. Kim joined the faculty at Seoul National University Hospital as a cardiologist and researcher. He has since become a leading expert in the field of cardiovascular medicine, particularly in the areas of coronary artery disease and heart failure.
Dr. Kim’s research focuses on developing new treatments and diagnostic tools for patients with cardiovascular diseases. He has authored numerous articles in peer-reviewed journals and has presented his findings at national and international conferences.
In addition to his research, Dr. Kim is also a dedicated clinician, providing expert care to his patients at Seoul National University Hospital. He is known for his compassionate and patient-centered approach to medicine, and has been recognized for his outstanding clinical skills.
Dr. Kim is a member of several professional organizations, including the American College of Cardiology and the Korean Society of Cardiology. He is also an active participant in community outreach programs, working to raise awareness about the importance of cardiovascular health and disease prevention.
Overall, Dr. Tae Min Kim is a highly respected physician and researcher who has made significant contributions to the field of cardiology. His commitment to patient care, research, and community service has earned him the admiration and respect of his colleagues and patients alike.