Dr Jagannath on the Patient Population in the LINKER-MM1 Trial in Multiple Myeloma

Sundar Jagannath, MBBS, director, Center of Excellence for Multiple Myeloma, professor, medicine (hematology and medical oncology), The Tisch Cancer Institute, Mount Sinai, discusses the patient population 

evaluated in the phase 1/2 LINKER-MM1 trial

 (NCT03761108) of linvoseltamab (REGN5458) in relapsed/refractory multiple myeloma.

The patient characteristics of those enrolled in the LINKER-MM1 trial reveal a cohort that mirrors the demographic diversity and disease severity often encountered in real-world multiple myeloma populations, Jagannath begins. A total of 117 patients received the 200 mg dose of linvoseltamab across the phase 1 and phase 2 portions of the study. Additionally, 17.1% of the patients identified as African American, indicating a patient representation that aligns with the broader United States population, a factor significant for assessing external validity in clinical trials, he reports.

A notable inclusion criterion was the prerequisite for patients to have undergone at least 3 prior lines of therapy, including exposure to an immunomodulatory drug, a proteasome inhibitor, and daratumumab (Darzalex), Jagannath explains, saying that such requirements highlight the advanced disease state of the enrolled population. Moreover, the study design specifically allowed for inclusion of patients who were double refractory in the phase 1 portion and expanded to those who were triple-class refractory in phase 2, he notes.

The severity of disease burden was further evidenced by other clinical characteristics. Many patients had bone marrow infiltration exceeding 50% by plasma cells, indicating extensive myeloma involvement. The median soluble BCMA level, a marker correlating with tumor burden, was notably elevated at 368.0 ng/mL, with a broad range spanning from 18.7 ng/mL to 4430.0 ng/mL across patients, Jagannath expands. This collectively points to a population burdened by high tumor activity, a key consideration for understanding treatment response and outcomes, according to Jagannath.

Incorporation of patients with extramedullary disease, confirmed through independent review committee adjudication, further highlights the comprehensive spectrum of disease manifestations within the study cohort, he continues. The inclusion of diverse patient profiles aligns with the external validity criteria essential for regulatory evaluations, particularly for potential FDA assessments, Jagannath says. The study's ability to reflect the real-world patient population lends credence to the potential generalizability of findings to broader patient populations, Jagannath concludes.

Videos

Sundar Jagannath, MBBS, discusses the patient population evaluated in the LINKER-MM1 trial of linvoseltamab in relapsed/refractory multiple myeloma.

Vitaly Margulis, MD, urologic oncologist, Harold C. Simmons Comprehensive Cancer Center, professor, urology, Paul C. Peters, MD, Chair in Urology, UT Southwestern Medical Center, discusses significant factors and comorbidities that may affect treatment decisions for patients with renal cell carcinoma (RCC). 

® State of the Science Summit™, Margulis and colleagues from Moffitt Cancer Center each gave presentations on topics spanning RCC care. Margulis says that, in his approach to patient care, 2 primary factors guide his decision making. Firstly, the patient's unique characteristics and circumstances, including their overall performance status, play pivotal roles in treatment decisions, he explains. Additionally, Margulis considers a patient’s life expectancy based on their comorbidities. Knowing the patient's goals helps create a treatment plan that aligns with their expectations, Margulis notes. Symptoms also hold significant weight in the assessment of the patient, as does the socioeconomic support structure surrounding the patient, Margulis expands.

The second factor to consider centers around the specifics of the cancer itself. Understanding the extent of the disease is paramount, Margulis expands. Assessing the symptomatic nature of both the primary tumor and any metastatic sites provides valuable insights into symptom management and the overall burden of the disease on the patient, he notes.

Risk assessments are another critical aspect of making treatment decisions, particularly when metastatic disease is identified. Categorizing the patient into an appropriate risk group based on various factors, including the extent of metastasis and the cancer's aggressiveness, informs treatment decisions and helps predict outcomes, he says.

Furthermore, the patient’s socioeconomic status can affect treatment decisions. For example, many patients require systemic therapies that often necessitate travel to specialized cancer centers for infusions, Margulis continues. Some patients face logistical challenges in accessing these facilities due to geographical distance, transportation limitations, or a lack of caregiver support, he notes. These obstacles can result in patients’ noncompliance with prescribed treatments, leading to suboptimal treatment outcomes, he concludes.

Vitaly Margulis, MD, discusses significant factors and comorbidities that may affect treatment decisions for patients with renal cell carcinoma.


Dr Margulis on Patient Factors to Consider in the Treatment of RCC

John O. Mascarenhas, MD, associate professor of medicine, hematology, and medical oncology at the Icahn School of Medicine at Mount Sinai; director of the Adult Leukemia Program; and leader of Clinical Investigation within the Myeloproliferative Disorders Program at Mount Sinai, and a member of the Tisch Cancer Institute, discusses the need to develop curative therapies in myelofibrosis.

Currently, the only curative-intent treatment for patients with myelofibrosis is hematopoietic stem cell transplant, says Mascarenhas.

However, many patients are not eligible for transplant due to advanced disease or comorbidities, Mascarenhas explains. Additionally, transplant is associated with significant toxicity, as well as an increased risk of morbidity and mortality.

Although JAK inhibitors have been a welcome addition to the myelofibrosis armamentarium, the agents do not elicit a survival benefit, says Mascarenhas. 

As such, novel combination regimens with JAK inhibitors should be evaluated for potential overall survival benefit among this population, Mascarenhas explains. 

Although it may not provide cure, the telomerase inhibitor imetelstat (GRN163L) could provide potential overall survival benefit in patients with myelofibrosis, concludes Mascarenhas.

John O. Mascarenhas, MD, discusses the need to develop curative therapies in myelofibrosis.  



Dr. Mascarenhas on the Need to Develop Curative Therapies in Myelofibrosis 

Warner K. Huh, MD, the 51st President of the Society of Gynecologic Oncology; and professor, vice chair, and division director of the Division of Gynecologic Oncology at the University of Alabama at Birmingham, discusses some of the key challenges faced in the management of gynecologic cancers in light of the COVID-19 crisis, shares some of the resources provided by the SGO COVID-19 task force, and projects what is needed to quell the pandemic, which he refers to as version of the Great Depression.

Please visit 

 to watch the entitreity of the MJH Life Sciences News Network, which provides the latest news across a variety of healthcare specialties, and a number of interviews with experts in the medical field, many of which are focused on the ongoing 

Warner K. Huh, MD, discusses some of the key challenges faced in the management of gynecologic cancers in light of the COVID-19 crisis, shares some of the resources provided by the SGO COVID-19 task force, and projects what is needed to quell the pandemic, which he refers to as version of the Great Depression.

Dr. Huh on SGO COVID-19 Task Force Efforts

Is there a checklist that can be used along with operating room supervision to assess how well a breast cancer surgeon performs a particular procedure?

Maisam Fazel, FRCS, MS, MB BChir, of Imperial College Healthcare NHS Trust in the United Kingdom, believes it is not only desirable but also possible to shift surgical training toward a competency-based approach. His research on developing an assessment tool for latissimus dorsi breast reconstruction (LDBR) surgery was among the top-scoring abstracts at the Miami Breast Cancer Conference.

Fazel adapted the Objective Structured Assessment of Technical Skill tool used in the UK surgical curriculum to LDBR, creating categories specific to the procedure. He then used the tool to assess 15 breast reconstruction trainees, who were divided into 3 groups of 5 trainees each based on 2, 4, and 7 years of postinternship experience, respectively.  

The assessment tool “was able to significantly discriminate between trainees of different seniority,” with more experienced trainees performing better than those with less seniority.

In this podcast, Fazel discusses his research.

In this podcast, Maisam Fazel, FRCS, MS, MB BChir, discusses his research into a checklist for breast cancer surgeons.

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Articles

Dr Jagannath on the Patient Population in the LINKER-MM1 Trial in Multiple Myeloma

Dr Margulis on Patient Factors to Consider in the Treatment of RCC

Dr. Mascarenhas on the Need to Develop Curative Therapies in Myelofibrosis

Dr. Huh on SGO COVID-19 Task Force Efforts

Breast Reconstruction Trainee Assessment