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COTA and Hackensack Meridian Health at ASCO 2024

Compared to information from clinical trials, real-world data (RWD) provides oncologists and cancer researchers with data on how diverse groups of patients are treated in current clinical practice. Researchers from Hackensack Meridian Health and COTA teamed up to analyze real-world treatment outcomes for people with multiple myeloma – a type of blood cancer. The findings, presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting, demonstrate the value of RWD for oncologists in unlocking more optimal, safer ways to treat their patients.

Our Chief Medical Officer Dr. CK Wang sat down with Dr. Harsh Parmar, oncologist at Hackensack Meridian Health and first author of the ASCO abstracts, to discuss the research, why RWD is crucial to studying key outcomes like overall survival (OS), and how oncologists can use the findings to inform their care. For more information, find our full ASCO abstracts here and here.

Q: What drove you to conduct this research? What unmet need in cancer care did your team observe that warranted further investigation?

Dr. Parmar: The current treatment paradigm for newly diagnosed multiple myeloma (NDMM) follows the standard convention: induction therapy followed by a stem cell transplant for eligible patients, then maintenance therapy. This paradigm has been tested in many clinical trials with impressive outcomes, but questions remain about the value of maintenance therapy post-transplantation. For example, we haven’t seen evidence of maintenance therapy leading to improvements in OS – defined as the amount of time that patients are still alive after starting cancer treatment – but we have seen associations between maintenance therapy and an increased risk of second primary cancers or reduced quality of life. With these studies, we wished to better understand real-world outcomes for patients.

Q: Why did you choose to study these outcomes in RWD instead of with clinical trial data?

Dr. Parmar: Randomized trials often have limited follow-up time, making it difficult to assess long-term outcomes like OS. Trials also have strict inclusion criteria that may not reflect the real-world patient population. RWD enables the assessment of OS in larger, more diverse patient cohorts treated in routine practice over longer time horizons.

Building the right dataset for an analysis like ours involves aggregating patient data from electronic health records (EHRs) and other sources, structuring it into analyzable datasets, and conducting rigorous statistical analyses to compare OS between different treatment approaches while controlling for confounding variables.

Q: How did Hackensack Meridian Health use RWD in these analyses to inform and improve patient care?

Dr. Parmar: We utilized COTA’s RWD platform to uncover insights about real-world treatment patterns and outcomes across their multiple myeloma patient population. This enabled us to identify best practices associated with superior outcomes, recognize areas for quality improvement, and deploy evidence-based approaches to enhance the care delivered to each individual patient based on their risk profile and disease characteristics.

Q: What made COTA’s RWD particularly useful for this analysis, and for oncology providers in general?

Dr. Parmar: COTA’s RWD is derived from leading cancer centers and captures deep clinical, molecular, and outcomes data on large patient cohorts. The datasets are rigorously de-identified, structured, and curated by cancer experts to enable detailed analyses. This high-quality, contemporary data reflects the current standard of care and allows assessment of outcomes and treatment patterns in specific patient subgroups, making it an invaluable asset for research and quality improvement initiatives that directly inform patient care.

Q: What were your findings from the ASCO abstracts?

Dr. Parmar: In one study, we compared the effect of maintenance therapy – lenalidomide being the most common – in the real-world setting with data from patients who did not receive maintenance after a stem cell transplant. We found no impact on OS with the use of maintenance therapy. In fact, the non-maintenance therapy arm showed a trend toward improved median OS (the time after the start of cancer treatment that half of the patients in the study group are still alive) at 126.3 months, about 18 months longer than the maintenance arm. While the time to next therapy was longer for the maintenance arm than the non-maintenance arm, the non-maintenance arm showed a 10-month improved time to next therapy after relapse.

In our second study, we learned that in a real-world cohort, NDMM patients who received tandem transplant without maintenance therapy had a significantly improved OS and time to next therapy after first relapse compared to those who received a single transplant and maintenance therapy. Specifically in high-risk patients, time to next therapy following relapse was significantly longer with the tandem approach – 34 months versus 12 months. This translated into a statistically significant OS outcome.

Q: What implications do these findings have for the future of patient care?

Dr. Parmar: These results provide strong real-world evidence supporting the use of tandem transplant in eligible, high-risk NDMM patients. The findings are consistent with other trials, providing important confirmation that these outcomes are achievable in routine clinical practice.

Given the convincing efficacy data, oncologists should consider tandem transplant without maintenance as the preferred approach over single transplant followed by maintenance to improve long-term outcomes in appropriate patients. They should also assess all NDMM patients for transplant eligibility and consider tandem transplant for those who are young and fit enough to tolerate it, especially if they have high-risk features.

Additionally, in our large cohort of nearly 2,000 patients, we found that maintenance therapy did not have an impact on OS. Not using maintenance therapy actually shows we can preserve the sensitivity of the disease to the therapy used for maintenance, leading to improved outcomes. Especially for a chronic disease like multiple myeloma, until we have a cure, time off therapy with the non-maintenance approach is key to preserving patients’ quality of life.

We can carry these findings into patient care at Hackensack Meridian Health to improve and optimize the ways we treat individuals with multiple myeloma.