Deep and targeted research is our most important tool for optimizing therapeutic interventions for people with cancer.
There are two key components for producing high-quality, innovative research. The first is access to robust and actionable data reflective of real-world population and situations. The second is a collaborative, objective approach to scientific investigation that includes the brightest minds from the clinical, life sciences, regulatory, and business environments.
At the American Society of Hematology’s (ASH) 64th Annual Meeting this year, the inspiring results of bringing these principles together will be on display.
COTA is honored to announce that our team has directly contributed to three abstracts accepted for poster presentation at the December conference. Two of these studies were conducted in close partnership with researchers from the FDA.
Four other accepted abstracts leverage COTA’s real-world data (RWD) to support their crucial work around hematologic cancer.
COTA’s three accepted abstracts cover a range of hematologic cancers, including Multiple Myeloma (MM), Acute Myeloid Leukemia (AML), and Chronic Lymphocytic Leukemia (CLL).
Little is known about the longitudinal clinical course of patients with poor performance status (PS) in traditional clinical trials, as this information is typically assessed only by clinicians at baseline, and many patients with detriments in PS are excluded. Researchers from COTA and the FDA sought to explore PS in a real-world cohort of patients with Multiple Myeloma to demonstrate feasibility of assessing patient-reported PS and to explore the value of these longitudinal data.
The team found an increasing discordance of PS over time between patients and clinicians at key clinical timepoints. The directionality of discordance (less dysfunction reported by patients) is the reverse of other reported PRO comparisons to clinician assessment. Previous analyses of symptomatic adverse events have shown patients report more frequent and severe symptoms when compared to clinician-report.
Real-world data (RWD) can provide insight into the utilization, effectiveness, and safety of treatment regimens in routine clinical practice and has demonstrated usefulness in understanding the treatment landscape.
In this cohort of patients with ND-AML, the predominant first-line treatment was intensive chemotherapy. Treatment group by year of diagnosis indicates that over time, greater proportions of patients are receiving HMA+ven as first-line intervention, predominantly among older patients and those with adverse risk per ELN stratification. This study shows the capability of using RWD to characterize the ND-AML treatment landscape, particularly after the introduction of novel therapeutic agents.
Targeted therapies have become key therapeutic strategies in the first-line setting. Currently, there are no head-to-head comparisons for BTKi vs. BCL2 novel therapies in the frontline setting. Real-world data (RWD) is a valuable tool to investigate important clinical questions outside of clinical trials.
In this study, conducted by researchers from COTA and the University of Rochester Wilmot Cancer Institute, the real-world cohort of patients treated with venetoclax or BTKi therapy in the first-line setting, patients receiving venetoclax tended to be younger and diagnosed more recently compared to those receiving BTKi treatment. The team found 3-year PFS and OS to be longer for patients receiving first-line venetoclax-based therapy as compared to BTKi, though future research will conduct efficacy assessment in a matched population.
In a set of additional accepted poster presentations, COTA’s real-world data fuels investigations into even more cancers, including diffuse large B-cell lymphoma (DLBCL) and Relapsed/Refractory Multiple Myeloma (RRMM).