The fruits of COTA’s expanded research and consulting services — Real-World Insights and Real-World Support — will be on display at the annual Congress of the European Hematology Association (EHA) being held in Frankfurt and online June 8-11. These additional services leverage COTA’s deep real-world data (RWD) expertise to expedite cost-effective drug development, deliver actionable clinical insights, and support regulatory submissions.
At EHA, our partners will be presenting research powered by COTA data and supported by our experienced team of regulatory, data science, and oncology experts. Along with our collaborators, we aim to better understand existing treatment patterns in specific hematologic cancers with the goal of providing a foundation for future oncology innovation.
This adds to recent research at ASCO where COTA contributed to seven accepted abstracts across six cancer types, at ISPOR where Roche Diagnostics illustrated how RWD from COTA can uncover meaningful patterns in biomarker testing, and at NCCN where researchers from COTA and a top 10 pharma company studied real-world disease-free survival rates using COTA data.
DLBCL is the most common subtype of non-Hodgkin lymphoma. Standard of care for frontline therapy remains chemoimmunotherapy; however, nearly half of the patients will experience relapse or refractory (R/R) disease. A research team from COTA and Merck Sharp & Dohme, a subsidiary of Merck & Co., analyzed RWD from 1347 eligible patients, the majority of whom (81.3%) received treatment in the community practice setting.
The team found that a quarter of patients (25.2%) who received first line treatment subsequently required a second line of treatment. More than 40% of second line patients proceeded to a third line, and just over a third (36.2%) of those needed a fourth treatment option. R/R disease was more common in later lines of therapy (48.8% in second line, 40.5% in third line, and 54.9% in fourth line), and overall survival rates were “remarkably lower” with each additional line of therapy required.
The study concludes that there is a significant need for improved therapy options for patients who do not respond to the current initial standard of care.
Venetoclax (VEN) combined with azacitidine (AZA) represents the standard frontline therapy for patients with newly diagnosed acute myeloid leukemia (AML) not suitable for intensive induction chemotherapy. However, there is a lack of clarity around real-world treatment, dosing and sequencing patterns, as well as overall and event-free survival rates for individuals with certain molecularly defined subgroups.
Researchers from COTA and the Oregon Health and Science University used RWD to examine how VEN is being used in the community oncology environment. They found that out of 331 eligible patients, 148 (44.7%) had VEN treatment interruptions of more than 7 days in the first line therapy setting. Top reasons for early treatment discontinuation were toxicity, affecting 20.8% of patients, and AML disease progression, affecting 8.8% of patients.
A total of 115 patients experienced relapsed/refractory disease after first line VEN therapy and were treated with multiple different treatments in the second line setting including additional low-intensity therapy (60.9%), intensive chemotherapy (26.1%), and investigational therapies (8.7%). Median overall survival for the population was 13.9 months and differed by molecular mutation status.
The research team concluded that there is a lack of consensus on the best treatment approach for patients failing first line VEN therapy and that there is a greater need for novel treatment options for patients in this disease setting.
A separate team from Novartis, Memorial Sloan Kettering, Yale Cancer Center, and Genesis Research used COTA data to ask different questions about the use of VEN for AML patients in the US. In this study, the team analyzed data on 1163 individuals who initiated VEN treatment as first line treatment during or after 2018.
The team found that toxicity was the main cause of VEN dose reduction and discontinuation. Dose reduction was reported in approximately 30% of patients and 53% discontinued at least one VEN regimen during their treatment with a median treatment duration of 49.5 days.
Median overall survival of patients treated with VEN was 14.4 months from first line treatment initiation, indicating the need for more effective therapies with reduced toxicity for patients diagnosed with AML.
Patients with higher-risk myelodysplastic syndrome tend to have poor outcomes, necessitating the need for a better understanding of current treatment patterns and how to improve upon them. Researchers from Novartis, the University Hospital of Salamanca in Spain, and the Moffitt Cancer Center in Florida utilized COTA’s MDS data to conduct a retrospective, descriptive analysis of MDS treatment patterns in the US.
The team found that patients with intermediate and high-risk MDS were more likely to be treated at community cancer centers, while those with very high-risk MDS tended to receive care at academic medical centers. Hypomethylating agents (HMAs) were the most common initial treatment, while 17% received allogeneic stem cell transplant (alloSCT) therapy. Median time to treatment initiation ranged from 2.2 months for intermediate risk individuals to just 0.9 months for the highest risk individuals.
However, response rates decreased markedly between the intermediate and very high risk individuals. People with lower risk disease achieved any treatment response 73% of the time, while the highest risk patients responded just 58% of the time. About 20% of patients ultimately transformed into other hematologic cancer types.
The researchers concluded that available treatment options for patients with very high risk MDS remain limited, and more work needs to be done to meet the needs of these individuals.