April 10, 2021 – A study from Memorial Sloan Kettering (MSK) found that copanlisib plus rituximab resulted in a 48 percent reduction in the risk of disease progression or death vs placebo plus rituximab in patients with relapsed indolent non-Hodgkin lymphoma (iNHL). Results from this phase III trial CHRONOS-3 were presented by Matthew J. Matasar, MD, Medical Oncologist and Regional Care Network Medical Site Director, MSK Bergen, on April 9 during a media preview of the American Association for Cancer Research (AACR) Annual Meeting Week 1. The virtual meeting will be held on April 10 to 15.
“Relapsed indolent non-Hodgkin lymphomas are generally not curable, and we lack treatment options that are safe and effective. The combination of copanlisib plus rituximab represents a new potential standard of care for patients with relapsed disease across several subtypes of indolent non-Hodgkin lymphoma,” said Dr. Matasar. “We are pleased with the results of the phase III CHRONOS-3 trial because it shows that we may have a new non-chemotherapy-based treatment that can be given safely and effectively to these patients.”
Rituximab monotherapy is a recognized standard of care for patients with relapsed iNHL who had a long remission after previous rituximab-based therapy or who are unwilling or unfit to be treated with chemotherapy. However, clinical benefits have been found to be short lived. Copanlisib is a selective, potent, i.v. pan-class I PI3K inhibitor, with predominant on-target activity against the PI3K-α and PI3K-δ isoforms1,2 that is approved as monotherapy for the treatment of relapsed follicular lymphoma (FL) in patients who had received ≥2 systemic therapies.
In the CHRONOS-3 trial, 458 patients with relapsed iNHL were randomly assigned to copanlisib plus rituximab (307 patients) or to placebo plus rituximab (151 patients). Of these patients, 60 percent had follicular lymphoma, 20.7 percent had marginal zone lymphoma, 10.9 percent had small lymphocytic lymphoma, and 8.3 percent had lymphoplasmacytic lymphoma/Waldenström macroglobulinemia. Nearly all patients (99 percent) had received rituximab and 24 percent had received at least one line of rituximab monotherapy prior to this trial.
After a median follow up of 19.2 months, the study met its primary end point of progression-free survival with a 48 percent reduction in the risk of lymphoma progression or death in the copanlisib-rituximab arm. Significant reductions were seen for follicular lymphoma, marginal zone lymphoma, and small lymphocytic lymphoma. Median PFS was 21.5 months in the copanlisib-rituximab arm and 13.8 months in the placebo-rituximab arm.
Overall response rate was 80 percent in the copanlisib-rituximab arm, versus 47.7 percent in the placebo-rituximab arm. Complete response rate 33.9 percent in the copanlisib-rituximab arm, verus 14.6 percent in the placebo-rituximab arm. Median overall survival could not be estimated at the time of assessment.
Experts in MSK’s Lymphoma Service have been diagnosing and treating lymphoma of all types for many decades and care for more than 1,200 people with lymphoma each year. The multidisciplinary team of more than 30 experts are internationally renowned in their diverse specialties, including medical oncology, radiology, radiation oncology, pathology, genetics, bone marrow transplant, and symptom management. The MSK Lymphoma Service boosts the latest techniques and state-of-the-art technology and one of the largest and most innovative clinical trial programs for lymphoma in the world.
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Disclosure: This study was sponsored by Bayer AG. Dr. Matasar has received honoraria from Bayer AG and subsidiaries of Bayer AG for advising and related activities. Bayer AG also provides research funding for Dr. Matasar through Memorial Sloan Kettering Cancer Center (MSK). In addition, Dr. Matasar has received honoraria from Roche/Genentech for advising and related activities, and the company also provides research funding for him through MSK.
About Memorial Sloan Kettering (MSK):
As the world’s oldest and largest private cancer center, Memorial Sloan Kettering has devoted more than 135 years to exceptional patient care, influential educational programs and innovative research to discover more effective strategies to prevent, control and, ultimately, cure cancer. MSK is home to more than 20,000 physicians, scientists, nurses and staff united by a relentless dedication to conquering cancer. Today, we are one of 51 National Cancer Institute-designated Comprehensive Cancer Centers, with state-of-the-art science and technology supporting groundbreaking clinical studies, personalized treatment, and compassionate care for our patients. We also train the next generation of clinical and scientific leaders in oncology through our continually evolving educational programs, here and around the world. Year after year, we are ranked among the top two cancer hospitals in the country, consistently recognized for our expertise in adult and pediatric oncology specialties. www.mskcc.org.
