Q: Can you provide some practical guidance for initiating copanlisib in the thirdline FL setting? This approach is supported by randomized prospective trials of observation versus immediate treatment. Hypertension and hyperglycemia, however, can occur with co- panlisib. and you may need to create a new Wiley Online Library account. The term “relapsed” refers to disease that reappears or grows again after a period of remission. Please put "ADA Inquiry" in the subject line of your email. In that study patients with either newly diagnosed, relapsed or refractory FL were treated with 4 weekly doses of rituximab.66 Patients with either responding or stable disease at week 12 were randomized to observation or maintenance with one dose every 2 months for 4 doses. In United States, three different PI3K inhibitors have been ap- proved by the FDA: idelalisib, a primarily delta inhibitor; duvelisib, a gamma-delta inhibitor; and copanlisib, an alpha-delta inhibitor. Presented at the 2018 American Society of Hematology Annual Meeting, December 2, 2018; San Diego, CA. Dreyling M, Ghielmini M, Rule S, et Newly diagnosed and relapsed follicular lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. The most impressive of these is the combination of lenalidomide plus rituximab. However in the context of current induction therapy that includes chemotherapy and rituximab in the majority of patients, it is uncertain if the response data to single agent rituximab is as high or durable as in patients who did not receive rituximab plus chemotherapy induction. Copanlisib is administered via a one-hour intravenous (IV) infusion on days one, eight, and 15 of a 28-day cycle. The median PFS was 7.2 months for patients with diabetes compared to 13.8 month for patients without, while the median PFS for patients with hypertension was 19.0 months compared to 11.3 months for those without. There are a multitude of new approaches that have been studied in patients with FL. In addition, all hypoglycemia and hyperglycemia events were grade ≤ 3 and transitory. A: This is probably the most important finding, because we know that patients relapsing within 2 years of chemotherapy have a more aggressive course and their median survival is only in the range of 5 years. Lymphoma Research Getting the Facts: Follicular Lymphoma. "If relapse on bendamustine and rituximab occurs within 2 years, that result is inferior to the expectation, and that would change my approach to the disease.". Q: In the thirdline setting, is R-chemotherapy still a consideration? With chemotherapy, we really tailor treatment according to the distinct patient characteristics and preferences. Multicenter Analysis of Advanced Stage Grade 3A Follicular Lymphoma Outcomes by Frontline Treatment Regimen. The material on this site is for informational purposes only, and is not a substitute for medical advice, diagnosis or treatment provided by a qualified health care provider. 2017; Dreyling M, Morschhauser F, Bouabdallah K, et Phase II study of copanlisib, a PI3K inhibitor, in relapsed or refractory, indolent or aggressive lymphoma. However the induction chemotherapy was intense and remissions had to be sustained for 12 months prior to initiation of vaccination.121 Based on these studies idiotype vaccination will be pursued further in follicular NHL. A lot of clinicians use that 2-year cutoff for chemoimmunotherapy based on data that suggest that few patients progress within 2 years, and those patients that do, have poor outcomes. In one report, the median overall survival of selected untreated patients was 19 years. These autoimmune toxicities usually occur after a couple of months of treatment. “These results suggest that copanlisib should be explored as treatment for patients failing to achieve durable responses in the firstline setting,” the researchers concluded. These were designed to have perhaps less infusion toxicity and better ADCC effector function.87-89 Obinutuzumab, is the first type II, glycoengineered and humanized monoclonal anti‐CD20 antibody.90 In rituximab refractory pts in the high dose cohort, the response rate was 55% with median PFS of 11.9 months.90 Studies of obinutuzumab combination with chemotherapy, have shown 93–98% response rates in relapsed and refractory FL patients.91.