ICML 2019 | Overview of the phase II SMART START trial

During ICML 2019 in Lugano, Switzerland, the Lymphoma Hub were pleased to speak to Dr. Jason Westin, MD Anderson Cancer Center, Texas, US about the investigator-initiated, single‐arm, open‐label, phase 2 study (NCT02636322) phase II SMART SMART trial of rituximab, lenalidomide, and ibrutinib alone prior to combination with chemo for patients with newly diagnosed DLBCL.

Dr. Westin emphasized this is the first time this has ever been tried, using these drugs without the confounder of chemotherapy.

The Smart Start trial demonstrates the chemotherapy‐free combination of rituximab 375 mg/m2, ibrutinib 560 mg, and lenalidomide 25mg demonstrated an ORR of 86%, and a CRR of 36% prior to any chemotherapy. For all the patients that went onto triplet and get chemotherapy had a CRR of 96%, with PFS at a year of over 90%. Dr. Westin says even though this is a small trial and is not practice-changing yet, but what it does show is the potential for these targeted agents is large cell lymphoma do exist.

Further studies are planned with other novel agents and with fewer cycles of chemotherapy consolidation for patients achieving a CR with RLI alone.