ASH 2020 | SYMPATICO: safety and efficacy of ibrutinib plus venetoclax for R/R MCL

Constantine Tam, MBBS (Hons), MD, FRACP, FRCPA, The Peter MacCallum Cancer Centre, Melbourne, Australia, outlines the results of the safety run-in period of the Phase III SYMPATICO study (NCT03112174) evaluating ibrutinib plus venetoclax for patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL). Ibrutinib is approved for use in R/R MCL and has shown synergistic activity with venetoclax in preclinical models and early trials. The safety run-in was undertaken to determine if a 1-month ibrutinib lead-in would be needed in the randomized phase of the trial to reduce the risk of tumor lysis syndrome (TLS). The study started both drugs simultaneously and identified no new safety signals, with dose limiting toxicities and TLS events occurring rarely. The combination induced high overall response rates and the median progression-free survival is yet to be reached at a median of 22 months. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.