Assessments
death, toxicity, TTP, DLBCL, PD, lymphoma, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, ADVERSE EVENT, DISEASE, LYMPHOMA, TTP, CANCER
Efficacy endpoints including ORR, DOR, PFS, TTP and OS were analyzed for all patients with lymphoma, including the additional DLBCL expansion cohort, and for the full DLBCL subgroup (both expansion cohorts and the escalation cohort combined), based on data collected up to June 29, 2021. This report includes extended follow-up data for patients included in the initial analysis, as well as data for additional DLBCL patients. DOR was also analyzed among the separate DLBCL cohorts, and assessments of ORR were made in the GCB, non-GCB, or unknown GCB classified DLBCL subgroups.Responses were assessed in patients who received at least one dose of study drug and had at least one post-baseline disease assessment (response-evaluable population). Assessments were performed at cycles 2, 4, 6, then every 3 cycles through cycle 24, and thereafter every 6 cycles (until disease progression or the start of alternative therapies). PFS, TTP and OS were evaluated in the ITT population, based on the time from the date of first study drug administration to the date of first documentation of PD (PFS/TTP) or death (PFS/OS).The safety population was defined as all patients in any lymphoma cohort receiving at least one dose of study drug. Adverse events and toxicity were assessed continually during treatment and were graded in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03.Statistical analyses were primarily descriptive without formal hypothesis testing. Median DOR, PFS and OS were estimated using the Kaplan–Meier method.