Kaplan–Meier curve for estimated median DOR in the DLBCL combined cohort (response-evaluable population).
lymphoma, PD, death, DLBCL
LYMPHOMA, EVENTS, EVENT, DISEASE PROGRESSION
DOR was defined as the time from the date of first documentation of PR or better to the date of first documentation of PD or relapse. Among patients with CR, no patients had a PD/relapse event, and data were censored with a range of less than one month (1 day) to 63.0 months with responses ongoing for all 14 patients at the time of data cut. Among patients with PR, 4 patients had a PD/relapse event, and data were censored for the remaining 8 patients.Within the subgroup of patients with DLBCL (excluding those enrolled in dose escalation), 33 patients in the first expansion cohort were evaluable for response and 25 in the second cohort were evaluable for response. The ORR was 24% (95% CI, 11.1–42.3) in the first DLBCL cohort (18% with CR and 6% with PR) and 56% (95% CI, 34.9–75.6) in the second DLBCL cohort (20% with CR and 36% with PR). Considering all response-evaluable patients with DLBCL enrolled in the study (The median progression-free survival (PFS) in all patients with lymphoma was 2.0 months (95% CI, 1.6–3.3); 86 patients (69%) experienced PFS events, of which 53 (62%) were due to progression and 33 (38%) were due to death. In patients with DLBCL, the median PFS was 1.6 months (95% CI, 1.5–1.9), and 67 patients (75%) experienced PFS events; 41 (61%) were due to disease progression and 26 (39%) were due to death (