Long-term outcomes in the NIBIT-M4 trial
DISEASE
At data cutoff, July 1st 2022, with a minimum follow-up of 45 months, 6 (31%) of the 19 patients enrolled in the NIBIT-M4 study were alive. The median OS was 25.6 months (95% CI, 0.0-52.9), while the median PFS was 5.2 months (95% CI, 4.0–6.4); the 5-year OS rate was 28.9% with a 5-year PFS rate of 5.3%; median Duration of Response (DoR) was 20.6 months (95% CI, 12.4–28.8). Eighteen patients (95%) were treatment-naive at study entry and 1 (5%) had received PD-1 mAb as first-line therapy. Three patients were in Complete Response (CR) and off-study therapy, while 13/19 (68%) had received subsequent line(s) of therapy, including immunotherapy, target therapy, and/or chemotherapy; among those, 5 patients who had achieved a disease control (DC) had a median time to the subsequent treatment of 18.9 months (range 10.3–39.0) (Fig. 