The single-arm pivotal trial enrolled 70 patients with cHL who either failed autologous stem cell transplantation (ASCT) or who were ineligible for ASCT. The primary endpoint was overall response rate (ORR) as defined by the Lugano 2014 criteria. Secondary endpoints included progression-free survival (PFS), duration of response (DOR), complete response (CR) rate, time to response, safety, and tolerability. As of the data cutoff, the median follow-up time was approximately 6.0 months. A review of responses by an independent review committee, provided in June 2018, demonstrated:
- The ORR was 73 percent, including 50 percent CR, and the median DOR had not been reached.
- Frequency and severity of adverse events were generally consistent with the previously reported Phase 1 safety and tolerability data for tislelizumab, or, in the case of certain immune-related events such as hypothyroidism and fever, consistent with previous reports of other PD-1 antibodies for the treatment of cHL.
