For a phase 2 study, researchers looked at PET-adapted nivolumab alone or in combination with ifosfamide, carboplatin, and etoposide (NICE) as a first-line salvage treatment and a bridge to autologous hematopoietic cell transplantation (AHCT) in RR classical Hodgkin lymphoma (cHL).
Patients with RR cHL were given 240 mg nivolumab every two weeks for a total of six cycles (C). Patients with complete response (CR) after C6 underwent AHCT, whereas those with worsening illness at any stage or who were not in CR after C6 got NICE for two cycles. The main outcome was the CR rate according to the 2014 Lugano classification at the end of protocol treatment. There were 43 individuals who could be evaluated for toxicity and 42 who could be evaluated for response. Thirty-four patients were given nivolumab alone, while nine were given nivolumab plus NICE.
There were no unanticipated side effects with nivolumab or NICE. The overall response rate (ORR) after nivolumab was 81%, while the CR rate was 71%. All nine NICE patients responded, with 8 (89%) reaching CR. The ORR and CR rates at the completion of protocol treatment were 93% and 91%, respectively. About 33 patients were bridged straight to AHCT, with 26 following Nivo alone. The 2-year progression-free survival (PFS) and overall survival (OS) rates in all treated patients (n=43) were 72% and 95%, respectively. The 2-year PFS was 94% among 33 patients who bridged directly to AHCT (95% CI: 78-98).
PET-adapted sequential salvage treatment with nivolumab/nivolumab+NICE was well tolerated and successful, with a high CR rate and most patients bridging to AHCT without chemotherapy.