KEY TAKEAWAYS
- Phase 2 clinical trial assessed PET-adapted NICE in patients with relapsed/refractory cHL.
- The primary aim was to determine the CR according to the 2014 Lugano classification upon the conclusion of the protocol therapy.
- Patients were administered 240 milligrams of nivolumab every 14 days for six cycles.
- The overall response rate and CR rate were 93% and 91% upon completion of the therapeutic protocol.
- A total of 43 patients underwent toxicity evaluation, while 42 patients underwent response evaluation.
- PET-adapted sequential salvage therapy utilizing nivolumab/nivolumab+NICE exhibited favorable tolerability and efficacy.
In phase 2 clinical trial, PET-adapted nivolumab was assessed as a standalone treatment or in conjunction with ifosfamide, carboplatin, and etoposide (NICE) as the initial salvage therapy and bridge to autologous hematopoietic cell transplantation (AHCT) for patients with relapsed/refractory (RR) classical Hodgkin lymphoma (cHL). Patients diagnosed with relapsed or refractory classical Hodgkin lymphoma were administered 240 milligrams of nivolumab every 14 days for a maximum of six cycles. Patients who achieved complete response (CR) following C6 treatment underwent AHCT, while those who experienced progressive disease at any stage or did not attain CR after C6 were administered NICE for two cycles. The principal objective was the complete response rate according to the 2014 Lugano classification upon the conclusion of the protocol therapy. A total of 43 patients underwent toxicity evaluation, while 42 patients underwent response evaluation. A total of 34 individuals were administered nivolumab monotherapy, while 9 individuals were administered nivolumab in combination with NICE.
No unforeseen toxicities were noted subsequent to the administration of nivolumab or NICE. Following the administration of nivolumab, the observed overall response rate (ORR) was 81%, with a corresponding complete response (CR) rate of 71%. All 9 patients who underwent NICE treatment exhibited a positive response, with eight of them (89%) attaining a complete remission. Upon completing the therapeutic protocol, the overall response rate (ORR) and complete response (CR) rates were determined to be 93% and 91%, respectively. A total of 33 patients underwent direct bridging to AHCT, out of which 26 received Nivolumab monotherapy. The 2-year progression-free survival (PFS) and overall survival in the treated patient population (n = 43) were 72% and 95%, respectively. In a cohort of 33 patients who underwent direct bridging to autologous hematopoietic cell transplantation (AHCT), the two-year progression-free survival (PFS) rate was found to be 94% (95% CI: 78-98). The PET-adapted sequential salvage therapy utilizing nivolumab/nivolumab+NICE exhibited favorable tolerability and efficacy, leading to a substantial CR rate and enabling most patients to undergo AHCT without needing chemotherapy.
Source:https://pubmed.ncbi.nlm.nih.gov/35316328/
Clinical Trial:https://clinicaltrials.gov/ct2/show/NCT03016871
Mei MG, Lee HJ, Palmer JM, Chen R, Tsai NC, Chen L, McBride K, Smith DL, Melgar I, Song JY, Bonjoc KJ, Armenian S, Nwangwu M, Lee PP, Zain J, Nikolaenko L, Popplewell L, Nademanee A, Chaudhry A, Rosen S, Kwak L, Forman SJ, Herrera AF. Response-adapted anti-PD-1-based salvage therapy for Hodgkin lymphoma with nivolumab alone or in combination with ICE. Blood. 2022 Jun 23;139(25):3605-3616. doi: 10.1182/blood.2022015423. PMID: 35316328; PMCID: PMC9227101.
