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Nivolumab, a programmed death protein 1 (PD-1) antibody, is under accelerated approval by the US Food and Drug administration (FDA)1 for patients with relapsed and refractory (R/R) classical Hodgkin lymphoma (cHL), who have relapsed or progressed after autologous stem cell transplant (ASCT). For newly-diagnosed cHL, multiagent chemotherapy is the current standard of care.2,3 This has proved a good treatment strategy for early-stage, naive cHL but remains suboptimal for advanced-stage patients.2
The CheckMate 205 (NCT02181738) phase II trial4 demonstrated that nivolumab monotherapy has an acceptable safety profile and leads to good and durable responses in patients with R/R cHL. In an extended cohort (Cohort D) of the CheckMate 205 study, single-agent nivolumab followed by a period of nivolumab in combination with doxorubicin, vinblastine, and dacarbazine (N-AVD), was evaluated for safety and efficacy in advanced-stage previously-untreated cHL. These results were published in the Journal of Clinical Oncology3 by Radhakrishnan Ramchandren from the University of Tennessee, Knoxville, TN, USA, and colleagues on 21 May 2019.
The primary endpoints of this analysis were safety and tolerability, measured as an increase in Grade 3–5 treatment-emergent adverse events (TEAEs) between first dose and one month after last dose. Secondary endpoints, included overall response rate (ORR) and complete response (CR) rate, as assessed by an independent radiology review committee (IRC).
Baseline characteristic |
Patients (N = 51) |
---|---|
Median age (range) |
37 (18–87) years |
Ann Arbor stage: II III IV |
20% (n= 10) 24% (n= 12) 57% (n= 29) |
International Prognostic Index (IPI) score: 0–1 2–3 ≥4 Unreported |
24% (n= 12) 41% (n= 21) 25% (n= 13) 10% (n= 5) |
Bulky disease |
31% (n= 16) |
Extranodal disease |
49% (n= 25) |
|
At end of nivolumab monotherapy |
After two N-AVD combination cycles |
At end of N-AVD combination treatment (EOT) |
---|---|---|---|
ORR (95% CI) |
69% (54–81) |
90% (79–97) |
84% (71–93) |
CR rate (95% CI) |
18% (8–31) |
51% (37–65) |
67% (52–79) |
Tumor lesion burden reduction >50% |
71% (35/49) |
98% (45/46) |
100% (46/46) |
Progressive disease (PD) |
- |
- |
6% |
Nivolumab monotherapy, followed by a period of nivolumab in combination with AVD chemotherapy, showed a manageable safety profile and led to very good responses in previously-untreated, advanced-stage patients with cHL.
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