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On Saturday, 15 June 2019, during the 24th Congress of the European Hematology Association (EHA) in Amsterdam, NL, Eva Domingo-Domènech, from the Institut Catala d’Oncologia, Barcelona, ES, discussed the results of a phase II study (NCT02181738; CheckMate 205) in patients with newly diagnosed, previously untreated classical Hodgkin lymphoma (cHL). During this trial, patient cohort D received multi-agent chemotherapy with nivolumab, doxorubicin, vinblastine, and dacarbazine (N-AVD).1
Current multi-agent chemotherapy regimens lead to suboptimal results in newly diagnosed patients with advanced-stage cHL. However, the use of nivolumab, an anti–PD-1 checkpoint inhibitor, followed by N-AVD has shown promising activity in this patient population, as indicated by the 9-month follow-up of the CheckMate 205 that was presented last year at EHA.2 This year, Dr Domingo-Domènech provided an update on the study results after a 2-year follow-up of the patient cohort.
Characteristics |
Newly diagnosed cHL |
---|---|
Median age (range), years |
37 (18–87) |
Male patients |
32 (63%) |
International Prognostic Score at diagnosis 0–1 2–3 ≥4 Not reported |
12 (24%) 21 (41%) 13 (25%) 5 (10%) |
Disease stage at diagnosis II III IV |
10 (20%) 12 (24%) 29 (57%) |
B symptoms at diagnosis |
41 (80%) |
Bulky disease |
16 (31%) |
Extranodal involvement |
25 (49%) |
* values may not total ORR due to rounding; ORR, objective response rate; CMR, complete metabolic response (Deauville ≤3); IRC, independent review committee; PMR, partial metabolic response | ||||
Response rate* (%) |
End of monotherapy |
After two combination cycles |
End of therapy |
|
---|---|---|---|---|
IRC |
ORR |
71 |
90 |
86 |
CR |
18 |
51 |
69 |
|
PR |
53 |
39 |
18 |
|
Investigator |
ORR |
67 |
88 |
84 |
CR |
25 |
71 |
80 |
|
PR |
41 |
18 |
4 |
|
IRC-Deauville |
ORR |
88 |
84 |
76 |
CMR |
18 |
71 |
75 |
|
PMR |
71 |
14 |
2 |
Treatment-related AEs in ITT population |
Any grade, n (%) |
Grade 3–4, n (%) |
---|---|---|
Total patients with treatment-related AEs |
49 (96) |
30 (59) |
Immune-mediated Rash Increased alanine aminotransferase Increased aspartate aminotransferase Infusion-related reaction Pneumonitis |
3 (6) 2 (4) 1 (2) 2 (4) 1 (2) |
0 2 (4) 1 (2) 0 0 |
Hematologic/investigations (≥ 5% patients) Neutropenia Decreased white blood cell count Decreased neutrophil count Febrile neutropenia Increased alanine aminotransferase Anemia Increased amylase |
24 (47) 7 (14) 6 (12) 5 (10) 4 (8) 4 (8) 3 (6) |
21 (41) 1 (2) 6 (12) 5 (10) 2 (4) 1 (2) 0 |
All others (≥ 10% patients) Nausea Infusion-related reaction Fatigue Pyrexia Constipation Hypothyroidism Vomiting Arthralgia Stomatitis |
18 (35) 16 (31) 13 (25) 7 (14) 7 (14) 7 (14) 7 (14) 6 (12) 6 (12) |
1 (2) 0 0 1 (2) 0 0 0 0 0 |
Nivolumab followed by N-AVD offered benefit to patients with newly diagnosed, advanced stage cHL, leading to high ORR (86%) and CMR (75%), as well as prolonged PFS (83% at 21 months). The therapy was also well tolerated. Dr Domingo-Domènech concluded that this treatment strategy may be a promising alternative to the current standard of care for newly diagnosed, previously untreated patients with advanced-stage cHL.
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