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Camrelizumab plus GEMOX as salvage therapy for R/R cHL: Results from a phase II trial
For patients with relapsed/refractory (R/R) classical Hodgkin lymphoma (cHL), standard salvage therapy consists of high-dose chemotherapy followed by autologous stem cell transplantation (auto-HSCT); however, the efficacy of conventional salvage chemotherapy treatment can vary.1 Camrelizumab, a humanized IgG4 monoclonal antibody targeting PD-1, has demonstrated efficacy in patients with R/R cHL based on long-term results from a phase II trial (NCT03155425).1
Here, we summarize results from a phase II trial (NCT04239170) assessing the safety and efficacy of camrelizumab, in combination with the gemcitabine and oxaliplatin (GEMOX) chemotherapy regimen, followed by auto-HSCT in patients with R/R cHL, recently published Liu et al.1 in BMC Medicine.1
Study design and patient population1
- This was a single-arm, open-label trial
- Patients were transplant-eligible, aged ≥18 years, and had R/R cHL
- Patients received two biweekly cycles of 200 mg camrelizumab, followed by 4-week cycles of 200 mg camrelizumab, 1,000 mg/m2 gemcitabine, and 100 mg/m2 oxaliplatin on Days 1 and 15
- Patients with a complete response (CR) or a partial response (PR) following an additional cycle could proceed to auto-HSCT
- The primary endpoint was CR rate
Key findings1
Patient characteristics
- In total, 42 patients were enrolled
- Median age was 34 years (range, 21–58 years)
Treatment response
Upon completion of the protocol therapy, the CR rate was 64.3% (Figure 1).
Figure 1. Response rates after protocol therapy*
*Data from Liu, et al.1
†Includes all patients who received at least one dose of the study drug.
‡Includes patients with at least one posttreatment response evaluation.
Auto-HSCT
- In total, 29 patients (CR, n = 24; PR, n = 5) received auto-HSCT
- Of the five patients with PR who underwent auto-HSCT, four achieved CR following auto-HSCT
Survival
- After a median follow-up of 20.7 months, the median progression-free survival and overall survival have not been reached.
- The 12-month progression-free survival and overall survival rates were 96.6% and 100%, respectively.
Safety
Grade 3 treatment-emergent adverse events occurred in 28.6% of patients (Table 1).
Table 1. TEAEs occurring in ≥5% of patients*
|
TEAEs, % |
Any grade |
Grade 1 |
Grade 2 |
Grade 3 |
Grade 4 |
|
ALT, alanine aminotransferase; AST, aspartate aminotransferase; LDH, lactate dehydrogenase; RCCEP, reactive cutaneous capillary endothelial proliferation; TEAE, treatment-emergent adverse events. |
|||||
|
≥1 TEAE |
97.6 |
16.7 |
50.0 |
28.6 |
2.4 |
|
ALT increased |
57.1 |
52.4 |
2.4 |
2.4 |
0 |
|
Neutrophil count decreased |
47.6 |
14.3 |
19.0 |
14.3 |
0 |
|
Vomiting |
45.2 |
23.8 |
19.0 |
2.4 |
0 |
|
Nausea |
42.9 |
40.5 |
2.4 |
0 |
0 |
|
White blood cell decreased |
38.1 |
9.5 |
21.4 |
4.8 |
2.4 |
|
AST increased |
35.7 |
31.0 |
4.8 |
0 |
0 |
|
RCCEP |
35.7 |
35.7 |
0 |
0 |
0 |
|
Hypertriglyceridemia |
35.7 |
31.0 |
2.4 |
2.4 |
0 |
|
Platelet count decreased |
35.7 |
26.2 |
4.8 |
4.8 |
0 |
|
Hyperuricemia |
14.3 |
14.3 |
0 |
0 |
0 |
|
LDH increased |
11.9 |
11.9 |
0 |
0 |
0 |
|
Anemia |
11.9 |
11.9 |
0 |
0 |
0 |
|
Fever |
9.5 |
9.5 |
0 |
0 |
0 |
|
Infectious pneumonia |
9.5 |
0 |
9.5 |
0 |
0 |
|
Interstitial pneumonia |
9.5 |
0 |
4.8 |
4.8 |
0 |
|
Pruritus |
9.5 |
7.1 |
2.4 |
0 |
0 |
|
Anorexia |
9.5 |
9.5 |
0 |
0 |
0 |
|
Hypokalemia |
7.1 |
7.1 |
0 |
0 |
0 |
| Key learnings |
| These results indicate that camrelizumab in combination with GEMOX is an effective salvage therapy with a tolerable safety profile in patients with R/R cHL, allowing patients to proceed to auto-HSCT consolidation. |
References
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