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2024-04-26T08:49:24.000Z

Camrelizumab plus GEMOX as salvage therapy for R/R cHL: Results from a phase II trial

Apr 26, 2024
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Learning objective: After reading this article, learners will be able to cite a new development in the treatment of classical Hodgkin lymphoma.

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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

≥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

ALT, alanine aminotransferase; AST, aspartate aminotransferase; LDH, lactate dehydrogenase; RCCEP, reactive cutaneous capillary endothelial proliferation; TEAE, treatment-emergent adverse events.
*Adapted from Liu, et al.1

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.

  1. Liu Y, Ping L, Song Y, et al. Camrelizumab plus gemcitabine and oxaliplatin for relapsed or refractory classical Hodgkin lymphoma: a phase II trial. BMC Med. 2024;22(1):107. DOI: 1186/s12916-024-03329-8

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