Relapsed/refractory patients

Update from the phase III COLUMBA (MMY3012) study 

The randomized, open-label, parallel assignment phase III COLUMBA (MMY3012) study (NCT03277105) investigated the impact of either subcutaneous (SC) or intravenous (IV) administration of daratumumab (Darzalex®) on response rates in patients with relapsed/refractory multiple myeloma (RRMM).

The study found that daratumumab, co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), administered subcutaneously is non-inferior to IV administration.

  • Patients (N = 522) were randomized to either:
    • SC daratumumab: 1800 mg with rHuPH20 2000 U/mL (N = 263)
    • IV daratumumab: 16 mg/kg (N = 259)
  • Both were administered:
    • Once-weekly in cycles 1 and 2
    • Every two weeks in cycles 3–6
    • Every four weeks in cycle 7
    • Continued until disease progression, unacceptable toxicity or study end
  • Co-primary endpoints:
    • Overall response rate (ORR)
    • Maximum trough of daratumumab (Ctrough)
      • Daratumumab serum pre-dose concentration on day 1 of cycle 3
  • ORR:
    • SC daratumumab: 41.1% (N = 263)
    • IV daratumumab: 37.1% (N = 259)
  • Mean Ctrough rate
    • SC daratumumab: 499 mg/mL (N = 149)
    • IV daratumumab: 463 mg/mL (N = 146)

No additional safety concerns were raised. The pharmaceutical company expected to present the data at an upcoming medical conference, publish in a peer-reviewed journal, and consider a regulatory submission for this formulation.

Providing daratumumab subcutaneously may result in a benefit to patients owing to the quicker and more convenient method of administration.

References
  1. OncLive. Subcutaneous daratumumab succeeds in phase III myeloma trial. https://www.onclive.com/web-exclusives/subcutaneous-daratumumab-succeeds-in-phase-iii-myeloma-trial [Accessed 2019 Feb 26]
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