Daratumumab as second-line treatment for relapsed multiple myeloma

  • National Institute for Health and Care Excellence

  • curated by Dawn O'Shea
  • Medical news
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In draft recommendations issued this week, NICE has recommended daratumumab plus bortezomib plus dexamethasone for use within the Cancer Drugs Fund as a second-line treatment option for relapsed multiple myeloma.

The clinical evidence to support the recommendation was drawn from the international open-label CASTOR trial of daratumumab plus bortezomib plus dexamethasone compared with bortezomib plus dexamethasone. In CASTOR, second-line treatment with daratumumab plus bortezomib plus dexamethasone was associated with increased progression-free survival compared to bortezomib plus dexamethasone (median 26 months vs 8 months) after a median follow-up of 27 months (pre-specified interim analysis; hazard ratio [HR] 0.23; 95% CI 0.16-0.33; P

However, overall-survival (OS) data from CASTOR were immature. At the median follow-up of 27 months, the data showed that the addition of daratumumab halved the risk of death (HR 0.50; 95% CI 0.30-0.84; P=0.008).

NICE also commented on the absence of a direct comparison between daratumumab plus bortezomib plus dexamethasone and carfilzomib plus dexamethasone.

The estimates of cost-effectiveness presented by the company and NICE’s evidence review group differed significantly due to the uncertainty surrounding long-term OS benefit. However, NICE agreed that if the company’s estimates are confirmed by extra trial data, there is potential for daratumumab plus bortezomib plus dexamethasone to be cost-effective.

While long-term data is awaited, NICE has approved second-line daratumumab plus bortezomib plus dexamethasone for use within the Cancer Drugs Fund for relapsed multiple myeloma.

The appeal period for this appraisal will close at 5pm on 26 March 2019. A final recommendation is expected to be published next month.