Ash 2018 – Survival benefit or no, Darzalex has a new use

Presenters of Maia, the first-line multiple myeloma study of Darzalex, have defended its ability to change clinical practice even though it is still a long way from showing a survival advantage. The trial, presented in an Ash late-breaker, is vital to extend the Genmab/Johnson & Johnson drug's reach by combining it with the US-dominant backbone of Revlimid and dexamethasone. The combo’s progression-free survival benefit is considerable, with a strong effect after 30 months, but an immature overall survival analysis shows a negligible separation in the curves so far. The problem is that Darzalex is already available second and third line, meaning that progressing control-arm subjects could receive it; and, if these patients’ survival improves, the active arm’s benefit could be squeezed. Hôpital Claude Huriez’s Dr Thierry Facon, who presented the late-breaker, would not say how many control patients went on to get Darzalex or what the lack of a final OS benefit would mean for Maia, but brushed aside such concerns by stressing to Vantage that the Maia population was relatively elderly. He called Darzalex a new front-line standard of care in transplant-ineligible patients, and discussion at an Ash press briefing centred on the exorbitant cost of such a combo.

Progression-free survival in Maia. Source: Ash presentation.

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