Phase III ANDROMEDA study of subcutaneous Darzalex shows long term positive response in light chain amyloidosis.- Janssen Pharma

Longer-term results from a median follow up of 20.3 months showed rates of haematologic complete response (hemCR) remained significantly higher in patients treated with daratumumab SC in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) compared to VCd alone (Abstract #8003). In the study comparing D-VCd (n=193) to VCd (n=188), the primary endpoint, hemCR, remained significantly higher with D-VCd compared to VCd, increasing from 53 percent vs. 18 percent (at median follow-up of 11.4 months) to 59 percent vs. 19 percent (at 20.3 months). At 20.3 months median follow-up, more patients achieved a very good partial response or better (at least VGPR) with D-VCd than VCd (79 percent vs 50 percent). Median time from randomisation to at least VGPR was shorter in patients receiving D-VCd compared to VCd. Among cardiac responders treated with D-VCd (n=118) compared to VCd (n=117), response rates increased from 42 percent to 57 percent at 12 months for those treated with D-VCd compared to an increase of 22 percent to 28 percent at 12 months for VCd. Among patients who had renal responses treated with D-VCd (n=117) compared to VCd (n=113), rates remained stable increasing from 54 percent to 57 percent at 12 months for those treated with D-VCd and remaining at 27 percent at 12 months for VCd. At longer-term follow-up, no new safety signals were observed for daratumumab SC.These data will be featured in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting on Tuesday, June 8, and following at the 26th European Hematology Association (EHA) Congress on Friday, June 11. Earlier findings from the Phase III study supported the recent Positive Opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending use of daratumumab in combination with VCd for the treatment of adult patients with newly diagnosed systemic AL amyloidosis. A decision by the European Commission (EC) is expected in the coming weeks.