Isa-VCd induction in NDMM patients with severe renal impairment show no new safety concerns

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Published: 26 Jun 2024
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Prof Evangelos Terpos - University of Athens, School of Medicine, Athens, Greece

Prof Evangelos Terpos speaks to ecancer at EHA 2024 about his EAE116 study.

The EAE116 study is a phase 2 clinical trial investigating the effects of isatuximab, bortezomib, cyclophosphamide, and dexamethasone (Isa-VCd) as induction therapy in newly diagnosed multiple myeloma patients with severe renal impairment.

Preliminary results from 43 patients show that Isa-VCd induces significant hematologic and renal responses, with a renal response rate of 60.5% and an overall response rate of 82.9%.

The safety profile is consistent with known data, with no new safety concerns.

Further follow-up is needed for a comprehensive evaluation of long-term outcomes.

Isa-VCd induction in NDMM patients with severe renal impairment show no new safety concerns

Prof Evangelos Terpos - University of Athens, School of Medicine, Athens, Greece

This is another very interesting study because we have patients with severe renal impairment with creatinine clearance below 30 and we don’t have a lot of studies that are focussed on this population. All these patients are newly diagnosed patients with multiple myeloma and we have the combination of isatuximab, bortezomib, cyclophosphamide and dexamethasone. The study includes 51 patients and we give it for 8 cycles. Then after the 8th cycle the patients will continue with isatuximab only plus lenalidomide at a dose of 10mg or according to the renal impairment of the patients.

51 patients had to be included in this study, the recruitment has been finished. We present the data of the first 40 patients because we had more follow-up for these 40 patients. What we have seen is, first of all, that isa-VCd offers an important myeloma response rate of around 83% with the vast majority of the patients to achieve VGPR or CR. Also that we have a 60% of renal response rate which is an amazing result to me, with some of the patients who were dialysis dependent to become dialysis independent, and 35% of the patients to achieve either a complete or partial renal response.

So we have seen that the combination of isatuximab, bortezomib, cyclophosphamide and dexamethasone probably is a very good combination for patients with severe renal impairment. So we’re talking for a really difficult to treat group of patients with dramatic comorbidity. This 83% response rate, anti-myeloma response rate, and more than 60% of renal response rate give us a lot of hope that we are going to have one of the standards of care for these patients at first line.

I want also to mention that the median age of the patients of that group is 72 years. So it is a group of patients that is also elderly, includes an elderly population. This combination seems to be very effective for these patients too.