We had two presentations of clinical trials, phase II clinical trials, in high risk smouldering multiple myeloma in ASH this year. The first one is ixazomib, lenalidomide and dexamethasone or RID, this is an all-oral combination in high risk smouldering myeloma patients. We enrolled 59 patients but we presented the first 29 patients today as an interim analysis and we’ve shown that there was a very deep response – 93% response rate. Over 60% or so of the patients had a complete remission or very good partial remission; we’re looking whether they have minimal residual disease now. Indeed, if this is true with long-term follow up and we can prevent progression in those patients with an oral combination that’s very well tolerated we’re hoping that this will become the new backbone for treatment of smouldering myeloma patients.
Again, this is an oral combination so it’s easy for our patients to take. Most of the grade 3s and 4s were some neutropenia, thrombocytopenia and there was no neuropathy, which is very important, that was grade 3 or 4 in the ixazomib combination. We don’t know if we can go into phase III next but definitely there is a lot of excitement and interest in this. We have a long-term follow-up to be done so we don’t know yet until we finish complete accrual and until we follow those patients but the hope is, indeed, this could be one of the new options that we have for our patients and give them the potential to prevent progression in smouldering multiple myeloma.
The other study is elotuzumab, lenalidomide and dexamethasone so based on the backbone of len/dex that was presented by Marivi Mateos from the Spanish group. We added elotuzumab which is a SLAMF7 antibody trying to, again, harness the immune system to prevent progression in patients with smouldering myeloma. We know that high risk smouldering they have a chance of progression, 50% chance of progression, within two years to overt disease. The question was really can we prevent progression, can we delay it for those patients, especially by using something that can enhance the immune system. We showed this time 50 patients accrual with a three year follow-up and we have indeed a very long term event free survival in those patients as well as progression free survival – at three years it was 95%. We know that the historical control of rev/dex that the Spanish study had done was about 77%. Again, it’s hard to compare studies but this is the first time we see that indeed there is a long remission and long progression free survival in patients with high risk smouldering myeloma. This will just build up all of the other options of trials and other options of treatment for our patients with smouldering disease.