Shaji Kumar, MD
At the 2017 European Hematology Association (EHA) Annual Congress, Shaji Kumar, MD, presented research showing that patients with newly-diagnosed multiple myeloma who did not elect to undergo stem cell transplant (SCT) but remained on single-agent ixazomib (Ninlaro) maintenance fared as well as those who received SCT.
In an interview with OncLive
at EHA, Kumar, professor of Medicine, Mayo Clinic, discussed his ixazomib maintenance trial, the latest FDA activity in myeloma, and the potential of chimeric antigen receptor (CAR) T-cell therapy in the field.
OncLive: Please provide an overview of your study of ixazomib, lenalidomide, and dexamethasone?
The combination of a proteasome inhibitor and an immunomodulatory drug remains the current standard for the initial therapy of multiple myeloma. The combination of bortezomib (Velcade) and lenalidomide (Revlimid) has shown improved overall survival (OS) and has become the most commonly used treatment in the United States, and its use is increasing around the world.
Ixazomib is the first oral proteasome inhibitor introduced in the clinic and is currently approved for use in relapsed myeloma in combination with lenalidomide and dexamethasone. Given the results we have seen with the bortezomib/lenalidomide/dexamethasone combination, this ixazomib/lenalidomide/dexamethasone combination was studied in the newly diagnosed setting as well. It gives the opportunity to use a completely oral initial therapy in myeloma.
The initial phase I/II study that was done enrolled 66 patients, the early part of which included dose-escalation of the ixazomib in combination with standard doses of lenalidomide and dexamethasone. The study results were originally published almost 2 years ago, and that had immediate follow-up of 14 months. It showed the regimen to be quite effective and also well tolerated.
The current analysis actually focuses on the long-term outcomes with a median follow-up of 55 months. It enrolls 42 patients out of the 66 who did not go to a stem cell transplant but continued on therapy with ixazomib. Out of the 42, there were 25 patients who got ixazomib maintenance as a single agent after the 12 months of induction therapy.
What were the findings?
Overall, what we found was that among these 42 patients, the response rate was about 80%, including about 63% of the patients with a very good partial response or better. The toxicity was very well managed, and in the maintenance portion, there were hardly any new toxicities that we encountered—primarily hematologic-like anemia. There were no cumulative hematological toxicities with long-term ixazomib maintenance, and there was a deepening of response with about 8 of the 25 patients going from a very good partial response to a complete response.