Rafael Fonseca, MD reviews the MAIA clinical trial and strategies for choosing the appropriate patients with transplant-ineligible newly diagnosed MM.
Rafael Fonseca, MD: In 2022, we have two main options that are proposed as a standard of care for patients who are newly diagnosed and are transplant-ineligible and those are VRd or the combination of the Daratumumab plus Lenalidomide and Dexamethasone [DARA-Rd] which has been explored and we'll talk more about this in the MAIA regimen. Now, both of these regimens are supported by the treatment guidelines such as NSCCN as well as mSMART and both of them are supported by category one evidence because they have, behind that recommendation randomized phase-III trials with improvement in overall survival.
I would say that while the treatment of myeloma has evolved and we have all of these new drugs and regimens, the availability of this clinical trial is actually simplifying our ability to select the best regimens for patients such as we are discussing here. There are some circumstances where a patient potentially could benefit from a doublet and that really depends more on the fitness and whether a patient has a frail status. I would say that given that we see drugs like Daratumumab contribute very little to the toxicity, it would be reasonable to consider more patients who would be frail. And we'll talk more about this into the category of available to receive the triplet. However, there's patients with very advanced age or comorbidities that are still being treated with the doublet-based combination.
Dr. Thierry Facon [MD] from the French group updated at the last EHA [European Hematology Association] meeting the results regarding overall survival for patients who are treated in the MAIA regimen. This study is really quite remarkable because we have seen that it very significantly prolongs progression-free survival, but more importantly prolongs overall survival. And we'll talk more about a simulation study I presented at the ASH meeting. We're seeing that at 5 years, we have not reached that median overall survival for patients who are treated with this 3-drug combination.
The MAIA study, for reference, was a randomized phase-III study that compared the 3 drugs Daratumumab, Lenalidomide, and Dexamethasone versus Lenalidomide and Dexamethasone for newly diagnosed transplant-ineligible patients. The study has been published. It's been published to its primary endpoint which was progression-free survival, but it's also been published with regards to the overall survival. The overall survival difference as is not only statistically significant but it's actually quite notable from what we have seen reported. If one looks at 60 months which is that really 5-year range, we're really in the 60% overall survival and 70% overall survival ranges and depending on how we actually look at the data.
So, everyone is very excited, particularly because to satisfy its two important tenants. One is we have the 3-drug combination that is highly effective; and two, this is in the absence of the risk of things such as peripheral neuropathy which we have seen with Bortezomib. I look forward for additional updates into the future so that perhaps one day then, we will know what the median overall survival is for patients treated with this triplet. But as of now, we know clearly is better than the doublet and within previous clinical trials for this patient population.
Transcript edited for clarity.