Jatin Shah, MD: When patients have newly-diagnosed myeloma and they start thinking about their initial induction therapy, for those patients with active disease with end-organ damage that need intervention, there are multiple options that we can use. Importantly, a lot of the data that we have now over the last two years has really confirmed that the use of 3 drug regimens, with both an IMID and a proteasome inhibitor, for example, from the SWOG S777 Study, which looked at Revlimid plus VELCADE and dexamethasone versus Revlimid and dexamethasone, those patients with the 3 drugs had superior outcomes both in response rates, progression-free survival, as well as overall survival. So I think that’s very exciting, now that we see this in multiple different studies.
So we start thinking for our newly diagnosed patients, again, thinking with our oncological principles, use your best therapies, and use your best combinations early. I think it’s important, now that we’ve seen this proven in multiple phase III studies, including initial therapy as well. I think it’s important when you start thinking about newly diagnosed patients, that all of these patients should have their best therapies upfront that lead to improvements in outcomes, improvements in quality of life, less pathologic factors, less renal failure, improvements in quality of life, and better long-term disease control for our patients. So I think that’s very important for newly diagnosed patients.
Importantly, I think all these patients benefit from a 3-drug combination. So if you think about our older patients, they still benefit from 3 drugs and that was shown in the SWOG phase III study. And for transplant-eligible patients who are younger, they also benefit from having a 3-drug regimen because that gives you optimal disease control before a transplant. So, I think when you think about initial therapy, I think all patients benefit from a 3-drug combination.
After the initial induction therapy with a 3-drug regimen, the next big question comes up to us, are these patients transplant eligible or ineligible? So for those patients who are transplant ineligible, it’s very reasonable to continue what they had for induction therapy and consider some sort of maintenance therapy for these patients. And for transplant-eligible patients, it’s important to consider an early autologous stem cell transplant as an important standard of care for these patients. But then, after that, I think then the discussion comes to maintenance therapy for these patients as well.
There have been now several phase III studies looking at maintenance therapy with lenalidomide versus placebo, both demonstrating improvements in progression-free survival, as well as a US study demonstrating improvements in overall survival, which is a key really endpoint for all of our patients and important for us as globally as a healthcare community.
There’s also been a meta-analysis now that just recently published or presented at ASCO, again, looking at maintenance therapy. Again, showing improvement in impression-free survival as well as overall survival for these patients. So I think, clearly, maintenance therapy now is a standard of care leading to improvements in outcomes for patients that’s clear and not really statistically significant, but clinically significant, and that’s the key thing here. Because there is a high cost that we see for using maintenance therapy for long-term patients and I think if they’re going to stay on long-term therapy really to understand there’s a significant benefit with progression-free and/or ROS wild.
So, this is not some small clinically insignificant statistical benefit we see. It really is truly a valuable clinical benefit that we see for maintenance therapy. Again, we see this if they get transplant or no transplant, we see the benefit of maintenance therapy for our patients.