So, in this meeting, I’m going to be presenting the final data on CARTITUDE-1, that’s the study that led to approval of cilta-cel in its original results. Now, this is a follow-up of close to three years, median follow-up, and it’s final results with overall PFS, OS and other results. So this study is a BCMA-targeting CAR-T cell, cilta-cel, that has been in this particular study used in patients with relapsed/refractory myeloma...
So, in this meeting, I’m going to be presenting the final data on CARTITUDE-1, that’s the study that led to approval of cilta-cel in its original results. Now, this is a follow-up of close to three years, median follow-up, and it’s final results with overall PFS, OS and other results. So this study is a BCMA-targeting CAR-T cell, cilta-cel, that has been in this particular study used in patients with relapsed/refractory myeloma. Very advanced patient population, median six lines of therapy, 85 to 88% patient were triple class refractory. They had their cells collected, cilta-cel produced, and received infusion.
So in these final results, the overall response hasn’t changed, of course, it is 98% response rate with 82% complete remission rates – so very high response rates. What is exciting in this presentation and this final result is that now we have reached the median PFS, which is 35 months, close to three years, similar duration of response, and median overall survival for patients at three years is close to 63%. And so it’s an incredibly high response rate for a very advanced patient population. Important finding also that patients who have sustained MRD negativity, they have much improved or higher PFS, at 75% at three years. And the toxicity signals haven’t changed with update, there were no new neurotoxicity, there were few increased incidence of second malignancies, especially, there were ten patients overall with AML or MDS and this has been observed with other CAR-T cells, so we are closely monitoring it across the board.
But overall, to summarize, it’s an incredibly effective CAR-T treatment, gives deep responses and now our results confirm that they are durable responses, making it one of the important choices for later treatments. But also very importantly we’ll begin to use it earlier on as and when available.