Teclistamab continues to demonstrate deep and durable responses in relapsed/refractory multiple myeloma
Dr Alfred Garfall - Penn Medicine Abramson Cancer Center, Philadelphia, USA
We were presenting at this meeting long-term follow-up from the MajesTEC-1 study. So this was the pivotal phase I/II study that demonstrated the safety and efficacy of teclistamab, which is a BCMA-directed T-cell engaging bispecific antibody for relapsed/refractory multiple myeloma.
The phase II population from that study was 165 patients that initially demonstrated an overall response rate of 63%. That was the basis for this drug’s FDA approval. We’re presenting the long-term follow-up of that study, demonstrating the duration of response. The main finding from the study is an updated estimate of the duration of response in patients who received teclistamab. The last time this was presented was with a median follow-up of around 22 months and that follow-up has now been extended to 30 months. What we see is that the estimate of the median duration of response has actually improved a bit from 20 to 24 months. So these are quite durable responses in patients with relapsed/refractory myeloma receiving just a single agent. These are the kinds of responses that you would expect only previously to see with CAR T-cell therapy, we’re now seeing with a single agent antibody that can be given as a subcutaneous injection.
The other main finding is that with extended follow-up and longer-term dosing we don’t see any new safety signals. So we continue to see problems with infections and cytopenias but those were already part of the known safety profile of this agent. With even longer term exposure we see that those are still problems but we don’t see any new safety signals emerging which is important because teclistamab was the first agent to be FDA approved in this class of therapies as a CD-3 engaging bispecific antibody that is continuously dosed over a long period of time from multiple myeloma patients. So it’s important to demonstrate and assess whether there are new safety signals that emerge over time.
So far as we continue to see infections, it seems like the rate of infections might be lowering a bit as patients receive less frequent dosing in the later stages of therapy. As there is more widespread adoption throughout the study of some of the prophylactic measures for infections that we now consider to be standard in the use of this drug, namely the proactive use of intravenous immunoglobulin as primary prophylaxis for infection and additionally the use of pneumocystis prophylaxis and viral prophylaxis.
What could be the impact of this research?
This is already an FDA approved drug that is in use where it’s approved. So it’s more as reassurance about long-term safety of the approach and better information about expectations for long-term outcomes among those patients who achieve a response.
