Hi, I am Dr. Anas Younes. I am the Chief of Lymphoma Service at Memorial Sloan Kettering Cancer Center, and I would like to discuss in the next few minutes the new expanded indication of pembrolizumab which now covers patients with relapsed and refractory Hodgkin lymphoma. As many of you know, a few months ago, one of the other checkpoint inhibitors, nivolumab, was approved for Hodgkin lymphoma with restricted indication. The approval was for patients with relapsed Hodgkin lymphoma failing both autologous transplant and brentuximab vedotin. So, the new indication for pembrolizumab, which is another PD-1 targeted checkpoint inhibitor, actually covers a bit wider indication for patients with relapsed Hodgkin lymphoma. So, it covers both refractory patients and patients who had at least three prior treatment regimens, irrespective of whether they had brentuximab vedotin or not, and also irrespective of whether they had autologous transplant or not. So for example, the patient who failed ABVD frontline therapy, then let’s say get ICE, and then had only partial remission, then get gemcitabine-based regimen, they can go straight to receive pembrolizumab without the need to go to autologous transplant or brentuximab vedotin. The approval came as a result of a large phase 2 trial with multiple cohorts. It had three different cohorts that covered multiple different clinical scenarios. In each different scenario, the response rate was consistent, almost 70% overall response rate with reasonably durable responses.
So, the first scenario covered patients who progressed after autologous transplant and subsequent brentuximab vedotin, so the same cohorts like the one that led to the approval of nivolumab ‒ 69 patients treated with an overall response rate of 72% and a CR rate of about 21%, pretty good responses. Then the other two cohorts that were included in this approval announcement, one covered patients who failed salvage chemotherapy, ineligible for autologous transplant but received brentuximab vedotin. For example, the patient who got ABVD, did not respond, got ICE, did not respond, you call him transplant ineligible, you give brentuximab vedotin, and also did not have a good response, so before going to transplant, you can now give pembrolizumab. That third cohort is a patient who failed autologous transplant but did not get to receive brentuximab vedotin. So, these are brentuximab vedotin naive. Again, you can get pembrolizumab with also a high response rate and reasonable CR rate. So, it is very exciting news for patients with Hodgkin lymphoma. Now, they have at least two checkpoint inhibitors approved. Pembrolizumab has a wider indication, so it covers multiple clinical scenarios for this patient population. In terms of safety, it is the same safety profile like in any other cancer. There is no unique toxicity signal on Hodgkin lymphoma compared let’s say to other patients with solid tumors. This agent is relatively safe, treatment given as an outpatient, for pembrolizumab is given every 3 weeks. The nice thing about pembrolizumab is the indication is also extended to pediatric patients, so not only for adult, but also for pediatric patients, although at different doses approved for each age group. So, with this, I think it is exciting news for patients with Hodgkin lymphoma, and those agents you will see will be incorporated with other active agents including brentuximab vedotin and other chemotherapy regimens.