ICML 2021 | ELARA: tisa-cel in R/R follicular lymphoma

We enrolled a population of patients with relapsed and refractory follicular lymphoma and a phase two trial with tisagenlecleucel. And the primary objective of this study was to look at the overall response rate, complete response rate of the drug and these relapsed patients. The eligibility criteria really just included patients that have relapsed or refractory disease. And we excluded patients that had transformed lymphoma. We enrolled several patients. We enrolled 98 patients, 97 were infused, and we were able, at least at this meeting, I’ll be reporting the efficacy on the 94 patients that were evaluable. And with that, we saw a very impressive overall response rate of 86% with a CR rate of 66%.

At the current follow-up, which was 11 months, we have not yet hit a median duration of response. The probability of a responding patient to remain in response more than six months was 79% and many patients actually converted from PR to CR and that usually occurred between month three and month six. So we’re very excited about a very strong signal with regards to efficacy in these patients who have often pretty refractory disease.

And we noticed that this efficacy or this complete response rate appeared to be consistent across several subgroups that we looked at, including patients that had early progression from first-line therapy. These are the POD24 patients prior stem cell transplant, as well as patients who had prior PI3K inhibitors, as well as again, patients that had multiple lines of treatment up to over four lines of therapy. Those patients all tended to have a fairly similar response rates in the 80% range.

In the trial We also looked obviously at adverse events, not surprising. We saw adverse events in pretty much all patients. These are all great. About 77% of patients had adverse events, which were suspected to be drug-related, 76% of the events were grade three or four, and around 45% of patients had a grade three, four event, which was suspected to be related to tisagenlecleucel. We did see some cytokine release syndrome, although no patients, zero, had a grade three cytokine release syndrome. And we only saw one patient with a grade three of neurologic adverse event.

We did see some cytopenias, including neutropenia and anemia that occurred grade 3 and 27 and 13% of patients. Very little levels with thrombocytopenia only a 9% had a grade three or four event. We saw some patients who had prolonged depletion of B cells as would be expected with a CAR T-cell therapy. Although there were no patients who had a prolonged depletion of B cells that were grade three or greater.

We also looked at the management of cytokine release syndrome and 34% of patients as 16 patients received a tocilizumab, and 6% of patients had corticosteroids that we only observed at this report, three deaths, none of these were due to CAR T-cell. All of them were due to progression of the underlying disease.