BASEL (dpa-AFX) - Novartis' (NVS) Kymriah or tisagenlecleucel demonstrated strong efficacy in high-risk patients with relapsed or refractory follicular lymphoma, as per a subgroup analysis from an about 17-month median follow-up of the pivotal Phase II ELARA study.
In the subgroup analysis, results showed high rates of durable responses were induced by Kymriah in patients for the majority of high-risk disease subgroups, who typically have a poor prognosis.
Complete response rate (CRR), overall response rate (ORR), and durability of response (DOR) were maintained in most patients in the high-risk subgroups, with the exception of those in three of the nine subgroups analyzed: those with progression-of-disease within two years (POD24), high total metabolic tumor volume (TMTV) and patients who had received five or more prior lines of therapy.
A separate analysis of hospitalization and intensive care unit patterns for patients treated in the inpatient and outpatient settings in the ELARA trial suggest Kymriah may reduce healthcare resource utilization for patients with relapsed or refractory follicular lymphoma treated in the outpatient setting.
Among patients treated in the outpatient setting (n=17), 35% did not require hospitalization during the first two months of the post-infusion period; those who did had a lower median average length of stay than the patients infused in an inpatient setting (4 days [n=17] vs 12 days [n=80]).
Additionally, the mean hospitalization costs in the post-infusion period were substantially lower in the outpatient versus inpatient setting.
Novartis said it is committed to bringing the benefits of Kymriah to more patients with advanced blood cancers worldwide, with regulatory submissions for follicular lymphoma in the US and EU complete in October 2021. If approved in this indication, Novartis will look to confirm these results of the ELARA trial and related analyses in the real-world setting.
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