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Novartis Reports Strong Response Rates In Kymriah Drug Trial On Relapsed Follicular Lymphoma

Swiss pharma giant Novartis AG (NVS) on Wednesday announced positive data from the primary analysis of the pivotal Phase II ELARA trial of Kymriah in patients with relapsed or refractory follicular lymphoma.

The company said the primary analysis of trial demonstrated a 66% complete response rate and 86% overall response rate with one-time Kymriah infusion.

The company said that in the primary analysis, 97 patients were infused and evaluated for safety, 94 patients were okayed for efficacy with a median follow-up of 11 months. No patients experienced grade 3/4 Cytokine Release Syndrome or CRS, the most common side effect associated with CAR-T therapy.

Grade 1 or 2 CRS, as defined by the Lee Scale, was found in 49 percent of patients. Grade 1 or 2 neurological events or NEs occurred in 9 percent of patients and one patient experienced grade 4 NEs and recovered.

Novartis said that around sixty-five percent of patients experienced grade =3 adverse events within 8 weeks post-infusion, most commonly neutropenia and anaemia. The company said three patients under trail died from progressive disease and no deaths were treatment related. Kymriah was administered in the outpatient setting for 18 percent of patients in the ELARA trial, the company added.

Novartis said that Kymriah brought about responses for most of the patients treated, with 66 percent and the overall response rate being 86 percent.

Response rates were consistent across high-risk patient subgroups, the company added.

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