Benzinga | Dec 16, 2021 06:01PM EST

Gilead's Kite, Daiichi Sankyo Report Authorized First YESCARTA CAR T-Cell Therapy Treatment Site In Japan

-- Kite and Daiichi Sankyo to Expand YESCARTA(r) Collaboration in Japan --

SANTA MONICA, Calif. & TOKYO--(BUSINESS WIRE)-- Kite, a Gilead Company, and Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that YESCARTA(r) (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T-cell therapy, will be available to patients with relapsed or refractory large B-cell lymphomas in Japan through the first treatment center now authorized by Daiichi Sankyo. Kite and Daiichi Sankyo will also build on the exclusive licensing deal for commercialization rights for axicabtagene ciloleucel in Japan, formalized in January 2017. Both partners are pleased to agree on a broadening of their business collaboration in Japan.

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"We are pleased to bring the benefits of axicabtagene ciloleucel to eligible patients in Japan, in collaboration with Daiichi Sankyo," said Warner Biddle, Kite's Global Head of Commercial. "Japan has the second-largest number of people diagnosed with non-Hodgkin lymphoma globally1 and we remain committed to bringing our innovative CAR T-cell therapies to additional new markets."

"We are pleased to be able to deliver axicabtagene ciloleucel, Daiichi Sankyo's first cell therapy product, to patients in Japan," said Akio Sakurai, Daiichi Sankyo Corporate Officer, Head of Sales Division. "By strengthening our collaboration with Kite, the originator of axicabtagene ciloleucel and a world leader in cell therapy, we will strive to bring this innovative therapy to as many patients as possible."

CAR T-cell therapy is a complex immunotherapy, and all hospitals must complete a rigorous training process before administering axicabtagene ciloleucel to patients. These hospitals receive specific training in handling and risk minimization procedures in order to ensure that patient safety remains a priority.

Several factors are considered when qualifying a hospital, including their specialist skills and services, geographic coverage and experience in managing other complex procedures, such as stem cell transplantation and a co-located intensive care unit.

Axicabtagene ciloleucel has been approved in Japan for treatment of patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma. The use of axicabtagene ciloleucel is limited to patients not previously treated with a CD-19 CAR-positive T-cell infusion; patients previously treated with two or more lines of treatment including chemotherapy or an autologous stem cell transplant; and, patients ineligible for an autologous stem cell transplant. In January 2017, Daiichi Sankyo received exclusive development, manufacturing and commercialization rights for axicabtagene ciloleucel in Japan from California-based Kite, a Gilead Company.

The approval of axicabtagene ciloleucel in Japan is based on data from the global pivotal trial conducted by Kite (ZUMA-1)2 and results of a Phase 2 study conducted by Daiichi Sankyo in Japan. In the Japanese Phase 2, open-label, single-arm study, the same dose (2.0 x 106 cells/kg) of axicabtagene ciloleucel as used in the ZUMA-1 study was administered to assess efficacy and safety in 16 Japanese patients with relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed follicular lymphoma or high-grade B-cell lymphoma. The study reached its primary endpoint, demonstrating an objective response rate (ORR) of 86.7% (95% CI: 59.5 -- 98.3%).

The overall safety and tolerability profile of axicabtagene ciloleucel in the Japan trial was consistent with that observed in ZUMA-1. Dose limiting toxicity was not observed. Grade ?3 treatment emergent adverse event occurred in all patients; most commonly neutropenia (81.3%), lymphopenia (81.3%) and thrombocytopenia (62.5%). Cytokine release syndrome (CRS), a typical CAR T-cell therapy-emergent adverse event, occurred in 13 patients (81.3%, all Grade), with Grade ?3 CRS in one patient (6.3%). No neurological events, another CAR T-cell therapy-emergent adverse event, were observed.