Yescarta® Is First CAR T-cell Therapy to Demonstrate High Response Rates and Durable Clinical Benefit in a Pivotal Indolent Non-Hodgkin Lymphoma Study

-- 92 Percent of Patients with Relapsed or Refractory iNHL Achieved a Response to Yescarta, Including 76 Percent with a Complete Response --

-- Primary Analysis Supports Supplemental Biologics License Application (sBLA) for Yescarta Currently Under Priority Review by the U.S. Food & Drug Administration (FDA) --

SANTA MONICA, CA, USA I December 05, 2020 I Kite, a Gilead Company (Nasdaq: GILD), today announced results from the primary analysis of ZUMA-5, a global, multicenter, single-arm, open-label Phase 2 study evaluating Yescarta® (axicabtagene ciloleucel) in adult patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL) after at least two prior lines of therapy. After a single infusion of Yescarta, 92 percent of iNHL patients (n=104 evaluable for efficacy) responded, including 76 percent of patients achieving a complete response (CR) at a median follow-up of 17.5 months. The data are being presented in an oral session during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract #700). The presentation is also being considered for Best of ASH and has been selected for inclusion in the ASH Annual Meeting Press Program.

Based on these data, the U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Yescarta for the treatment of relapsed or refractory follicular lymphoma (FL) and marginal zone lymphoma (MZL) after two or more prior lines of systemic therapy, with a target action date under the Prescription Drug User Fee Act (PDUFA) of March 5, 2021. Yescarta has previously been granted a Breakthrough Therapy Designation (BTD) by the FDA for these indications. If approved, Yescarta would become the first chimeric antigen receptor (CAR) T therapy approved for the treatment of relapsed or refractory indolent NHLs.

“It is encouraging to see this level of response to CAR T-cell therapy in a heavily pretreated and multiply relapsed patient population, in whom response duration to other available therapies is expected to be short,” said Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School. “Our goal with treatment is to prolong overall survival, and the impressive durability following a one-time treatment of axicabtagene ciloleucel is incredibly promising for relapsed/refractory patients, who are often at a higher risk for early progression.”

Ninety-four percent of patients with relapsed or refractory FL (n=84) responded to Yescarta, including 80 percent of patients achieving a CR and 64 percent of patients in an ongoing response at a median follow-up of 17.5 months. Of patients with relapsed or refractory MZL (n=20), 85 percent responded to Yescarta, with 60 percent achieving a CR. Median duration of response (DOR), progression-free survival (PFS) and overall survival (OS) were not reached.

In the safety analysis (n=146), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events (NEs) occurred in 7 percent and 19 percent of patients, respectively. Lower incidence of Grade 3 or higher NEs was observed in patients with FL (15 percent) compared to MZL (41 percent), and CRS rates were comparable between the two groups. There were three Grade 5 adverse events, including one patient with multisystem organ failure in the context of CRS related to treatment with Yescarta, one with aortic dissection unrelated to Yescarta treatment, and one with coccidioidomycosis infection unrelated to Yescarta treatment.

“As we continue to advance Kite’s cell therapy franchise, this analysis further demonstrates the practice-changing potential of Yescarta in additional hematologic malignancies,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. “We’re excited about the potential role of Yescarta in indolent NHL and look forward to continuing to work with the FDA to bring it to these patients as soon as possible.”

Kite has presented four-year survival data for Yescarta in the ZUMA-1 study of patients with refractory large B-cell lymphoma. Based on these data and other data presented at ASH, Kite believes that Yescarta could bring the hope of survival to patients with a number of other hematological malignancies.

Yescarta has not been approved by any regulatory agency for the treatment of indolent NHL, including FL or MZL. Its safety and efficacy have not been established in these lymphomas.

Yescarta was the first CAR T-cell therapy to be approved by the FDA for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), and high grade B-cell lymphoma and DLBCL arising from FL. Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a risk evaluation and mitigation strategy (REMS) due to these risks; see below for Important Safety Information.

About Indolent Non-Hodgkin Lymphoma

Follicular lymphoma (FL) and marginal zone lymphoma (MZL) are both forms of indolent non-Hodgkin lymphoma (NHL) in which malignant tumors slowly grow but can become more aggressive over time.

FL is the most common form of indolent lymphoma and the second most common type of lymphoma globally. It accounts for approximately 22 percent of all lymphomas diagnosed worldwide. MZL is the third most common lymphoma, accounting for 8 to 12 percent of all B-cell NHLs.

Despite advances in management and substantial improvements in long-term survival, patients living with FL have varied outcomes. Currently, there are limited options for the treatment of relapsed or refractory FL and MZL after two or more lines of therapy.

About ZUMA-5

ZUMA-5 is a single-arm, multicenter, open-label Phase 2 study that aims to enroll patients (≥18 years old) with relapsed or refractory iNHL of either follicular lymphoma (FL) or marginal zone lymphoma (MZL) subtypes, who received at least two prior lines of systemic therapy, including an anti-CD20 monoclonal antibody combined with an alkylating agent. The objectives of the study are to evaluate the efficacy and safety of a single infusion of Yescarta in this patient population. The primary endpoint of the trial is objective response rate (ORR) as assessed by an independent review committee per the 2014 Lugano Classification. Secondary endpoints include CR rate, DOR, PFS, OS, safety and CAR T cell and cytokines levels. The study is ongoing.

About Kite

Kite, a Gilead Company, is a biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kite is engaged in the development of innovative cancer immunotherapies. The company is focused on chimeric antigen receptor and T cell receptor engineered cell therapies. For more information on Kite, please visit www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. The company strives to transform and simplify care for people with life-threatening illnesses around the world. Gilead has operations in more than 35 countries worldwide, with headquarters in Foster City, California. For more information on Gilead Sciences, please visit the company’s website at www.gilead.com.

SOURCE: Gilead Sciences

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