Kite’s Tecartus™ (KTE-X19) Granted Conditional Marketing Authorization for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma in Europe

-- 93 Percent of Patients in ZUMA-2 Pivotal Trial Responded to Single Infusion of Tecartus --

-- Tecartus is First CAR T Therapy in Relapsed or Refractory MCL and Kite Becomes the First Company with Multiple Approved Cell Therapies in Europe --

SANTA MONICA, Calif.--()--Kite, a Gilead Company (Nasdaq: GILD), today announced that the European Commission has granted conditional marketing authorization for Tecartus™ (autologous, anti-CD19-transduced CD3+ cells; formerly KTE-X19). Tecartus is a chimeric antigen receptor (CAR) T cell therapy for adult patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor. Conditional authorization is granted in the interest of public health where the benefit of immediate availability outweighs the risk of less comprehensive data available.

The conditional marketing authorization is supported from the multinational, single-arm, Phase 2 open-label ZUMA-2 pivotal trial in patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor. ZUMA-2 demonstrated an overall response rate (complete or partial) of 93 percent, with 67 percent of patients achieving a complete response, as assessed by an Independent Radiologic Review Committee following a single infusion of Tecartus. In the safety analyses, Grade 3 or higher cytokine release syndrome (CRS) and neurologic events were observed in 15 percent and 33 percent of patients, respectively.

Significant gaps in treatment remain for patients with mantle cell lymphoma who progress following initial therapies,” said Professor John G. Gribben, Consultant Haematologist and Medical Oncologist at Barts and The London NHS Trust, London. “The availability of this first cell therapy for relapsed or refractory mantle cell lymphoma, following at least two lines of systemic therapy including a BTK inhibitor, provides an important option for patients in Europe.”

Kite is committed to bringing the curative intent potential of CAR T-cell therapy to patients with hematological cancers,” said Ken Takeshita, MD, Kite’s Global Head of Clinical Development. We are proud our second cell therapy has been approved for use in Europe, and I extend my thanks to the patients who participated in the clinical trial and their families and caregivers, clinical researchers, regulators and dedicated colleagues at Kite who helped make this approval possible for patients living with relapsed or refractory mantle cell lymphoma.”

Mantle cell lymphoma is a rare form of non-Hodgkin lymphoma that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. Patients with relapsed or refractory mantle cell lymphoma after two or more lines of systemic therapy including a BTK inhibitor have a poor prognosis, with a median overall survival of 6 to 10 months. In Europe, it is estimated that at least 7,400 people are diagnosed with mantle cell lymphoma each year.

Tecartus is a CAR T-cell therapy, an individualized method of treatment that harnesses the body’s own immune system to target cancer cells. The therapy uses the XLP™ manufacturing process that includes T cell enrichment, a necessary step in certain B cell malignancies in which circulating lymphoblasts are a common feature. In recognition of its potential to benefit patients with significant unmet medical need, Tecartus was granted Priority Medicines (PRIME) designation by the EMA.

Conditional marketing authorization in Europe is initially valid for one year but can be extended or converted into an unconditional marketing authorisation after the submission and assessment of additional confirmatory data. Conditional approval is granted to a medicinal product that fulfils an unmet medical need where the benefit of immediate availability outweighs the risk of less comprehensive data than normally required. It requires additional monitoring and post-marketing data before full approval is granted.

For full details on the Special Warnings and Precautions for Use and Adverse Reactions (including appropriate management), please refer to the EU Summary of Product Characteristics (SmPC).

About ZUMA-2

ZUMA-2 is an ongoing, multinational, single arm, Phase 2 open-label pivotal trial. The study enrolled 74 adult patients with relapsed or refractory mantle cell lymphoma who had previously received anthracycline- or bendamustine-containing chemotherapy, an anti-CD20 antibody therapy and a BTK inhibitor (ibrutinib or acalabrutinib). The treatment was manufactured for 71 patients and administered to 68 patients. The primary endpoint was objective response rate per the Lugano Classification (2014), defined as the combined rate of complete response and partial responses as assessed by an Independent Radiologic Review Committee.

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.

Forward-Looking Statement

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that the European Commission may not extend or convert the conditional marketing authorization into an unconditional marketing authorization for Tecartus for the treatment of relapsed or refractory mantle cell lymphoma. In addition, physicians and patients may not see the potential benefits of Tecartus, and there is the possibility of unfavorable results from other ongoing and additional clinical studies involving Tecartus. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation to update any such forward-looking statements.

Kite, the Kite logo, Tecartus, XLP and GILEAD are trademarks of Gilead Sciences, Inc., or its related companies.

For more information on Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. Follow Kite on social media on Twitter (@KitePharma) and LinkedIn.

Contacts

Monica Tellado, Investors
(650) 219-3882

Nathan Kaiser, Media
(650) 522-1853

Contacts

Monica Tellado, Investors
(650) 219-3882

Nathan Kaiser, Media
(650) 522-1853