Kite Announces Initial Results From a Phase 1 Study of T Cell Receptor (TCR) Cell Therapy in HPV-16-Positive Solid Tumors
– Data at the 2018
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TCR therapy is a type of personalized immunotherapy designed to activate the immune system's ability to recognize and target specific tumors. TCR therapy involves engineering an individual’s own T cells to express naturally occurring receptors that can recognize specific tumor antigens. Epithelial cancers caused by HPV, including cervical, head and neck, anal and genital cancers, contain a protein called E7 inside tumor cells. Patients with these tumors whose cancers have relapsed and/or are refractory to standard therapy are currently incurable.
In this study, eight patients with metastatic HPV-16 cancers received a single infusion of gene-engineered E7 T cells at one of three dose levels. Patients had received between three and seven prior lines of systemic cancer therapy. In the initial six patients, the E7 TCR was expressed by 90-99 percent of the infused T cells, and E7 T cells were detectable in the peripheral blood six weeks following treatment. The study is ongoing.
Partial responses (Response Evaluation Criteria in Solid Tumors (RECIST); RECIST 1.1) were observed in three out of the seven evaluable patients and another two patients had stable disease. To date, the responses have lasted as long as nine months and have occurred in patients with vulvar, oropharyngeal and anal cancer. Two of these patients had been previously treated with anti-PD1 checkpoint blockade.
“Metastatic HPV-cancers are incurable and poorly addressed by standard
No dose-limiting toxicity occurred. The most common grade 3 or higher adverse events were anemia, lymphopenia, leukopenia and neutropenia, each of which occurred in all seven evaluable patients.
The trial is part of a
HPV has a causal role in nearly all cervical cancers, and in many head
and neck and anogenital malignancies. HPV-16 is the most commonly found
strain in these cancers. More than 33,000 cases of HPV-associated
cancers are diagnosed each year in the U.S. and more than 10,000 deaths
are attributed to the disease, according to the
“Findings from this Phase 1 study validate the E7 protein as a viral
target for TCR therapy,” said
KITE-439 is investigational and has not been proven safe or efficacious.
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
possibility of unfavorable results from additional clinical trials
involving KITE-439 for the treatment of HPV-16 E7 solid tumors or other
HPV-associated cancers. In addition, Kite may be unable to submit the
IND for KITE-439 in the currently anticipated timelines or at all. 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
For more information on Kite, please visit the company’s website at www.kitepharma.com. Learn more about Gilead at www.gilead.com, follow Gilead on Twitter (@GileadSciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.
Gilead Sciences, Inc.
Sung Lee, 650-524-7792
Nathan Kaiser, 650-522-1853