- Data from cohort 2 of the innovaTIL-01 study support polyclonal approach necessary to treat metastatic melanoma -
SAN CARLOS, Calif., April 01, 2019 (GLOBE NEWSWIRE) -- Iovance Biotherapeutics, Inc. (IOVA), a late stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, today announced data from an investigation of the persistence and diversity of circulating T cells from metastatic melanoma patients from the innovaTIL-01 (C-144-01) study receiving lifileucel TIL therapy. Results from an analysis of the persisting T cell clones circulating 42 days following infusion, as compared to the initial TIL product, demonstrated two phenomena: first, that TIL product from 100 percent of the evaluated patients in Cohort 2 of the innovaTIL-01 trial are persisting in circulation at 42 days post-infusion, and second, that each patient has a unique TIL product with almost no overlap between patients for expanding clones in the human body observed post-infusion. Furthermore, the small number of overlapping clones between a few patients were not associated with a clinical response. The uniqueness of the clonal profiles associated with response highlights the challenge of identifying a few T cell receptors as mediators of activity and supports using a polyclonal product such as the Iovance bulk TIL to treat high mutational load solid tumors.
“Investigation of pharmacokinetics of lifileucel TIL in metastatic melanoma patients demonstrates excellent persistence of lifileucel 42 days post-infusion. In addition, the ability of lifileucel TIL therapy to generate responses in melanoma appears to be the result of each patient’s specific populations of their TIL product targeting the patient’s unique mutated tumor antigens” commented Maria Fardis, Ph.D., MBA, president and chief executive officer of Iovance. “The results of this study suggest that high mutational load solid tumors such as melanoma are unlikely to be effectively treated with products against a single or a small number of antigens, implying a potential need for a patient specific, polyclonal product such as Iovance’s TIL product lifileucel.”
Identification of specific cancer-associated antigens responsible for an antitumor immune response continues to be an area of active research.1,2 The ability of autologous TIL therapy to respond to the unique cancer antigens present in each individual patient may be a factor in the response rates observed with lifileucel treatment.
Study results were detailed in a late-breaking poster presentation, “Persistence of cryopreserved tumor-infiltrating lymphocyte product lifileucel (LN-144) in C-144-01 study of advanced metastatic melanoma,” at the American Association for Cancer Research (AACR) 2019 Annual Meeting. The presentation abstract and additional information is available on the AACR conference website at http://www.aacr.org.
Additional information about the registration-enabling innovaTIL-01 (C-144-01) study of lifileucel in advanced melanoma is available at https://clinicaltrials.gov/ct2/show/NCT02360579.
- Robbins PF, et al., Mining exomic sequencing data to identify mutated antigens recognized by adoptively transferred tumor-reactive T cells. Nature Medicine. 2013 Jun;19(6):747-52. doi: 10.1038/nm.3161.
- Lu YC, et al., Efficient identification of mutated cancer antigens recognized by T cells associated with durable tumor regressions. Clinical Cancer Research. 2014 Jul 1;20(13):3401-10. doi: 10.1158/1078-0432.CCR-14-0433.
About Iovance Biotherapeutics, Inc.
Iovance Biotherapeutics intends to commercialize lifileucel, an autologous cell therapy product using TIL technology that amplifies the body’s own immune response to eradicate solid tumors or attack blood cancers. The company is currently conducting the pivotal study innovaTIL-01 in patients with metastatic melanoma. In addition, the company’s TIL therapies are being investigated for the treatment of patients with locally advanced, recurrent or metastatic cancers including cervical, head and neck, and non-small cell lung cancer. For more information, please visit www.iovance.com.
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