NEW YORK, Sept. 16, 2015 (GLOBE NEWSWIRE) -- Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that Steven A. Rosenberg, MD, PhD, chief of surgery at the National Cancer Institute (NCI), presented updated data from a Phase 2 clinical trial of TIL therapy in metastatic melanoma. The updated results were presented on September 16, 2015 at the American Association for Cancer Research Inaugural International Cancer Immunotherapy Conference in New York.
Consistent with prior findings, updated data from the Phase 2 trial in heavily pre-treated patients with metastatic melanoma confirmed that TIL treatment was associated with high, durable objective response rates (ORR), including in patients who were refractory to checkpoint inhibitors.
The randomized, Phase 2 clinical trial was conducted at NCI in a total of 101 patients with advanced metastatic melanoma, who were equally divided between two treatment groups. Both groups were treated according to standard TIL protocol using chemoablation, with the second group also receiving total body irradiation.
Treatment with autologous TIL followed by IL-2 resulted in an overall response rate (ORR) of 54% in both arms combined. Twenty-four patients (24%) had complete responses; of these patients, 23 (96%) showed durability of this response at 30 to 47 months following treatment. Median follow-up time was approximately 35 months. There were no significant differences in clinical outcomes between patients who received total body irradiation and those who did not.
Overall survival (OS) was approximately 80% at 12 months, and median OS has not yet been achieved. Median progression-free survival was approximately 10 months, and 35% of patients were without disease progression at 4 years.
"These updated data from the NCI study confirm the potential of TIL to produce long-term, durable responses in patients with metastatic melanoma, including patients who are refractory to other therapies and have few other treatment options," said Elma Hawkins, PhD, Lion's President and CEO. "We hope to continue along this trajectory in our recently initiated Phase 2 study in the treatment of refractory metastatic melanoma."
About Lion Biotechnologies
Lion Biotechnologies, Inc. is a clinical-stage biotechnology company focused on the development of cancer immunotherapy products for the treatment of various cancers. The company's lead product candidate is an adoptive cell therapy using tumor-infiltrating lymphocytes (TIL) for the treatment of patients with refractory metastatic melanoma, and is based on a clinical Cooperative Research and Development Agreement with the National Cancer Institute. TIL therapy is also being evaluated in physician-sponsored clinical trials at MD Anderson Cancer Center and Moffitt Cancer Center. For more information, please visit http://www.lionbio.com.
Forward Looking Statements
This press release contains certain forward-looking statements that are subject to a number of risks and uncertainties, including the risks relating to the Company's ability to conduct its Phase 2 clinical trial in metastatic melanoma and to further successfully develop or commercialize the Company's TIL technologies. Additional risks and uncertainties are described in the Company's most recently filed quarterly report on Form 10-Q and annual report on Form 10-K. Except as permitted by law, the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.