The study enrolled 25 patients, 21 of which completed the trial and were evaluable for response. The upcoming publication will highlight that of the 16 patients with stage IV disease, two had a complete response (CR) per Response Evaluation Criteria in Solid Tumors (RESIST), one had stable disease (SD), and four had no evidence of disease (NED) after resection. Furthermore, of the nine patients with stage II/III disease, three remained NED, and one stage IIC patient had slow progressive disease (PD) with a single site resected, this patient is currently NED. The median overall survival was 29 months, with 60% of the patients surviving for longer than one year. Of the 25 patients enrolled, 12 (48%) were still alive. All evaluable patients (21/21) seroconverted, developing autoimmune antibodies. Importantly, 4 of 25 patients developed vitiligo, correlating with two CR patients by RECIST criteria and two NED patients. Dorgenmeltucel-L HyperAcute immunotherapy in combination with pegylated interferon-alpha 2b was shown to be safe and well-tolerated in this study with no serious adverse events reported.
"These data demonstrated a complete response rate of 12.5% in patients with metastatic disease, which is on par with some early data from checkpoint inhibitors. Moreover, the complete responses observed were durable. In addition, 4 of the 16 patients with metastatic disease who were resected did not experience disease recurrence during the follow up period. The two patients who achieved complete responses also had more targeted autoimmunity manifested by vitiligo and did not demonstrate any off target autoimmunity as has been observed with checkpoint inhibitors," stated
"A significant unmet need remains for improved treatment options for high-risk resected and metastatic melanoma patients," said
Dorgenmeltucel-L HyperAcute immunotherapy consists of melanoma cell lines that have been genetically modified to express alpha-gal carbohydrates on cell surface molecules.
About HyperAcute Immunotherapy
NewLink's HyperAcute immunotherapy platform creates novel biologic products that are designed to stimulate the human immune system to recognize and attack cancer cells. HyperAcute product candidates are composed of human cancer cells that are tumor specific, but not patient specific. These cells have been modified to express alpha-gal, a carbohydrate for which humans have pre-existing immunity. These alpha-gal-modified cells stimulate a rapid and powerful human immune response that trains the body's natural defenses to seek out and destroy cancer cells. The objective of HyperAcute immunotherapies is to elicit an antitumor response by "educating" the immune system to attack a patient's own cancer cells. HyperAcute immunotherapies do not require any tissue from individual patients and use intact whole cells rather than cell fragments or purified proteins. We believe these unique properties of HyperAcute products result in the stimulation of a robust immune response.
NewLink's lead product candidate, algenpantucel-L (HyperAcute pancreas), is being studied in a Phase 3 trial (IMPRESS: "Immunotherapy for Pancreatic Resectable cancer Survival Study") under a Special Protocol Assessment with the
NewLink has several HyperAcute product candidates focused on other tumor types in various stages of development, including tergenpumatucel-L, which is in an adaptive design, randomized Phase 2b/3 clinical trial currently accruing up to 240 patients with non-small cell lung cancer.
NewLink is a biopharmaceutical company focused on discovering, developing and commercializing novel immuno-oncology products to improve treatment options for patients with cancer. NewLink's portfolio includes biologic and small molecule immunotherapy product candidates intended to treat a wide range of oncology indications. NewLink's product candidates are designed to harness multiple components of the immune system to combat cancer without significant incremental toxicity, either as a monotherapy or in combination with other treatment regimens. For more information please visit http://www.linkp.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of NewLink that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements, within the meaning of The Private Securities Litigation Reform Act of 1995. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "target," "potential," "will," "could," "should," "seek," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the prospects and efficacy of algenpantucel-L, tergenpumatucel-L, dorgenmeltucel-L and our other HyperAcute product candidates and related clinical trials, plans to develop and commercialize our product candidates; ongoing and planned preclinical studies and clinical trials, the timing for completion of enrollment and outcomes of our other ongoing clinical studies; and any other statements other than statements of historical fact. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that NewLink makes due to a number of important factors, including those risks discussed in "Risk Factors" and elsewhere in NewLink's Annual Report on Form 10-K for the period ended
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