On June 28, 2017 Aduro Biotech, Inc. (Nasdaq:ADRO), a biopharmaceutical company with three distinct immunotherapy technologies, reported that the first patient has been dosed in the company’s Phase 2 clinical trial in malignant pleural mesothelioma (MPM) (Press release, Aduro Biotech, JUN 28, 2017, View Source [SID1234519704]). The trial, which will involve approximately 35 patients, will evaluate the tolerability, safety and efficacy of CRS-207, Aduro’s LADD (live, attenuated double-deleted) based immunotherapy, in combination with KEYTRUDA (pembrolizumab), an anti-PD-1 therapy marketed by Merck (known as MSD outside the United States and Canada), for the treatment of patients with MPM whose disease progressed following prior treatment. Schedule your 30 min Free 1stOncology Demo! "We are excited to initiate this Phase 2 trial to evaluate the combination of CRS-207 and pembrolizumab, an anti-PD-1 therapy, which we believe has the potential to be a synergistic combination therapy for patients with malignant pleural mesothelioma," said Natalie Sacks, M.D., chief medical officer at Aduro. "Mesothelioma is an aggressive cancer with a poor prognosis and limited treatment options; currently, there are no FDA-approved therapies indicated for second- or third-line treatment. We have received Orphan Drug Designation in the U.S. and E.U. for CRS-207 for this indication, and we are committed to doing all that we can to bring new treatment options to patients facing this difficult disease."
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The multicenter, single-arm, open-label Phase 2 study is designed to evaluate the safety and efficacy of CRS-207 with pembrolizumab in adults with previously treated MPM. The trial will be conducted at up to 10 sites and will enroll approximately 35 patients who have failed one to two prior treatments. The primary efficacy endpoint is objective response rate, defined as the proportion of patients with either complete or partial responses. For additional information about the study, please visit www.clinicaltrials.gov (NCT03175172).
Earlier this year, Aduro announced a clinical collaboration with Merck, through a subsidiary, relating to the investigation of CRS-207 used in combination with pembrolizumab for the treatment of MPM. This is the second clinical collaboration formed this year between the two companies, with the first announced in January 2017 relating to the investigation of CRS-207 used in combination with pembrolizumab for the treatment of gastric cancer.
Previously Reported Clinical Data with CRS-207 in Malignant Pleural Mesothelioma
In June 2016, data from a Phase 1b study evaluating CRS-207 alone and in combination with standard chemotherapy in patients with newly-diagnosed MPM were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). Data from this study demonstrated that CRS-207 induced encouraging anti-tumor responses. Following treatment with the combination of CRS-207 and standard chemotherapy, disease control was observed in 94 percent of the 36 patients evaluated, including 3 percent with a complete response, 56 percent with partial responses, and 36 percent experiencing stable disease. Prior to receiving chemotherapy, patients received two doses of CRS-207 alone. During this period, 31 percent of patients experienced some tumor shrinkage, supporting the clinical activity of single-agent CRS-207. Additionally, paired pre- and on-treatment tumor biopsies demonstrated CRS-207 induced important changes in the tumor microenvironment, including an increase in infiltrating CD8+ T cells and other immune cell types that are thought to be essential for immunotherapy, including dendritic cells and natural killer cells.
About Malignant Pleural Mesothelioma
Mesothelioma is a form of cancer that affects the smooth layer of mesothelial cells that surround the chest, lungs, heart and abdomen. Malignant pleural mesothelioma (MPM), which affects the thin balloon-shaped lining of the lungs, is the most common form of this disease and accounts for approximately 3,000 cases a year in the United States. MPM is an aggressive disease with a poor prognosis. Most MPM patients are not candidates for surgical resection. The tumor-associated antigen mesothelin is overexpressed on the majority of mesothelioma tumors. Currently, there is no U.S. Food and Drug Administration-approved therapy for second- or third-line treatment of MPM.
About LADD and CRS-207
LADD is Aduro’s proprietary platform of live, attenuated double-deleted Listeria monocytogenes strains that have been engineered to generate an innate immune response and to express tumor-associated antigens to induce tumor-specific T cell-mediated immunity. CRS-207, the company’s lead LADD product candidate, has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma and pancreatic, non-small cell lung, ovarian, endometrial and gastric cancers.