On September 26, 2015 Aduro Biotech, Inc. (Nasdaq:ADRO) reported the presentation of updated, interim safety and efficacy data from an ongoing Phase 1b clinical trial of its novel immunotherapy, CRS-207, in combination with standard of care chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM) (Press release, Aduro BioTech, SEP 26, 2015, View Source;p=RssLanding&cat=news&id=2090581 [SID:1234507554]). Of the 34 evaluable patients, disease control was observed in 94% (32/34), including 59% (20/34) with partial responses and 35% (12/34) experiencing stable disease following treatment with CRS-207 and chemotherapy. Of note, in three patients who had tumor biopsies completed, biomarker analysis data available at the time of the presentation showed in all three patients a consistent and marked recruitment of immune cells, including CD8+ T-cells, dendritic cells and natural killer cells, following treatment with CRS-207.
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The results were presented by Raffit Hassan, M.D., co-chief of the Thoracic and GI Oncology Branch at the National Cancer Institute, in a spotlight poster presentation (abstract #515/P249) at the 40TH European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper)/18TH European Cancer Congress (ECC) being held September 25-29, 2015 in Vienna, Austria.
"The data in this trial continue to be impressive in the front-line treatment of mesothelioma," said Dr. Hassan. "We are encouraged by the high disease control rate in patients treated with this combination and will continue to evaluate and track the durability of the responses, which are ongoing."
Dirk G. Brockstedt, Ph.D., senior vice president of Research and Development at Aduro added, "Our new immunohistochemistry biomarker data is interesting as it is supports our hypothesis that the tumor microenvironment is altered by our immunotherapy. These data show an increase of tumor-attacking immune cells recruited and deployed where they are needed most. We look forward to presenting final results from this trial with additional biomarker data in 2016. As previously announced, based on the compelling data thus far, we plan to advance the combination regimen with CRS-207 and chemotherapy into a pivotal Phase 3 clinical trial in the front-line setting."
At the time of the ESMO (Free ESMO Whitepaper) presentation, the multi-center Phase 1b study had completed enrollment with 38 patients who were chemotherapy-naïve, with unresectable MPM, good performance status (ECOG 0 or 1) and adequate organ function. Under the trial design, eligible patients received two treatments with CRS-207 two weeks apart, followed by up to six cycles of standard of care pemetrexed and cisplatin chemotherapy three weeks apart and two CRS-207 treatments three weeks apart. Clinically stable patients receive CRS-207 maintenance courses every eight weeks and are followed until disease progression. Objectives of the study are safety, immunogenicity, objective tumor responses and tumor marker kinetics.
Median duration of response was 5.3 months (95% CI: 4.7 – 16.7 months) and median progression free survival was 8.5 months (95% CI: 6.9 – 10.8 months). No treatment-related serious adverse events or unexpected toxicities were observed. Treatment, follow-up and immune response evaluations are ongoing.
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. Based on prior studies, expected median time to progression is 5.7 months and median overall survival is 12.1 months with combination pemetrexed and cisplatin chemotherapy. The tumor-associated antigen mesothelin is overexpressed on the majority of mesothelioma tumors.
About CRS-207
CRS-207 is one of a family of product candidates based on Aduro’s live-attenuated, double-deleted (LADD) Listeria monocytogenes immunotherapy platform that induces a potent innate and T cell-mediated adaptive immune response. CRS-207 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.