New “Orphan Drug” For Malignant Pleural Mesothelioma (MPM), CRS-207, Has Been Approved By FDA

Malignant pleural mesothelioma (MPM), a form of cancer that affects the smooth layer of mesothelial cells that surround the lungs, is the most common form of mesothelioma and accounts for approximately new 3,000 cases a year in the US.

Pleural mesothelioma is an aggressive disease with a poor prognosis and most patients are not candidates for surgical resection. According to medical studies, the expected median progression-free survival for a person with pleural mesothelioma is 5.7 months and overall survival is 12.1 months with combination pemetrexed and cisplatin chemotherapy.

The tumor-associated antigen mesothelin is overexpressed in virtually all cases of mesothelioma.

This new pleural mesothelioma treatment, CRS-207, has been engineered to express the tumor-associated antigen mesothelin, which is over-expressed in many cancers including mesothelioma.

From the March 2015 company press release about this FDA action, “Aduro Receives Orphan Drug Designation for CRS-207 in Mesothelioma”:

Aduro is developing CRS-207 for patients with malignant pleural mesothelioma who have not received prior therapy and are not eligible for surgical resection. Patients are currently being enrolled in a single-arm Phase 1b clinical trial of CRS-207 in combination with standard-of-care chemotherapy. Interim results presented at the International Mesothelioma Interest Group Conference in October 2014 demonstrated a 94% rate of disease control (partial response and stable disease) for the 16 treated, evaluable patients with response data. Specifically, 75% (12/16) had confirmed partial responses and 19% (3/16) experienced stable disease. At the time of the presentation, estimated progression-free survival was 7.5 months, with one patient on study for more than 19 months. That patient is currently receiving maintenance therapy with CRS-207 alone following the combination treatment with chemotherapy. Based on these encouraging results, Aduro opened an expansion cohort of up to a total of 40 patients and expects to finish enrollment in the study in 2015, with top-line results presented in 2016.

We will continue to monitor the progress of these clinical trials for this new pleural mesothelioma treatment CRS-207 and report significant developments here.

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