Expert Discusses Promise of CRS-207 Vaccine in Mesothelioma

Excerpt:

“The investigational cancer vaccine CRS-207 may improve response and survival when given with chemotherapy in patients with malignant pleural mesothelioma (MPM) according to results of a phase Ib trial.

“CRS-207, a live-attenuated, double-deleted Listeria monocytogene engineered to express the tumor-associated antigen mesothelin, was administered with chemotherapy to 38 patients with MPM. Of 34 evaluable patients, 59% (n = 20) had partial response posttreatment and 35% (n = 12) had stable disease, for an overall disease-control rate 94%. Median progression-free survival was 8.5 months and median overall survival had not been reached.

“Immunohistochemistry data from 3 patients revealed an increase in tumor-infiltrating lymphocytes (TILs) post–CRS-207. Treatment-associated changes in circulating immune cells and biomarkers were also observed.”

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ELCC 2016 Press Release: Immunotherapy With Live Bacterium Improves Response Rate in Malignant Pleural Mesothelioma

Excerpt:

“Immunotherapy with a live bacterium combined with chemotherapy demonstrated more than 90% disease control and 59% response rate in patients with malignant pleural mesothelioma (MPM), according to the results of a phase Ib trial presented today at the European Lung Cancer Conference (ELCC) 2016 in Geneva, Switzerland.

“ ‘Malignant pleural mesothelioma is a cancer of the lining of the lung and is rare but difficult to treat,’ said Prof Thierry Jahan, professor of medicine at the UCSF Helen Diller Family Comprehensive Cancer Center in San Francisco, US. ‘Standard of care treatment with pemetrexed and platinum compound chemotherapy gets a 30% response rate but a modest impact on survival. So there is a clear unmet need in targeting this specific population.’

“Patients with MPM strongly express the mesothelin antigen in the tumour. CRS-207 is a live, attenuated Listeria monocytogenes bacterium that contains two gene deletions to diminish its pathogenicity and has also been engineered to express mesothelin.”

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FDA Grants Breakthrough Status to Immunotherapy Combination for Pancreatic Cancer

The gist: A new pancreatic cancer treatment combines two drugs, known as CRS-207 and GVAX Pancreas. This combo treatment boosts a patient’s own immune system to fight cancer. It has been tested in volunteer patients in clinical trials, and has shown promising results for people with metastatic pancreatic cancer. The U.S. Food and Drug Administration (FDA) has now granted breakthrough therapy designation for CRS-207 plus GVAX Pancreas, meaning that review and approval will be accelerated so that the drug can more quickly reach patients in the U.S., outside of clinical trials.

“The FDA today granted breakthrough therapy designation to the combination of two immunotherapies — CRS-207 and GVAX Pancreas — for the treatment of metastatic pancreatic cancer, according to Aduro BioTech, the combination treatment’s manufacturer.

“The combination of GVAX, an irradiated, granulocyte-macrophage colony–stimulating factor vaccine, and CRS-207, an immunotherapy vaccine containing live-attenuated Listeria monocytogenes bacteria, induces a potent innate and T-cell–mediated immune response.

“ ‘We are extremely pleased to receive Breakthrough Therapy Designation and the high degree of FDA collaboration toward advancement of our program that it confers,’ Stephen T. Isaacs, chairman, president and CEO of Aduro, said in a press release. ‘This designation underscores the potential of our combination immunotherapy approach to make a difference in the lives of patients with pancreatic cancer, which remains a very difficult cancer to treat. We are encouraged by our phase 2 results and look forward to completing enrollment in our phase 2b ECLIPSE trial by end of 2015.’ “


Aduro Announces ASCO Presentation of Promising Results from Phase 1b Clinical trial of its Novel Immunotherapy for the Treatment of Mesothelioma

“Aduro BioTech, Inc., a clinical stage biotechnology company, today announced the presentation of safety and efficacy data from a Phase 1b clinical trial of its novel immunotherapy CRS-207 in combination with standard chemotherapy in patients with unresectable malignant pleural mesothelioma (MPM). Of the 16 evaluable patients, 69% (11/16) had confirmed durable partial responses (PR) with 25% (4/16) experiencing stable disease (SD) after CRS-207 and chemotherapy. 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 poster presentation at the 2014 American Society of Clinical Oncology Meeting (ASCO) held in Chicago.”

Editor’s note: Scientists have developed a new drug called CRS-207 for treating mesothelioma. CRS-207 is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer. A clinical trial testing CRS-207 in volunteer patients found promising results for the drug.


Immunotherapy Duo Improves Survival in Metastatic Pancreatic Cancer

Overall survival was improved in metastatic pancreatic cancer patients through an innovative immunotherapy strategy in a multicenter study reported at the 2014 Gastrointestinal Cancers Symposium.

“ ‘This is the first time a randomized study has shown that immunotherapy is effective in pancreatic cancer,’ said Dung T. Le, MD, Assistant Professor of Medicine at the Johns Hopkins University Sidney Kimmel Comprehensive Cancer Center, Baltimore. ‘This is just a first step, and we believe we’ll be able to take this approach further.’ ”

“The novel treatment, which may be better tolerated than standard chemotherapy, involves two different anticancer vaccines: GVAX Pancreas followed by CRS-207. GVAX is composed of pancreatic cancer cells that have been genetically modified to secrete granulocyte-macrophage colony-stimulating factor (GM-CSF), which stimulates the immune system. GVAX is given with low-dose cyclophosphamide to inhibit regulatory T cells and boost the vaccine’s efficacy. The second vaccine, CRS-207, is live-attenuated Listeria monocytogenes (Lm), which has been genetically modified to be safe for human use while retaining its ability to stimulate an immune response against the protein mesothelin on pancreatic tumor cells.

“The combination essentially trains the body to recognize and attack pancreatic tumors. In mouse tumor models, Lm/GVAX vaccines are synergistic, and in a phase I study of CRS-207, patients with pancreatic ductal adenocarcinoma who had received prior GVAX lived more than 15 months, Dr. Le explained.”

Editor’s note: Immunotherapy treatments work by boosting a patient’s own immune system to fight cancer. This story describes such a treatment, which combines two “cancer vaccines” called GVAX Pancreas and CRS-207. Scientists found promising results for the treatment in pancreatic cancer patients.