New Mesothelioma Drug Fast Tracked by FDA
The immunotherapy drug ONCOS-102 has been granted Fast Track designation by the Food and Drug Administration (FDA). Fast Track designation speeds up the regulatory review process for the drug.
What Is ONCOS-102?
ONCOS-102 is an immune activator designed for pleural malignant mesothelioma and other solid tumors that are difficult to treat. The drug is being developed by Targovax, a small biotech company located in Norway. It is also being tested for use treating melanoma and colorectal cancer.
How Does It Work?
In the initial trial documents, the researchers describe ONCOS-102 as an “Immune-priming GM-CSF Coding Oncolytic Adenovirus”. The treatment is engineered to replicate inside only the cancer cells, resulting in their death. It leaves healthy cells unharmed. It also stimulates the immune system to create more ONCOS-102 particles, and to recognize and kill more tumor cells.
According to Targovax’s Chief Medical Officer, Dr. Magnus Jaderberg, “It is most encouraging that survival continues to track so well in the ONCOS-102-treated first line group. We have earlier seen and reported how ONCOS-102 drives profound remodeling of the tumor microenvironment. It is now becoming clear that this is translating into long-term survival benefit.”
Why Was ONCOS-102 Fast Tracked?
The FDA Fast Track designation is based on the promising interim results of the trial which were encouraging enough to speed the approval process. The results in February (21 months into the trial) showed that patients who received ONCOS-102 in combination with standard chemotherapy survived for months more than patients receiving only standard chemotherapy. With standard chemotherapy, patients at 21 months had a median overall survival rate of 13.5 months; with ONCOS-102 added, that increased to 20.5 months. Based on these positive interim results, the FDA issued the Fast Track designation.
Next Phase of ONCOS-102 Clinical Trial
Targovex, in partnership with Merck, plans to open a new phase of the clinical trial of ONCOS-102, pairing it with Merck’s cancer drug Keytruda. The new trial will compare the effectiveness of Keytruda plus chemotherapy to ONCOS-102, Keytruda and chemotherapy. Keytruda was only approved for malignant mesothelioma patients with specific genetic markers in 2020, after more than 600 clinical trials. Mesothelioma patients who wish to participate in any clinical trial should contact their doctor.
What Can You Do?
Thornton Law Firm has represented individuals and their families in mesothelioma claims since 1978. If you have been diagnosed with mesothelioma or any asbestos-related disease, please call Attorney Andrew Wainwright using our toll-free number 888-632-0108 or tell us your story here for a free, confidential consultation.