Another novel mesothelioma therapy is close to approval.
The U.S. Food and Drug Administration (FDA) granted “fast-track” designation to ONCOS-102 for malignant pleural mesothelioma. The therapy is an oncolytic adenovirus that breaks up tumor cells and signals to the body’s immune system.
Fast-track designation is for therapies showing promise for unmet needs in serious medical conditions. Malignant mesothelioma fulfills a “serious medical condition” with “unmet needs.”
Receiving this designation is massive for Targovax, the European manufacturer of ONCOS-102. The company can communicate more regularly with the FDA. This allows for expedited development and review.
The press release states, “The US FDA granted Fast-Track designation to ONCOS-102 based on encouraging pre-clinical and clinical efficacy associated with broad immune activation observed to date.”
ONCOS-102 for Mesothelioma: Promising Survival Rates
ONCOS-102 has had momentum for around one year as a new mesothelioma treatment. In the current clinical study, ONCOS-102 has led to a median survival of 20.5 months. Half the patients receiving ONCOS-102 reached the 21-month follow-up.
This treatment was paired with intravenous chemotherapy. It outperformed chemotherapy alone by a median of seven months.
At the one-year follow-up, the disease control rate was 90%, and the one-year survival rate was 64%.
All of these stats surpass chemotherapy on its own. The two-year survival rate for ONCOS-102 should be released soon and again outperform chemotherapy.
The adenovirus also delivers immune-stimulating proteins, called cytokines. The proteins alert the immune system to swarm the disbanded cells. The body’s T-cells locate cancerous molecules from the cancer cells, helping respond to the disease.
ONCOS-102 With Immunotherapy Checkpoint Inhibitors?
Dr. Magnus Jaderberg, the chief medical officer for Targovax, discussed U.S. clinical trial plans on a recent Mesothelioma Guide podcast. He said Memorial Sloan Kettering Cancer Center and the Mayo Clinic will be part of the U.S. study.
The original intent was to pair ONCOS-102 with immunotherapy drug Keytruda in the study. The FDA approval of Opdivo and Yervoy in October 2020 may alter that plan.
“(This trial) is the first time anyone has combined an oncolytic virus with a checkpoint inhibitor for this specific disease,” Dr. Jaderberg said at the time.
Sources & Author
- Continued survival benefit in Targovax’s ONCOS-102 trial in mesothelioma at the 21-month follow-up. PRNewswire. Retrieved from: https://www.prnewswire.com/news-releases/continued-survival-benefit-in-targovaxs-oncos-102-trial-in-mesothelioma-at-the-21-month-follow-up-301233073.html. Accessed: 02/23/2021.
- Targovax Releases Update for Mesothelioma Trial Combining ONCOS-102 and Chemotherapy. BioSpace. Retrieved from: https://www.biospace.com/article/releases/targovax-releases-update-for-mesothelioma-trial-combining-oncos-102-and-chemotherapy/. Accessed: 05/04/2020.
- Targovax receives Fast-Track designation for ONCOS-102. BioSpace. Retrieved from: https://www.biospace.com/article/releases/targovax-receives-fast-track-designation-for-oncos-102/. Accessed: 02/17/2021.
Sources & Author