FDA Fast Tracks New Immunotherapy Drug for Mesothelioma

FDA Fast Tracks New Immunotherapy Drug for Mesothelioma

The U.S. Food and Drug Administration (FDA) recently gave immunotherapy drug ONCOS-102 Fast Track designation for mesothelioma. ONCOS-102 is designed for hard-to-treat solid tumors, such as pleural mesothelioma tumors.

ONCOS-102 received FDA Fast Track designation after positive clinical trial results. The designation accelerates the review process for drugs that meet certain criteria set by the FDA.

FDA Accelerates Review of Immunotherapy Drug for Mesothelioma

Biotech company Targovax recently announced its clinical drug ONCOS-102 was given FDA Fast Track designation for pleural mesothelioma. This means the FDA will speed up the review process of ONCOS-102.

The FDA Fast Tracks an emerging treatment if it meets two criteria:

  1. The drug treats a life-threatening disease.
  2. The drug fills an unmet medical need.

ONCOS-102 meets the criteria as a mesothelioma treatment, because mesothelioma is a deadly cancer with no current cure.

Fast Track designation will allow the FDA to communicate more frequently about ONCOS-102 clinical trials and speed up a development plan.

Fast Tracked treatments improve a drug’s chances of receiving Priority Review for a future Biologics License Application (BLA). It also may allow developers to submit parts of the application early to shorten review time.

ONCOS-102 has also received the FDA’s Orphan Drug Designation. Orphan Designation gives a drug’s sponsor developmental incentives, including tax credits for clinical testing.

How Could ONCOS-102 Impact Mesothelioma Patients?

ONCOS-102 is an immunotherapy treatment designed to allow the body’s immune system to attack solid tumors. According to researchers, ONCOS-102 has shown broad immune system activation and has met safety standards.

The FDA Fast Tracked ONCOS-102 based on positive pre-clinical and clinical data. In a recent phase I/II clinical trial, ONCOS-102 was given to pleural mesothelioma patients along with chemotherapy treatment.

Of the 31 patients in the randomized trial, 20 participants received ONCOS-102 during treatment. These patients also underwent standard of care chemotherapy.

The remaining 11 patients in the control group only received chemotherapy treatment.

At the 21-month follow-up, researchers found:

  • Half of the patients in the ONCOS-102-treated group were alive.
  • Median survival of patients in the experimental group will be 20.5 months or longer, based on current data.

Mesothelioma patients in the control group had a median survival of 13.5 months. Researchers say the results show ONCOS-102 may support long-term mesothelioma survival.

“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.”

-Dr. Magnus Jäderberg, Chief Medical Officer of Targovax

Mesothelioma is an aggressive cancer. Most patients have an average life expectancy of 12 – 21 months. Clinical trials allow patients to test emerging treatments to potentially improve survival.

Upcoming Clinical Trial Will Continue to Test ONCOS-102

Targovax said it will partner with Merck & Co. to test the efficacy of ONCOS-102 in an upcoming mesothelioma clinical trial. The upcoming phase II trial will test ONCOS-102 in combination with immunotherapy treatments.

ONCOS-102 will be administered to mesothelioma patients in combination with Keytruda®️ (pembrolizumab).

Upcoming trials will build on the current results of immunotherapy treatment. In recent years, researchers have seen promising results treating mesothelioma with Keytruda®️ and other immunotherapy drugs.

Mesothelioma patients interested in participating in a clinical trial should contact their doctor. A specialist can help patients determine the best treatment plan for their individual case.