FDA Fast Tracks ONCOS-102 for Mesothelioma

Researchers have found various immunotherapy drugs may be effective in treating mesothelioma. Most recently, a clinical trial testing immunotherapy drug ONCOS-102 showed promising results for pleural mesothelioma.

As a result, the U.S. Food and Drug Administration (FDA) gave Fast Track designation to ONCOS-102 for pleural mesothelioma. The designation can expedite the development of the drug and the review process. This means FDA approval of ONCOS-102 could come sooner, providing earlier access to patients.

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ONCOS-102 Shows Promising Results as Mesothelioma Treatment

ONCOS-102 is an immunotherapy drug known as an oncolytic virus. Targovax designed the drug to activate the body’s immune system to attack solid tumors. Researchers have been testing ONCOS-102 in combination with chemotherapy for mesothelioma. The recent clinical trial’s positive data led to the FDA Fast Track designation.

The randomized clinical trial included 31 pleural mesothelioma patients. Of this group, 11 underwent chemotherapy alone. The others were treated with ONCOS-102 and chemotherapy.

Researchers found those treated with chemotherapy alone had a median survival of 13.5 months. Based on their data, they estimated the median survival for patients treated with the combination therapy would be 20.5 months or longer. At the 21-month follow-up, half of the patients treated with ONCOS-102 and chemotherapy were still alive.

ONCOS-102 Survival Data Encourages Researchers

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, explained this data indicates ONCOS-102 could lead to long-term survival for patients.

Dr. Jäderberg said the data is encouraging and supports the efficacy of immunotherapy for mesothelioma. He stated, “The survival data also holds up well to the recently FDA-approved ipilimumab and nivolumab combination.”

In October 2020, immunotherapy drugs Opdivo®️ (nivolumab) and Yervoy®️ (ipilimumab) received FDA approval. The combination therapy is approved as a first-line treatment for pleural mesothelioma patients who are not eligible for surgery. The approval came after a promising clinical trial. Results showed the immunotherapy combination had a median survival of 18.1 months. Comparatively, patients treated with chemotherapy had a median survival of 14.1 months.

Dr. Jäderberg mentioned the current data in the clinical trial “strongly suggest[s] combining ONCOS-102 with checkpoint inhibition could further boost efficacy in this highly malignant and difficult-to-treat cancer.”

What Does the FDA Fast Track Designation Mean for Patients?

The promising pre-clinical and clinical data from the ONCOS-102 clinical trial led to the FDA’s Fast Track designation. This designation will facilitate the development of ONCOS-102 and can expedite its review.

FDA’s Fast Track process is meant to expedite the review of drugs for serious illnesses, such as mesothelioma, to fill an unmet medical need. The purpose is to get these treatments to the patients earlier.

Because of the Fast Track designation, the following may occur:

• More frequent communication with the FDA around the development plan and clinical trials to collect needed data
• Eligibility for Accelerated Approval and Priority Review
• Rolling review for its Biologic License Application (BLA), meaning Targovax can submit portions of the application as they are completed and quicken the review process

Overall, this designation could grant patients access to ONCOS-102 sooner.

Continued Research of ONCOS-102 for Mesothelioma

Targovax will continue to test the efficacy of ONCOS-102 in mesothelioma clinical trials. The company is collaborating with Merck & Co. to open a clinical trial testing ONCOS-102 with another immunotherapy drug.

The new clinical trial will test the combination of ONCOS-102, Keytruda and chemotherapy as a first-line mesothelioma treatment. Participants will be treated with either the triplet therapy or a combination of Keytruda and the standard of care. Keytruda, a checkpoint inhibitor, has previously shown survival benefits for pleural mesothelioma patients.

The companies hope to open the clinical trial later this year. Mesothelioma patients interested in participating in this or other clinical trials should talk to their doctors.