Research and clinical trials
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A new immunotherapy vaccine, ONCOS-102, may become the answer to the large proportion of mesenchymal cancer patients who fail to respond to a newly approved combination of checkpoint inhibitors.
ONCOS-102, a genetically engineered adenovirus, showed an overall survival rate of 21.9-25 months in a randomized phase II clinical trial when combined with standard chemotherapy in a first-line setting.
By comparison, the median survival of patients in the trial who received standard chemotherapy was only 13.5 months.
The vaccine is the flagship product of Targovax, a small Scandinavian biotech company that specializes in hard-to-treat cancers.
“We now have the data that enables us to move forward with this. We just have to be careful not to blow too many trumpets today and get ahead of ourselves,” Dr. Magnus Jaderberg, chief medical officer of Targovax, told Asbestos.com’s Mesothelioma Center. But the results are amazing.” “We are excited about what we saw.”
New study ONCOS-102 likely
Targovax is expected to soon announce the launch of another study, potentially involving prominent mesothelioma specialty centers within the United States. The study will pair ONCOS-102 with the immunotherapy combination of Opdivo and Yervoy, which was approved by the Food and Drug Administration in 2020 and the European Commission in 2021.
The combination of Opdivo and Yervoy, generally known as nivolumab and ipilimumab, was the first approved systemic treatment for mesothelioma 16 years ago, but was not effective for an estimated 50% of patients.
“These are the people we need to reach, these patients are still not getting the treatment they need with what’s on the market today,” Gaderberg said. “This is where combination can be effective.”
The latest approval stemmed from a large-scale Phase III clinical trial that produced a median overall survival of 18.1 months, compared with 14.1 months for chemotherapy. It was less of an improvement than what the ONCOS-102 vaccine showed in a much smaller study.
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Expect better results in the long term
The most recent study involved only 31 patients and was spread out to five cancer centers in Spain and France. Of the 20 patients who received the ONCOS-102 vaccine, half were still alive two years later, compared to none of those receiving chemotherapy only.
Progression-free survival was 9.8 months versus 7.6 months when comparing ONCOS-102 patients with those receiving chemotherapy only.
“Our numbers are small, but the data point in the right direction,” Jaderberg said. “With mesothelioma, there is a huge need for a new treatment that can provide better long-term outcomes for patients.”
For years, the most effective treatment for mesothelioma was a multidisciplinary approach based on severe surgery. Unfortunately, less than a third of those diagnosed qualify for surgery, leaving the majority of patients with little hope.
ONCOS-102 vaccine on FDA fast track
Earlier this year, the Food and Drug Administration granted fast-track status to ONCOS-102, hoping to speed up the regulatory approval process. The appointment arose from previous reports of increased survival of patients receiving the vaccine.
The vaccine is also being tested for skin cancer and colorectal cancer. The safety and tolerability profile has been good for every type of cancer.
As part of the latest study, analysis of tumor tissues performed before and during treatment showed extensive remodeling of the tumor microenvironment from the vaccine.
It included increased T-cell infiltration and a change in immune activity, significantly different from the control group receiving only chemotherapy.
Previous studies of ONCOS-102 also demonstrated a stronger immune response.
Gaderberg said the synergy between ONCOS-102 and drugs like Opdivo and Yervoy could provide better clinical benefits than either could provide alone, or even in combination with chemotherapy, that was used in the latest study.
He believes that ONCOS-102 will eventually be part of the standard of care for mesothelioma.
“The recently approved treatment is spreading all over the world. It is a very effective standard of care,” he said. “But half of the patients don’t respond. At this point, these are the patients we can really help.”
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