Tedopi, a novel lung cancer vaccine, demonstrated improved survival and safety profile, according to preliminary findings from a phase 3 trial.
The novel vaccine, Tedopi, improved both efficacy for survival and the drug’s safety profile for patients with non-small cell lung cancer (NSCLC), according to a recent press release from OSE Immunotherapeutics, the manufacturer of the drug.
Tedopi is an anti-cancer immunotherapy (vaccine) that activates tumor-specific T-cells to effectively kill the tumor, according to the drug’s manufacturer. The drug is formulated in a way that includes five different proteins that are present on lung cancer cells, which helps teach the immune system to react against lung cancer, Dr. Justin Favaro, a medical oncologist who is board certified in hematology and oncology at Oncology Specialists of Charlotte in North Carolina, described in an interview with CURE®.
The cancer vaccine is reported to offer benefits to patients who have advanced or metastatic NSCLC and are HLA-A2 positive, meaning the HLA proteins on the immune cells alert the immune system that there are tumor cells present. Patients who may benefit from the vaccine have also received three previous lines of monotherapy with secondary resistance to immune checkpoint inhibitors.
“HLA-A2 positive has not been something we’ve used before; this is all kind of a new marker for this particular vaccine,” Favaro said. “We think that marker allows the vaccine would work better in those patients. But in terms of just general lung cancer, what we do when they first come in is we do all the different known markers that allow us to determine treatment options for them.”
In a phase 3 randomized study, Tedopi demonstrated positive results regarding overall survival (the period from diagnosis or treatment where patients are still alive) and improved safety and quality of life profiles in monotherapy, compared with chemotherapy in patients with advanced or metastatic NSCLC and showed progression at least 12 weeks after consecutive treatment with chemotherapy and immune checkpoint inhibitors.
“Tedopi is the first cancer vaccine to demonstrate positive results on survival in a randomized phase 3 trial in advanced and metastatic NSCLC cancer patients in third line. A significant reduction of the risk of death by 41% was achieved with a better safety profile and a maintained quality of life,” Benjamin Besse, director of clinical research at Gustave Roussy Institute and principal investigator of the ATALANTE-1 clinical trial, said in the press release.
“This study, conducted in patients with secondary resistance to immunotherapy, compared Tedopi monotherapy with standard of care docetaxel or pemetrexed chemotherapies,” Besse said. “Further evaluation is clearly warranted in a second line of treatment of advanced and metastatic NSCLC, to potentially make this cancer vaccine available to hard-to-treat patients in failure and with high medical needs.”
The preliminary findings from the study established a significant improvement for overall survival after patients received Tedopi. Data also determined that Tedopi reduced risk of death by 41%, the press release stated. The overall survival rate (OSR) for patients after one year was 44.4% for patients in the Tedopi group within the study, whereas the OSR was 27.5% for patients in the chemotherapy group.
“The benefit of the (lung cancer) vaccine is that with relatively minor side effects, (it) could improve (patient) survival,” said Favaro during the interview. “When they looked at these patients and looked at their quality of life, the feeling was that yes, there were some side effects from the vaccine, although they were pretty mild, injection site reactions, fevers, muscle aches (and) flu type symptoms were most common.”
Regarding the improved safety profile and quality of life in the study’s patient-participants, the researchers found that the maintained general health condition with time to ECOG deterioration was longer in the Tedopi group. ECOG is a scale that determines a patient’s ability to care for themselves, in which ECOG deterioration refers to the lack of ability for a patient to care for themselves. According to the data, the researchers reported that ECOG deterioration in the Tedopi group was 9 months versus 3.3 months in the chemotherapy group.
The researchers also found that participants tolerated Tedopi well, with fewer side effects that were from grades 3 to 5. No treatment-emergent side effects were of any concern in the Tedopi group.
Although the novel lung cancer vaccine is not yet approved by the Food and Drug Administration, Favaro noted that patients should stay on the lookout for the potential approval.
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