The phase 3 INTerpath-009 trial has been initiated to evaluate an individualized neoantigen therapy plus Keytruda (pembrolizumab) in the adjuvant treatment of resectable stage 2, 3A or 3B non-small cell lung cancer whose disease did not completely respond to neoadjuvant Keytruda plus platinum-based chemotherapy.
Global recruitment has also started for this trial, with the first patients enrolling in Canada, according to a press release from Merck, the manufacturer of Keytruda, and Moderna, the manufacturer of the individualized neoantigen therapy V940 (mRNA-4157).
According to the release, individualized neoantigen therapies are typically created to elicit an antitumor immune response by creating T-cell responses based on the mutations present on a patient’s tumor. A neoantigen, as noted by the National Cancer Institute, is a protein that develops on a cancer cell when specific mutations occur in tumor DNA that may play a role in aiding the body create an immune response against these specific cancer cells.
“While the overall survival rates for patients with non-small cell lung cancer have significantly improved in recent years, lung cancer contributes to be the leading cause of cancer death worldwide,” said Dr. Marjorie Green, senior vice president and head of oncology, global clinical development at Merck Research Laboratories, in the release.
Glossary:
Adjuvant treatment: additional treatment after the primary treatment to reduce the risk for cancer recurrence
Neoadjuvant treatment: the first treatment given to potentially shrink the tumor before the main treatment
Overall survival: the time when a patient with cancer is still alive
Pathological complete response: the lack of all indicators of cancer as determined by tissue samples removed after treatment
Distant metastasis: cancer that spreads from the original location to other lymph nodes or organs
mRNA: a type of RNA in cells that carry genetic information to create proteins
In the INTerpath-009 trial, researchers are aiming to include 680 patients with resected stage 2, 3A or 3B non-small cell lung cancer who did not achieve a pathological complete response to Keytruda plus platinum-based chemotherapy. Other specific eligibility criteria for this trial include an Eastern Cooperative Oncology Group performance status of 0 (fully active) or 1 (restricted activity), and no EGFR mutation, which is a genetic mutation that can be found in some patients with non-small cell lung cancer.
After undergoing surgical resection, these patients will be randomly assigned to receive either V940 plus Keytruda or placebo plus Keytruda.
The main areas of interest for researchers include disease-free survival (the time from randomization to any recurrence), an occurrence of a new primary non-small cell lung cancer or all-cause death, whichever occurs first, according to the press release. Other areas that researchers will focus on include distant metastasis-free survival, overall survival, lung cancer-specific survival, disease-free survival after initiation of the next line of therapy, quality of life and safety, according to the trial’s ClinicalTrials.gov listing.
“We believe that our mRNA technology has the potential to improve the outcomes of those affected by lung cancer, and together, INTerpath-002 and INTerpath-009 are designed to demonstrate this potential in early-stage lung cancer, with and without prior neoadjuvant therapy,” said Dr. Kyle Holen, senior vice president and head of development, Therapeutics and Oncology at Moderna, said in the release.
The trial’s listing on ClinicalTrials.gov notes that the estimated primary completion date of this trial is May 16, 2033, during which the final data would be collected for the primary outcome.
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