NEW YORK – McGill University Health Center has begun enrolling non-small cell lung cancer patients within two Phase III trials testing the activity of Merck and Moderna's individualized neoantigen vaccine V940 in combination with Merck's checkpoint inhibitor Keytruda (pembrolizumab).
MUHC, located in Montreal, said last week that it is among the first sites to begin enrolling NSCLC patients into two global, Phase III studies: INTerpath-002 and INTerpath-009. The institution has enrolled the first Canadian patient into INTerpath-002, which is evaluating V940 plus Keytruda as an adjuvant NSCLC treatment in those who haven't received neoadjuvant treatment. MUHC has further enrolled the first patient worldwide into INTerpath-009, which is also evaluating V940 and Keytruda in the adjuvant setting, though among those who have received neoadjuvant treatment.
Merck and Moderna are codeveloping V940. The personalized neoantigen therapy is created by first harvesting patients' tumor cells, then analyzing the samples alongside normal tissue cells to identify up to 34 neoantigens unique to each patient's cancer. The researchers then encode the neoantigens into an mRNA strand, which they pack into an injectable lipid nanoparticle and administer to patients intramuscularly.
In the INTerpath-002 trial, researchers are enrolling patients with stage II to IIIB NSCLC and comparing their disease-free survival on V940 plus Keytruda versus just Keytruda. They are also tracking patients' overall survival, distant metastasis-free survival, lung cancer-specific survival, and other measures of safety and efficacy as secondary endpoints.
The goal of the similarly designed INTerpath-009 is to compare the activity of the same treatment combination against Keytruda in patients with stage II to IIIB NSCLC who first receive neoadjuvant Keytruda and chemotherapy but do not achieve a pathologic complete response. Researchers will track the same set of endpoints in this trial as in INTerpath-002.
Merck and Moderna announced they were going to conduct the INTerpath-002 trial in December 2023 and the INTerpath-009 study in October.
The drugmakers are also studying V940 in tumor types other than NSCLC. In the open-label Phase IIb KEYNOTE-942 study, at 18 months posttreatment, patients with high-risk melanoma on adjuvant Keytruda and V940 had a recurrence-free survival rate of 79 percent versus 62 percent for patients on Keytruda alone.