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Moderna's Personalized Cancer Vaccine Plus Keytruda Shows Early Efficacy in HNSCC

NEW YORK – Cambridge, Massachusetts-based Moderna on Wednesday announced that the combination of its personalized cancer vaccine mRNA-4157 and pembrolizumab (Merck's Keytruda) was well-tolerated and demonstrated preliminary efficacy as a treatment for patients with head and neck cancers.

Specifically, at the Society for Immunotherapy of Cancer's 2020 virtual meeting, Moderna showed that in the dose expansion cohort of a Phase I trial the vaccine immunotherapy combination shrunk tumors in 50 percent of patients with human papillomavirus (HPV)-negative head and neck squamous cell carcinomas.

Out of 10 such patients, two patients achieved a complete response and three patients achieved partial responses, which are still ongoing. Four patients' cancers remained stable, contributing to a disease control rate of 90 percent. The median progression-free survival among these patients was 9.8 months, which, according to the company, marks a significant improvement over the two-month median progression-free survival seen in patients treated with pembrolizumab alone.

Compared to the 50 percent response rate with the vaccine immunotherapy combination, patients on pembrolizumab monotherapy achieved a 14.6 percent response rate. Based on these data, Moderna plans to increase the size of the HPV-negative head and neck cancer patient cohort in the clinical trial.

Moderna's personalized cancer vaccine relies on neoantigens detected in patients' individual tumors to elicit immune responses. The company identifies these neoantigens through tumor sequencing and proprietary predictive algorithms and can encode up to 34 neoantigens into the vaccine.

"We are encouraged by these interim data from our personalized cancer vaccine program," Stephen Hoge, Moderna's president, said in a statement. "This study demonstrates the ability of Moderna’s mRNA personalized cancer vaccine to elicit clinical activity when given in combination with pembrolizumab."

In addition to announcing the interim data from its ongoing trial, Moderna also announced that it had appointed Praveen Aanur as VP and therapeutic area head for oncology development.