Moderna Inc.’s stock surged 6% on Tuesday, emerging as the top gainer in the S&P 500 index, following the release of promising data related to its cancer vaccine, suggesting potential effectiveness in treating indications beyond its initial focus on melanoma.
During a presentation at the American Association for Cancer Research’s annual meeting on Monday, Moderna shared encouraging findings regarding its cancer vaccine’s performance in a trial involving patients with HPV-negative head-and-neck squamous-cell cancer (HNSCC). The trial revealed that combining Moderna’s vaccine with Merck’s Keytruda yielded a higher overall survival rate compared to treatment with Keytruda alone, as observed in earlier Phase 2/3 studies.
The data, which were based on a follow-up conducted approximately nine months after the trial’s completion on May 4, 2023, showed promising outcomes. Out of the 28 patients enrolled in the trial, 22 received MRNA-4157, Moderna’s personalized cancer vaccine. Notably, six participants discontinued the trial before receiving treatment due to death or disease progression and were excluded from the analysis.
Among the recipients of the vaccine, approximately 27% exhibited an overall response rate (ORR), with a progression-free survival (PFS) of 3.4 months and an overall survival (OS) of 24.6 months. Analysts at Jefferies noted that these results compared favorably to the Keytruda monotherapy studies, which reported ORRs of 18% and 15%, with PFS durations of 2.1 months and OS durations of 8.8 months and 8.4 months, respectively.
“This is encouraging and could even support Moderna potentially going into 1L (first line) in combination with PD1 — where Keytruda is approved in combo with chemo with a 36% ORR, 4.9 mos PFS and 13 mos OS,” wrote analysts led by Michael J. Yee in a note to clients.
Keytruda, a monoclonal antibody targeting the PD-1 pathway, has demonstrated efficacy in various cancer treatments by enhancing the immune response against tumors.
Yee further suggested that Moderna might advance its vaccine into larger Phase II or pivotal Phase III trials directly, especially considering the significant promise demonstrated in the HNSCC trial.
Although Moderna currently focuses on studying the vaccine’s efficacy in treating melanoma, HNSCC remains a serious and challenging disease with a poor prognosis, underscoring the urgent need for effective treatment options.
The debate surrounding Moderna’s potential filing for accelerated approval for adjuvant melanoma continues, particularly as the company progresses with enrollment in a Phase 3 confirmatory trial. Jefferies anticipates discussions between Moderna and the Food and Drug Administration (FDA) once enrollment reaches an advanced stage, likely in the latter half of the year.
With Moderna’s stock up 13% year-to-date, Jefferies maintains a buy rating on the company’s shares, highlighting the significant promise of its cancer vaccine development efforts amidst ongoing advancements in the field.