Benzinga - by Vandana Singh, Benzinga Editor.
Recently, on clinicaltrials.gov, Merck & Co Inc (NYSE:MRK) posted a new trial of Moderna Inc’s (NASDAQ:MRNA) V940, an individualized neoantigen therapy (INT), plus pembrolizumab for locally resectable advanced cutaneous squamous cell carcinoma (LA cSCC).
Phase 2 has three arms V940 plus pembrolizumab given as neoadjuvant and adjuvant treatment with standard of care (SOC), standard of care (surgical resection with/without adjuvant radiation therapy (RT) only at investigator’s discretion) and pembrolizumab monotherapy given as neoadjuvant and adjuvant treatment with SOC.
This phase will assess the safety and efficacy of V940 in combination with pembrolizumab as neoadjuvant and adjuvant therapy in participants with resectable LA cSCC compared to standard-of-care SOC only.
The primary hypothesis is that V940 plus pembrolizumab with SOC is superior to SOC only concerning event-free survival (EFS) as assessed by the investigator.
Phase 3 expansion will be determined by a prespecified Go-No-Go decision in which 412 additional participants will be randomized to V940 plus pembrolizumab with SOC and SOC only, without changing the inclusion/exclusion criteria for the additional enrollment or study endpoints.
The study is not yet enrolling participants. It is expected to start next month, and the study is expected to conclude by 2029, as per the government website.
The companies are already collaborating for two Phase 3 trials of V940 (mRNA-4157) plus Keytruda for melanoma and non-small cell lung cancer.
Jefferies, in its note, writes that this third new trial suggests even more investment put to work on the program and speaks to continued confidence in a broad program. The analyst notes that cSCC is ~20% of malignant cutaneous melanoma and a more aggressive form of skin cancer.
RBC Capital says this is the first potentially pivotal trial that will also explore both neo-and adjuvant therapy, and cSCC is on the rise, with around one million cases diagnosed in the U.S. each year.
Price Action: MRNA shares are up 8.96% at $112.26 on the last check Monday.
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