Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) reported fresh findings from the phase IIb KEYNOTE-942 research, which assessed their customized cancer vaccine (PCV) candidate, mRNA-4157/V940, in melanoma. The findings were revealed at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO).

The study’s data showed that combining mRNA-4157 with Merck’s blockbuster immuno-oncology medicine Keytruda resulted in a statistically significant and clinical improvement in distant metastasis-free survival (DMFS), an important secondary endpoint. When compared to those who received Keytruda alone, the combination lowered the chance of distant metastasis or death by 65%.

Moderna released comprehensive findings from the KEYNOTE-942 trial earlier this month. The study’s primary goal of recurrence-free survival (RFS) was met. The study’s findings revealed that when mRNA-4157 was paired with Merck’s Keytruda, it reduced the chance of disease recurrence or death by 44%. The findings of the study also revealed that a tailored neoantigen strategy could help melanoma patients.

The KEYNOTE-942 research compares the combination of mRNA-4157 and Keytruda versus Keytruda alone as an adjuvant treatment for patients with stage III/IV melanoma who have a high risk of recurrence following full resection.

Moderna and Merck are presently reviewing the aforementioned findings with regulatory authorities, and they also want to begin phase III research in melanoma patients later this year. The businesses also intend to broaden the PCV vaccine’s application to other cancer indications, such as non-small cell lung cancer.

Moderna stock has dropped 28.2% this year, compared to the industry’s 7.6% drop.

Based on the findings of the KEYNOTE-942 research, the mRNA-4157/Keytruda combination has been designated as a Priority Medicines (PRIME) program and breakthrough therapy in the melanoma indication in the European Union and the United States, respectively. These two designations give Moderna and Merck proactive regulatory support in the development of their combination treatment.

Merck and Moderna formed a strategic alliance in 2016 to develop and commercialize mRNA-based customized vaccines for the treatment of various cancers. Merck exercised its option to develop the PCV vaccine alongside Moderna in October. The companies will split costs and profits evenly under the conditions of the agreement.

Unlike other vaccines that are uniformly developed to treat all patients, the PCV vaccine intends to provide cancer patients with customized treatment. mRNA-4157 is customized for each patient based on the tumor’s unique mutational signature.

mRNA-based vaccinations, as opposed to standard immunizations, teach the body how to manufacture a specific protein that can help your immune system avoid or treat certain diseases. The COVID-19 pandemic underscored the enormous potential of mRNA-based therapies. Moderna and Pfizer used COVID vaccinations to achieve record-high immune responses against the virus when compared to typical protein-based and adeno-based vaccines.

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