Moderna ( MRNA Quick Quote MRNA - Free Report) and partner Merck ( MRK Quick Quote MRK - Free Report) announced new results from the phase IIb KEYNOTE-942 study, which evaluated their personalized cancer vaccine (“PCV”) candidate, mRNA-4157/V940, in melanoma indication. The results were announced at the 2023 American Society of Clinical Oncology (“ASCO”) Annual Meeting.
Data from the study showed that participants treated with a combination of mRNA-4157 and Merck’s blockbuster immuno-oncology drug Keytruda led to a statistically significant and clinical improvement in distant metastasis-free survival (“DMFS”), a key secondary endpoint of the study. The combination reduced the risk of distant metastasis or death by 65% compared with participants who were treated with Keytruda alone.
Earlier in April, Moderna announced detailed results from the KEYNOTE-942 study. The study
achieved its primary endpoint of recurrence-free survival (“RFS”). Data from the study showed that mRNA-4157, when combined with Merck’s Keytruda, exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%.The study’s results also suggested that a personalized neoantigen approach may benefit melanoma patients.
The KEYNOTE-942 study is evaluating the combination of mRNA-4157 and Keytruda, compared to Keytruda alone, as an adjuvant treatment for stage III/IV melanoma patients with a high risk of recurrence following complete resection.
Moderna and Merck are currently discussing the above results with regulatory authorities and also intend to start a phase III study in melanoma patients later this year. The companies also plan to expand the PCV vaccine to other cancer indications, including non-small cell lung cancer.
In the year so far, the stock has lost 28.2% compared with the
industry’s 7.6% fall. Image Source: Zacks Investment Research
Based on the data from the KEYNOTE-942 study, the mRNA-4157/Keytruda combination has been granted Priority Medicines (“PRIME”) scheme and breakthrough therapy designations in the European Union and the United States, respectively, in the melanoma indication. The grant of these two designations provide Moderna and Merck proactive support from the regulatory agencies in the development of their combination therapy.
Merck and Moderna entered a strategic partnership in 2016 to develop and commercialize mRNA-based personalized vaccines to treat various types of cancer. Last October, Merck exercised its option to develop the PCV vaccine with Moderna. Per the terms of collaboration, the companies will share costs and profits equally.
Unlike other vaccines that are uniformly designed to treat all patients, the PCV vaccine aims to bring individualized treatment to cancer patients. mRNA-4157 is tailored for each patient, based on the unique mutational signature of a patient's tumor.
As opposed to traditional vaccines, mRNA-based vaccines teach the body how to make a specific protein that can help your immune system prevent or treat certain diseases.The COVID-19 pandemic further demonstrated the significant potential of mRNA-based therapeutics. By way of COVID vaccines, Moderna and Pfizer have generated immune responses against the virus at record-high levels compared with traditional protein-based and adeno-based vaccines.
Zacks Rank & Stocks to Consider
Moderna currently carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the overall healthcare sector include
Novo Nordisk ( NVO Quick Quote NVO - Free Report) and Novartis ( NVS Quick Quote NVS - Free Report) . While Novo Nordisk sports a Zacks Rank #1 (Strong Buy), Novartis carries a Zacks Rank #2 (Buy). You can see . the complete list of today’s Zacks #1 Rank stocks here
In the past 60 days, the consensus estimate for Novo Nordisk’s 2023 and 2024 earnings per share has increased from $4.51 to $5.07 and $5.26 to $5.91, respectively. Shares of Novo Nordisk are up 16.6% in the year-to-date period.
Earnings of Novo Nordisk beat estimates in two of the last four quarters, met the mark one occasion while missing the mark on another. On an average, the company witnessed an average earnings surprise of 0.35%. In the last reported quarter, Novo Nordisk’s earnings met estimates.
In the past 60 days, estimates for Novartis’ 2023 and 2024 earnings per share have increased from $6.56 to $6.67 and $7.05 to $7.22, respectively. Shares of Novartis are up 9.5% in the year-to-date period.
Earnings of Novartis beat estimates in each of the last four quarters, witnessing an average earnings surprise of 5.15%. In the last reported quarter, Novartis’ earnings beat estimates by 10.32%.