Adding Moderna’s in-development cancer vaccine to a standard treatment for melanoma dramatically reduces cancer survivors’ risk of death or recurrence, according to newly shared trial data.
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Moderna and pharma giant Merck are developing an mRNA-based cancer vaccine, mRNA-4157 (V940), for people who’ve had high-risk melanomas removed.
The vaccine works by instructing the body to make up to 34 “neoantigens.” These are proteins found only on the cancer cells, and Moderna personalizes the vaccine for each recipient so that it carries instructions for the neoantigens on their cancer cells.
The idea behind the vaccine is that, by prompting the body to make these proteins, it can prepare the immune system to quickly identify and attack any new cancer cells bearing them, preventing recurrence.
What’s new? In the ongoing phase 2b KEYNOTE-942 study, Moderna and Merck are comparing the cancer vaccine’s ability to prevent melanoma recurrence or death when combined with Keytruda, Merck’s FDA-approved cancer treatment, to Keytruda alone.
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This should be understood for what it is — a press release. But hopefully there’s actually substance behind it.
Looks like there’s substance behind it:
In 2022, they reported that the combo therapy reduced high-risk patients’ risk of recurrence or death by 44% compared to only Keytruda in the two years after treatment.
They’ve now announced that people who received both therapies were 49% less likely to experience recurrence or death a median of three years after treatment compared to people in the Keytruda-only group. They were also 62% less likely to experience distant metastasis or death.
And this also sounds promising:
“We think that in some countries the product could be launched under accelerated approval by 2025,” Moderna CEO Stephane Bancel told AFP.
These are all self reported. They have an interest in inflating the effectiveness of the treatment.
I see your point.
Digging a bit deeper, looks like both the U.S. Food and Drug Administration and European Medicines Agency have used this data. The data has also been submitted for peer review:
Based on data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, the U.S. Food and Drug Administration and European Medicines Agency granted Breakthrough Therapy Designation and the Priority Medicines (PRIME) scheme, respectively, for mRNA-4157 (V940) in combination with KEYTRUDA for the adjuvant treatment of patients with high-risk melanoma. The companies previously presented data on the study’s primary analysis with a median planned follow-up of approximately two years. The study’s primary endpoint, RFS, was presented in April 2023 at the American Association for Cancer Research (AACR) Annual Meeting, and the study’s secondary endpoint, DMFS, data was presented in June 2023 at the American Society of Clinical Oncology (ASCO) Annual Meeting. Data from the primary analysis has been submitted for publication in a peer-reviewed journal.
