Drug Approval | February 23, 2023
Moderna and Merck announce investigational personalized cancer vaccine mRNA-4157/V940
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial
Moderna and Merck announced mRNA-4157/V940, in combination with KEYTRUDA, demonstrated a 44% reduction in the risk of disease recurrence or death in melanoma patients
Results are the first demonstration of efficacy for an investigational mRNA cancer treatment in a randomized clinical trial
In first-line metastatic NSCLC, KEYTRUDA-based regimens have now shown a five-year survival benefit in four trials
Longer-term survival results underscoring role of KEYTRUDA (pembrolizumab) in multiple cancer types, including advanced nonsquamous non-small cell lung cancer (KEYNOTE-189)
The safety profile of KEYTRUDA plus LENVIMA was consistent with previously reported data on the combination.
Acceptance based on results from the phase 3 KEYNOTE-091 trial
Immune-mediated events and infusion reactions were higher with KEYTRUDA (38% vs 9%, respectively).
Researchers found that the drug combination led to a sustained and tenfold increase in the production of CD8 T cells and natural killer cells
First disclosure from PILOT study of Breyanzi in second-line large B-cell lymphoma underscores important role of cell therapy earlier in treatment paradigm
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