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Moderna and Merck report positive Phase 3 results for mRNA melanoma vaccine
Moderna and Merck have announced positive topline results from a Phase 3 clinical trial for an experimental mRNA cancer vaccine, intismeran autogene (also known as V940 or mRNA-4157). The personalized therapy, which is custom-designed based on the unique genetic mutations of a patient's tumor, was administered in combination with the immunotherapy drug Keytruda.
The trial, which involved over 1,100 high-risk melanoma patients, met its primary endpoints for recurrence-free survival and distant metastasis-free survival. Previous Phase 2b data indicated that the combination therapy could reduce the risk of cancer recurrence or death by 49% compared to using Keytruda alone.
Experts have described the results as a significant breakthrough in cancer treatment. The vaccine works by using a patient's tumor DNA to identify specific mutations, creating a personalized mRNA instruction that teaches the immune system to recognize and attack remaining tumor cells. While the topline results are promising, full peer-reviewed data has not yet been published. The companies are also conducting research on similar mRNA therapies for other cancer types, including lung, bladder, and kidney cancers.
Entities
Georgina Long · Intismeran · Intismeran autogene · Keytruda · Melanoma Institute Australia · Merck & Co. · Moderna · Stéphane Bancel · melanoma
Claims
What the coverage asserts, and how many sources carry each claim.
- [● 4 SOURCES] The treatment combination achieved the secondary endpoint of distant metastasis-free survival. retirement.media
- [○ 1 SOURCE] The therapy could generate approximately $3 billion for treating melanoma by 2035.
- [● 2 SOURCES] Potential regulatory approval for the treatment could occur as early as 2027. retirement.media
- [● 2 SOURCES] No new safety signals emerged during the Phase 3 trial.
- [● 7 SOURCES] The trial included 1,137 high-risk patients with stage IIB-IV melanoma that had been surgically removed. retirement.media
- [● 18 SOURCES] The Phase 3 INTerpath-001 trial for the cancer vaccine intismeran autogene met its primary endpoint of recurrence-free survival. retirement.media
- [● 6 SOURCES] The Phase 3 study will continue to evaluate overall survival benefits. retirement.media
- [DISPUTED] The Phase 3 clinical trial included more than 100 patients with high-risk or advanced-stage melanoma.
- [○ 1 SOURCE] Moderna’s stock price surged by approximately 100% following the results.
- [● 52 SOURCES] The mRNA vaccine was tested in combination with Merck’s immunotherapy Keytruda. retirement.media · www.adnkronos.com · rpp.pe · www.svd.se · www.europesays.com · +26 more
- [● 44 SOURCES] The treatment reduced the risk of cancer spreading to other parts of the body. retirement.media · www.adnkronos.com · www.svd.se · www.europesays.com · www.forchecaudine.com · +20 more
- [● 10 SOURCES] Merck’s stock rose by over 8% in pre-market trading. retirement.media · massinformacion.com.mx · www.t-online.de · theasset.nl · abcnews.al · +1 more