Intismeran autogene
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MRNA & MRK's Personalized Cancer Therapy Delivers Strong 5-Year Data
ZACKS· 2026-01-22 17:40
Core Insights - Moderna's shares increased by 15.8% following the announcement of positive five-year follow-up data from a phase IIb study on its personalized cancer therapy for high-risk melanoma patients [1][6] Group 1: Study Overview - The KEYNOTE-942/mRNA-4157-P201 study assessed Moderna's mRNA-based individualized neoantigen therapy (intismeran autogene) in combination with Merck's PD-L1 inhibitor, Keytruda, for treating high-risk melanoma patients post-surgery [2][7] - The study showed that the combination therapy significantly improved recurrence-free survival, reducing the risk of recurrence or death by 49% compared to Keytruda alone [3][4] Group 2: Long-term Efficacy and Safety - The follow-up analysis indicated sustained and clinically meaningful improvements in recurrence-free survival, marking a significant milestone for the therapy [3][4] - The safety profile of intismeran autogene combined with Keytruda remained consistent with previous studies [5] Group 3: Future Developments - Moderna and Merck plan to present additional follow-up data at upcoming medical meetings [4][7] - Beyond melanoma, the therapy is being evaluated in pivotal phase III studies for non-small cell lung cancer and other cancer types, with a commercial launch targeted for next year [9] Group 4: Pipeline Expansion - Moderna is focusing on expanding its oncology pipeline, including the development of mRNA-4359, an investigational therapy for melanoma and metastatic non-small cell lung cancer, with data expected in 2026 [10]
Moderna, Inc. (MRNA) Shareholder/Analyst Call Transcript
Seeking Alpha· 2025-10-17 20:06
Core Insights - The company is excited to share new data on asset 4359, which is becoming a late-stage asset similar to INT [1] - The presentation includes discussions on melanoma and the data related to 4359, featuring experts in the field [1] Pipeline Overview - The company utilizes mRNA technology in various innovative ways, including personalized therapies through the Intismeran autogene program [2] - Off-the-shelf therapies are being developed, referred to as cancer antigen therapies (CATs), along with a T-cell engager program [2] - The company is also advancing in vivo cell therapy programs, which are expected to enhance cell therapy applications [2] Efficacy Potential - The company believes that its programs hold the promise of potential efficacy across a wide range of indications and different therapeutic areas [3]