Moderna Inc. (NASDAQ:MRNA) and Merck & Co. Inc. (NYSE:MRK) on Tuesday shared median five-year follow-up data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 study of mRNA-based individualized neoantigen therapy for a serious type of skin cancer.
The trial evaluated intismeran autogene (mRNA-4157 or V940) in combination with Merck’s Keytruda (pembrolizumab) for high-risk melanoma (stage III/IV) following complete resection (removed surgically).
In this pre-planned analysis, adjuvant treatment with intismeran autogene plus Keytruda demonstrates sustained and clinically meaningful improvement in the study’s primary endpoint, recurrence-free survival (RFS), reducing the risk of recurrence or death by 49% compared to Keytruda alone.
Moderna and Merck plan to present further data from follow-up analyses of primary and secondary endpoints at an upcoming medical meeting.
The analysis builds on the primary analysis conducted at approximately two years of follow-up, as well as a subsequent analysis at three years of follow-up.
The safety profile of intismeran autogene in combination with Keytruda in the study remains consistent with that previously reported.
In collaboration with Merck, the Phase 3 clinical trial for adjuvant melanoma (INTerpath-001) is fully enrolled.
Two non-small cell lung cancer (NSCLC) Phase 3 studies, evaluating adjuvant treatment for completely resected and resectable NSCLC after receiving neoadjuvant Keytruda plus platinum-based chemotherapy, are enrolling.
Phase 2 study for adjuvant renal cell carcinoma is fully enrolled.
Randomized Phase 2 studies for resected muscle-invasive and resected non-muscle-invasive bladder cancer are enrolling, a Phase 2 study of first-line treatment for patients with metastatic melanoma, and a Phase 2 study of first-line treatment for patients with metastatic squamous NSCLC are also enrolling.
Analyst Take
William Blair on Tuesday wrote, “While incremental, we view today's 5-year data update on intismeran as positive maintenance of an impressive effect over Keytruda monotherapy, the first therapy, to our knowledge, to show added benefit in this post-surgical setting.”
Analyst Myles Minter views the 5-year update as consistent with previous RFS analyses from intismeran data, which shows that adaptive immune responses to intismeran are nearly entirely predictive of tumor control.
MRNA Price Action: Moderna shares were up 2.8% at $43.00 on Tuesday, according to Benzinga Pro data.
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