Moderna, Merck cancer vaccine succeeds in Phase 3 trial
Moderna and Merck have announced positive Phase 3 results for their personalized mRNA cancer treatment Intismeran in patients with high-risk melanoma, marking a major milestone for mRNA-based cancer therapies, reports a Qazinform News Agency correspondent.
The companies said the Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival. Intismeran, given in combination with Merck's Keytruda, reduced the risk of cancer recurrence and spread compared with Keytruda alone.
"This is the first time that we've seen really clinically significant, statistically significant improvements over checkpoints like Keytruda in this population, and it is the first time we've done that with an individualized treatment," Moderna President Stephen Hoge said.
The trial enrolled 1,137 patients with stage IIB-IV melanoma whose tumors had been completely removed by surgery. Participants received either Keytruda combined with up to nine doses of the personalized therapy or Keytruda alone for about one year. The companies said no new safety signals were identified.
Intismeran is individually designed using mutations identified in each patient's tumor. The mRNA-based treatment is intended to train the immune system to recognize and attack cancer cells carrying those mutations.
Detailed Phase 3 results, including the magnitude of the treatment's benefit, have not yet been released and are expected to be presented at an upcoming medical meeting. Overall survival data are also not yet available.
The findings build on earlier Phase 2b results. Five-year follow-up data showed that Intismeran combined with Keytruda reduced the risk of recurrence or death by 49% and the risk of distant metastasis or death by 59% compared with Keytruda alone.
Moderna and Merck said they are discussing the results with regulatory authorities regarding potential submissions.
The companies are also studying Intismeran in other cancers, including non-small cell lung cancer, as part of a broader clinical development program.
Earlier, Qazinform News Agency reported that hospitals in the Kazakh capital are adopting artificial intelligence technologies to improve cancer and stroke diagnostics, significantly reducing the time needed to make medical decisions.
