Merck and Moderna are preparing regulatory filings for intismeran autogene, their personalised mRNA cancer vaccine combined with Keytruda, and used a STAT Summit appearance on Thursday to lay out how they will choose what to test next.
The vaccine became the first mRNA cancer therapy to succeed in a phase 3 trial when the companies announced in August that it significantly delayed recurrence and the development of metastatic disease in patients with resected stage IIB to IV melanoma. Earlier five year follow up from the phase 2b study showed a 49 percent reduction in the risk of recurrence or death and a 59 percent reduction in the risk of distant metastasis or death against Keytruda alone.
Expansion is the expensive question. Moderna president Stephen Hoge said the partners have a lot of exploring to do and need to prioritise where they explore, while Merck research chief Dean Li argued the map is partly drawn already: Keytruda’s fifteen years of trials show which tumours are immunologically hot, which are cold, and where checkpoint inhibition almost worked. The vaccine is also being evaluated in non small cell lung cancer, renal cell carcinoma and bladder cancer, and Tempus has expanded its role in the sequencing and sample logistics the individualised manufacturing process requires.
Full phase 3 results will be presented on October 24 at the ESMO Congress presidential symposium, the meeting’s most prominent session, where the size and durability of the melanoma benefit will set the terms for every tumour the partners choose next.