First combination regimen to demonstrate significant reduction in recurrence risk in completely resected stage IIB-IV melanoma compared to Keytruda alone as adjuvant treatment.
Intismeran autogene in combination with anti-PD-1 therapy Keytruda (pembrolizumab) can facilitate longer cancer-free survival in completely resected stage IIB-IV melanoma, new Phase III data shows.
The findings from MSD and Moderna represent the first positive Phase III readout for an individualised neoantigen therapy (INT) alongside an mRNA-based cancer therapy.
According to Professor Georgina Long, the study’s principal investigator, the new data from the Phase III INTerpath-001 study “represent a landmark moment for adjuvant melanoma treatment. This is the first Phase III study to show that intismeran, a treatment designed based on the unique mutational ‘fingerprint’ of a patient’s own tumour, given in combination with pembrolizumab can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to Keytruda alone.
“Intismeran in combination with pembrolizumab has the potential to establish a new treatment paradigm in the adjuvant melanoma setting, helping patients remain cancer-free for longer.”
This latest data builds on MSD and Moderna’s five-year follow up findings from the Phase IIb trial of this combination therapy, released in January. The combination therapy enabled a 49 percent reduction in the risk of recurrence or death and a 59 percent reduction in the risk of distant metastasis or death compared to Keytruda only.
Stéphane Bancel, CEO of Moderna, said that “for many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational. We are now helping turn that vision into a reality.
“Together with Merck, we have started to demonstrate the transformative potential of this technology to address critical unmet needs in the adjuvant melanoma setting.”
The safety profiles for combination treatment of intismeran and Keytruda in this trial were consistent with previous findings. No new safety signals were identified.
“These first Phase III findings for intismeran in combination with Keytruda as adjuvant therapy reinforce the promise of a more personalised approach to cancer treatment”
Dr Dean Li, President, Merck Research Laboratories
Dr Dean Li, President, Merck Research Laboratories said: “By intervening earlier in the course of disease, when many cancers are considered most treatable, the goal of adjuvant therapy given after surgery is to increase the possibility of cure for more patients.
“These first Phase III findings for intismeran in combination with Keytruda as adjuvant therapy reinforce the promise of a more personalised approach to cancer treatment. We believe individualised neoantigen therapies have the potential to redefine how patients with completely resected stage IIB-IV melanoma are treated. Together with Moderna, we look forward to presenting data from INTerpath-001 at an international medical meeting and sharing with regulatory authorities
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