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Rachel V Thomas

Moderna and Merck’s Custom-Made mRNA Cancer Vaccine Shows Promise In Late-Stage Melanoma Trial

A personalized <span>mRNA cancer vaccine</span> developed by pharma giants <span>Moderna</span> and <span>Merck</span> has shown promise for patients with <span><a href="https://www.healthandme.com/health/melanoma">melanoma</a></span>, a potentially deadly form of skin cancer, in a late-stage trial. 

The vaccine, called <span>intismeran autogene</span>, or mRNA-4157/V940, is custom-made for each patient using the unique genetic blueprint of their tumor. 

The Phase 3 results build on earlier Phase 2b findings and showed that the combination of <span>intismeran</span> and <span>Keytruda</span> reduced the risk of cancer recurrence or death by 49% and reduced the risk of distant cancer spread or death by 59% up to five years.

“These Phase 3 findings represent a pivotal moment for the field of cancer research. 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,” said Stéphane Bancel, CEO of Moderna.

<h2>Trial Shows Longer Cancer-Free Survival </h2>

The Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). 

Intismeran autogene in combination with Keytruda demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared with Keytruda alone. 

The findings were seen in patients with stage IIB, IIC, III, or IV cutaneous melanoma who had undergone complete surgical removal of their cancer and had not previously received systemic therapy. 

The companies, however, aim to continue evaluation of other key secondary endpoints, including overall survival. 

Intismeran autogene is an experimental "neoantigen therapy" that uses specific mutations in a patient’s tumor to train the immune system to recognize and fight cancer cells.

The treatment is designed using a patient’s tumor sample to identify the unique mutational signature, or “fingerprint,” of their cancer and generate an anti-tumor immune response. 

Each therapy contains synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient’s tumor.

After administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, helping generate specific T-cell responses against cancer cells.

<h2>How Was the Phase 3 Trial Conducted? </h2>

<ul><li>1,137 patients with high-risk, resected stage IIB-IV melanoma took part in the trial. </li><li>Participants were randomly assigned 2:1 to receive either: </li><li>Intismeran autogene + Keytruda </li><li>Keytruda alone </li><li>Intismeran was given every three weeks for up to nine doses. </li><li>Keytruda was given every six weeks for up to nine cycles, for about one year. </li><li>The trial assessed the safety and effectiveness of the combination compared with Keytruda alone. </li></ul>

<h2>Were There Any Safety Concerns? </h2>

The safety profiles of intismeran autogene and Keytruda in the trial were consistent with those observed in previously reported studies of the combination. No new safety signals were observed. 

“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,” said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia. 

Long said the results “represent a landmark moment for adjuvant melanoma treatment.” 

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A personalized mRNA cancer vaccine developed by pharma giants Moderna and Merck has shown promise for patients with melanoma, a potentially deadly form of skin cancer, in a late-stage trial. The vaccine, called intismeran autogene, or mRNA-4157/V940, is custom-made for each patient using the unique genetic blueprint of their tumor. The Phase 3 results build on earlier Phase 2b findings and showed that the combination of intismeran and Keytruda reduced the risk of cancer recurrence or death by 49% and reduced the risk of distant cancer spread or death by 59% up to five years.“These Phase 3 findings represent a pivotal moment for the field of cancer research. 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,” said Stéphane Bancel, CEO of Moderna.Trial Shows Longer Cancer-Free Survival The Phase 3 INTerpath-001 trial met its primary endpoint of recurrence-free survival (RFS) and a key secondary endpoint of distant metastasis-free survival (DMFS). Intismeran autogene in combination with Keytruda demonstrated statistically significant and clinically meaningful improvements in RFS and DMFS compared with Keytruda alone. The findings were seen in patients with stage IIB, IIC, III, or IV cutaneous melanoma who had undergone complete surgical removal of their cancer and had not previously received systemic therapy. The companies, however, aim to continue evaluation of other key secondary endpoints, including overall survival. What Is Intismeran Autogene? Intismeran autogene is an experimental "neoantigen therapy" that uses specific mutations in a patient’s tumor to train the immune system to recognize and fight cancer cells.The treatment is designed using a patient’s tumor sample to identify the unique mutational signature, or “fingerprint,” of their cancer and generate an anti-tumor immune response. Each therapy contains synthetic mRNA coding for up to 34 neoantigens and is tailored to the unique biology of an individual patient’s tumor. After administration, the RNA-encoded neoantigen sequences are translated in the body and presented to the immune system, helping generate specific T-cell responses against cancer cells. How Was the Phase 3 Trial Conducted? 1,137 patients with high-risk, resected stage IIB-IV melanoma took part in the trial. Participants were randomly assigned 2:1 to receive either: Intismeran autogene + Keytruda Keytruda alone Intismeran was given every three weeks for up to nine doses. Keytruda was given every six weeks for up to nine cycles, for about one year. The trial assessed the safety and effectiveness of the combination compared with Keytruda alone. Were There Any Safety Concerns? The safety profiles of intismeran autogene and Keytruda in the trial were consistent with those observed in previously reported studies of the combination. No new safety signals were observed. “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,” said Professor Georgina Long, the study’s principal investigator and medical director of Melanoma Institute Australia. Long said the results “represent a landmark moment for adjuvant melanoma treatment.” 

moderna and merck’s custom-made mrna cancer vaccine shows promise in late-stage melanoma trial

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Moderna and Merck’s Custom-Made mRNA Cancer Vaccine Shows Promise In Late-Stage Melanoma Trial

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Moderna and Merck’s Custom-Made mRNA Cancer Vaccine Shows Promise In Late-Stage Melanoma Trial

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