Moderna:
“Along with our partners at Merck, we announced positive results from the Phase 3 INTerpath-001 study of intismeran autogene, our investigational individualized neoantigen therapy, in combination with pembrolizumab as adjuvant treatment in patients with completely resected Stage IIB-IV melanoma. This marks the first and only combination regimen to demonstrate a clinically meaningful improvement over pembrolizumab alone, a current standard-of-care for these patients.
In our latest IR Insights, members of our executive team sat down to reflect on what this means.”
Eric Lefkofsky, Founder and CEO of Tempus:
“Congratulations to Moderna and Merck on today’s positive Phase 3 results for INTerpath-001, a major milestone for melanoma treatment and the future of more personalized care.
We are proud to partner with Moderna and Merck in support of this important program, sequencing patients as it advances, and we’re excited to see this work continue for the benefit of patients.”
Rob Davis, Chairman and Chief Executive Officer at Merck:
“Today is an important day for Merck, our partners at Moderna and most importantly, for patients.
This morning, we announced the first positive Phase 3 topline results evaluating Merck and Moderna’s investigational individualized neoantigen therapy (INT) in combination with our company’s immunotherapy in the adjuvant setting for certain patients with completely resected stage IIB-IV #melanoma.
This is a defining moment in cancer research. This achievement is a testament to the talent and creativity of Merck and Moderna scientists. I am immensely grateful to the patients and investigators involved in this trial. Thank you for helping to make this progress possible.
Joshua Brody, Director of the Lymphoma Immunotherapy Program at Icahn School of Medicine at Mount Sinai:
“Awesome results from what will soon be the next FDA-approved cancer, vaccine, making people live longer without cancer!”
Stéphane Bancel, Founding CEO at Moderna:
“Today is an important milestone for Moderna.
In 2020, mRNA helped change what was possible in infectious disease, as our teams worked to deliver a COVID-19 vaccine at unprecedented speed, in less than a year.
Today, we announced that our Phase 3 study of intismeran autogene, our individualized neoantigen therapy, in combination with KEYTRUDA® met both its primary Recurrence Free Survival (RFS) endpoint and key secondary Distant Metastasis-Free Survival (DMFS) endpoint in melanoma.
We will share the detailed clinical data at an upcoming international medical conference.
But today, I am grateful to the patients and families who participated in this Phase 3 study, to our colleagues at Merck, and to the Moderna teams who have worked for 10 years toward this moment.
Our ambition has always been bigger than any one medicine: to use mRNA to create many families, or modalities, of new innovative medicines for patients.
From infectious disease to cancer, we are still at the beginning of what may be possible with mRNA science to help improve people’s lives.
Proud of the progress. Humbled by the responsibility. Optimistic about what comes next.”
Birgitte Rønø, Chief Scientific Officer at Evaxion A/S:
“Big news for melanoma patients and personalized cancer vaccines today from MSD and Moderna with the positive data from the INTerpath-001 trial.
This is very encouraging for the field of immuno-oncology in general and for the personalized vaccine approach in particular. To that end, we at Evaxion are also buoyed by the new data which further enhance our excitement in EVX-01, our AI-designed personalized vaccine which has also demonstrated strong data in melanoma patients.
Despite numerous treatment options, huge unmet medical needs remain within melanoma, making it crucial to develop new and better treatments. We are encouraged by today’s positive news and happy to be among the companies working toward this goal.”
Kristen Dahlgren, Chief External Affairs Officer at Parker Institute for Cancer Immunotherapy:
“Today, we got an important glimpse of what that future could look like!
Merck and Moderna announced positive results from a large Phase 3 trial of an individualized cancer vaccine for people who have high-risk melanoma. The concept is strightforward: analyze a patient’s tumor, identify what makes their cancer unique, create a vaccine specifically for them, and teach their immune system what to attack.
In this study, patients who received the personalized vaccine along with the immunotherapy Keytruda went longer without their cancer returning or spreading than those who received Keytruda alone. There is still a lot we need to learn when the full data are released. And one successful trial doesn’t mean the work is done.
But this matters.
This type of hope is why I left my job as an NBC correspondent to push for better treatments for cancer patients. I am so grateful to now work every day alongside people trying to harness the immune system to fight cancer at the Parker Institute for Cancer Immunotherapy . Now we need to get trials like this to all cancer patients. Let’s go!”
Arturo LoAIza-Bonilla, Systemwide Chief of Hematology and Oncology at St. Luke’s University Health Network:
“So we have interesting and big news today: Merck and Moderna announced at 6:45 a.m. EDT today that Phase III INTerpath-001 met its primary recurrence-free survival endpoint and key distant-metastasis-free survival endpoint.
The trial randomized 1,137 patients with completely resected stage IIB-IV melanoma to intismeran autogene plus pembrolizumab versus pembrolizumab alone. The companies describe this as the first positive Phase III result for both an individualized neoantigen therapy and an mRNA-based cancer therapy. No new safety signal emerged. Importantly, the effect sizes have not yet been disclosed and overall survival remains under follow-up, so this is a landmark platform validation, not yet a complete practice-changing dataset. It seems the data will be presented at ESMO – European Society for Medical Oncology in Madrid (will be there!!)
Intismeran is manufactured from each patient’s tumor and encodes up to 34 patient-specific neoantigens; Merck and Moderna now have nine Phase II/III studies across melanoma, NSCLC, bladder cancer and RCC. Hoping for a successful program!”
