IR Insights: Recapping Positive Phase 3 Topline Results for Intismeran Autogene Plus Pembrolizumab in Adjuvant Melanoma

Today marks an extraordinary milestone for Moderna, for mRNA science and, most importantly, for patients with cancer.

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.

I sat down for an episode of IR Insights alongside David Berman, our Chief Development Officer, to reflect on what this means:

For many years, the idea that we could take the unique genetic fingerprint of a patient’s tumor and use mRNA to create a medicine designed specifically for that individual patient’s cancer sounded like science fiction. Today, we have demonstrated the clinical benefit of this approach in a global Phase 3 study with our investigational individualized neoantigen therapy in combination with pembrolizumab.

This is more than an important milestone for one program. We have started to demonstrate the potential of an entirely new class of medicine—and an entirely new way of thinking about cancer care: using the information encoded within an individual patient’s cancer to design a specific therapy that helps train their immune system to fight it.

Even more so, it’s further validation of what’s possible with mRNA technology. Our work to advance mRNA has already resulted in five approved products, helping protect people around the world from infectious diseases. But our ambitions for our mRNA platform never stopped there, and today we see what it could mean for cancer.

The flexibility of our mRNA platform is unlocking a broad range of possibilities to intervene at different stages of the cancer journey – from working to keep cancer from returning after surgery, to exploring its potential to treat patients whose disease has already advanced, to potentially helping prevent certain cancers before they develop.

Continuing to push the boundaries of cancer care

Together with Merck, we are now studying intismeran in combination with pembrolizumab and other anti-cancer therapies, and as a monotherapy, across multiple tumor types and stages of disease, including melanoma, lung, bladder and kidney cancers. We will continue to follow patients in INTerpath-001 to evaluate other key secondary endpoints including overall survival, present these results to the scientific community and engage with regulators as we work toward our goal of bringing individualized cancer therapies to patients.

Moments like today are only possible because of years of work across our company and with our partners. To our teams in research, development, clinical, manufacturing, digital, regulatory and every function that has helped advance this program: thank you. And to the patients, families and investigators who placed their trust in this science: we are deeply grateful.

When we started Moderna, we believed mRNA could fundamentally change what medicine can do. Today, as we see its potential in cancer, it is one of those moments that remind us why we took on this challenge to tackle cancer more than ten years ago, and why we will continue to invest in mRNA science. That belief feels more powerful than ever—and the possibilities ahead are only beginning to come into view.

Forward Looking Statements

This post and accompanying video contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the potential of intismeran in combination with pembrolizumab; the potential of individualized neoantigen therapies as a new class of medicine for cancer patients; the potential of mRNA technology, including for cancer care; the possibilities to intervene at different stages of the cancer journey, including to potentially prevent certain cancers before they develop; the INTerpath clinical development program and ongoing clinical studies; engagement with regulators on potential filing submissions; and the evaluation of key secondary endpoints, including overall survival. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this post are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2025, filed with the U.S. Securities and Exchange Commission (SEC), and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this post in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this post.