Darwin's Our Take 8.24.26: Moderna, Merck announce positive Phase III trial results for personalized mRNA cancer therapy

A personalized messenger RNA (mRNA) therapy Moderna and Merck are jointly developing as a patient-specific cancer treatment provides statistically significant and clinically meaningful results when combined with Merck’s Keytruda (pembrolizumab), based on an interim analysis of results from a Phase III trial in patients with melanoma.

In a randomized, double-blind, Phase III trial called INTerpath-001, investigators are evaluating the therapy, intismeran autogene, in patients with completely resected stage IIB-IV melanoma who have not had prior treatment with systemic therapy. The control group consists of patients receiving Keytruda only.

Top-line results show the trial met its primary endpoint of recurrence-free survival (RFS) and its secondary endpoint of distant metastasis-free survival (DMFS), the companies said in a press release.

The findings represent “the first positive Phase III readout for an individualized neoantigen therapy (INT) and for an mRNA-based cancer therapy,” the companies said.

The trial is also the first Phase III study “to demonstrate a clinically meaningful improvement over Keytruda alone … in the adjuvant setting for patients with resected melanoma,” they added.

The study is ongoing, with other secondary endpoints, including overall survival, also being evaluated.

Georgina Long, principal investigator of the study and medical director of Melanoma Institute Australia, said the trial results “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 tumor, given in combination with [Keytruda] can reduce the risk of recurrence or death in patients with completely resected stage IIB-IV melanoma compared to Keytruda alone,” Long said.

Stephane Bancel, Moderna’s CEO, said the findings represent “a pivotal moment for cancer research.”

“For many years, the idea of creating an mRNA treatment designed specifically for an individual patient’s cancer was aspirational,” Bancel added. “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 companies said data from the trial would be presented at an upcoming medical meeting and shared with regulatory authorities.

OUR TAKE: Merck and Moderna established their mRNA research partnership in 2016, with Merck paying Moderna $200 million up front. At the time, they called referred to the therapies they would be developing as personalized cancer vaccines. Now, they call them INTs.

Merck paid Moderna another $250 million in 2022 to exercise its option for intismeran. From that point on, according to their agreement, the companies equally share the cost of development (and commercialization, should the therapy eventually be approved).

MedCity News reported that the trial evaluating intismeran as an adjuvant treatment for melanoma is the most advanced of eight Phase II and Phase III intismeran studies currently underway. The other trials are evaluating the therapy in various tumor types such as non-small cell lung cancer, bladder cancer, and renal cell carcinoma.

According to Biopharma Dive, results from those trials are expected later this year or in early 2027 and should provide better insight into how much commercial promise intismeran holds.

Meanwhile, industry analysts hailed the melanoma trial results as a “landmark moment,” a “major win,” and a “historic cancer vaccine success.”

Moderna’s share price skyrocketed from $62.51 in after-market hours on Aug. 18 to a high of $189.45 on Aug. 19 when the trial results were announced. The jump in price added $45 billion to Moderna’s market cap, Fierce Biotech reported.

Merck’s share price increased as well, though not as dramatically.

HCR #217: A Conversation with Wei-Li Shao, President, Omada Health

Between 80% and 90% of health outcomes are shaped by what happens between doctor visits. Yet the entire U.S. health care system, from payment models to primary care, is built around the visit itself. Wei-Li Shao, President of Omada Health, joins John to break down why persistent, in-between-visit care is the missing layer in chronic disease management, and how pairing GLP-1 therapy with the right behavioral support program could be one of the most powerful levers the health care system has yet to fully pull. Find us on YouTube, Spotify, Apple, or wherever you get your podcasts.

What else you need to know

Epic has launched AI tools to assist with prior authorizations and outpatient visits. The timing coincided with the company’s annual User Group Meeting in Verona, Wis., where CEO Judy Faulkner provided an update on an array of platforms, tools, and services that are in development or being implemented.

One of those is a tool clinicians can use to find out in real time whether prior authorization is needed before scheduling an appointment or starting treatment. Epic described the tool in a blog post as “a new industry-standard API called Coverage Requirements Discovery.” The API eliminates time-consuming tasks involved in requesting prior authorization, such as making phone calls, sending faxes, and typing patients’ information into insurance portals.

So far, Ochsner Health, Froedtert ThedaCare Health, Denver Health, and Summit Health have implemented the new API and can use it to check on prior authorization requirements for patients with UnitedHealthcare, Network Health, and Aetna health plans. Epic said 16 additional payers are in testing.

Four clinicians at Ochsner Health are among the first to use Epic’s outpatient tool called Ergo Visit. Using AI, Ergo Visit compiles information from patients’ electronic health records and other sources to create summaries clinicians can use ahead of and during office visits. Afterward, Ergo Visit can draft notes and identify issues that need to be reviewed. Additional details are available in this blog post by Epic.

Providence will completely shut down its insurance business. The Renton, Wash.-based health system announced in March that it was considering selling Providence Health Plan. Then, in May, Providence said it would wind down its commercial business and was looking into transferring its Medicaid business to another insurer. Providence also said at the time that it was in discussions with an unnamed insurer to take over its Medicare Advantage business, but those talks have since failed to produce an agreement.

“We are in discussion with regulators about this development and the broader wind-down of Providence’s health plan operations,” a spokesperson told Becker’s Hospital Review. “We will share more details with our members and the public as we are able under applicable regulations.”

Universal Health Services finalized its acquisition of Talkspace, a company that provides remote behavioral health counseling and related services. The acquisition was announced in March and is valued at approximately $835 million. King of Prussia, Pa.-based UHS said in an Aug. 17 press statement that Talkspace’s virtual care platform complements the health system’s own network of affiliated behavioral health facilities, which includes more than 380 inpatient behavioral health facilities. Talkspace serves patients throughout the U.S. and Puerto Rico and has a network of about 6,000 licensed behavioral health professionals.

Healthcare Dive reported that UHS CEO Marc Miller remarked during an interview: “We’ll now be the only company in the United States that will have a nationally scaled, end-to-end continuum in behavioral health. We’ll be able to offer something that nobody else offers.”

Prescription drug prices have dropped 3.1% since July 2025, according to the latest Consumer Price Index report released by the Bureau of Labor Statistics. The decrease is the steepest annual drop in prescription drug prices since 1963, according to Becker’s Hospital Review, and may be attributable to multiple factors, including the White House’s most-favored-nation pricing deals, expanded availability of generics through the TrumpRx marketplace, Medicare’s recent coverage of GLP-1s, and Medicare negotiations established under the Inflation Reduction Act passed in 2022. The first round of those Medicare-negotiated drug prices — some as much as 79% lower than the list prices, according to Axios — took effect in January of this year.

Bristol Myers Squibb’s Zenbexus (iberdomide) received accelerated approval for patients with multiple myeloma. The oral drug, a cereblon-modulating protein degrader (CELMoD), is a first-in-class therapy indicated for adults with multiple myeloma who have received at least one prior line of therapy. Administered daily, Zenbexus is to be used in combination with Johnson & Johnson’s Darzalex Faspro (daratumumab and hyaluronidase-fihj) and dexamethasone.

Full approval of Zenbexus may be contingent upon verification of clinical benefit in one or more confirmatory trials. The drug has a list price of $28,000 per month, Biopharma Dive reported.

BMS gained three investigational CELMoDs in 2019 with the $74 billion acquisition of Celgene, including mezigdomide, which is under FDA review and could be approved by May 13, BMS noted in a news release. Zenbexus and mezigdomide are being positioned as potential successors to Revlimid (lenalidomide) and Pomalyst (pomalidomide), both of which have competition from generic versions.

What we’re reading

The Original “Yes.” JAMA, 8.20.26 (subscription/registration required for full access)

Prior Authorization Metrics Provide New Insights into Insurer Practices, but Gaps Remain. KFF, 8.13.26

The Fair Pay, Fair Play TPA: A Proposal To Disrupt The Market For Health Plan Administration. Health Affairs, 8.7.26