Clinical Daily Summary: What Happened on November 7, 2026

Moderna prepares filing for personalized melanoma vaccine

Moderna said it is preparing to seek approval for intismeran autogene, its personalized cancer vaccine developed with Merck.1 In Phase 3 INTerpath-001, the vaccine plus Keytruda cut recurrence-or-death risk by 42% versus Keytruda alone in patients with surgically removed, high-risk melanoma.1

At two years, 82.2% of patients receiving the combination were alive without recurrence, compared with 70.0% in the control group.1 Treatment-related grade 3 to 5 adverse events occurred in 14.2% of combination recipients and 13.4% of controls. Follow-up for overall survival continues.1

The vaccine selects up to 34 neoantigen targets from each patient’s tumor mutations, aiming to direct T cells against cancer cells.1 The partners share development costs and profits equally. Merck exercised its option to develop and commercialize the treatment with a $250 million payment in 2022.1

Ziltivekimab and pelacarsen miss cardiovascular outcomes despite biological effects

In Novo Nordisk’s ZEUS trial, ziltivekimab lowered interleukin-6, an inflammation marker, but did not reduce heart attacks, strokes or deaths versus placebo.2 The full findings were presented at the American Heart Association’s scientific sessions and published in the New England Journal of Medicine.2

Novo had already stopped two other ziltivekimab trials after a monitoring committee judged them unlikely to succeed.2

In the Novartis-funded Phase 3 HORIZON trial, pelacarsen substantially lowered lipoprotein(a), or Lp(a), but did not change rates of heart attack, stroke, urgent coronary revascularization or death versus placebo.3 Participants were followed for nearly five years. Results were presented at the same scientific sessions and published in the same journal.3 Lp(a) is a genetically determined cardiovascular risk factor carried by about one in five people.3

Novartis reports nine tumors among Zolgensma recipients

Since Zolgensma’s 2019 approval, Novartis has reported nine tumor cases among recipients, including seven newly disclosed cases.456 The company said two cases suggest DNA from the therapy’s adeno-associated virus vector entered patients’ genomes. Both patients remain under observation.45

Novartis said more than 6,000 patients received the gene therapy through trials, access programs or routine care.45 Regulators are reviewing the reports. They do not establish that Zolgensma caused the tumors or support a reliable estimate of incidence.4

On November 4, SMA UK and the National Multidisciplinary Team said examinations were available for three cases. Two tumors were reportedly associated with treatment and one was not.4 The organizations said the other cases were unresolved.4

Also worth knowing

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  Follow-up data from 14 patients with primary aldosteronism found a hormone marker remained 99% below pretreatment levels and average systolic blood pressure stayed about 25 mmHg lower for up to two years after treatment. The small study had no randomized control group.7

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  Amgen’s observational study of more than 544,000 adults linked Repatha to a 20% lower heart-attack risk than ezetimibe. The analysis cannot establish that Repatha caused the difference.89

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  VeonGen reached FDA alignment on the design and manufacturing strategy for a pivotal Phase 3 gene-therapy trial for an inherited eye disease. In its earlier study, 13 of 15 patients improved on a vision chart.10

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  Gilead’s Phase 3 IDEAL study found normal alkaline phosphatase levels at week 52 in 75.4% of Livdelzi recipients, versus 16.1% on placebo, among adults with primary biliary cholangitis.11

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  Mondego Bio started a first-in-human Phase Ia study of oral MB-388 in healthy volunteers. The company expects initial human data in December 2026.12

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  A team in China reported fewer seizures in three people treated with a gene therapy and a drug, its first clinical result with the chemogenetic approach.13

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  Moderna and Oxford University’s Ebola vaccines received backing for pivotal testing.14

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• STAT+: New tumor cases show common gene therapy tool can come with risk STAT Biotech
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