--- title: 'Clinical Daily Summary: What Happened on November 7, 2026' headline: Moderna prepares melanoma-vaccine filing after Phase 3 benefit description: Two cardiovascular drugs changed biological markers but did not cut events. Novartis disclosed nine tumors in Zolgensma recipients, with possible vector-DNA integration in two cases. url: https://thebench.bio/news/clinical/2026-11-07 topic: clinical date: '2026-11-07' covers: - '2026-11-06' - '2026-11-07' date_published: '2026-11-08T00:01:56Z' date_modified: '2026-11-08T00:01:56Z' tags: - Industry - Clinical - Research - Funding sources: 14 publisher: TheBench.Bio --- # Clinical Daily Summary: What Happened on November 7, 2026 **Moderna prepares melanoma-vaccine filing after Phase 3 benefit** Two cardiovascular drugs changed biological markers but did not cut events. Novartis disclosed nine tumors in Zolgensma recipients, with possible vector-DNA integration in two cases. ## Today in brief Moderna plans to seek approval with Merck for its personalized melanoma vaccine after a Phase 3 trial cut recurrence-or-death risk by 42% against Keytruda alone. [1] Ziltivekimab lowered interleukin-6 and pelacarsen lowered Lp(a), but neither reduced cardiovascular events in its Phase 3 trial. [2] [3] Novartis has received reports of nine tumors in Zolgensma recipients. It said two cases suggest the treatment’s vector DNA entered patients’ genomes. [4] [5] ## 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. [4] [5] [6] The company said two cases suggest DNA from the therapy’s adeno-associated virus vector entered patients’ genomes. Both patients remain under observation. [4] [5] Novartis said more than 6,000 patients received the gene therapy through trials, access programs or routine care. [4] [5] 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 - 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] - 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. [8] [9] - 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] - 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] - 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] - 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] - Moderna and Oxford University’s Ebola vaccines received backing for pivotal testing. [14] ## The day in numbers - **42%**: Lower recurrence-or-death risk with Moderna and Merck’s vaccine plus Keytruda than with Keytruda alone in Phase 3. [1] - **9 cases**: Tumor reports among Zolgensma recipients received by Novartis, including two with possible vector-DNA integration. [4] [5] - **Nearly 5 years**: HORIZON follow-up, during which pelacarsen did not change cardiovascular events versus placebo. [3] - **14 patients**: Participants in the primary aldosteronism follow-up study with sustained hormone-marker and blood-pressure changes. [7] ## Also published - [Brinsupri, Rasonque extend biotech's launch momentum](), BioCentury - [New Breast Cancer Biomarker Could Help Guide Less Invasive Surgery](), Inside Precision Medicine - [Novartis reveals cancer cases possibly linked to gene therapy Zolgensma](), BioPharma Dive - [STAT+: New tumor cases show common gene therapy tool can come with risk](), STAT Biotech - [Zooming out from ovaries: how has renaming PMOS changed lives? ](), Labiotech - [What FDA Inspections Reveal About the Quality of APAC Clinical Trial Sites](), Applied Clinical Trials - [How Changes in a Tumor Have a Significant Impact on Treatment Options](), Pharmaceutical Executive - [The 10 Most Powerful Study KRIs in RBQM and GCP Issues They Can Prevent](), Applied Clinical Trials - [Kidney care raises its ambitions at ASN Kidney Week 2026](), pharmaphorum ## Sources 1. [Moderna, Merck move toward filing for personalized melanoma therapy as COVID sales lift Q3](), Drug Discovery and Development, 2026-11-06 2. [STAT+: Despite Novo drug’s failure, cardiologists say they will still pursue anti-inflammatories](), STAT Biotech, 2026-11-07 3. [STAT+: Failure of Novartis Lp(a) drug raises questions about cardiovascular strategy](), STAT Biotech, 2026-11-07 4. [Spinal muscular atrophy: Tumors reported following Novartis gene therapy](), European Biotechnology, 2026-11-06 5. [Novartis Confirms Nine Cases of Tumors in Children Treated with Gene Therapy Zolgensma](), GEN, 2026-11-06 6. [STAT+: Amgen’s Repatha linked to fewer heart attacks](), STAT Biotech, 2026-11-06 7. [New Drug Strategy May Put Hormone-Driven Hypertension Into Lasting Remission](), Inside Precision Medicine, 2026-11-07 8. [Amgen’s Repatha reduces heart attack risk in real-world study](), Clinical Trials Arena, 2026-11-06 9. [Amgen Real-World Study Links Evolocumab to Lower Heart Attack Risk Than Ezetimibe](), BioPharm International, 2026-11-06 10. [ACT Brief: Asia Pacific Site Perceptions, Community Access Gap, and VeonGen Gene Therapy Alignment](), Applied Clinical Trials, 2026-11-06 11. [Gilead seeks wider use for Livdelzi on Phase III liver disease success ](), Clinical Trials Arena, 2026-11-06 12. [Mondego Bio begins Phase Ia trial of oral MB‑388](), Clinical Trials Arena, 2026-11-06 13. [Novel gene therapy lets drug dampen brain cell activity, reducing seizures](), Science News, 2026-11-06 14. [Moderna, Oxford Uni Ebola jabs backed for pivotal testing](), pharmaphorum, 2026-11-06 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: [2]: [3]: [4]: [5]: [6]: [7]: [8]: [9]: [10]: [11]: [12]: [13]: [14]: