Tuesday, 30 June 2026

Vol. 1 · No. 28 Tuesday, 30 June 2026 “Evidence is the record. Scrutiny is the standard.”

Trials Today

Phase 3 NCT03907488 — Nivolumab+AVD vs Brentuximab Vedotin+AVD in Advanced Classical Hodgkin Lymphoma — NCI-sponsored; n=994; primary endpoint 2-year PFS; results posted June 28–30 2026; first direct head-to-head comparison of both approved regimens
Phase 3 NCT06077864 — Survodutide (BI 456906) Cardiovascular Outcomes Trial in Overweight/Obesity — Boehringer Ingelheim; n=5,531; 5-point MACE primary endpoint; primary completion May 8 2026; top-line results not yet posted as of June 30
Phase 3 NCT05091567 — IMforte: Lurbinectedin + Atezolizumab Maintenance vs Atezolizumab in Extensive-Stage SCLC — Roche/Jazz; n=660; co-primary endpoints IRF-assessed PFS and OS; results posted this week; first-line maintenance setting for one of oncology's hardest-to-treat cancers
Phase 3 NCT07613294 — ACCLAIM-CTA: Lepodisiran siRNA for Elevated Lp(a) with Atherosclerotic CVD — Eli Lilly; n=252; primary endpoint percent change in non-calcified coronary plaque volume by CCTA at Week 104; newly registered June 2026; first Phase 3 to use serial CCTA plaque as primary endpoint

At the Agencies

EMA CHMP recommends revoking Tavneos (avacopan) marketing authorisation — GCP breach, data manipulation findings (June 26, 2026) — CHMP concluded pivotal ADVOCATE trial data were incorrect and misleading; recommendation to revoke EU marketing authorisation pending European Commission decision
FDA proposes to withdraw Tavneos (avacopan) NDA approval — Federal Register docket 2026-08455 (April 30, 2026) — Cites alleged post-lock readjudication of primary endpoint and 76 postmarketing DILI cases including 8 deaths; public comment period closed June 29; formal hearing requested by Amgen
FDA grants PMA to LungFX (Lung Bioengineering/United Therapeutics) for centralized ex vivo lung perfusion (June 29, 2026) — First PMA for centralized EVLP device; pivotal data showed higher 12-month mortality in LungFX arm vs non-EVLP comparator; FDA approved on option-value basis for patients who would otherwise receive no transplant
FDA grants full PMA to Artivion AMDS Hybrid Prosthesis for acute DeBakey Type I aortic dissection with malperfusion (June 29, 2026) — Upgrades device from Humanitarian Device Exemption; PERSEVERE trial (n=93, non-randomized) showed 72% reduction in all-cause mortality vs historical controls at 30 days; first aortic arch remodeling device to reach PMA
FDA issues Complete Response Letter for LNTH-2501 (Ga-68 edotreotide) PET imaging kit for neuroendocrine tumors (June 26, 2026) — Manufacturing deficiency at third-party facility; no safety or efficacy concerns cited; second PDUFA delay after March 2026 three-month extension; Lantheus has not disclosed remediation timeline
EMA CHMP reverses prior negative opinion; recommends trofinetide (Daybu) for Rett syndrome in EU (June 22–25 CHMP meeting) — First potential EU-approved treatment for Rett syndrome neurobehavioral symptoms; FDA approved Daybue (trofinetide) in March 2023; EC decision expected within ~2 months

Who's Who

Robert Michael

Chief Executive Officer, AbbVie

Announced AbbVie's $10.9 billion all-cash acquisition of Apogee Therapeutics on June 22, 2026, adding zumilokibart (APG777), an IL-13–targeting monoclonal antibody in late-stage development for atopic dermatitis and asthma, to AbbVie's immunology pipeline as it braces for Humira biosimilar headwinds.

The story →

On the Wire

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Full wire (160) →

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Tuesday, 30 June 2026 edition — The Vital Record