Novartis Presents Actinium-Based RLT Phase 1 Data at ASCO 2026 Alongside Pluvicto and Pipeline Updates

Novartis's decision to advance a Phase 1 actinium-225 PSMA-617 program into public data disclosure at ASCO 2026 signals a meaningful step-change in radiopharmaceutical manufacturing complexity, one that CMC teams and plant heads at RLT-capable facilities should be tracking closely. The company will present data from more than 65 company- and investigator-sponsored abstracts across the 2026 ASCO Annual Meeting and the European Hematology Association Congress.

The actinium-based program, designated 225Ac-PSMA-617 (AcTION), targets metastatic castration-resistant prostate cancer in patients with or without prior lutetium-177 PSMA therapy. Unlike lutetium-177, actinium-225 is an alpha emitter with a substantially shorter half-life and more constrained global supply, introducing distinct handling, shielding, and release-testing requirements that differ materially from the established Pluvicto manufacturing framework. The oral presentation is scheduled for June 1 at ASCO.

On the established portfolio side, Pluvicto's PSMAddition subgroup analysis will present efficacy outcomes stratified by disease volume and de novo versus recurrent metastatic hormone-sensitive prostate cancer, data that could influence label discussions and, by extension, commercial batch demand planning. Scemblix's 144-week ASC4FIRST analysis, covering efficacy, safety, and tolerability in first-line Ph+ CML-CP, will be presented at both ASCO and EHA, offering the longest controlled dataset yet for asciminib against investigator-selected tyrosine kinase inhibitors.

At EHA, the hematology pipeline broadens the regulatory picture further. Phase 3 data for ianalumab in primary immune thrombocytopenia from the VAYHIT2 trial will be presented alongside Phase 2 pelabresib monotherapy data in myelofibrosis post-JAK inhibitor failure, and early safety and efficacy data for rapcabtagene autoleucel, a rapidly manufactured autologous CD19 CAR-T therapy, in refractory autoimmune disease. Each asset carries distinct manufacturing and supply-chain profiles that will require facility-readiness assessments well ahead of any potential regulatory submissions.

For Kisqali, the NATALEE biomarker analysis drawing on baseline gene expression data from the largest CDK4/6 inhibitor trial dataset to date will be presented orally on May 30; a separate real-world outcomes analysis in African American and low socioeconomic status patients with HR+/HER2- metastatic breast cancer adds post-progression data relevant to payer and formulary discussions in the US market.

The actinium-225 program's progression toward Phase 1 data readout sets a near-term checkpoint for facilities considering RLT capacity expansion, particularly around alpha-emitter handling infrastructure and the specialized qualified person oversight those operations require.

Source: Novartis via GlobeNewswire, May 21, 2026.