ASCO 2026: Novartis’s New PSMAddition Analysis Supports Broad Pluvicto Use Across mHSPC Patient Groups

Following its May 17 announcement that the Phase 3 PSMAddition trial met its primary endpoint, Novartis has now reported subgroup analyses showing that Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) maintained radiographic progression-free survival benefits across diverse patient populations with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC).

The findings, presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, build on the trial’s previously reported primary endpoint, which demonstrated a 28% reduction in the risk of radiographic progression or death when Pluvicto was added to standard of care.

Rather than focusing on the overall study outcome, the latest analysis examined whether treatment benefit remained consistent across different patient populations defined by disease burden and disease presentation.

Consistent Benefit Across Diverse Patient Populations

The analysis showed that Pluvicto maintained similar radiographic progression-free survival (rPFS) improvements regardless of disease volume or whether patients presented with newly diagnosed metastatic disease or experienced recurrence following earlier treatment.

Patients with high-volume disease achieved a hazard ratio of 0.72, while those with low-volume disease achieved a hazard ratio of 0.73. Similar outcomes were reported among patients with de novo and recurrent disease, each showing hazard ratios of 0.74.

These findings suggest that the treatment effect observed in PSMAddition (NCT04720157) was not driven by a single patient subgroup but was broadly distributed across clinically distinct populations.

Why the Findings Matter

Metastatic hormone-sensitive prostate cancer remains a highly heterogeneous disease. Physicians often tailor treatment strategies based on disease burden and whether metastases are present at diagnosis or develop after prior local therapy.

The subgroup analysis provides additional confidence that Pluvicto may offer benefit across a broad spectrum of patients. More than 80% of prostate cancers express prostate-specific membrane antigen (PSMA), the target of Pluvicto’s radioligand therapy approach, making the treatment relevant to a large proportion of patients with advanced disease.

Pluvicto delivers beta-emitting radiation directly to PSMA-expressing tumor cells while limiting exposure to surrounding healthy tissues. The therapy is already approved in later-stage prostate cancer and is now being evaluated in earlier treatment settings.

Safety Remained Consistent

The safety profile remained generally consistent with previous Pluvicto studies. Grade 3 or higher adverse events occurred in 50.7% of patients receiving Pluvicto plus standard therapy compared with 43.0% of patients receiving standard therapy alone.

The most frequently reported adverse events included dry mouth, fatigue, nausea, hot flushes, and anemia.

Regulatory Reviews Underway

The new subgroup findings arrive as regulatory reviews continue in the United States, China, and Japan. Novartis has already submitted applications seeking to expand Pluvicto into the mHSPC setting, with initial decisions expected during the second half of 2026.

The company believes the latest analysis further supports Pluvicto’s potential role as an earlier treatment option for a broad range of patients with PSMA-positive metastatic prostate cancer.

 References

Pluvicto™ demonstrated consistent efficacy across key patient subgroups in metastatic hormone-sensitive prostate cancer | Novartis