At a Glance
- Novartis released real-world PRECISION platform data; studies to be presented at ASCO GU Symposium February 26, 2026.
- Taxane-naïve mCRPC patients (n=500) achieved median PFS 13.5 months overall; 15.8 months post-1 ARPI vs 12.7 months post->1 ARPI.
- 6% overall rate of ≥50% PSA decline from baseline across subgroups, confirming strong biochemical efficacy.
- Subsequent therapies (n=442) yielded median PFS 8.6 months overall (ARPI: 10.7 months; taxane: 7.2 months).
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Novartis announced compelling real-world data from its PRECISION platform via press release today, with studies to be presented at the ASCO Genitourinary Cancers Symposium on February 26, 2026. These U.S.-based analyses explore Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) outcomes, treatment sequencing, and patterns in metastatic prostate cancer (mPCa), offering practical insights beyond controlled trials.
Strong Real-World PFS with Pluvicto in Taxane-Naïve mCRPC
In taxane-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with at least one androgen receptor pathway inhibitor (ARPI), Pluvicto delivered a median progression-free survival (PFS) of 13.5 months (95% CI: 11.7–14.7 months).
Patients receiving Pluvicto after just one prior ARPI fared even better, with a median PFS of 15.8 months (95% CI: 11.7–18.6 months), compared to 12.7 months (95% CI: 10.7–14.0 months) after multiple ARPIs.
PSA50 (Prostate-Specific Antigen) response rates defined as ≥50% PSA decline from baseline, a key surrogate for clinical benefit were consistently high across groups.
Outcome | All patients (n=500) | 1 ARPI (n=256) | >1 ARPI (n=244) |
Median PFS | 13.5 months | 15.8 months | 12.7 months |
PSA50 | 62.6% | 61.4% | 63.8% |
These findings align closely with the pivotal PSMAfore trial, which drove Pluvicto’s approval for PSMA-positive mCRPC patients post-ARPI and suitable for delaying taxane chemotherapy. PSMAfore showed Pluvicto more than doubling median radiographic PFS (rPFS) versus ARPI switch (11.6 vs. 5.6 months in updated analysis).
Daniel George, MD, from Duke University School of Medicine, affirms that Pluvicto delivers clinically meaningful responses in diverse mCRPC patients across settings, mirroring PSMAfore trial results and boosting confidence for post-ARPI use.
Note that PRECISION PFS incorporated biochemical, radiographic, and clinical measures, differing from PSMAfore’s blinded rPFS primary endpoint.
Post-Pluvicto Therapies Retain Effectiveness
A separate analysis confirmed meaningful responses to subsequent systemic therapies like taxanes, ARPIs, PARP inhibitors, or others after Pluvicto discontinuation in mCRPC patients, many with prior ARPI and chemotherapy exposure. This supports flexible sequencing amid emerging options.
Subsequent Therapy | Patients (n) | Median PFS |
All | 442 | 8.6 months (95% CI: 7.2–10.1) |
ARPI | 176 | 10.7 months (95% CI: 8.1–19.3) |
Taxane | 188 | 7.2 months (95% CI: 5.9–9.4) |
Dr. Xiao Wei from Dana-Farber Cancer Institute highlights the need for optimized therapy sequencing amid new options, noting reassuring evidence that Pluvicto does not impair subsequent systemic treatments’ effectiveness.
Persistent Gaps in mHSPC Guideline Adherence
In metastatic hormone-sensitive prostate cancer (mHSPC), guidelines endorse intensified therapy with androgen deprivation therapy (ADT) plus ARPI. Yet, among 43,415 U.S. patients treated from 2020–2025, 39.2% received ADT monotherapy, while 55.5% got the recommended ADT+ARPI combo. Though adoption is rising, these gaps highlight opportunities to optimize early care.
The Role of Novartis’ PRECISION Platform
PRECISION aggregates harmonized data from over 56,500 U.S. mPCa patients, enabling robust real-world evidence (RWE) to guide decisions.
Liviu Niculescu, Novartis US Chief Medical Officer, states Pluvicto is reshaping mPCa standards, with these real-world insights from PRECISION complementing clinical trials to better inform routine practice.
These studies bridge trial data and routine practice, potentially boosting clinician confidence in Pluvicto and underscoring needs in sequencing and adherence.
Reference
New real‑world data reinforce earlier use of Pluvicto™ before chemotherapy in metastatic castration-resistant prostate cancer, 24 February 2026, New real‑world data reinforce earlier use of Pluvicto™ before chemoherapy in metastatic castration-resistant prostate cancer | Novartis
About Writer
Samiksha Jadhav
She is a pharmacy graduate with focused expertise in clinical research methodology, pharmacovigilance, medical coding, and medical writing. In her words, she is enthusiastic about manuscript writing and regulatory documentation, dedicated to contributing to high-quality, research-driven medical literature.