Launch Readiness Evidence Generation Plan for 177Lu-PNT2002

Authors

Jennifer Nguyen, PharmD, Thomas Jefferson UniversityFollow

Document Type

Presentation

Publication Date

4-10-2024

Comments

Presentation: 30:08

Abstract

¹⁷⁷Lu-PNT2002 is a prostate-specific membrane antigen (PSMA)-targeted radioligand therapy (RLT), a promising new class of treatment for metastatic castration-resistant prostate cancer (mCRPC).¹⁷⁷Lu-PNT2002 shows promising interim results from their phase 3 SPLASH trial, demonstrating safety and efficacy in patients with mCRPC who have progressed on an androgen receptor pathway inhibitor (ARPI). FDA approval of ¹⁷⁷Lu-PNT2002 is anticipated in 2025. The objective of this capstone project was to conduct an evidence gap analysis of mCRPC and current therapies to develop a value evidence generation framework for ¹⁷⁷Lu-PNT2002 by the US HEOR team. A rapid literature review (RLR) sought to identify the unmet need in mCRPC. The RLR revealed mCRPC has no curative treatment option, a poor survival prognosis, and limited evidence on optimal treatment sequence in mCRPC, suggesting that ¹⁷⁷Lu-PNT2002 holds promise as a potential therapy to address these needs. The competitor landscape analysis identified three key areas of differentiation for ¹⁷⁷Lu-PNT2002 compared to other treatments: mechanism of action, route of administration, and quality of life benefits. The evidence generation framework included tools such as a population calculator, budget impact model, and AMCP dossier, as well as real-world evidence studies to assess treatment patterns, clinical outcomes, and economic burden. Overall, the findings emphasize the urgent need for targeted treatments in mCRPC and suggested that ¹⁷⁷Lu-PNT2002 may have a role in addressing these needs. This capstone provides a roadmap for generating the necessary evidence to support potential FDA approval of ¹⁷⁷Lu-PNT2002 to improve outcomes for mCRPC patients.

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Language

English