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(Albany, US) On October 30, 2026, DelveInsight’s “Neuroendocrine Prostate Cancer Market Insights, Epidemiology and Market Forecast – 2036” report provides comprehensive insights into the Neuroendocrine Prostate Cancer (NEPC) market and pipeline landscape across the 7MM. It covers marketed and emerging drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type, and examines the market drivers and barriers shaping the space.

Discover the latest drugs and treatment options in the Neuroendocrine Prostate Cancer Pipeline @ https://www.delveinsight.com/report-store/neuroendocrine-prostate-cancer-market

Key Takeaways from the Neuroendocrine Prostate Cancer Report

• In February 2025, Phanes Therapeutics announced dosing of the first patient in a clinical study of peluntamig (PT217) in combination with chemotherapy. Peluntamig has received FDA Fast Track Designation for metastatic de novo or treatment-emergent NEPC, and Phanes has a clinical supply agreement with Roche to evaluate it with atezolizumab.

• In February 2024, the US FDA granted Fast Track Designation to BioXcel Therapeutics’ BXCL701 in combination with a checkpoint inhibitor for metastatic small cell NEPC that progressed on chemotherapy.

• Tarlatamab (Amgen) is being evaluated in an ongoing Phase II study in DLL3-positive metastatic prostate cancer, including NEPC.

• DelveInsight estimates about 24,500 NEPC incident cases in the 7MM in 2025, with about 18,600 expressing DLL3. In the US, 78% of incident cases were distant-stage disease.

• In Japan, the NEPC market was about USD 5 million in 2025 and is projected to reach about USD 53 million by 2036, a CAGR of about 25% from 2026 to 2036. The US was the largest contributor among the 7MM in 2025.

• No therapies are approved specifically for NEPC. Treatment relies on platinum-based chemotherapy and off-label regimens extrapolated from small-cell lung cancer, and responses are often short-lived.

• Leading Neuroendocrine Prostate Cancer companies include Phanes Therapeutics, Amgen, Merck Sharp & Dohme, Bristol-Myers Squibb, Merck, Daiichi Sankyo, Moonlight Bio, SystImmune, and others.

• Promising therapies include peluntamig (PT217), tarlatamab (AMG 757), pembrolizumab (KEYTRUDA), nivolumab (OPDIVO), sacituzumab tirumotecan (sac-TMT), gocatamig, ML26, and others.

Get insights into clinical trials, emerging therapies, and leading companies with DelveInsight @ Neuroendocrine Prostate Cancer Treatment Drugs

Neuroendocrine Prostate Cancer Overview

NEPC is a rare and highly aggressive subtype of prostate cancer characterized by neuroendocrine differentiation and loss of androgen receptor signaling. It most commonly arises as treatment-emergent disease (T-NEPC) after prolonged androgen deprivation therapy and androgen receptor pathway inhibitor treatment in metastatic castration-resistant prostate cancer, and only rarely occurs de novo. It is associated with rapid progression, frequent visceral metastases, and poor prognosis. Diagnosis depends on metastatic tissue biopsy with immunohistochemistry for markers such as synaptophysin, chromogranin A, CD56, and neuron-specific enolase, because PSA often stays low and PSMA-PET sensitivity is reduced, contributing to underdiagnosis. Platinum-based chemotherapy (carboplatin or cisplatin with etoposide or docetaxel) is the standard first-line treatment, with second-line options including cabazitaxel, topotecan, lurbinectedin, and temozolomide-based regimens.

Common features include:

• Rapid disease progression

• Frequent visceral metastases

• Low PSA despite extensive metastatic disease

• Loss of PSMA expression

• Poor prognosis and short-lived treatment responses

Neuroendocrine Prostate Cancer Emerging Drugs Profile

Peluntamig (PT217): Phanes Therapeutics Peluntamig is a first-in-class, native IgG-like bispecific antibody targeting DLL3 and CD47. It binds DLL3-expressing tumor cells while blocking the CD47 “do not eat me” signal, enhancing macrophage-mediated phagocytosis and anti-tumor immunity. It is being developed for small-cell lung cancer and neuroendocrine carcinomas, including NEPC, and is being studied in the Phase I/II SKYBRIDGE trial as monotherapy and in combinations. Currently, the drug is in Phase I/II.

Tarlatamab (AMG 757): Amgen Tarlatamab is a first-in-class DLL3-targeted bispecific T-cell engager (BiTE) that redirects CD3-positive T cells to DLL3-expressing tumor cells, promoting T-cell-mediated cytotoxicity. It is approved for extensive-stage small cell lung cancer, and is being evaluated in a Phase II study in DLL3-positive metastatic prostate cancer, including NEPC. Currently, the drug is in Phase II for NEPC.

Pembrolizumab (KEYTRUDA): Merck Sharp & Dohme Pembrolizumab is a PD-1 immune checkpoint inhibitor (monoclonal antibody) being studied in NEPC after progression on prior chemotherapy. Currently, the drug is in Phase II for NEPC.

Nivolumab (OPDIVO) + Ipilimumab (YERVOY): Bristol-Myers Squibb This combination of a PD-1 inhibitor and a CTLA-4 inhibitor is being studied in NEPC or aggressive variant metastatic prostate cancer. Currently, the combination is in Phase II.

Sacituzumab Tirumotecan (sac-TMT): Merck Sac-TMT is a topoisomerase I inhibitor antibody-drug conjugate being studied in NEPC after progression on prior chemotherapy. Currently, the drug is in Phase II.

Explore groundbreaking therapies and clinical trials in the Neuroendocrine Prostate Cancer Pipeline @ Neuroendocrine Prostate Cancer Treatment Drugs

Neuroendocrine Prostate Cancer Market Drivers

• Rising NEPC incidence: Prolonged survival of prostate cancer patients on androgen receptor-targeted therapies, an aging population, and more treatment-emergent disease are expanding the patient pool, especially among those aged 75 to 84.

• No approved NEPC-specific therapy: The absence of targeted options creates a large unmet need and strong opening for new entrants.

• Biomarker-driven opportunity: Roughly 18,600 DLL3-expressing cases across the 7MM define a substantial population eligible for targeted therapies.

• Advances in molecular understanding: Insight into lineage plasticity and neuroendocrine differentiation supports precision therapies beyond chemotherapy.

• Diverse pipeline: DLL3-targeted agents, bispecific antibodies, antibody-drug conjugates, checkpoint inhibitors, CAR-T therapies, and Aurora kinase and EZH2 inhibitors are in development.

• Regulatory support: Fast Track designations for peluntamig and BXCL701 may speed development.

• Improving diagnostics: Molecular profiling, liquid biopsy, and routine assessment of neuroendocrine differentiation and DLL3 expression may expand identification of eligible patients.

Learn about new drugs, pipeline developments, and key companies with DelveInsight’s expert analysis @ Neuroendocrine Prostate Cancer Market Drivers and Barriers

Neuroendocrine Prostate Cancer Market Barriers

• Underdiagnosis: Diagnosis requires invasive metastatic biopsies that are infrequently performed, so true prevalence is likely underestimated.

• Limited diagnostic tools: There is no validated serum biomarker or imaging modality, PSA stays low, and PSMA-PET sensitivity is reduced.

• No standardized guidelines: Treatment is based on off-label regimens extrapolated from small-cell lung cancer.

• Rapid resistance: Most patients develop chemotherapy-resistant disease quickly, resulting in limited survival.

• Rarity and small market: NEPC is a small population, and the Japan market was only about USD 5 million in 2025.

• Early-stage pipeline: Most candidates are in Phase I/II, with no approved therapies yet and significant clinical risk.

• High therapy cost: Estimated tarlatamab acquisition costs of roughly USD 203,000 in Japan may pose reimbursement challenges.

Scope of the Neuroendocrine Prostate Cancer Report

• Coverage: 7MM (US, EU4, UK, Japan)

• Companies: As listed above

• Therapies: Peluntamig (PT217), tarlatamab (AMG 757), pembrolizumab (KEYTRUDA), nivolumab (OPDIVO), sacituzumab tirumotecan (sac-TMT), gocatamig, ML26, and others

• Assessment by Product Type: Mono, Combination, Mono/Combination

• Assessment by Clinical Stage: Discovery, Pre-clinical, Phase I, Phase II, Phase III

Download DelveInsight’s in-depth Neuroendocrine Prostate Cancer report today! @ Neuroendocrine Prostate Cancer Companies

Table of Contents

1. Introduction

2. Executive Summary

3. Neuroendocrine Prostate Cancer: Overview

4. Pipeline Therapeutics

5. Therapeutic Assessment

6. DelveInsight’s Analytical Perspective

7. Late Stage Products (Phase III): None currently

8. Mid Stage Products (Phase II): Tarlatamab (Amgen), Pembrolizumab (Merck Sharp & Dohme), Nivolumab + Ipilimumab (Bristol-Myers Squibb), Sacituzumab Tirumotecan (Merck)

9. Early Stage Products (Phase I): Peluntamig (Phanes Therapeutics), Phase I/II

10. Preclinical and Discovery Stage Products

11. Inactive Products

12. Key Companies

13. Key Products

14. Unmet Needs

15. Market Drivers and Barriers

16. Future Perspectives and Conclusion

17. Analyst Views

18. Appendix

19. About Us

About DelveInsight

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe.

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