LNTH-1095 / Lantheus - LARVOL DELTA

I-131-1095 Radioligand Plus Enzalutamide vs Enzalutamide for mCRPC That Progressed During Abiraterone (ARROW). (clinicaltrials.gov) - P2 | N=120 | Completed | Sponsor: Progenics Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

PSMA-targeted radioligand therapy (RLT) with 131I-LNTH-1095 (1095) plus enzalutamide (enza) vs enza alone in chemotherapy-naïve patients (pts) whose piflufolastat F 18-avid metastatic castration-resistant prostate cancer (mCRPC) progressed on abiraterone (abi): ARROW (ESMO 2024) - P2 | "There was statistically and clinically significant improvement in PSA RR for enza+1095 vs enza alone."

Clinical • Metastases • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase 2, single-arm trial evaluating 131I-PSMA-1095 targeted radioligand therapy for metastatic castration-resistant prostate cancer. (PubMed, Nucl Med Commun) - "131I-PSMA-1095 is highly active against heavily-pretreated PSMA-positive mCRPC, significantly decreasing tumor burden as measured by PSA. Adverse events, mainly hematologic toxicity, were not infrequent, likely related to off-target irradiation. This hematologic toxicity, as well as a higher logistical burden associated with use, could represent relative disadvantages of 131I-PSMA-1095 compared to 177Lu-PSMA-617."

Journal • Metastases • P2 data • Genito-urinary Cancer • Hematological Disorders • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia

ARROW: Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Progenics Pharmaceuticals, Inc. | Trial completion date: Jun 2024 ➔ Sep 2024 | Trial primary completion date: Jun 2023 ➔ Sep 2023

Trial completion date • Trial primary completion date • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1, Open-label, Dose-Ascending Study to Evaluate the Safety and Tolerability of the Therapeutic Radiopharmaceutical 131I-MIP-1095 for the Treatment of Metastatic Castration-Resistant Prostate Cancer. (PubMed, Clin Nucl Med) - P1 | "131I-MIP-1095 demonstrated favorable dosimetry, biodistribution, and safety, as well as a modest PSA response supporting further investigation for treatment of men with mCRPC.Clinical Trial Registration: ClinicalTrials.gov identifier: NCT03030885, Registered January 25, 2017 (https://clinicaltrials.gov/ct2/show/NCT03030885)."

Journal • Metastases • P1 data • Genito-urinary Cancer • Hematological Disorders • Leukopenia • Oncology • Prostate Cancer • Solid Tumor • Thrombocytopenia • Xerostomia

ARROW: Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone (clinicaltrials.gov) - P2 | N=120 | Active, not recruiting | Sponsor: Progenics Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting

Combination therapy • Enrollment closed • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

MIP 1095 I-131: Expiry of patents in US/EU related to composition-of-matter and radio-labelled forms in 2027 (Lantheus Holdings) - Annual Report 2021: Expiry of patents in US related to stable compositions in 2030 and radio-labelling processes in 2031

Patent • Oncology

ARROW: Study of I-131-1095 Radiotherapy in Combination With Enzalutamide in Patients With Metastatic Castration-resistant Prostate Cancer Who Are Chemotherapy Naive and Have Progressed on Abiraterone (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Progenics Pharmaceuticals, Inc.; N=175 ➔ 120

Clinical • Combination therapy • Enrollment change • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Progenics Pharmaceuticals announces presentations at the 2020 American Society of Clinical Oncology Genitourinary Cancers Symposium Annual Meeting (ASCO GU) (GlobeNewswire) - "Progenics Pharmaceuticals, Inc...announced that three abstracts highlighting PyL^TM (¹⁸F-DCFPyL), I-131 1095, and PSMA AI have been selected for oral and poster presentations at the upcoming American Society of Clinical Oncology Genitourinary Cancers Symposium Annual Meeting (ASCO GU)..."

Clinical data

Progenics Pharmaceuticals Doses First Patient in Phase 2 Clinical Study of 1095 Radiotherapy for the Treatment of Metastatic Prostate Cancer (GlobeNewswire, Progenics Pharmaceuticals Inc.) - "Progenics Pharmaceuticals, Inc (NASDAQ:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, today announced that the first patient has been dosed in the Company’s Phase 2 clinical study evaluating I-131 1095 radiotherapy in combination with enzalutamide for the treatment of metastatic castration resistant prostate cancer (mCRPC)….The trial is expected to enroll approximately 120 patients at 25 sites in the U.S. and Canada….we plan to evaluate initiating a pivotal trial of 1095 in 2020.'"

Enrollment status • Trial status

Progenics Pharmaceuticals Announces First Quarter 2019 Financial Results and Business Update (GlobeNewswire, Progenics Pharmaceuticals Inc.) - "'We are excited to report that the U.S. commercial launch of AZEDRA for the treatment of advanced or metastatic pheochromocytoma and paraganglioma is proceeding well and as expected. We will record our initial AZEDRA revenues in the second quarter'...Progenics has initiated a Phase 2 trial of 1095 in combination with enzalutamide in chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) and will begin enrolling patients within the quarter...the Company will evaluate initiating a pivotal trial of 1095 in 2020....The Phase 3 CONDOR trial is a multi-center, open label trial that will enroll approximately 200 male patients with biochemical recurrence of prostate cancer in 14 sites in the United States and Canada. Patient enrollment for the trial is ahead of schedule and is expected to be completed in the fourth quarter of 2019."

Commercial • Enrollment status • Launch • New trial

Use of an Experimental Radiopharmaceutical (131I-MIP-1095) in Men With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (clinicaltrials.gov) - P1; N=10; Completed; Sponsor: Memorial Sloan Kettering Cancer Center; Active, not recruiting ➔ Completed; Trial completion date: Jan 2020 ➔ Apr 2019; Trial primary completion date: Jan 2020 ➔ Apr 2019

Clinical • Trial completion • Trial completion date • Trial primary completion date

Progenics Pharmaceuticals Announces Fourth Quarter and Full-Year 2018 Financial Results and Business Update (GlobeNewswire, Progenics Pharmaceuticals Inc.) - “The Phase 3 CONDOR trial is a multi-center, open label trial that will enroll approximately 200 male patients with biochemical recurrence of prostate cancer…The Company expects to complete enrollment in the fourth quarter of 2019 and report data in early 2020….Progenics plans to initiate a Phase 2 trial of 1095 in combination with enzalutamide in chemo-naïve patients with metastatic castration-resistant prostate cancer (mCRPC) who are refractory to novel anti-androgen drugs (NAAD) in the second quarter of 2019.”

Enrollment closed • Enrollment open • New P2 trial • P3 data