pocuvotide satetraxetan (Lu-177-DGUL) / CellBion - LARVOL DELTA

Efficacy and safety of Lu-177-DGUL in a phase 2 study of patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO-GU 2026) - P1/2 | "Key eligibility criteria included patients with metastatic castration-resistant prostate cancer (mCRPC) who had progressed after treatment with an androgen receptor pathway inhibitor (ARPI) with or without docetaxel, had at least one PSMA-positive lesion on baseline imaging using Ga-68-NGUL, and an ECOG performance status of ≤ 2. Lu-177-DGUL demonstrated promising anti-tumor activity and a manageable safety profile in PSMA-positive mCRPC. The consistent anti-tumor activity observed across subgroups, including pre- and post-taxane, highlights its potential as a robust treatment for mCRPC."

Clinical • Metastases • P2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1

Cellbion and drugmaker Ahn-gook Pharmaceutical said on Tuesday they had signed a preliminary agreement to jointly develop radiopharmaceutical cancer treatments. (Korea Biomedical Review) - "The companies signed the memorandum of understanding (MOU) on Monday. The non-binding deal covers joint research in radiopharmaceutical therapy (RPT), technology and data sharing, and the search for new drug candidates. Cellbion, which develops radiopharmaceuticals for diagnosing and treating cancer, is awaiting a decision from the Ministry of Food and Drug Safety (MFDS) on conditional marketing approval for its lead drug, 177Lu-DGUL (lutetium (¹⁷⁷Lu) pocuvotide satetraxetan), a prostate cancer treatment that has completed mid-stage domestic trials."

Licensing / partnership • Prostate Cancer

CellBion announced on July 30 that it has initiated the first patient administration in a clinical trial of ‘Lu-177-DGUL (pocuvotide satetraxetan)’ and ‘Keytruda (pembrolizumab)’ combination therapy targeting patients with metastatic castration-resistant prostate cancer. [Google translation] (The Bio) - "The company explained that patient administration took place on July 29, marking the start of full-scale clinical development of the Lu-177-DGUL combination therapy."

Trial status • Castration-Resistant Prostate Cancer

CellBion, KDDF sign clinical project agreement to accelerate Keytruda combination trial of prostate cancer RPT 'pocuvotide' (BioNews) - "Through the support program, CellBion plans to assess the safety and preliminary efficacy of a combination regimen comprising its prostate cancer-targeted radiopharmaceutical candidate, ‘pocuvotide (Lu-177-pocuvotide, active ingredient 177Lu-DGUL),’ and the immune checkpoint inhibitor, ‘pembrolizumab (marketed as Keytruda)...The clinical trial will enroll patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed despite prior treatment with androgen receptor pathway inhibitors (ARPIs)."

Licensing / partnership • Trial status • Castration-Resistant Prostate Cancer

Survival outcomes and subgroup efficacy analysis of Ga-68-NGUL and Lu-177-DGUL (pocuvotide satetraxetan) in patients with mCRPC: Results from a phase 1/2 study. (ASCO 2026) - P1/2 | "Ga-68-NGUL and Lu-177-DGUL (Pocuvotide Satetraxetan) demonstrates promising survival benefits in mCRPC. The clinical response is particularly robust in patients with lung or lymph node metastases and those completing more treatment cycles. The significant difference in rPFS observed only under PCWG3-modified criteria highlights the importance of using PCWG3-specific assessments in bone-predominant mCRPC."

Clinical • P1/2 data • Castration-Resistant Prostate Cancer • Prostate Cancer

Favorable Safety and Low Organ Dosimetry of 68Ga-NGUL and 177Lu-DGUL: Results from a Phase I/II clinical trial (SNMMI 2026) - P1/2 | "In this Phase I/II clinical study, 177Lu-DGUL demonstrated a favorable safety profile with an organ dosimetry pattern characterized by relatively low absorbed doses to critical organs. The observed safety outcomes were consistent with the dosimetric findings and support further clinical application of this novel PSMA-targeting radioligand therapy."

Clinical • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • Solid Tumor • Xerostomia

Predictive Value of Baseline PSMA PET Imaging Biomarkers in 177Lu-DGUL Therapy: A Phase I/II trial Subanalysis in mCRPC (SNMMI 2026) - P1/2 | "In this clinical trial subanalysis, baseline SUVmean was identified as the primary imaging biomarker for predicting clinical and biochemical response to 177Lu-DGUL. These findings underscore the central role of PSMA expression intensity in driving therapeutic success and support the use of SUVmean for effective patient stratification in the mCRPC setting."

Biomarker • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • Solid Tumor • FOLH1

Favorable Safety and Low Organ Dosimetry of 68Ga-NGUL and 177Lu-DGUL: Results from a Phase I/II clinical trial (SNMMI 2026) - P1/2 | "In this Phase I/II clinical study, 177Lu-DGUL demonstrated a favorable safety profile with an organ dosimetry pattern characterized by relatively low absorbed doses to critical organs. The observed safety outcomes were consistent with the dosimetric findings and support further clinical application of this novel PSMA-targeting radioligand therapy."

Clinical • P1/2 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Prostate Cancer • Solid Tumor • Xerostomia

Safety, dosimetry, and RP2D determination of Ga‑68‑NGUL and Lu‑177‑DGUL (pocuvotide satetraxetan) in mCRPC: Results from a phase 1/2 study (AACR 2026) - P1/2 | "Ga‑68‑NGUL and Lu‑177‑DGUL demonstrated a favorable safety profile, predictable dosimetry, and meaningful antitumor activity in mCRPC. Phase 1 confirmed acceptable organ radiation exposure, and Phase 2 showed clinically relevant responses with manageable toxicity at the RP2D. These findings support further evaluation of Lu‑177‑DGUL in comparative and later‑phase trials."

Clinical • P1/2 data • Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer

The phase 1 clinical trial for patients with metastatic castration-resistant prostate cancer using the combination therapy of radiopharmaceutical (RPT) 'Lutetium (177Lu) DGUL (177Lu-pocuvotide)' and Keytruda (ingredient pembrolizumab), which Cellbion is jointly conducting with MSD, will begin this month. [Google translation] (HIT News) - "...Cellbion announced that it plans to begin dosing patients in the main clinical trial (named IGNITE Trial), which was approved on September 12th of last year, this month....However, this clinical trial is planned to be longer than a typical phase 1 clinical trial, with the goal of completion in December 2029, and the company explained that it is intended to maintain Keytruda treatment for participating patients even after RPT administration."

Trial status • Castration-Resistant Prostate Cancer

CellBion…announced on December 30 that it has completed the submission of a conditional approval application to the Ministry of Food and Drug Safety (MFDS) for ‘177Lu-pocuvotide’ (development code), a treatment candidate for metastatic castration-resistant prostate cancer (mCRPC) (The Bio) - "The application was supported by data from the Phase 2 Clinical Study Report (CSR) received on December 12. CellBion plans to leverage the ‘conditional approval’ system, which permits market authorization based on Phase 2 clinical evidence....CellBion plans to formally disclose the detailed Phase 2 clinical trial data underpinning its conditional approval application at the American Society of Clinical Oncology-Genitourinary Cancers Symposium (ASCO-GU) scheduled for February 2026..."

Korea filing • P2 data • Castration-Resistant Prostate Cancer

CellBion…announced on December 15 that it had received the final clinical study report (CSR) on December 12 for its domestic Phase 1/2 clinical trial of ’177Lu-pocuvotide,’ a treatment candidate for metastatic castration-resistant prostate cancer (mCRPC). (The Bio) - "Based on the CSR, the company plans to complete the conditional approval application process with the Ministry of Food and Drug Safety (MFDS) within the year....Analysis of the CSR data showed that 177Lu-pocuvotide achieved an objective response rate (ORR) of 35.9%, surpassing its predefined clinical target and demonstrating strong efficacy....CellBion plans to present detailed findings from the Phase 2 clinical trial at the American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium, scheduled to take place in San Francisco, United States, in February next year."

Korea filing • P1/2 data • P2 data • Castration-Resistant Prostate Cancer

MSD and CellBion launch Korea’s 1st radioligand-immunotherapy trial for prostate cancer (Korea Biomedical Review) - "CellBion announced Wednesday that it has entered into a clinical trial collaboration and supply agreement with MSD (Merck & Co. in the U.S. and Canada) to evaluate the combination of its PSMA-targeting radioligand, Lutetium (177Lu) DGUL, with MSD’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with advanced prostate cancer....The phase 1 trial will enroll approximately 30 patients with Taxane-naïve (T-naïve), treatment-resistant prostate cancer. Participants will be assigned to either a monotherapy arm receiving Lu-177-DGUL alone or a combination arm receiving both Lu-177-DGUL and Keytruda."

Commercial • Genito-urinary Cancer • Prostate Cancer

CellBion’s prostate cancer RPT candidate achieves 47.5% ORR, surpassing rival drug Pluvicto’s 29.8% (The Bio) - P1/2 | N=73 | NCT05547061 | Sponsor: Cellbion Co., Ltd. | "Among the 61 patients evaluated, 29 achieved either a complete response (CR) or partial response (PR), resulting in an ORR of 47.54%. Furthermore, among 59 patients evaluated using PET/CT imaging, 46 demonstrated either a complete metabolic response (CMR) or a partial metabolic response (PMR), resulting in a total metabolic response rate of 77.97%....While direct comparisons may not be straightforward, CellBion highlights that these outcomes surpass the ORR observed for the competing drug Pluvicto in its phase 3 clinical trial. In this clinical trial (VISION Trial) conducted on 319 participants, Pluvicto reported an ORR of 29.8%.The last patient administration is scheduled for March 2025, with CellBion planning to submit its approval application later that year after receiving the CSR."

Filing • P2 data • Trial status • Metastatic Castration-Resistant Prostate Cancer

Selvion leaps to become a global leader in radiopharmaceuticals through KOSDAQ listing [Google translation] (Pharm News) - "Selvion is pursuing development with the goal of completing phase 2 clinical trials for 'Lu-177-DGUL' in the first half of 2025 and early domestic launch through conditional approval in the fourth quarter of the same year. Conservatively estimated sales of a single 'Lu-177-DGUL' pipe are expected to increase from KRW 3.321 billion in the first year of launch to KRW 37.179 billion in 2026 and KRW 42.93 billion in 2027. The company expects to price 'Lu-177-DGUL' at 90% of the marketed drug and also expects to secure price competitiveness."

Approval • Trial status • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer

Phase Ib trial of cabozantinib (Cabometyx®) combined with Lu-177 DOTATATE radioligand therapy in patients with advanced, somatostatin receptor positive NETs. (NANETS 2023) - "Cabozantinib 20mg daily starting 14 days prior to standard doses of Lu-177 PRRT had no dose limiting toxicities during cycle 1 allowing dose escalation to 20mg/40mg alternate daily dosing. Preliminary efficacy signals with initial response are promising. Updated safety and efficacy information will be reported for the first 6 patients enrolled."

Clinical

CellBion's innovative prostate cancer drug, Lu-177-DGUL, secures 'GIFT' designation (Korea Biomedical Review) - "On Monday, the Ministry of Food and Drug Safety (MFDS) designated Lu-177-DGUL as the 11th agent to benefit from its 'Global Innovative Products on Fast Track' (GIFT) program, signifying a significant milestone in the quest to offer a beacon of hope for prostate cancer patients who currently have limited viable treatment options. Lu-177-DGUL is a drug designed to combat metastatic castration-resistant prostate cancer (mCRPC) in adult patients who exhibit positivity for prostate-specific membrane antigen (PSMA) and have been unresponsive to standard treatment protocols....CellBion said it is fully committed to bringing this revolutionary treatment to market, with approval and launch targeted for the first half of 2024."

Launch non-US • Non-US regulatory • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Vancouver Clinic Earns Therapeutic License to Administer New Drug to Treat Prostate Cancer (PRNewswire) - "INITIO Medical Group is the first private nuclear medicine facility in Canada to be awarded a therapeutic license to administer Lutetium-177-PSMA (prostate specific membrane antigen) for the treatment of advanced prostate cancer, specifically 'metastatic castration resistant prostate cancer' also known as 'mCRPC'....INITIO received the license from the Canadian Nuclear Safety Commission last week and will begin offering patient treatments after March 15."

Commercial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 1/2 Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Anti-tumor Activity of Ga-68-NGUL / Lu-177-DGUL in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Refractory to Standard Therapy (clinicaltrials.gov) - P1/2 | N=73 | Recruiting | Sponsor: Cellbion Co., Ltd.

New P1/2 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The Centre for Probe Development and Commercialization expands into Asia and executes a development, manufacturing, and clinical supply agreement for 177Lu-PSMA (DGUL) With South Korea-based CellBion (PRNewswire) - "The Centre for Probe Development and Commercialization (CPDC) is pleased to announce the initiation of a development, manufacturing, and supply agreement with CellBion for Lu-177-radiolabelled PSMA (DGUL) therapeutic agent. Under the terms of the agreement, CPDC will develop and manufacture CellBion's drug product for Phase II clinical supply in South Korea with the goal of expanding into North America."

Licensing / partnership • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor