Complete remission at 8.97% and partial remission at 26.92% demonstrate best-in-class efficacy
[by Ji, Yong Jun] CellBion is nearing commercialization of its radiopharmaceutical (RPT) candidate ‘177Lu-DGUL (Pocuvotide),’ developed for the treatment of prostate cancer. Phase 2 topline results indicated an objective response rate (ORR) of 35.9%. With the final clinical study report (CSR) expected in the fourth quarter, the company intends to seek conditional approval for 177Lu-DGUL.
CellBion announced on September 4 the topline results of its Phase 2 clinical trial for ‘177Lu-DGUL (Pocuvotide),’ a radiopharmaceutical (RPT) candidate for 인터넷 바카라 사이트 cancer. The results emphasized critical efficacy data, particularly the primary endpoint of objective response rate (ORR) and the final clinical report (CSR) expected for the fourth quarter of the year.
Cellbion explained that 177Lu-DGUL targets 인터넷 바카라 사이트 cancer, a condition whose prevalence continues to rise with an aging population. The Phase 2 trial focused on patients with late-stage disease who had failed to respond to existing treatment options. Efficacy was evaluated in 78 of the 91 participants who had received at least one administration of the investigational drug and for whom tumor assessments were available.
The primary efficacy endpoint, 인터넷 바카라 사이트, was 35.90% (28 of 78 patients; 95% CI; 25.00-47.01). Complete remission (CR) rate and partial remission (PR) rate were 8.97% and 26.92%, respectively. These figures outperform the 인터넷 바카라 사이트 of 29.8%, CR of 6.8%, and PR of 23.0% reported in the VISION clinical trial, which evaluated PLUVICTO, Novartis' first-in-class new drug, in combination with standard treatment.
"The Phase 2 clinical trial was conducted as a single-arm study, with final ORR criteria requiring at least two CR or PR evaluations per patient, standards considered more stringent than those applied for PLUVICTO in combination with the control group (standard treatment). Nevertheless, 인터넷 바카라 사이트 demonstrated markedly superior efficacy," a CellBion official emphasized.
Safety evaluation indicated that ‘xerostomia,’ a frequent adverse event associated with 인터넷 바카라 사이트-specific membrane antigen (PSMA)-targeted radiopharmaceuticals, was observed in 13.19% of patients (12 of 91). The company explained, "177Lu-DGUL demonstrated best-in-class safety differentiation and competitiveness when compared directly with existing treatment options."
Moreover, based on the PCWG-modified RECIST v1.1 criteria, the ORR was 41.03% (32 of 78 patients; 95% CI; 29.60-52.15). This evaluation accounts for disease-specific features of 인터넷 바카라 사이트 cancer by rigorously assessing alterations in sclerotic bone metastases.
Using mPERCIST criteria applied to PSMA PET/CT imaging (positron emission tomography), the proportion of patients achieving complete metabolic response (CMR) and partial metabolic response (PMR) was 81.69% (58 of 71 patients; 95% CI; 70.73-89.87).
"177Lu-DGUL was designated as a Global Innovative Drug Fast Track (GIFT) product by the Ministry of Food and Drug Safety in July 2023," a CellBion official stated. "Phase 2 clinical trials in Korean 인터넷 바카라 사이트 cancer patients confirmed an excellent efficacy and safety profile."
"Once the final clinical trial report (CSR) is secured in the fourth quarter, we will file for conditional approval and work to deliver the novel drug as quickly as possible to patients with refractory 인터넷 바카라 사이트 cancer," the official further added.