Delving into the Latest Updates on Mopidamol with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Rapenton, OLX 102, OLX-102

+ [2]

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

Neoplasms

Active Indication

Head and Neck Neoplasms

Inactive Indication

Non-Small Cell Lung CancerOvarian Cancer

Originator Organization

C.H. Boehringer Sohn AG & Co. KG

Active Organization

C.H. Boehringer Sohn AG & Co. KG

Inactive Organization

Agenus, Inc.

License Organization-

Drug Highest PhaseApproved

First Approval Date

Germany (01 Jan 1980),

Head and Neck Neoplasms

Regulation-

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Structure/Sequence

Molecular FormulaC19H31N7O4

InChIKeyFOYWNSCCNCUEPU-UHFFFAOYSA-N

CAS Registry13665-88-8

Previous research on Radium-223 treatment patterns in metastatic prostate cancer has been limited to select sites, oncology practices, or claims databases. Limited data exists on the use and outcomes of Radium-223 in Medicare population the largest public insurance provider for people aged 65 years and older in the United States. Therefore, this study used a nationwide population database of cancer registries linked to Medicare claims to examine Ra-223 treatment patterns, factors associated with treatment completion, and their associations with survival outcomes.

PATIENTS AND METHODS:

A retrospective cohort analysis was conducted on 1062 Medicare beneficiaries (≥ 66 years) with prostate cancer who initiated Ra-223 treatment between January 2016 and June 2020. Eligible men had 12 months of continuous Medicare Parts A/B/D enrollment prior to Ra-223 initiation and were followed for a minimum of 6 months. Primary outcomes included completion of ≥ 5 cycles of Ra-223 and overall survival. Factors influencing completion were analyzed with multivariate logistic regression, and survival was estimated using Kaplan-Meier and proportional hazards regressions.

RESULTS:

The cohort was 79.9% nonhispanic White, 6.8% Hispanic, and 6.1% nonhispanic Black, with a mean age of 75.6 years (SD = 6.6). Overall, 59.4% completed ≥ 5 cycles. Men receiving Ra-223 as first-line (21.1%) or second-line metastatic castration-resistant prostate cancer(mCRPC) therapy (44.1%) were more likely to complete treatment than those receiving third-line or later (aOR = 1.76,1.56, 95% CI, [1.22-2.54], [1.17-2.08]). Completing ≥ 5 cycles of Ra-223 was associated with longer survival (18.5 vs. 11.1 months, P < .001; aHR = 0.51, 95% CI, [0.44, 0.59]), as was first- or second-line therapy use (18.4, 14.8 months vs. 13.8 months, P < .001; aHR = 0.56,0.82; 95% CI, [0.45-0.68], [0.69-0.96]) compared to Ra-233 as third-line or later.

CONCLUSION:

The majority of men received ≥ 5 cycles of Ra-223. Early initiation of Ra-223 was associated with higher completion rates and better survival outcomes, underscoring the importance of early Ra-223 use in managing mCRPC.

01 Jul 2024·CUAJ-Canadian Urological Association Journal

Real-world evaluation of access-driven Canadian treatment sequences in progressive prostate cancer (REACTIVATE).

Article

Author: MacPhail, Corin ; Cheung, Winson Y ; Faure, Mareva ; Ko, Jenny J ; Mbuagbaw, Lawrence ; Sunderland, Katherine ; Faizi, Shoaib ; Lowther, Jennifer ; Lee-Ying, Richard ; Royer, Catherine ; Tyldesley, Scott

INTRODUCTION:

The results of the phase 3 ALSYMPCA trial showed that Radium-223 (Ra-223) improves overall survival (OS) and delays onset of first symptomatic skeletal event vs. placebo in patients with metastatic castration-resistant prostate cancer (mCRPC). The purpose of the REACTIVATE study was to inform the optimal placement of Ra-233 in the treatment sequence by evaluating clinical outcomes and healthcare resource utilization using real-world data from multiple Canadian provinces.

METHODS:

This retrospective cohort study analyzed patient outcomes according to Ra-223 placement using administrative databases of four Canadian provinces, encompassing 4301 patients with mCRPC who received at least two lines of life-prolonging therapy (LPT) for mCRPC. Outcomes included OS, event-free survival (EFS), and healthcare resource utilization. Each province was analyzed separately.

RESULTS:

OS, measured from the start of second-line LPT, differed between provinces: those in Ontario receiving second-line Ra-223 had a longer OS vs. those receiving it in third-line or later (hazard ratio [HR ] 0.79, 95% confidence interval [CI] 0.66-0.95). There was no difference between lines of therapy in patients in British Columbia (HR 1.165, 95% CI, 0.894-1.518, p=0.2576), and OS was numerically worse but not statistically significant in patients receiving Ra-223 in second-line in Quebec (HR 1.44, 95% CI, 0.93-2.24). Other outcomes also varied across provinces, with second-line use of Ra-223 being associated with longer EFS and reduced healthcare utilization vs. third-line use in Ontario but not in Quebec.

CONCLUSIONS:

Significant heterogeneity exists in the management and outcomes of mCRPC between provinces, particularly regarding the placement of Ra-223 in the treatment sequence.

28 Aug 2023·Journal of clinical medicine

Prevalence and Prognostic Implications of PSA Flares during Radium-223 Treatment among Men with Metastatic Castration Resistant Prostate Cancer.

Article

Author: Khan, Nabeeha ; Fleshner, Neil E ; Emmenegger, Urban ; Chow, Edward ; Kapoor, Anil ; Zalewski, Pawel ; Phillips, Cameron ; Sidhu, Amanjot ; Briones, Juan

Radium-223 (Ra233) prolongs the survival of men with symptomatic bone-predominant metastatic castration-resistant prostate cancer (mCRPC). However, prostate-specific antigen (PSA) response patterns are not closely associated with Ra223 therapy outcomes. Herein, we sought to analyze the impact of Ra223-induced PSA flares on patient outcome. Using a retrospective cohort study of Ra223 treatment in four Ontario/Canada cancer centres, we identified 134 patients grouped into sub-cohorts according to distinct PSA response patterns: (i) initial PSA flare followed by eventual PSA decline; (ii) PSA response (≥30% PSA decrease within 12 weeks of treatment); and (iii) PSA non-response. We analyzed patient characteristics and outcome measures, including overall survival (OS), using the Kaplan-Meier method and log-rank testing. PSA flares were observed in 27 (20.2%), PSA responses in 11 (8.2%), and PSA non-responses in 96 (71.6%) patients. Amongst PSA flare patients, 12 presented with post-flare PSA decreases below baseline and 15 with PSA decreases below the flare peak but above baseline. Although only six flare patients achieved ≥30% PSA decreases below baseline, the median OS of all flare patients (16.8 months, 95% CI 14.9-18.7) was comparable to that of PSA responders and non-responders (p = 0.349). In summary, around 20% of mCRPC patients experience Ra223-induced PSA flares, whose outcome is similar to that of men with or without PSA responses. Further studies are needed regarding suitable biochemical surrogate markers of response to Ra223.

100 Deals associated with Mopidamol

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