Clinical Progress

An analysis of Apalutamide's R&D progress and its clinical results presented at the 2024 ASCO_GU Annual Meeting

23 February 2024
4 min read

Early PSA response has been found to be associated with improved outcome in mHSPC patients treated with androgen deprivation therapy (ADT) plus androgen receptor pathway inhibitors (ARPI). Recently, the 2024 ASCO_GU updated the treatment effect on OS varies.  

Apalutamide's R&D Progress

Apalutamide is a small molecule drug that targets the androgen receptor (AR). It is primarily used in the treatment of various neoplasms, urogenital diseases, mouth and tooth diseases, digestive system disorders, and liver diseases. 

According to the Patsnap Synapse, Apalutamide was first approved in the United States in February 2018 by the originator organization, Janssen Global Services LLC. It has also received approval in China. And the clinical trial distributions for Apalutamide are primarily in the United States, China and United Kingdom. The key indication is Prostatic Cancer. 

Detailed Clinical Result of Apalutamide

This secondary analysis of TITAN trial was aimed to explore the treatment effect (ADT) plus ARPI) on OS varies based on early PSA response in mHSPC patients.  

In this study, the authors performed a secondary analysis of TITAN study in which men with mHSPC were randomly assigned to ADT plus placebo vs. ADT plus apalutamide (ADT+APA). To compare the association of OS with early PSA response, defined as achieving a PSA nadir of ≤0.2 ng/mL at ≤6 months of randomization, between two arms, we applied multivariable Cox regression model on a landmark population with an interaction term between the treatment arm and PSA response. Adjusted OS were calculated. Confounders were chosen based on their association with PSA response and OS.

The result showed that 1049 patients were eligible with 526 in the ADT arm and 523 in the ADT+APA arm. Approximately 24% (125/526) patients in the ADT arm and 62% (323/523) patients in the ADT+APA arm achieved early PSA nadir. On landmark analysis, ADT+APA was associated with improved OS among those with an early PSA nadir (HR: 0.66; 95% CI: 0.44-1.00) but no improvement in OS among those without an early PSA nadir (HR: 1.15 [0.87-1.46]) with differential treatment effect between groups stratified by early PSA nadir by 6 months (p=0.03). Adjusted 4-year OS for patients who reached PSA nadir was 66% (95% CI: 56-75) in the ADT alone arm and 78% [74-83] in the ADT+APA arm while for patients who did not reach PSA nadir, adjusted 4-year OS was 46% [41-52] and 47% [40-54] in the ADT alone and ADT+APA arm, respectively. Numbers needed to treat (NNT) was 7.8 (95% CI: 6 to 15) for the overall landmark population, 7.7 [5 to 36] for patients with PSA nadir by 6 months, and 55 [10 to -4] for those without PSA nadir, respectively.

It can be concluded that in this exploratory analysis of TITAN study, early PSA nadir at or before 6 months was associated with superior OS in both treatment arms. However, there was evidence of differential treatment effect on OS based on early PSA nadir with no beneficial effect from ADT+APA in those who did not reach early PSA nadir. Patients with lack of early PSA nadir had inferior and similar OS in both treatment groups. Further investigation is needed to determine how to best manage patients treated with doublet therapy without an early PSA response.

How to Easily View the Clinical Results Using Synapse Database?

If you want to know the other clinical results of popular conferences, please lick on the “Clinical Results” on the homepage of Patsnap Synapse, which provides multi-dimensional screening and filtering of drugs, indications, targets, companies, result evaluation, release date, popular conferences, etc. to help you quickly locate the data you need. 

Select the clinical meeting you are interested in, such as ESMO. In the results, you can quickly locate the data you want to view by indication, phase and drug name. 

图形用户界面, 文本, 应用程序

描述已自动生成

A single result clearly shows important information such as registration number, phase, indication, Sponsor/Collaborator, biomarker, Trial number, dosing regimen and more. 

图形用户界面, 文本, 应用程序

描述已自动生成

If you would like to view more information about this result, you can go to the result detail page by clicking on the title. 

Above the headings, we provide the original source of the outcome data. The basic information is supplemented with more information beyond the list, such as company, study. design, etc. 

In the important Outcome Measures section, we provide both list and flowchart forms, which are convenient for you to overview the comparison group information and core indicator data. 

Finally, if you need to download these results, you can conveniently check the check boxes on the left side of the list, or directly click the "Export" button to download the data for personalized analysis and file sharing.

Click on the image below to embark on a brand new journey of drug discovery!

图形用户界面, 文本, 应用程序, 聊天或短信

描述已自动生成

Citius Pharma Resubmits LYMPHIR™ BLA for Treatment of Adult Relapsed/Refractory CTCL
Latest Hotspot
3 min read
Citius Pharma Resubmits LYMPHIR™ BLA for Treatment of Adult Relapsed/Refractory CTCL
22 February 2024
Citius Pharma re-submits its LYMPHIR™ BLA, comprising Denileukin Diftitox, aiming to treat relapsed/refractory Cutaneous T-Cell Lymphoma in adults.
Read →
Strategically Search Mupirocin on Synapse: A How-to Guide
Drug Insights
2 min read
Strategically Search Mupirocin on Synapse: A How-to Guide
22 February 2024
Mupirocin (BACTROBAN) is an antibiotic that blocks RNA synthetase and treats impetigo from Staph aureus and Streptococcus pyogenes when applied to the skin.
Read →
FDA Approves Kurome's Clinical Trials for AML and Advanced MDS Drug KME-0584
Latest Hotspot
3 min read
FDA Approves Kurome's Clinical Trials for AML and Advanced MDS Drug KME-0584
22 February 2024
Kurome Therapeutics has received authorization from the FDA to conduct clinical trials for KME-0584, aimed at addressing Acute Myeloid Leukemia (AML) and advanced-stage Myelodysplastic Syndromes (MDS).
Read →
User-friendly Guide to Find Quetiapine on Synapse
Drug Insights
2 min read
User-friendly Guide to Find Quetiapine on Synapse
22 February 2024
Quetiapine, marketed as SEROQUEL, is an atypical antipsychotic medication developed and produced by AstraZeneca.
Read →
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.