Strategic risk assessment in oncology: Utilizing single-agent activity to boost combination therapy approvals.

ABSTRACT:

Background

This study examines whether single-agent activity in early clinical phases correlates with the approval likelihood of combination therapies in oncology. Using the Intelligencia AI database, we investigated the impact of monotherapy efficacy on the success rates of combination therapies.

Methods

The analysis included combinational therapies across various solid tumor types, assessing the approval rates and the presence of monotherapy efficacy with cut-off date September 12, 2024, and an assessment of 3896 programs. We analyzed historical clinical trial data focusing on Objective Response Rate (ORR) as a metric of single-agent activity (SAA).

Results

Approval rate for combination programs across all indications and phases was 4.2 %. Programs that included app

SUBMITTER: Kasim A 

PROVIDER: S-EPMC12811421 | biostudies-literature | 2026 Feb

REPOSITORIES: biostudies-literature