Why Oncology Global Safety Teams Should Develop the Safety Section of the Study's Target Product Profile (TPP).

Abstract

Oncology Global Safety Teams (GSTs) are not universally tasked with the development of the risk section of the products target product profile (TPP). This fact makes little sense since the GST is tasked by the company to identify, analyze, and mitigate a product's risks. The TPP, in essence, establishes boundaries for go/no-go decisions around a product or products in combination treatment. Involvement of the Oncology GST in producing a well-researched and evidenced based TPP safety section allows the team to develop knowledge around the drug(s) studied or added to a study arm. The increased use of umbrella and platform studies for early-phase oncology trials allows an excellent resource for the use of clinical data to estimate the risk of developmental drugs combined to treat a given oncology indication. To shorten time to marketing, companies are including developmental products with novel mechanisms early within their development cycles. Antibody drug conjugates (ADCs) and bi-directional antibodies are a few examples of products combined in arms of a platform or umbrella study early and with only immature clinical data available. This article will share a novel analytical approach for safety teams to develop a well thought-out and defendable safety section to the TPP. Strategies to estimate the risks associated with combination therapies will be brought forward. The advantages of having the safety team involved early in the benefit/risk, go/no-go decisions for a study or the addition of a study arm will be detailed. The early development of a well-documented TPP will enhance chances of a successful product submission.