Novel Clinical Trial Designs In Oncology: An Histology-Independent Approach

Cancer’s heterogeneity is a leading reason why product development in this therapeutic area is so risky and costly – and why the pharma industry has not yet addressed all needs in the market. Because low-incidence tumors present recruitment challenges and have lower commercial potential than high-incidence ones, they receive less attention from drug developers; meanwhile, new therapies for high-incidence tumors must demonstrate higher efficacy than therapeutic alternatives in order to differentiate themselves.

For years, drug developers have used histology as the fundamental analytical unit by which they study new agents for their effectiveness. Homogenous patient cohorts (based on their histological distinctions) produce more predictable outcomes. This rationalization is consistent with the mechanisms of action for many cytotoxic agents and some classes of targeted therapies. For example, the cytotoxic effects of taxanes in breast, ovarian, prostate, and lung tissues are likely attributable to inherent metabolic properties of the tumor, such as drug absorption/uptake, DNA replication/cell division, and mechanisms of drug resistance. Likewise, the effects of angiogenesis inhibitors (e.g., bevacizumab) in certain solid tumors are related to the neovascularization properties of specific tumors and the molecular targets that are involved.

Despite the technical merits – and proven success – of this path for drug development, histology-based approaches can be inefficient and costly as they require sponsors to conduct separate Phase...

More from Archive

Final Chance To Have Your Say: Take Our Reader Survey This Week

 

Editor’s note: This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.

Early Development Deals: Ipsen's Strategy For Biomarker-Driven Success

 

Mary Jane Hinrichs, Ipsen’s head of early development, talks to In Vivo about getting ahead of the competition by securing deals for candidates before they enter Phase I trials.   

Shape Our Content: Take The Reader Survey

 

Editor’s note: We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in the coverage topics, content format or the method in which you receive and access In Vivo, or if you love it how it is, now is the time to have your voice heard.

In Partnership with Cerba Research

Prioritizing Safety in CAR-T Therapy: Patient Monitoring with Cerba Research’s Testing Portfolio

The cell and gene therapy (CGT) clinical trial landscape in general and CAR-T cell clinical trials in particular are a special focus for the FDA, EMA, and other regulatory agencies. The whole industry is thus aware of the recent FDA safety investigation and requirements for labeling CAR therapy products.

More from In Vivo

The 360 Degrees Of European Biotech Financing In 2025

 
• By 

Almost halfway through 2025, and financing for European biotech could be described as challenging. Market volatility, geopolitical instability and trade barriers all loom large in biotech CEO minds when pitching for funding. In Vivo talked to biotechs and investors to gain a realistic view of the current market for company funding so far this year.

Rising Leaders 2025: Pedro Valencia’s ADC Vision At AbbVie

 
• By 

From chemical engineering to cancer innovation, AbbVie's rising oncology leader is advancing next-generation ADCs to tackle difficult-to-treat tumors with a patient-centered approach.

Leaders At The Frontier: Conversations From SynBioBeta 2025

 
• By 

Mini-profiles of five synthetic biology companies and their leaders from SynBioBeta 2025 reveal how AI integration, data-driven platforms and interdisciplinary teams are revolutionizing drug discovery and manufacturing.