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Published on: December 9, 2015
The evolution of precision oncology: The ongoing impact of the Drug Rediscovery Protocol (DRUP)
Soemeya F Haj Mohammad1, Hans J L Timmer2, Laurien J Zeverijn3
1Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands; Department of Molecular Oncology & Immunology, Netherlands Cancer Institute, Amsterdam, the Netherlands. s.f.haj_mohammad@lumc.nl.
Background And Purpose:
The Drug Rediscovery Protocol (DRUP) is a Dutch, pan-cancer, nonrandomized clinical trial that aims to investigate the efficacy and safety of targeted and immunotherapies outside their registered indication in patients with advanced or metastatic cancer.
Patients:
Patients with advanced or metastatic cancer are eligible when there are no standard of care treatment options left and the tumor possesses a molecular genomic variant for which commercially available anticancer treatment is accessible off-label in DRUP. Clinical benefit is the study's primary endpoint, characterized by a confirmed objective response or stable disease after at least 16 weeks of treatment.
Results:
More than 2,500 patients have undergone evaluation, of which over 1,500 have started treatment in DRUP. The overall clinical benefit rate (CBR) remains 33%. The nivolumab cohort for patients with microsatellite instable metastatic tumors proved highly successful with a CBR of 63%, while palbociclib or ribociclib in patients with tumors harboring CDK4/6 pathway alterations showed limited efficacy, with a CBR of 15%. The formation of two European initiatives (PCM4EU and PRIME-ROSE) strives to accelerate implementation and enhance data collection to broaden equitable access to anticancer treatments and gather more evidence.
Conclusion:
DRUP persists in improving patients access to off-label targeted or immunotherapy in the Netherlands and beyond. The expansion of DRUP-like clinical trials across Europe provides countless opportunities for broadening the horizon of precision oncology.
Insights
The Drug Rediscovery Protocol (DRUP) trial offers off-label targeted and immunotherapies to advanced cancer patients. While overall benefit is 33%, specific treatments show varied success, highlighting precision oncology
Area of Science:
- Oncology
- Clinical Pharmacology
- Genomics
Background:
- The Drug Rediscovery Protocol (DRUP) is a Dutch, pan-cancer clinical trial.
- It focuses on patients with advanced or metastatic cancer who have exhausted standard treatment options.
Purpose of the Study:
- To investigate the efficacy and safety of targeted and immunotherapies used off-label.
- To provide access to novel anticancer treatments for patients with specific molecular genomic variants.
Main Methods:
- Nonrandomized clinical trial design.
- Patient eligibility requires advanced cancer, no standard options, and a targetable molecular genomic variant.
- Primary endpoint is clinical benefit, defined as objective response or stable disease for at least 16 weeks.
Main Results:
- Over 1,500 patients have been treated in the DRUP trial.
- The overall clinical benefit rate (CBR) is 33%.
- Nivolumab showed a 63% CBR in microsatellite instable tumors, while CDK4/6 inhibitors had a 15% CBR.
Conclusions:
- DRUP successfully improves patient access to off-label therapies in the Netherlands and Europe.
- Expansion of similar trials promotes precision oncology and equitable access to cancer treatments.
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