ASCO has expanded its Targeted Agent and Profiling Utilization Registry (TAPUR™) study with two new developments:
- The study added its first antibody-drug conjugate (ADC), fam-trastuzumab deruxtecan-nxki (T-DXd), to determine if a wider group of patients would benefit from this medicine.
- Separately, the study portfolio now includes the combination therapy of dabrafenib and trametinib. TAPUR will help generate data that the manufacturer could use to address regulatory requirements for this combination in an indication that was recently approved by the U.S. Food and Drug Administration (FDA).
The TAPUR clinical trial evaluates off-label treatments for different cancer types by using genomic testing to identify gene alterations in patients to match them to treatment options. By participating in the TAPUR study, drug manufacturers and regulatory authorities can collect high-quality data on the safety and efficacy of targeted anticancer drugs used outside of their original indications approved by the FDA. Under the study protocol, participating patients receive these medications at no cost.
T-DXd
T-DXd is the first ADC to be included in the TAPUR Study. The study will evaluate whether T-DXd is effective at treating solid tumors that have any amplification of the HER2 gene or non–small cell lung cancer with HER2 immunohistochemistry (IHC) 2+/3+. The inclusion of T-DXd in the TAPUR study advances the momentum of an April 2024 regulatory milestone, when the FDA granted accelerated approval to the drug for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. This study has the potential to help broaden the patient population eligible to receive T-DXd.
Dabrafenib Plus Trametinib
In June 2022, the FDA granted accelerated approval to the two-drug BRAF/MEK inhibitor combination therapy of dabrafenib plus trametinib for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors with BRAF V600E mutations whose disease has progressed following prior treatment and who have no satisfactory alternative treatment options. While this approval opened new options for patients, the TAPUR study provides an established platform to collect additional evidence on the impact of this combination.
“Now completing its 10th year, the TAPUR study continues to evolve by adding innovative treatments to the platform, like our first [ADC] cohorts,” said Richard L. Schilsky, MD, FACP, FSCT, FASCO, Principal Investigator of TAPUR. “We're also excited about this new opportunity to work with companies to help with their postmarket commitments, expanding the potential impact of the study data by its inclusion in regulatory filings related to these treatments.”
The TAPUR study has enrolled more than 3,000 patients with advanced cancer across 272 sites around the United States and will soon add sites in Puerto Rico.
T-DXd (Enhertu) is developed and commercialized globally by Daiichi Sankyo and AstraZeneca, except in Japan, where Daiichi Sankyo maintains exclusive rights. Dabrafenib (Tafinlar) and trametinib (Mekinist) are manufactured and marketed by Novartis Pharmaceuticals.
