ASCO Expands TAPUR Study with First Antibody-Drug Conjugate and BRAF/MEK Inhibitor Combination
核心洞察
The American Society of Clinical Oncology has expanded its TAPUR Study to include fam-trastuzumab deruxtecan-nxki, marking the first antibody-drug conjugate addition to the precision medicine trial platform.
The study will evaluate the ADC's effectiveness in solid tumors (搜索) with HER2 (搜索) gene amplification and non-small cell lung cancer (搜索) with HER2 IHC2+/3+ expression.
TAPUR also added the dabrafenib plus trametinib combination therapy to generate additional post-market data for BRAF V600E (搜索) mutation-positive solid tumors (搜索).
The American Society of Clinical Oncology (ASCO (搜索)) has significantly expanded its Targeted Agent and Profiling Utilization Registry (TAPUR™) Study with two major additions that advance precision oncology research. The landmark trial now includes its first antibody-drug conjugate, fam-trastuzumab deruxtecan-nxki, and the combination therapy of dabrafenib plus trametinib, marking a strategic evolution in the study's approach to evaluating targeted cancer (搜索) treatments.
First ADC Integration Targets HER2-Positive Cancers
Fam-trastuzumab deruxtecan-nxki represents a milestone as the first antibody-drug conjugate incorporated into the TAPUR Study platform. The trial will evaluate the drug's effectiveness in treating solid tumors (搜索) with any amplification of the ErbB2 (搜索) (HER2 (搜索)) gene and non-small cell lung cancer (搜索) with HER2 IHC2+/3+ expression.
This expansion builds on the FDA's April 2024 accelerated approval of fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2 (搜索)-positive (IHC3+) solid tumors (搜索) who have received prior systemic treatment and have no satisfactory alternative treatment options. The TAPUR Study has the potential to help broaden the patient population eligible to receive the drug by generating evidence for expanded indications.
BRAF/MEK Combination Therapy Addition
The study portfolio now includes the two-drug combination therapy of dabrafenib plus trametinib, which received FDA accelerated approval in June 2022. This BRAF/MEK inhibitor combination is approved for treating adult and pediatric patients with unresectable or metastatic solid tumors (搜索) with BRAF V600E (搜索) mutations whose disease has progressed following prior treatment and who have no satisfactory alternative treatment options.
The TAPUR platform provides an established framework to collect additional evidence on this combination's impact, potentially supporting manufacturers' post-market regulatory commitments.
Study Design and Clinical Impact
The TAPUR clinical trial evaluates off-label treatments across different cancer (搜索) types by using genomic testing to identify gene alterations in patients and match them to appropriate treatment options. Through this approach, drug manufacturers and regulatory authorities can collect high-quality data on the safety and efficacy of targeted anti-cancer drugs used outside their original FDA-approved indications.
"Now completing its 10th year, the TAPUR Study continues to evolve by adding innovative treatments to the platform, like our first antibody drug conjugate cohorts," said Dr. Richard L. Schilsky, MD, FACP, FSCT, FASCO, Principal Investigator of the TAPUR Study. "We're also excited about this new opportunity to work with companies to help with their post-market commitments, expanding the potential impact of the study data by its inclusion in regulatory filings related to these treatments."
Study Scale and Access
The TAPUR Study has enrolled more than 3,000 patients with advanced cancer (搜索) across 272 sites throughout the United States and will soon expand to include sites in Puerto Rico. Under the study protocol, participating patients receive these medications at no cost, addressing both research objectives and patient access needs.
Fam-trastuzumab deruxtecan-nxki (brand name ENHERTU®) is developed and commercialized globally by Daiichi Sankyo and AstraZeneca, except in Japan where Daiichi Sankyo maintains exclusive rights. Dabrafenib (brand name Tafinlar®) and trametinib (brand name Mekinist®) are manufactured and marketed by Novartis Pharmaceuticals.