ASCO's TAPUR Study Expands to Enroll Patients Receiving Immunotherapy

With an expansion that includes immunotherapy combination treatments, the American Society of Clinical Oncology (ASCO)’s Targeted Agent and Profiling Utilization Registry (TAPUR) Study has now grown to 500 participants and 16 therapies.

“This study just reached a key milestone and we're excited to explore these treatments further,” said ASCO chief medical officer Richard L. Schilsky, MD, FACP, FASCO. “While no conclusions about drug efficacy should be drawn at this point, we are very pleased with the growth and expansion of the TAPUR Study.”

The expansion now adds patients to the following study arms to TAPUR:

• Patients with ovarian cancer with KRAS, NRAS, and BRAF wildtype variants treated with cetuximab
• Patients with breast cancer with a high tumor mutation burden treated with pembrolizumab
• Patients with colorectal cancer with a BRAF V600E mutation treated with vemurafenib plus cobimetinib
• Patients with non—small cell lung cancer with CDKN2A deletion or mutation treated with palbociclib as monotherapy

The following study cohort, however, will be permanently closed:

• Patients with pancreatic cancer with CDKN2A loss or mutation treated with palbociclib as monotherapy

TAPUR, which provides patients access to drugs at no cost, is designed to evaluate FDA-approved targeted agents for indications other than those on the drug’s label, with the objective of using real-world evidence to identify alternative options for patients with advanced disease.

According to the ASCO press release, 510 participants are enrolled in the TAPUR Study, which is available at 83 clinical sites in 20 states. The study now includes a new drug combination, nivolumab plus ipilimumab, an immunotherapy treatment that boosts the immune system to target tumor cells. With this addition, there are a total of 19 drugs yielding 16 different targeted therapy options (some drugs are used in combination).

“The TAPUR trial gives us the chance to [apply] the technology and the science, and apply it to patients in real time, with everybody agreeing that they’re going to have access to the medicine, that they’re going to have payment for the treatments, and that the data are going to be available,” according to Leonard Lichtenfeld, MD, deputy chief medical officer, American Cancer Society.