Healio
Healio
November 17, 2017
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ASCO expands enrollment for TAPUR study

Richard Schilsky
Richard L. Schilsky

ASCO announced four cohorts of Targeted Agent and Profiling Utilization Registry, or TAPUR, will enroll additional patients with a variety of cancers.

The combination of nivolumab (Opidvo, Bristol-Myers Squibb) plus ipilimumab (Yervoy, Bristol-Myers Squibb) also is being added to the study, bringing the number of drugs evaluated to 19, with 16 different targeted therapy options.

“This study just reached a key milestone and we're excited to explore these treatments further,” ASCO chief medical officer Richard L. Schilsky, MD, FACP, FASCO, said in a press release. “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.”

As HemOnc Today previously reported, TAPUR is designed to identify signals of activity from commercially available anticancer agents among patients with advanced cancer and targetable genomic variants. In stage I, up to 10 patients are enrolled in cohorts based on tumor type, genomic variant and study drug. If two or more patients have objective response or stable disease at 16 weeks, the cohort is expanded to stage II and an additional 18 patients can be enrolled.

The study’s data safety and monitoring board recommended expanding to stage II and enrolling additional patients into four cohorts of patients with:

  • ovarian cancer and KRAS, NRAS and BRAF wild-type variants treated with cetuximab (Erbitux, Eli Lilly);
  • breast cancer with a high tumor mutation burden treated with pembrolizumab (Keytruda, Merck);
  • colorectal cancer with a BRAF V600E mutation treated with vemurafenib (Zelboraf, Genentech) plus cobimetinib (Cotellic, Genentech); and
  • non-small cell lung cancer with CDKN2A loss or mutation treated with palbociclib (Ibrance, Pfizer) monotherapy.

Although expansion of these cohorts indicates researchers have observed drug activity, this does not yet mean the data meet the definition of a positive trial. A positive trial at stage II requires objective response or at least 16 weeks of stable disease in at least seven patients.

The data safety and monitoring board recommended closing the cohort of patients with pancreatic cancer and CDKN2A loss or mutation treated with palbociclib monotherapy.

Five hundred ten patients are currently enrolled on TAPUR, which is available at 83 sites in 20 states.