Phase 1 trial of CUDC-101 combined drug with chemotherapy and radiation for head and neck cancer

Nine of 12 patients with head and neck cancer who were enrolled in a phase 1 clinical trial of CUDC-101 were free of progression at 1.5 years of median follow-up, according to a report in Clinical Cancer Research (2015; doi:10.1158/1078-0432.CCR-14-2820).

Head and neck cancer is among the few solid tumors whose incidence is increasing in the United States. Outcomes have been slow to improve.

CUDC-101, currently being developed by Curis Inc works by inhibiting two growth factors and an enzyme that effects DNA expression: EGFR, HER2, and HDAC. All of these are overexpressed in many cancers, including the target of this trial: the common type of especially aggressive head and neck cancer, which is caused by tobacco or alcohol, rather than by the human papillomavirus (HPV).

"We pretty much threw the kitchen sink at it," said Antonio Jimeno, MD, PhD, the clinical trial's senior author and director of the University of Colorado School of Medicine's Head and Neck Cancer Clinical Research Program in Aurora.

In the phase 1 trial CUDC-101 was combined with the standard of care for treatment of head and neck cancer, which includes cisplatin and radiation.

"Substantial technological advances in how we deliver radiation and chemotherapy are now enabling the addition of targeted agents to improve the cure rates and functional results in our patients," Jimeno said.

Specifically, the study was performed in 12 patients with medium- to high-risk head and neck cancer. At 18 months median follow-up, one patient's cancer had worsened, two had died, and nine remained free of disease. Blood and tumor samples showed that CUDC-101 had indeed inhibited the action of EGFR, HDAC, and HER2.

"By analyzing the molecular correlates obtained from our very motivated and generous patients we saw that the drug was doing what it was supposed to be doing,” said Jimeno. “The fact that this complex trial was feasible and didn't significantly add to the toxicity of chemotherapy and radiation that was given along with the study drug makes everybody more excited about pursuing further trials."

"This is one of the most complex studies undertaken by the Head and Neck Cancer program at the CU Cancer Center to date. We are proud to have led patient enrollment to complete the trial, which defined the proper dosing for this new drug. As much as the results, the trial mechanics themselves contributed to our ability to publish these findings in the leading journal for this kind of research with a trial of only 12 patients," Jimeno pointed out.

"Multidisciplinary care and access to clinical trials such as this one are probably among the factors that contribute to higher cure rates in dedicated, specialized Head and Neck Cancer Programs such as ours," Jimeno said.

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