Early Phase Clinical Research Center Is Poised to Provide New Benefits in Hawaii and Beyond

Although it has already distinguished itself as a National Cancer Institute (NCI)–designated center (a status it has held since 1996), the University of Hawaii Cancer Center in Honolulu hopes to further expand its impact and address unmet treatment needs for patients with cancer in Hawaii and other Pacific islands, as well as those of Hawaiian descent living on the US mainland, by providing access to phase 1 clinical trials with its planned Early Phase Clinical Research Center.1

“We are able to conduct certain types of clinical trials, but these are dominantly NCI Community Oncology Research Program studies because we have health disparity issues and health care access issues,” Naoto T. Ueno, MD, PhD, FACP, the center’s director and interim coleader of the cancer biology program, translational and clinical research, said in an interview with OncologyLive.

The plans for the Early Phase Clinical Research Center were announced in September 2019 after the University of Hawaii Cancer Center received a $6.5 million grant from the National Institutes of Health to “build a clinical research center that will significantly improve access to experimental treatments for patients [with cancer] in Hawaii.” This grant matched the $6.5 million approved by the Hawaii legislature for the project, bringing its total funding to $13 million.2

The main goal of the Early Phase Clinical Research Center is to provide access to cutting-edge therapeutics to Hawaiians without the need to travel to the continental United States, Ueno explained. This travel often has led to hardship for patients and their families in terms of finances, separation from loved ones, and disconnects in care, he added.

Recent research findings underscore the improved efficacy and safety of modern agents being evaluated in phase 1 clinical trials. In a retrospective study published in Hawaiian/Pacific Islander and American Indian/ Native Alaskan patients was extremely low.”5 The increased representation of Native Hawaiian and Pacific The Lancet, study authors analyzed patientlevel data from NCI-sponsored, investigatorinitiated phase 1 trials from January 2000 to May 2019 of patients with solid tumors.3

Results from the study showed that among response-evaluable patients (n = 9325), the overall response rate (ORR) for all trials during the study period was 12.2% (95% CI, 11.5%-12.8%), with a 2.7% (95% CI, 2.4%-3.0%) complete response (CR) rate. Notably, the ORR increased from 9.6% from 2000 to 2005 (95% CI, 8.7%10.6%) to 18.0% from 2013 to 2019 (95% CI, 15.7%-20.5%; P < .0001); the CR rates increased from 2.5% (95% CI, 2.0%-3.0%) to 4.3% (95% CI, 3.2%-5.7%), respectively. Additionally, the improvement in efficacy came without a significant negative impact on tolerability; the risk of treatment-related death was found to not change over time from 2000 to 2019 (P = .52).3 Naoto T. Ueno , MD, PhD, FACP Islander patients in phase 1 clinical trials that the Early Phase Clinical Research Center aims to achieve is crucial for not only giving care to the patients who need it in the immediate term but also for drug development, Ueno said. According to Ueno, the goal is to have the center operational by mid-2025. Construction is expected to be completed by the end of 2024, he said. “The ultimate goal is for our patients to stay [in Hawaii] and have a similar opportunity for quality care compared with the mainland.” n REFERENCES 1. 2.

As the only NCI-designated center within 2500 miles, the University of Hawaii Cancer Center serves a very large catchment area relative to other cancer centers, covering approximately 7 million square miles and approximately 2 million individuals. Outside of Hawaii, the center serves individuals in other areas of the Pacific, including American Samoa, Guam, Palau, and the Northern Mariana Islands.1,4

Research has indicated that Native Hawaiian and Pacific Islander patients are severely underrepresented in earlyphase clinical trials examining anticancer therapeutics. Findings from a 2021 review published in Future Oncology, demonstrated that across all regions globally, Native Hawaiian and Pacific Islander participants represented just 0.1% of the total number of participants (n = 9972). Similarly, among patients (n = 3197) in US-only trials, Native Hawaiian and Pacific Islander patients again comprised just 0.1% of the population. Study authors noted that “participation of Native Hawaiian/Pacific Islander and American Indian/ Native Alaskan patients was extremely low.”5

The increased representation of Native Hawaiian and Pacific Islander patients in phase 1 clinical trials that the Early Phase Clinical Research Center aims to achieve is crucial for not only giving care to the patients who need it in the immediate term but also for drug development, Ueno said. According to Ueno, the goal is to have the center operational by mid-2025. Construction is expected to be completed by the end of 2024, he said. “The ultimate goal is for our patients to stay [in Hawaii] and have a similar opportunity for quality care compared with the mainland.”

References

1. University of Hawai’i Cancer Center. National Cancer Institute. Updated June 27, 2023. Accessed January 3, 2024. https:// www.cancer.gov/research/infrastructure/ cancer-centers/find/uhawaiicc

2. UH Cancer Center receives $6.5M for state’s f irst cutting edge research clinic. News release. University of Hawai’i. September 26, 2019. Accessed January 3, 2024. https:// www.hawaii.edu/news/2019/09/26/ cancer-center-cutting-edge-research-clinic/

3. Chihara D, Lin R, Flowers CR, et al. Early drug development in solid tumours: analysis of National Cancer Institute-sponsored phase 1 trials. Lancet. 2022;400(10351):512-521. doi:10.1016/S0140-6736(22)01390-3

4. Catchment area. University of Hawaii Cancer Center. Accessed January 3, 2024. https:// www.uhcancercenter.org/128-education-andoutreach-info/671-catchment-area

5. Camidge DR, Park H, Smoyer KE, et al. Race and ethnicity representation in clinical trials: f indings from a literature review of phase I oncology trials. Future Oncol. 2021;17(24):32713280. doi:10.2217/fon-2020-1262