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

Naoto T. Ueno, MD, PhD, FACP

Although it has already distinguished itself by earning recognition as a National Cancer Institute (NCI)-designated center (a status it has held since 1996), the University of Hawaii Cancer Center hopes to further expand its impact and address unmet treatment needs for patients with cancer living in Hawaii and the surrounding areas, as well as those of Hawaiian descent living outside the islands, 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, director of the University of Hawaii Cancer Center and interim program coleader of the Cancer Biology Program, Translational and Clinical Research in Honolulu, said in an interview with OncologyLive. “There has not been much of a focus on phase 1 studies for several decades. Sometimes we do small phase 1 [studies], but not a lot.”

“The importance of a phase 1 center at the University of Hawaii Cancer Center is much greater than for any other cancer center in the United States. The cancer center relies on 5 different community centers to provide clinical trials support for patients [in] both industry- and NCI-supported trials. But all these community centers are independent of each other. How can you bring them together in a space where they will not be competitive? A Phase I center achieves this goal.

None of the community institutions have the capacity to have a true phase 1 center on their own,” David R. Gandara, MD, codirector of the Center for Experimental Therapeutics in Cancer at UC Davis Comprehensive Cancer Center in California, chief medical officer of the International Society of Liquid Biopsy, and adjunct clinical professor in the Translational and Clinical Research Program at the University of Hawaii Cancer Center, said in an interview with OncologyLive.

A First-of-its-Kind Center For Hawaii

The plans for the Early Phase Clinical Research Center were first announced in September 2019, when the University of Hawai’i 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 Hawai’i state legislature for the project, bringing its total funding to $13 million.²

The development of a program and recruitment of staff at the Early Phase Clinical Research Center will be a joint venture between the University of Hawaii Cancer Center and its partners in the Hawaii Cancer Consortium: Hawaii Pacific Health, Kuakini Medical Center, and the Queen’s Medical Center. The center is currently under construction in a shell space with a square footage of 36,000 at the University of Hawaii Cancer Center in the Kakaʻako district of Honolulu. The new facility will be named Hoʻōla, which means healing in Hawaiian.²

Phase 1 trials examine cutting-edge therapeutics and offer an option for patients with hard-totreat diseases who have not experienced efficacy with standard therapies. The main goal of the Early Phase Clinical Research Center is to provide the access to these trials and treatments that Hawaiians have been lacking without the need to travel to the continental United States as they’ve had to do in the past, Ueno explained. This necessary travel often leads to hardship for patients and their families in terms of finances, separation from loved ones, and disconnects in care, Gandara added.

“I was diagnosed with lung cancer 2 years ago, I have been treated with osimertinib [Tagrisso], and it has worked properly,” Diane Chong, a patient with lung cancer receiving treatment in Honolulu, said in an interview with OncologyLive. “However, at some point, I probably am going to have to do a clinical trial, which would mean having to travel to the mainland at an additional expense and time commitment. To have [access to] clinical trials here in Hawaii would definitely help individuals that are on this journey of cancer and knowing that we can be near friends and relatives during treatment is extremely valuable. The bottom line is that traveling to the mainland is expensive and involves staying in a place that you’re not familiar with, which puts even more stress on the situation. Being at home with family and friends is a very valuable benefit.”

Recent research findings have underscored the improved efficacy and safety of modern agents being evaluated in phase 1 clinical trials compared with those of the past. In a retrospective study published in the Lancet, study authors analyzed patient-level data from NCI-sponsored, investigator-initiated phase 1 trials of patients with solid tumors from January 2000 to May 2019.³

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%) complete response (CR) rate. Notably, the ORR increased from 9.6% (95% CI, 8.7%-10.6%) in 2000 to 2005 to 18% (95% CI, 15.7%-20.5%) in 2013 to 2019 (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

Beyond its anticipated clinical impact, the University of Hawaii Cancer Center announced that the establishment of the Early Phase Clinical Research Center will provide a significant boost on the Hawaiian economy. According to an economic analysis, the project will have an economic impact of $38.5 million over the next 10 years, with an approximate ongoing annual contribution of $6 million subsequently. Additionally, its construction will generate more than 30 short-term construction jobs and more than 65 long-term jobs once the center is operational. The facility will also house an Organoid Generation Facility, which will generate tumor models that are more representative of the population in Hawaii.^1,4

Making an Impact in Hawaii and Beyond

As the only NCI-designated center within 2500 miles, the University of Hawaii Cancer Center is unique in that it serves a very large catchment area relative to other cancer centers, covering approximately 7 million square miles and approximately 2 million individuals. Outside of the Hawaiian Islands, the center serves individuals from United States–Affiliated Pacific Islands, such as American Samoa, Guam, Palau, and the Northern Mariana Islands.^1,5

Research has indicated that Native Hawaiian and Pacific Islander patients are severely underrepresented in early-phase clinical trials examining anticancer therapeutics. In a 2021 review published in Future Oncology, investigators set out to better define race and ethnic representation in phase 1 oncology trials. To do so, they performed a rapid evidence assessment of published literature between January and December 2019 that included demographic representation of individuals recruited for phase 1 clinical trials of oncology agents.⁶

Findings from the study 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 United States–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.”⁶

The increased representation of Native Hawaiian and Pacific Islander patients in phase 1 clinical trials that the Early Phase Cancer 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.

“That’s why it’s important to create a phase 1 center in our area for [the] community [and why] the FDA considers it a very high priority area to develop a phase 1 center,” Ueno said. “Addressing diversity, equity, and inclusion is very important in drug development. Much of the development has been driven by studies of [White] patients, followed by Black and Hispanic [patients]. Native Hawaiian [and] Pacific Islander [patients] are not represented at all. We need to obtain data among this population; we are really the only area that could [do so] in a natural manner and enrich the population of Asian Americans, Native Hawaiians, and Pacific Islanders [in clinical trial data].”

According to Ueno, the goal is to have the Early Phase Clinical Research Center operational by the middle of 2025. Construction of the facilities 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,” he said. “[We also] want to address health disparity and drug interaction in our racially and ethnically diverse population, because there is a need for more personalized treatments. There are more Native Hawaiians living on the mainland than in Hawaii now; the impact could [also] be significant in the population on the mainland. It’s not only about Hawaii, but it will also help the entire population of the United States.”

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 first 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. University of Hawaiʻi Cancer Center project will diversify the Hawaiʻi economy. News release. University of Hawai’i Cancer Center. July 22, 2020. Accessed January 3, 2024. https://www.uhcancercenter.org/about-us/2020-news-articles/639-uh-cancer-center-project-will-diversify-the-hawaii-economy
5. Catchment area. University of Hawai’i Cancer Center. Accessed January 3, 2024. https://www.uhcancercenter.org/128-education-and-outreach-info/671-catchment-area
6. Camidge DR, Park H, Smoyer KE, et al. Race and ethnicity representation in clinical trials: findings from a literature review of phase I oncology trials. Future Oncol. 2021;17(24):3271-3280. doi:10.2217/fon-2020-1262