Ochsner's Precision Cancer Therapies Program Brings Early Phase Trials to the Community Setting

Early phase clinical trials allow patients with cancer to receive innovative therapies years before they are readily available, according to Marc Matrana, MD. However, most patients in the community setting do not have access to these trials.

“The number of experimental therapeutic programs around the country is limited,” said Matrana during the Association of Community Cancer Centers’ 35th National Oncology Conference, October 17-19 in Phoenix, AZ. “It is time consuming, it is expensive, it doesn’t build a profit—but we knew that we needed to [fulfill] an unmet need for our region.”

Matrana, who serves as medical director of the Ochsner Health System’s Precision Cancer Therapies Program in Jefferson, Louisiana, discussed the development of the program to provide early phase clinical trials in the community setting across the state.

Historically, phase I trials targeted patients across all cancer types and overall response rates ranged between 5% to 7%, with complete responses observed in 1% of patients. With current trends in precision medicine, however, patients can now be matched to the most appropriate therapy based on their underlying biology.

“By pairing drugs with genetic mutations that drive cancer, we can achieve response rates that approach 100% for some cancers,” Matrana said. Ochsner Health System has partnered with the Translational Genomics Research Institute (TGen), an Arizona-based, nonprofit medical research institute, who introduced the program to drug developers interested in entering early phase clinical trials. The close partnership allows Ochsner Health System to learn from TGen and continue to build and grow their program.

“We wanted TGen to teach us how to run the program, how to build relationships with the drug developers—and eventually we would do this on our own. The relationship is still evolving,” said Matrana, adding “at this point, we are much more independent, although we do rely on them for critical key aspects.”

As of September 26, 2018, the program has accrued 78 patients with 50 early phase trials currently open. These data exceeded all of the program’s annual goals, including patient enrollment, number of trials opened in 2018, and total number of open trials (FIGURE).

Additionally, hundreds of patients have been referred by their physicians across Louisiana and around the country, according to Matrana.

Ochsner Precision Cancer Therapies Program offers free next-generation sequencing (NGS) to all of its patients through the Strata trial, sponsored by the precision medicine company Strata Oncology (NCT03061305). This allows the program to provide more personalized therapy options and stratification to early phase clinical trials. The primary goal of the Strata trial is to understand the proportion of subjects available for clinical trials and approved targeted therapies in advanced cancer while assessing the feasibility of using a large-scale NGS screening program to match subjects for eligibility assessments in clinical trials and/or for approved targeted therapies. The Strata trial does not require additional procedures but rather uses surplus, or leftover tumor specimens for molecular profiling.

“It is extremely important for [NGS] to be done upfront, so that when a patient comes to us we know exactly where they fit in the clinical trial,” he said.

Although the program has succeeded expectations, Matrana admitted that the implementa- tion of an early phase clinical trials program is challenging. It requires a dedicated, multidisciplinary team in addition to space for both a phase I lab and a research pharmacy.

“Organization and constant communication is key,” he added. “Weekly rounds, regular pipeline meetings, steering committee meetings, and other regularly scheduled meetings with clear goals and agendas have been key to group cohesion and smooth program operations.”

Another component is the cost-benefit derived from philanthropic efforts, which played a major role in the establishment and the continuation of the program. “Philanthropy was a big piece of the puzzle, because these programs don’t generate a big profit. We are lucky to break even, but it is the downstream revenue that allows this to work.”

Moving forward, the program plans to continue building new partnerships with scientists and drug developers to open more early phase clinical trials, expand their multidisciplinary team, identify additional philanthropic opportunities, and accelerate the development of more personalized therapies.

Reference:

Matrana, M. Partnering to Deliver Precision Cancer Therapy in the Commu- nity. Presented at: Association of Community Cancer Centers 35th National Oncology Conference; October 17-19, 2018; Phoenix, AZ.