1. DiGiulio, Sarah

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For patients with cancer who are treated in community oncology settings, access to genomic profiling and the more personalized treatment it may allow is often limited. A partnership and new research effort aims to change that.

Axel Grothey, MD. Ax... - Click to enlarge in new windowAxel Grothey, MD. Axel Grothey, MD

The drug company Genentech and the community oncology center network OneOncology have teamed up and developed a basket trial, MyTACTIC, that will evaluate their effort to bring genomic profiling to cancer patients across the country within OneOncology's several community cancer center settings.


Axel Grothey, MD, Director of GI Research at West Cancer Center, is Medical Director of the OneOncology Research Network (OneR) and principal investigator of MyTACTIC. In an interview with Oncology Times, he shared his thoughts on the new research.


1 What is the MyTACTIC trial and how is it different from previous research that has looked at genomic profiling for patients with cancer?

"MyTACTIC is a multicenter, non-randomized, open-label Phase II basket trial study [that will be] conducted in the United States with the goal to link targeted agents to actionable biomarkers and genomic alterations in cancer patients. Ten subgroups, each characterized by specific biomarkers, have been identified for targeted intervention with either single agents or combination approaches with chemotherapy and immunotherapy. About 20-30 patients will be included per pre-defined molecular 'basket.' The threshold for therapeutic activity, mainly defined as response rate, varies from subgroup to subgroup.


"One of the key features of MyTACTIC is that it is almost exclusively conducted in a community setting, which has the opportunity to bring innovative cancer treatment approaches to a diverse patient population. The operational study center is able to provide assistance and guidance to participating community sites if required to successfully implement and conduct this scientifically ambitious study design.


"Patients treated at community sites have traditionally had less access to personalized, biomarker-driven trials, and MyTACTIC is trying to change this by bringing this innovative cancer trial to the patients. The novel idea is to bring personalized cancer therapy based on comprehensive molecular profiling to the diverse patient population of community oncology in the United States. In this aspect, it is unique and truly a trailblazing effort."


2 More specifically, how will it work? How will patients join the trial? Who is eligible?

"Cancer patients who have undergone comprehensive molecular profiling with identification of the specific genomic alterations or biomarker expression, which meet the study inclusion criteria, will be identified by each study site. A centralized, trial-based, molecular tumor board is being established to help in the identification of patients and to make recommendations for prioritization of molecular treatment baskets if a patient's cancer is found to have more than one qualifying alteration. Patients who in the assessment of their treating oncologist will be best served by being included in MyTACTIC will be centrally registered for potential study participation.


"Participating centers will have access to comprehensive genomic profiling tools within MyTACTIC tapping into existing, commercially available Clinical Laboratory Improvements Amendments (CLIA)-certified tests.


"The main innovation and value for patients and sites MyTACTIC provides is the access to targeted treatment options which would not be available outside of the study. In addition, the centralized molecular tumor board will be instrumental in providing guidance for patient care within and outside of MyTACTIC. This will conceivably enhance the value of genomic profiling in the community setting and lead to a more rapid adoption of this transformative technology.


"The study has been activated in the first sites. The accrual phase will be approximately 2-3 years with additional 1-year follow-up for patients enrolled in the study. Genomic profiling is available to all sites at the onset of the study. The estimated primary completion date is late 2024. Results will be evaluated on an ongoing basis depending on recruitment into each treatment arm."


3 What's the bottom line practicing oncologists and cancer care providers should know about this work?

"MyTACTIC is a collaborative effort between Genentech, Foundation Medicine [a company developing genomic profiling tools], and community oncology centers to allow cancer patients in a community setting to have access to innovative treatment options and benefit from the advances in genomic profiling in oncology. It has the chance to transform cancer care and cancer research by bringing cutting-edge diagnostic tools and targeted treatment approaches to cancer patients across the country."