December 2020 Update

JAX to Expand Clinical Trial to Maine and New Hampshire

On December 2, JAX announced that the Maine Cancer Genomics Initiative (MCGI) will participate in the American Society of Clinical Oncology's novel clinical trial, the Targeted Agent and Profiling Utilization Registry (TAPUR™) Study and will serve as a coordinating center for the precision medicine clinical trial at sites located in Maine and New Hampshire. MCGI's role as a coordinating center for the TAPUR™ Study will increase access to for patients in these two rural Northeastern states to promising treatments for specific mutations identified in their tumors. 

The national TAPUR™ Study provides patients who have exhausted standard treatment options with access to targeted study drugs matched to the genomic profiles of their cancers. The study now has enrolled more than 2,000 participants and includes patients with advanced solid tumors that are no longer responding to standard anti-cancer treatment or for whom no acceptable standard treatment is available. In addition, each participant’s cancer must also have at least one genomic alteration that can be targeted with a TAPUR™ Study drug. To determine this, a special laboratory test — called a genomic or molecular profiling test —must be performed on a sample of the tumor.

MCGI was established in 2016 in order to bring advanced testing and treatment to the state’s cancer patients. To date, MCGI has enabled genomic cancer testing for over 1,600 Maine's cancer patients and assembled an oncology alliance of practices from every major healthcare system and private practice in the state. Driven by the need for greater access to cancer genomic testing in Maine, MCGI has become a national model for community precision oncology (also known as personalized cancer care) in a rural setting. As MCGI moves into its next phase, its goal is to enroll an additional 3,200 cancer patients for genomic testing, potentially revealing information about their tumors that might make participation in the TAPUR Study a possible option for them.

By serving as a coordinating center, JAX's MCGI will make it possible for patients in northern New England with advanced cancer to access medications that may effectively target the genomic alterations in their cancer. Jens Rueter, M.D., medical director of The Jackson Laboratory said, "We expect that this will form the basis for successfully attracting additional clinical trials to the Northeast and other rural areas where this level of innovative medicine is truly needed." 

Read the full announcement here.

2020 MCGI Interns 

MCGI works directly with Colby College and the Daniel Hanley Center for Healthcare Leadership to offer undergraduate students first-hand opportunities to help advance genomic medicine through participation in projects that can transform health-related decisions. Knowledge acquired during the internships ultimately contribute to direct experience for the next generation of healthcare practitioners and better outcomes for the patients they will serve.

Our team is pleased to share the achievements of our 2020 interns and highlight how they’ve participated in the implementation, management, and advancement of various aspects of the MCGI Study. 

Ben Capodanno — Winter 2020
Double Major: Computational Biology; Mathematics/Statistics 

• Created the first prototype code for the MCGI Registry following the Agile software development framework. 
• Created data feeds from various sources for a resultant aggregate resource used as the basis for a registry research interface.
• Participated in software development efforts that enabled COVID-19 testing at the JAX clinical testing laboratory.
  
   

Sam Donahue — Winter 2020
Major: Computational Biology

• Prototyped clinical trial locations and explored options and specifics for integrating Clinical Knowledgebase (CKB) data.
• Composed scripts to determine gene identifiers and produced spreadsheets as a means to communicate progress and discuss issues. 
• Extended scripts to identify exons and associated exon information for canonical isoforms. 

Annie Schulman — Winter 2020
Major: Biology with Concentration in Neuroscience

• Compiled Continuing Medical Education (CME) application materials in support of JAX's McKusick Short Course.
• Participated in multiple facets of the MCGI CME process including applications for AMA Physician's Recognition Award (PRA) credits, event materials review, and generation of event summary reports for continuous improvement.
• Converted MCGI study patient data into an Access database format to support analyses and reporting of study outcomes.

Michelle Cao — Summer 2020 
Double Major: Chemistry/Biochemistry, East Asian Studies

• Served as the MCGI team’s interim GTB coordinator and acted as the primary process tester for a solution to automate parts of the MCGI Genomic Tumor Board (GTB) process.
• Analyzed GTB datasets with process improvement teams to evaluate digital solutions for the MCGI GTB series.
• Assisted in the re-structuring of tumor board data to facilitate analysis.

Zhaoyue 'Charis' Li — Summer 2020
Double Major: Computational Biology/Science, Technology, and Society (STS); Minor: Philosophy

• Delivered enhancements to the MCGI Registry to improve usability using multiple software processes and tools.
• Collaborated with MCGI stakeholders to understand information needs, provide feedback and design data display processes accordingly, with continuous improvement and flexibility in mind.
• Participated in adjustments to high-throughput COVID-19 data pipelines, independently trouble-shooting to make enhancements and fix bugs.

Oliver Steeves — Summer 2020
Major: Economics; Minor: Mathematics 

• Assisted in pilot data analysis of patient insurance claims to lay the groundwork for an economic utility study of genomic tumor testing.
• Researched publicly available tools to define costs of various oncology treatments and conducted analyses leveraging his coursework and experience in economics.
• Advanced skills in a variety of software programs including Microsoft Excel and Access through online tutorials and self-study.

Mei Tian — Summer 2020
Major: Computer Science

• Learned and applied two modern web frameworks to develop the prototype for the MCGI Registry's Admin app, allowing data sets and mappings to be defined for use by researchers in the MCGI Registry App.
• Collaborated with MCGI stakeholders to understand information needs, provide feedback and design data display processes accordingly, with continuous improvement and flexibility in mind.
• Participated in Github code reviews for MCGI Registry Admin app data pipelines.

Walk for Hope

Each year MaineGeneral Health celebrates a Day of Hope which unifies two of their signature events – Cancer Survivors Day and Walk for Hope. This year, the community came together to create a virtual celebration to promote hope and community while maintaining efforts to remain socially distant.

In addition to supporters who walked throughout the greater MaineGeneral Health community, providers and staff members at the Harold Alfond Center for Cancer Care (HACCC) spent 40 hours walking the HACCC Healing Gardens in support of their patients. In tribute, a baton filled with the first names of each person cared for since the HACCC opened its doors in 2007 was continuously carried by the staff during all the hours walked.

Members of the MCGI team participated in this event during the week and had the honor of passing the baton over to the HACCC providers as they walked the final round in completion of this year's Day of Hope.

Despite the challenges presented by the pandemic, nothing could stop the community from a celebration honoring and supporting our cancer survivors and fighters. 

New MCGI Educational Resources Available

PARP Inhibitors: Overview & Indications
For which patients are PARP inhibitors (PARPi) approved? What type of testing is required to determine if a patient meets criteria? This new web resources summarizes FDA-approved indications for PARPi for treatment and maintenance therapy and discusses emerging indications for use. 
Want a more general overview of PARPi? See the resource FAQ: PARP Inhibition Therapy.  
 
PD-L1 Testing: Ordering & Interpreting
Which patients should have PD-L1 testing? When is a positive PD-L1 result required to prescribe immunotherapy? This new web resource summarizes current guidelines for use and interpretation of PD-L1 testing. 
Want to understand how PD-L1 testing fits in with other immunotherapy biomarkers to inform treatment? See the overview Evaluating Immune Checkpoint Inhibition Biomarkers.
 
Blog: Financial Considerations of Genomic Tumor Testing
There are many reasons why the discussion of costs related to genomic tumor testing can be difficult. Tests vary in scope and cost, and prices are often not transparent. Multiple stakeholders, including insurance companies, utilization management services, and providers themselves, are involved in obtaining insurance coverage for a patient. In September, JAX wrote a blog about these issues to help demystify the process and discuss resources available for oncology providers and patients.

MCGI in the News 

MCGI was featured in the following stories throughout the quarter: 

The Harold Alfond™ Foundation pledged $500 million to boost Maine's economy through science and technology education to eight institutions, including JAX's MCGI. This news was shared by Precision Oncology News, WAGM-TV, WABI-5, Mainebiz, Mount Desert Islander, Portland Press Herald and others.

JAX medical director, Jens Rueter, M.D., was featured on Maine Public's call-in radio show, Maine Calling, as one of seven institutions represented. The guests represented higher education and research institutions in Maine which received grants awarded from The Harold Alfond™ Foundation.

Precision Oncology News wrote about the announcement that JAX's MCGI will be bringing the ASCO TAPUR Study to Maine and New Hampshire.