Reshaping the Oncology Landscape Through Biomarkers and Collaboration

Oncology is shifting from broad treatment protocols to a high-precision world of biomarkers and minimal residual disease (MRD) monitoring, making next-generation sequencing (NGS) and advanced diagnostics essential for treatment decision-making. This is true for both early-stage and metastatic disease, speakers explained during an Institute for Value-Based Medicine^® event in Atlanta, Georgia, hosted by The American Journal of Managed Care in February.

As these “invisible” markers become the standard for personalized care, they expose significant operational complexities regarding payer coverage, standardized testing protocols, and the logistical burden placed on both patients and providers. To truly realize the potential of these scientific advancements, the oncology community must bridge the widening gap between high-resource academic centers and underserved community settings where most patients receive care.

The Evolving Landscape of Precision Medicine and Biomarker Testing in Lung Cancer

In Atlanta, experts gathered to discuss the clinical and logistical complexities of integrating biomarker testing into lung cancer care. Conor Steuer, MD, an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, moderated the panel discussion, which highlighted how the shift toward precision medicine is reshaping treatment pathways from early-stage disease to the metastatic setting.

The panel began by addressing the transition of biomarker testing into early-stage non–small cell lung cancer. Kelsey Pan, MD, an assistant professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, noted that recent approvals of adjuvant therapies for EGFR- and ALK-mutated cancers have led to NGS being utilized at the point of diagnosis for nearly all patients. Ioana Bonta, MD, a board-certified physician for Georgia Cancer Specialists, noted that these changes are exciting, even if it makes the job a little harder for community oncologists who must keep pace with diverse testing requirements across multiple cancer types.

“Nobody can really remember all those [tests] and for different stages and for different cancer types,” Bonta said. “We really have to have a way to do it systematically and consistently, like a pathway.”

Katie O’Reilly, PharmD, BCOP, an oncology clinical pharmacy specialist at Emory Healthcare, emphasized that broader testing earlier on is vital to inform whether immunotherapy should even be considered, as certain mutations such as RET and ROS1 are associated with increased toxicity.

Pan added that turnaround time and tissue adequacy can be major hurdles to NGS tests, especially with many patients being diagnosed when they’re hospitalized and already very ill. She explained that results can take about 14 days, during which they have to hold systemic therapy to avoid starting something that could later conflict with the targeted therapy of choice.

Waiting for genomic results can be psychologically difficult for patients who are newly diagnosed and eager to start treatment, the panelists noted. Pan did say that many patients are understanding, especially when she frames the situation for them: The cancer has been growing for more than a year usually, and an extra week or 2 weeks is unlikely to change the overall prognosis, especially if that delay means choosing the best targeted therapy.

The panelists expressed excitement around the latest data for targeted therapies. Pan and O’Reilly noted their interest in HER2 developments, with the newly approved oral zongertinib (Hernexeos; Boehringer Ingelheim),¹ as well as the emergence of subcutaneous formulations. Oral drugs for HER2 improve patient quality of life by removing the need for infusions, which Pan called “annoying.” O’Reilly highlighted the subcutaneous version of amivantamab (Rybrevant Faspro; Johnson & Johnson), which was approved at the end of 2025, as a major development due to its decreased adverse effect profile.

However, O’Reilly pointed to challenges with reimbursement, because when cancer centers try to use therapies as soon as they are approved, payers aren’t always as up to date as the clinicians are. There are also barriers when using drugs off-label, although she said she can usually get it covered after writing appeal letters.

Operationalizing MRD: From Research Tool to Decision-Making End Point

As MRD transitions from a prognostic research tool to a decision-making end point, it has the potential to significantly impact total cost of care when managing hematologic malignancies, according to a discussion moderated by Ryan Haumschild, PharmD, MS, MBA, vice president of pharmacy at Emory Healthcare and Winship Cancer Institute.

“One of the things we talk about a lot [in hematology] is operationalizing MRD. I don’t think there’s any time [when] you talk hematology, that someone won’t bring up MRD in terms of what was the end point, how is that actionable, and what is the FDA saying about it,” Haumschild said.

In 2018, the FDA approved the first MRD test for acute lymphoblastic leukemia and multiple myeloma,³ but clinical consensus on its practical application is still being refined, explained Ajay K. Nooka, MD, MPH, FACP, a professor in the Department of Hematology and Medical Oncology at the Winship Cancer Institute of Emory University School of Medicine. Achieving MRD negativity is strongly prognostic of progression-free survival (PFS), but in multiple myeloma, the ultimate goal is utilizing MRD to guide treatment de-escalation.

In the lymphoma setting, MRD—specifically circulating tumor DNA—is increasingly used to resolve diagnostic ambiguity, said Jean Koff, MD, MS, a clinical investigator in the Bone Marrow and Stem Cell Transplant Center at the Emory University School of Medicine. For diffuse large B-cell lymphoma, MRD can clarify “indeterminate” PET scans, preventing unnecessary biopsies or premature switches in therapy. In mantle cell lymphoma, MRD negativity following induction can sometimes justify forgoing an autologous stem cell transplant, a high-cost procedure with significant morbidity, explained Sabarish Ram Ayyappan, MD, medical director of cellular therapies at City of Hope Cancer Center Atlanta.

Nooka presented a compelling pharmacoeconomic argument for payers to justify the use of routine MRD testing. His organization established a workflow with Adaptive Biotechnologies, the maker of the clonoSEQ test, so that now the cost of testing is negligible compared with the cost of continued maintenance therapy. Koff and Ayyappan noted similar agreements with the company resulting in cost savings.

“The test costs $1800 to $2000.... Still, it would be less than half the month’s cost of [lenalidomide] maintenance,” Nooka said. “So there’s a significant number of patients [who] can come off [maintenance therapy] if we can monitor these [tests] on a yearly basis.”

However, obtaining reimbursement remains a friction point. Although Medicare coverage is relatively stable for NGS testing such as clonoSEQ, commercial payers often require clinicians to cite specific National Comprehensive Cancer Network guidelines, Ayyappan said.

For MRD to be successfully operationalized in community settings, clinical guidelines must become more prescriptive, the panelists said. Koff expressed frustration with the current ambiguity in chronic lymphocytic leukemia (CLL) guidelines, which often reference specific clinical trials rather than offering actionable practice standards.

“The CLL guidelines…literally say you should test MRD based on the trial that you’re using the regimen for,” she said. “That is helpful for nobody…. I think, across the board, for lymphomas it should be made much more clear exactly when you [should] test, in what clinical context, and then exactly what you need to do based on the results.”

In 2024, the FDA’s Oncologic Drugs Advisory Committee voted to allow the use of MRD as an end point for accelerated approval of new treatments in multiple myeloma,⁴ which represented an important change. Historically, survival was the end point in trials, but as regimens improved and it took longer to get data on survival end points, PFS became the new end point. Now, this end point is also taking long with the expected median PFS on current 4-drug regimens followed by transplant and maintenance reaching 17 years, which delays the approval of drugs in a timely manner, Nooka said. Given that delay, MRD has become the new surrogate end point.

“Now, instead of doing an accelerated approval, no study should be approved based on a single-arm study,” he said. “They’re using the randomized trial with an MRD as an end point. In the same study, the PFS as an end point is already incorporated, so the drug could be approved early based on MRD, but the study still has to show PFS as an end point at some point to gain a full approval. That is where we’re heading, and probably…most of the studies in the future will be using the similar methodology.”

Expanding Access to Specialized Services and Clinical Trials

Haumschild also moderated the third panel of the night, which discussed the operationalization of academic standards within community oncology settings. The panelists focused on overcoming resource limitations through innovative partnerships, clinical trial expansion, and the optimization of in-house services to improve patient outcomes.

The high-specialization environment of academic centers often contrasts with the “many hats” worn by providers in community settings. Justin Austin, PharmD, director of pharmacy at Atlanta Cancer Care, noted that although academics benefit from deep subspecialization, community practices must be “more nimble” to navigate fewer resources. To bridge the gap in services like genetic counseling, Grady Memorial Hospital utilizes innovative workflows, such as utilizing navigators or nurse practitioners for initial testing and leveraging telehealth counselors provided by testing companies, explained Jade E. Jones, MD, a breast cancer specialist practicing at both Grady and Emory.

Andres Chang, MD, PhD, an assistant professor at Winship Cancer Institute, added that the size of the specialized centers leads to a trade-off. Although these centers have additional expertise, there are also additional layers to navigate, creating barriers to care for patients.

“Emory Winship, for example—the main site is not the most accessible place, being stuck in a suburb,” he said. “So there are different…advantages that communities and academic centers have.”

Community sites play an important role in clinical trials in order to capture diverse patient populations. Nisha Joseph, MD, an associate professor in the Department of Hematology and Medical Oncology at Emory University School of Medicine, highlighted how the Georgia Blood Cancer Trials Network, an initiative funded by Blood Cancer United,⁵ identifies trials appropriate for community sites and focuses on standard-of-care drugs rather than complex early-phase pharmacokinetic draws.

This collaborative model ensures that patients who live 4 hours from Atlanta can still access cutting-edge therapy without everything being centralized to the academic center, Chang said.

Strategies for Advancing Equity in Cancer Care

The fact that logistical and systemic barriers prevent underserved populations from receiving optimal cancer care is not news, but operationalizing changes to move from theory to actually address those issues can be a challenge, explained the final panel of the night.

Theresa Gillespie, PhD, an associate director for community outreach at Winship Cancer Institute, moderated the panel with the following participants:

• Oluwadunni Emiloju, MD, a gastrointestinal medical oncologist at Winship Cancer Institute
• Ruth Sacks, MD, an assistant professor at Emory University, specializing in breast, head, neck, and lung cancer
• Haumschild, filling in for his third panel of the night

Emiloju noted that there is a need to shift cancer screening from oncologists back to primary care to prevent patients from arriving at the oncologist’s office with advanced diagnoses. However, having screening available does not equate to getting screened.

“There might be a component of anxiety or fear,” she said. “Fear of having a cancer diagnosis…. That fear actually is a barrier to getting screening done, but one thing that we as a community need to do better at is actually promoting the fact that part of a healthy lifestyle is getting screened at the appropriate time.”

Sacks highlighted the importance of triggers in the electronic medical record as a reminder for screenings, and Haumschild pointed to mobile screening and a new prostate screening modality that was developed to reach the populations most at risk but the hardest to reach.

The panelists also addressed “time toxicity” and logistical barriers, such as transportation and childcare, that disproportionately affect rural and low-income patients. The shift toward more pragmatic trial designs and “hub-and-spoke” affiliation models is essential for improving data diversity. Echoing the conversation from the previous panel, Sacks noted that “clinical trials are very time consuming…. Even if you have somebody [who is] interested, they just may not have the means. So trying to create a way where it can be closer to home” is important.

However, changes on the federal level and cuts to these systems are also affecting these populations now. Sacks noted that what’s already happening in real time is that people are coming in with later-stage diagnoses of cancer.

“I think we’re going to see that there’s a shift in terms of the gains that we have,” she said, encouraging physicians and patient advocates to get involved to push the agenda.

References

1. McCormick B. FDA grants accelerated approval to zongertinib for HER2-mutant NSCLC. AJMC. February 26, 2026. Accessed March 12, 2026. https://www.ajmc.com/view/fda-grants-accelerated-approval-to-zongertinib-for-her2-mutant-nsclc

2. McCormick B. FDA approval of subcutaneous amivantamab offers faster, safer option for EGFR-mutated NSCLC. AJMC. December 18, 2025. Accessed March 12, 2026. https://www.ajmc.com/view/fda-approval-of-subcutaneous-amivantamab-offers-faster-safer-option-for-egfr-mutated-nsclc

3. FDA authorizes first next generation sequencing-based test to detect very low levels of remaining cancer cells in patients with acute lymphoblastic leukemia or multiple myeloma. FDA. News release. September 28, 2018. Accessed March 12, 2026. https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-next-generation-sequencing-based-test-detect-very-low-levels-remaining-cancer

4. Seymour C. FDA’s ODAC recognizes MRD as an accepted end point for accelerated approval in multiple myeloma. OncLive. April 12, 2024. Accessed March 12, 2026. https://www.onclive.com/view/fda-s-odac-recognizes-mrd-as-an-accepted-end-point-for-accelerated-approval-in-multiple-myeloma

5. Georgia Blood Cancer Trials Network. Winship Cancer Institute. Accessed March 12, 2026. https://winshipcancer.emory.edu/clinical-trials/georgia-blood-cancer-trials-network.php