ASCO

The FDA has announced the launch of an oncology-specific pilot program for physicians and patients who need access to investigational therapies.
Results from a new clinical trial suggest that limited access to care is the main contributing factor to the disparities in outcomes that exist between African American patients and white patients with cancer.
Formed 10 years ago with the Affordable Care Act, the Centers for Medicare & Medicaid Services (CMS) Center for Medicare & Medicaid Innovation (CMMI) has been tasked with developing new payment and delivery models designed to improve the efficiency of specialty care.
Dr Sanjiv Agarwala predicts that the cancer biomarkers of the future may be “mobile biomarkers,” meaning measures of the tumor microenvironment or immune response that change with therapy and may be able to determine treatment efficacy.
Dr Sanjiv Agarwala discusses the usefulness of MSI and TMB as novel biomarkers for various cancer types. His argument is that the first FDA approval of a therapy based on MSI rather than tumor type makes this biomarker useful, but TMB is not yet ready for “prime time.”
Dr Sanjiv Agarwala describes best practices developed at St. Luke’s Cancer Center, where a committee has been formed in which clinicians and pathologists meet to reach consensus on reflex testing of molecular biomarkers, as well as the value of biomarker testing in enhancing patient care.
Dr Sanjiv Agarwala argues that much of the biomarker data in melanoma presented at ASCO 2018 are around the value of PD-L1 testing; however, even PD-L1–negative melanoma patients seem to respond to anti–PD-1 therapy, although some studies suggest PD-L1–negative patients may be better candidates for combination immunotherapy.
Dr Sanjiv Agarwala reviews real-world data presented at ASCO 2018 on immunotherapy of melanoma that serve to reassure providers regarding current treatment approaches, but do not offer any significant practice-changing results.
Dr David Spigel discusses challenges and solutions to incorporating cancer biomarkers into patient care, including finding pathology resources to do the testing, issues around reimbursement, and educating colleagues on the value and operational aspects of biomarker testing in delivering personalized therapy to patients with cancer.
Dr Sanjiv Agarwala talks about exciting new results presented at ASCO 2018 in melanoma, including the durability of anti–PD-1 therapy in providing 40% overall survival at 5 years, updates on adjuvant therapy showing superiority of anti–PD-1 over anti–CTLA-4, and new results in combining immunotherapies.
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