We've rounded up the top 5 most read articles of June, including trial results from the 2018 American Society of Clinical Oncology Annual Meeting and a FDA breakthrough therapy designation for a gene therapy.
June saw big study results come out of the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting, FDA breakthrough therapy designations, disruptions in the healthcare system, and a wound care chain agreeing to pay over $20 million to Medicare.
The American Journal of Managed Care® has rounded up our top 5 most read news stories of the month:
KEYNOTE-042 Confirms First-Line Pembrolizumab Superior to Chemotherapy in PD-L1—Low Advanced NSCLC
During ASCO, a late-breaking abstract confirmed that pembrolizumab significantly improved the primary endpoint of overall survival over platinum-based chemotherapy in treatment-naïve advanced/metastatic non—small cell lung cancer (NSCLC) in the KEYNOTE-042 trial.
According to the researchers, the effect was agnostic of PD-L1 expression, meaning the monoclonal antibody was effective for tumors expression PD-L1 at >50%, >20%, and >1%. However, the secondary outcome of progression-free survival was not met at data cut-off on February 26, 2018.
FDA Grants Breakthrough Therapy Designation to Gene Therapy for Cerebral Adrenoleukodystrophy
Early in the month, the FDA granted breakthrough therapy designation to bluebird bio, Inc’s Lenti-D, the gene therapy for patients with cerebral adrenoleukodystrophy, an X-linked genetic disorder caused by a defect in the gene ABCD1. The mutation results in the abnormal breakdown of very-long-chain fatty acids and adversely affects adrenal and nervous system tissues in male children.
The breakthrough therapy designation for the gene therapy was supported by preliminary data from the ongoing phase 2 and 3 STARBEAM study. Currently, the only therapeutic option for patients with the rare disease is allogenic hematopoietic stem cell transplant, which must be done early in the course of the disease.
Phase 3 TAILORx Results Confirm Chemotherapy Unnecessary in 70% of Women With Early-Stage Breast Cancer
Coming as welcome news to some patients with breast cancer and the physicians who treat them, the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, successfully confirmed the benefit of endocrine therapy alone in patients with early-stage breast cancer who have an Oncotype DC Breast Recurrence Score (RS) of 11 to 25.
Results of the largest ever breast cancer treatment trial were presented at ASCO. The TAILORx trial was designed to help personalize treatment for women age 18 to 75 with hormone receptor-positive, HER2-negative, axillary node-negative breast cancer whose tumors were 1.1 cm to 5.0 cm in size and who had a mid-range RS.
Amazon, Berkshire Hathaway, JPMorgan Chase Announce CEO of Joint Health Company
In January, Amazon, Berkshire Hathaway, and JPMorgan Chase announced that they planned on forming a separate, independent healthcare company “free from profit-making incentives and constraints” to tackle the issue of rising healthcare costs for employees and their families.
This month, they took the next step in their joint venture by tapping Atul Gawande, MD, general and endocrine surgeon at Brigham and Women’s Hospital, and professor of surgery at Harvard T.H. Chan School of Public Health and Harvard Medical School, to become the chief executive officer, effective July 9.
The partnership also announced that the company will be headquartered in Boston. Read more about the announcement here.
Wound Care Chain Healogics Agrees to Repay Medicare $22.5 Million
On June 20, the Justice Department said that Healogics, a Florida-based wound care chain, agreed to pay up to $22.51 million to settle allegations that it violated the False Claims Act by knowingly causing wound care centers to bill Medicare for medically unnecessary and unreasonable hyperbaric oxygen therapy. Medicare covers the therapy, in which the entire body is exposed to oxygen under increased atmospheric pressure, as an adjunctive therapy to treat certain chronic wounds.
The wound care chain also entered into a 5-year Corporate Integrity Agreement with the HHS Office of the Inspector General, which includes, among other things, a claims review and a systems review—both to be conducted by an independent review organization.