Immuno-Oncology

Announced today, Bristol-Myers Squibb’s nivolumab (Opdivo) has received FDA approval as the first immuno-oncology treatment for patients with metastatic small-cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least 1 other line of treatment.

Next week, a CMS committee will hold a day-long meeting to discuss a national coverage determination (NCD) for chimeric antigen receptor (CAR) T-cell immunotherapies, and in Thursday’s New England Journal of Medicine, Peter B. Bach, MD, MAPP, reviewed several strategies open to CMS as it continues to try to determine how to pay for CAR T.

In a study published in JAMA Oncology, researchers found that a majority of patients eligible for immune checkpoint inhibitors started to receive the treatment within a few months of the drugs approval.

This week, the top managed care stories included, CMS allowing step therapy in Medicare Advantage plans in a bid to allow for drug price negotiation; larger practices with more resources, technology and care management processes have higher readmission rates than smaller practices; studies find that empagliflozin also reduces liver fat in patients with diabetes and nonalcoholic fatty liver disease.

Researchers from the University of Texas MD Anderson Cancer Center, along with the Pediatric Acute Lung Injury and Sepsis Investigators Network (PALISI), recently published guidelines in Nature Reviews Clinical Oncology for the management of chimeric antigen receptor (CAR) T-cell therapy for children with acute lymphoblastic leukemia.

A blood-based test to assess tumor mutational burden (TMB) was recently discovered as being able to accurately identify patients with non–small cell lung cancer (NSCLC) who could benefit from checkpoint inhibitor treatment. The study, conducted by researchers at UC Davis, Genentech, and Foundation Medicine, was published in Nature Medicine.

Celyad, a biopharmaceutical company that focuses on the development of chimeric antigen receptor (CAR) T-cell therapies, recently announced that the FDA has accepted its Investigational New Drug (IND) application for CYAD-101, the first non–gene-edited allogeneic clinical program.

Bristol-Myers Squibb recently announced that the European Commission has approved nivolumab (Opdivo) for the adjuvant treatment of adult patients with melanoma that have lymph node involvement or metastatic disease and who have undergone complete resection.

A new study published in Nature Biotechnology found that by attaching a kind of cytokine “backpack” to T-cells through the use of a nanoparticle gel enhanced their efficacy in treating tumors in mice.

KEYNOTE-048, a phase 3 trial studying pembrolizumab (Keytruda) as a first-line treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) whose tumors overexpress PD-L1, has met a primary end point of overall survival.

A recent systematic review and meta-analysis published in The Lancet Oncology found that men with advanced cancers respond better than women to treatment with anti-PD-1 or anti-CTLA-4 immune checkpoint inhibitors.

Genentech announced yesterday that the FDA has granted Breakthrough Therapy Designation to atezolizumab (Tecentriq) in combination with bevacizumab (Avastin) as a first-line treatment for patients with the most common form of liver cancer, advanced or metastatic hepatocellular carcinoma (HCC).