Noted Free

The FDA approved the anti-CCR4 monoclonal antibody mogamulizumab-kpkc (Poteligeo; Kyowa Hakko Kirin) for the treatment of relapsed/refractory mycosis fungoides and Sézary syndrome, two rare forms of non-Hodgkin lymphoma.

Certain germline mutations may increase the risk of triple-negative breast cancer (J Natl Cancer Inst 2018; 110:855–62). An analysis of genomic data from 10,901 women with the disease revealed that BARD1, BRCA1, BRCA2, PALB2, and RAD51D mutations were associated with high risk of triple-negative breast cancer in Caucasian women.

Regeneron Pharmaceuticals and bluebird bio teamed up to develop CAR T-cell therapies, with Regeneron investing $100 million in bluebird. The companies have chosen six initial drug candidates; per the 5-year deal, they will split research costs until a drug reaches clinical trials, at which point Regeneron can opt in 50/50 to continue developing it.

The FDA announced a pilot program to help drug developers use and gain regulatory input on complex innovative trial designs (CID) in their clinical development programs. CIDs include the use of seamless trial designs, modeling and simulations to assess trial operating characteristics, biomarker-enriched populations, Bayesian models, and other novel designs. The agency plans to share CID approaches considered through the pilot program with the broader scientific community.

Human papillomavirus (HPV) vaccination rates among adolescents ages 13 to 17 increased by 5% between 2016 and 2017 (MMWR Morb Mortal Wkly Rep 2018;67:909–17). However, the number of new cases of HPV-associated cancer climbed from 30,115 in 1999 to 43,471 in 2015 (MMWR Morb Mortal Wkly Rep 2018;67: 918–24).

Bristol-Myers Squibb's nivolumab (Opdivo) plus ipilimumab (Yervoy) may be an effective therapy for patients with metastatic melanoma who have untreated brain metastases (N Engl J Med 2018;379:722–30). In a phase II trial of 94 patients with the disease, 26% had a complete response and 30% had a partial response at a median follow-up of 14 months.

For more news on cancer research, visit Cancer Discovery online at http://cancerdiscovery.aacrjournals.org/CDNews.