Noted This Week

November 12–18

President Joe Biden nominated Robert Califf, MD, to head the FDA, replacing the agency’s acting commissioner, Janet Woodcock, MD. If confirmed, Califf would lead the FDA for the second time: He held that role from February 2016 to January 2017 under President Barack Obama.

The FDA approved pembrolizumab (Keytruda; Merck) as an adjuvant therapy for people with renal cell carcinoma considered to be at significant risk of recurrence following nephrectomy with or without resection of metastatic lesions. The decision was based on positive interim results in the KEYNOTE-564 trial, in which patients receiving the PD-1 inhibitor pembrolizumab experienced greater improvement in disease-free survival compared with those receiving placebo.

Lung cancer survival is increasing overall, but people of color continue to have poorer outcomes, according to the American Lung Association’s the new "State of Lung Cancer" report (available at https://www.lung.org/research/state-of-lung-cancer). The 5-year overall survival (OS) rate increased to 23.7%, up from 14.5%, but large disparities remain, with people of color less likely to receive an early diagnosis or be offered surgical treatment—and more likely to receive no treatment at all—than whites.

Researchers introduced MM-PSN, a tool using five types of data generated from genomic and transcriptomic profiling, which identified 12 distinct subtypes—previously undefined—of multiple myeloma in 655 patients newly diagnosed with the disease (Sci Adv 2021;7:eabg9551). The patients at the highest risk of relapse and short OS were those with both t(4;14) and 1q gain. The work may help researchers identify potential targeted treatments.

In the single-center MEMOIR study, patients with advanced melanoma who received immune checkpoint inhibitors later in the day had poorer survival than those with earlier appointments, researchers concluded (Lancet 2021 Nov 12 [Epub ahead of print]). Examining two groups of 73 patients, they found that the group in which at least 20% of infusions were received after 4:30 pm had a lower median OS than patients who received most of their infusions by midafternoon—4.8 years versus not reached, respectively. The authors noted that their results add to growing evidence suggesting that adaptive immune responses stimulated in the evening may be less effective.

In its "11th Annual Report to Congress on High-Priority Evidence Gaps for Clinical Preventive Services," the U.S. Preventive Services Task Force (USPSTF) called for greater attention to research gaps in health equity in cancer prevention and cardiovascular disease (available at http://www.uspreventiveservicestaskforce.org). The report calls for more research into screening, such as evaluating the effectiveness of colorectal cancer screening in people younger than 50 and how to increase lung cancer screening in socially and economically disadvantaged populations.

Sanofi announced it will invest $180 million in the French precision medicine start-up Owkin, which uses artificial intelligence to aid in the discovery of new cancer treatments. Sanofi’s stake in Owkin is between 10% and 15%, and the partnership will include a multiyear collaboration that will add to Sanofi’s research pipeline in areas such as breast and lung cancers and multiple myeloma.

PharmaEssentia's ropeginterferon alfa-2b-njft (Besremi) was approved for adults with polycythemia vera. The FDA’s decision was based on positive results in the PEGINVERA study, which showed that 61% of patients with the disease experienced a complete hematologic response after 7.5 years of treatment. Because serious adverse events were reported in 4% of study participants, the product will carry a boxed warning for an increased risk of aggravating autoimmune, ischemic, neuropsychiatric, and infectious disorders.


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