Noted This Week

January 8–14

Sanofi announced it will acquire Kymab for $1.1 billion up front and up to $350 million more in milestone payments. Sanofi will gain KY1044, an anti-ICOS antibody that is being tested alone and in combination with a PD-L1 inhibitor in solid cancers. Sanofi’s purchase also includes Kymab’s leading candidate KY1005, an anti-OX40L antibody being assessed for various immune disorders.

Novartis will pay BeiGene $650 million up front and as much as $1.55 billion in milestone payments for the PD-1 inhibitor tislelizumab. Novartis will acquire rights to develop, manufacture, and commercialize the drug in North America, Japan, the European Union, and six other European countries. Tislelizumab is approved in China for certain forms of classic Hodgkin lymphoma, urothelial carcinoma, and non–small cell lung cancer (NSCLC).

The American Cancer Society (ACS) reported that the cancer mortality rate decreased by 2.4% from 2017 to 2018 in the United States, the biggest single-year drop on record. The ACS estimated that there will be 1.9 million new cancer diagnoses and 600,000 cancer-related deaths in 2021. However, the projections don’t account for the COVID-19 pandemic, which has disrupted cancer screenings and care.

In The New England Journal of Medicine, a report revealed the distribution of KRASG12C mutations by race and sex. Researchers analyzed the prevalence of KRASG12C mutations in 32,138 patients with cancer, 13.8% of whom had NSCLC. They found that among patients with NSCLC, KRASG12C mutations occurred in 13% of white, 10.9% of Black, and 3.6% of Asian patients. This mutation was significantly more common in white and Asian women with NSCLC than their male counterparts.

The FDA approved crizotinib (Xalkori; Pfizer) in children and young adults with relapsed/refractory, systemic anaplastic large cell lymphoma who have ALK mutations. The approval was based on a phase I/II trial in which 26 patients had an objective response rate of 88% and a complete remission rate of 81%. An ALK inhibitor, crizotinib was previously approved for patients with NSCLC who have ALK or ROS1 mutations.

The FDA placed a clinical hold on Neoleukin Therapeutics’ phase I trial of NL-201. The agency asked Neoleukin to develop a new assay that more precisely measures dosing of the drug. NL-201 is a protein therapeutic that stimulates IL2 and IL15 signaling.

U.S. Customs and Border Protection and the FDA announced the seizure of counterfeit, unauthorized electronic cigarette (e-cigarette) cartridges. In January, a shipment of 33,681 cartridges was discovered at the Dallas Fort Worth International Airport in Texas. In December, the agencies seized 42 shipments of e-cigarette cartridges from China en route to several Texas counties. In both instances, the shipments included flavored cartridges that are illegal in the United States.


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