Noted This Week

November 8–14

The FDA granted an accelerated approval to zanubrutinib (Brukinsa; BeiGene) in patients with mantle cell lymphoma who have received at least one previous therapy. The approval is based on two single-arm studies in which the drug elicited an overall response rate (ORR) of 84%. A Bruton tyrosine kinase inhibitor, zanubrutinib is the first drug developed in China to be approved by the FDA.

Teva announced it will restart production of vincristine, a chemotherapy agent commonly used to treat pediatric cancers. A shortage of vincristine occurred after Teva stopped making the drug, and Pfizer, the sole remaining manufacturer, couldn’t keep up with a spike in demand. Teva said it will make the drug available as early as possible in 2020.

A second surgery followed by chemotherapy in recurrent ovarian cancer does not improve survival compared with chemotherapy alone, researchers reported in The New England Journal of Medicine. In a phase III trial, patients who had a second surgery and then chemotherapy had a median overall survival (OS) of 50.6 months and a median progression-free survival (PFS) of 18.9 months, compared with 64.7 months and 16.2 months, respectively, in patients who received only chemotherapy.

Aslan’s pan-HER2 inhibitor varlitinib plus capecitabine may not lead to better responses in patients with biliary tract cancer who have received prior therapy. In the phase III TreeTopp trial, the combination did not significantly improve median PFS or ORR compared with a placebo plus capecitabine. Aslan is also testing varlitinib in breast and colorectal cancers.

EMD Serono and Pfizer announced that the PD-1 inhibitor avelumab (Bavencio) may not be an effective maintenance therapy in patients with inoperable locally advanced or metastatic HER2-negative gastric or gastroesophageal cancers. In the phase III JAVELIN Gastric 100 trial, the therapy did not improve OS compared with chemotherapy or best supportive care. Avelumab is already approved for certain types of renal cell, urothelial, and Merkle cell carcinoma.

The American Lung Association released a report indicating that the 5-year survival rate in lung cancer has improved over the past decade, from 17.2% to 21.7%. According to the report, more than 228,000 people will be diagnosed with lung cancer in 2019; Kentucky has the highest rate of disease, and Utah has the lowest. Five-year survival rates ranged from 17% in Alabama to 26% in Connecticut.


Research Watch