Noted This Week
The FDA approved tazemetostat (Tazverik; Epizyme) in patients age 16 and older with inoperable metastatic or locally advanced epithelioid sarcoma. The decision was based on the phase II Study EZH-202 trial, in which the drug elicited an objective response rate of 15%. Tazemetostat is the first EZH2 inhibitor to be approved by the FDA.
Less than half of clinical trials report results to the FDA within a year of completion, according to findings in The Lancet. Researchers analyzed 4,209 trials and found that only 40.9% reported results within the 1-year timeframe required by the FDA Amendments Act of 2007. Industry sponsors were significantly more likely to report results than non-industry, non–U.S. government sponsors. The median time from trial completion to data submission was 424 days.
Newer drug combinations may help patients with certain liver and colorectal cancers maintain their quality of life longer than standard treatments, researchers reported at the American Society of Clinical Oncology’s 2020 Gastrointestinal Cancers Symposium in San Francisco, CA, January 23–25. In the phase III IMbrave 150 trial, patients with inoperable hepatocellular carcinoma treated with atezolizumab (Tecentriq; Genentech) plus bevacizumab (Avastin; Genentech) reported a median time to deterioration of 11.2 months, compared with 3.6 months for patients who received standard sorafenib (Nexavar; Bayer). In the phase III BEACON CRC trial, patients with BRAF-mutant colorectal cancer treated with encorafenib (Braftovi; Array BioPharma) and cetuximab (Erbitux; Lilly) with or without binimetinib (Mektovi; Array BioPharma) had a 44% to 46% reduction in the risk of their quality of life deteriorating compared with standard chemotherapy.
BeiGene announced that tislelizumab plus chemotherapy may be effective in patients with squamous non–small cell lung cancer. In a phase III trial, the combination extended progression-free survival (PFS) compared with chemotherapy alone. A PD-1 inhibitor, tislelizumab is approved in China for relapsed/refractory Hodgkin lymphoma.
The European Commission (EC) approved polatuzumab vedotin (Polivy; Roche) plus bendamustine and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for a stem-cell transplant. A CD79b-directed antibody–drug conjugate, polatuzumab vedotin was approved based on a phase Ib/II trial in which patients treated with the combination had a complete response rate of 40% and a median overall survival of 12.4 months, compared with 17.5% and 4.7 months in patients who received rituximab alone.
The EC also approved daratumumab (Darzalex; Janssen) plus bortezomib (Velcade; Millennium Pharmaceuticals), thalidomide, and dexamethasone (VTd) in patients with newly diagnosed multiple myeloma who are unable to receive a stem-cell transplant. The decision was based in part on the phase III CASSIOPEIA trial in which patients treated with the daratumumab-based combination had an 18-month PFS rate of 93%, compared with 85% in patients who received VTd alone.
Boston, MA’s Dana-Farber Cancer Institute will create the Riney Family Multiple Myeloma Initiative after receiving a $16.5 million donation from the family. The initiative will focus on three research areas: understanding the biological drivers of multiple myeloma, developing novel therapeutics, and creating the infrastructure for open-access data and resources.