Noted This Week
The FDA announced plans for an antitobacco effort targeting underage use of tobacco products. The agency will restrict sales of flavored electronic cigarette (e-cigarette) cartridges to retail stores that have age-restricted entry or age-restricted areas, and it will require more stringent age verification for online sales. The FDA also proposed bans on menthol in cigarettes and cigars, and other flavors in cigars.
Under pressure from the FDA, Juul Labs said it will stop selling certain flavored e-cigarette cartridges—namely mango, fruit, crème, and cucumber—in 90,000 retail stores, and it will also improve its online age-verification system. The company, which makes e-cigarettes that look like flash drives that are popular with teens, will also halt social media advertising of flavored cartridges.
Merck announced that the FDA approved the PD-1 inhibitor pembrolizumab (Keytruda) for patients with advanced hepatocellular carcinoma who previously received sorafenib (Nexavar; Bayer, Onyx). The approval was based on the phase II KEYNOTE-224 trial, in which 104 patients had an objective response rate of 17%; 89% of those who responded did so for at least 6 months, and 56% responded for at least 12 months. The drug is already approved for several other types of cancer.
GlaxoSmithKline’s experimental RIP1 inhibitor GSK547 may boost the effectiveness of immune checkpoint inhibitors against pancreatic cancer, according to findings in Cancer Cell. In mice with pancreatic cancer, the combination extended survival compared with immune checkpoint inhibitors alone; in human pancreatic cancer cells, GSK547 increased cytotoxic T-cell activation and decreased activation of immune system–suppressing T cells. An ongoing phase I clinical trial is testing a version of GSK547 called GSK095.
Merrimack Pharmaceuticals announced that it will halt development of the anti-HER2 drug MM-121 and lay off 60% of its staff. The decision comes after a phase II trial of the drug in combination with docetaxel showed no improvement in progression-free survival compared with docetaxel alone in patients with non–small cell lung cancer. Merrimack will continue to pursue its anti-EphA2 drug MM-310, which is being tested in a phase I trial for solid tumors.
Boehringer Ingelheim agreed to pay Epizyme $15 million up front plus $5 million in research funding in a deal that could earn Epizyme over $280 million more in milestone payments. Together, the companies will develop cancer therapies for small-molecule targets. For example, they are launching a helicase program that will focus on two novel epigenetic targets in the helicase and histone acetyltransferase families.