Noted This Week
November 27December 5
The FDA approved the PD-L1 inhibitor atezolizumab (Tecentriq; Roche/Genentech) plus chemotherapy in newly diagnosed patients with metastatic nonsquamous non–small cell lung cancer who do not have EGFR or ALK mutations. The approval was based on the phase III IMpower130 trial, in which patients treated with the combination had a median progression-free survival (PFS) of 7.2 months and a median overall survival of 18.6 months, compared with 6.5 months and 13.9 months, respectively, in patients who received chemotherapy alone.
The agency also issued a final guidance on adaptive designs for clinical trials. The guidance describes when and how adaptive trials—those that are modified based on accumulating data—should be used to provide evidence of the effectiveness and safety of drugs and biologics. The document also outlines what information should be reported to the FDA to facilitate the agency’s evaluation of such trials.
Foundation Medicine announced that the FDA approved FoundationOne CDx as a companion diagnostic for alpelisib (Piqray; Novartis), a PI3Kα inhibitor used with fulvestrant to treat men and postmenopausal women with PIK3CA-mutant, HR-positive, HER2-negative advanced breast cancer whose disease has worsened with an aromatase inhibitor. FoundationOne CDx is a next generation–sequencing test that can detect various genomic alterations, including insertions and deletions, gene rearrangements, and microsatellite instability.
A study in The Lancet Oncology reported that Aveo’s VEGFR inhibitor tivozanib may be effective in patients with metastatic renal cell carcinoma who have already received at least two therapies, including a VEGFR inhibitor. In the phase III TIVO-3 trial, the agent extended median PFS by 1.7 months compared with standard sorafenib (Nexavar; Bayer), and was similarly well tolerated.
Eli Lilly will tap executives from Loxo Oncology as it reorganizes its cancer research division following its purchase of Loxo for $8 billion in January 2019. Loxo’s former CEO and two members of its biotech leadership team will head a group that combines the laboratories of the two companies. The new group will focus on the development of the RET inhibitor selpercatinib (LOXO-292) and the Bruton tyrosine kinase inhibitor LOXO-305, among other agents.
Novartis and Amgen provided data to the American Society of Hematology Research Collaborative Data Hub, making them the first pharmaceutical companies to do so. The companies contributed deidentified data from nearly 500 patients with sickle cell disease and more than 1,000 patients with multiple myeloma. Launched in 2018, the Data Hub contains data from more than 3,000 patients with sickle cell disease and 2,000 patients with multiple myeloma that’s available to researchers.