November 2018 Vol 9, NO 11

Ribociclib combined with an aromatase inhibitor has been shown to significantly prolong progression-free survival (PFS) in premenopausal and postmenopausal women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC) who had not been treated previously for ABC.
Endocrine therapy (ET) is an established treatment for premenopausal women with hormone receptor–positive (HR+)/human epidermal growth factor receptor 2–negative (HER2−) advanced breast cancer (ABC). MONALEESA-7 (NCT02278120) was the first phase 3 randomized trial of a cyclin-dependent kinases 4 and 6 inhibitor (ribociclib) + ET in premenopausal women with HR+/HER2− ABC without prior ET for ABC.
CheckMate 032 (NCT01928394) is an open-label, phase 1/2 trial evaluating the efficacy and safety of nivolumab monotherapy and nivolumab plus ipilimumab in patients with advanced or metastatic solid tumors. In this study, nivolumab alone or in combination with ipilimumab showed durable responses, encouraging survival, and manageable safety in patients with small cell lung cancer (SCLC) that progressed after ≥1 previous platinum-containing regimens.
Ibrutinib is an inhibitor of Bruton’s tyrosine kinase (BTK) that has demonstrated activity in relapsed Waldenström’s macroglobulinemia (WM). Single-agent ibrutinib is approved in the United States and Europe for WM.
Palbociclib is the first-in-class cyclin-dependent kinase 4/6 inhibitor approved in the United States in combination with an aromatase inhibitor (AI) or fulvestrant for treating patients with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced or metastatic breast cancer (mBC) as initial or later-line endocrine therapy. More than 80,000 patients have been treated in the United States with palbociclib since its approval in February 2015, but data on real-world palbociclib utilization are limited.
Ibrutinib is a first-in-class, once-daily inhibitor of BTK approved in the United States for treatment of CLL/SLL. RESONATE-2 is a phase 3 study comparing first-line ibrutinib versus chlorambucil in patients with CLL/SLL. Primary results (median follow-up, 18.4 months) demonstrated ibrutinib reduced risk of progressive disease (PD) or death by 84% (Burger, 2015).
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