Abemaciclib, a CDK4 and CDK6 Inhibitor for the Treatment of Metastatic Breast Cancer

References

• Zhang MH , ManHT, ZhaoXD, DongN, MaSL. Estrogen receptor-positive breast cancer molecular signatures and therapeutic potentials. Biomedical Rep.2(1), 41–52 (2013).
   PubMedGoogle Scholar
• Lal P , TanLK, ChenB. Correlation of HER-2 status with estrogen and progesterone receptors and histologic features in 3,655 invasive breast carcinomas. Am. J. Clin. Pathol.123(4), 541–546 (2005).
   PubMed Web of Science ®Google Scholar
• Milani A , GeunaE, MitticaG, ValabregaG. Overcoming endocrine resistance in metastatic breast cancer: current evidence and future directions. World J. Clin. Oncol.5(5), 990–1001 (2014).
   PubMedGoogle Scholar
• Chen P , LeeNV, HuWet al. Spectrum and degree of CDK drug interactions predicts clinical performance. Mol. Cancer Ther.15(10), 2273–2281 (2016).
   PubMed Web of Science ®Google Scholar
• de Groot AF , JuijpersCJ, KroepJR. CDK4/6 inhibition in early and metastatic breast cancer: a review. Cancer Treat. Rev.60, 130–138 (2017).
   PubMed Web of Science ®Google Scholar
• Hamilton E , InfanteJR. Targeting CDK4/6 in patients with cancer. Cancer Treat. Rev.45, 129–138 (2016).
   PubMed Web of Science ®Google Scholar
• Murphy CG , DicklerMN. The role of CDK4/6 inhibition in breast cancer. Oncologist20(5), 483–490 (2015).
   PubMed Web of Science ®Google Scholar
• Vidula N , RugoHS. Cyclin-dependent kinase 4/6 inhibitors for the treatment of breast cancer: a review of preclinical and clinical data. Clin. Breast Cancer16(1), 8–17 (2016).
   PubMed Web of Science ®Google Scholar
• Komata T , KanzawaT, TakeuchiHet al. Antitumour effect of cyclin-dependent kinase inhibitors (p16INK4A, p18INK4C, p19INK4D, p21WAF1/CIP1 and p27KIP1) on malignant glioma cells. Br. J. Cancer88(8), 1277–1280 (2003).
   PubMed Web of Science ®Google Scholar
• Finn RS , CrownJP, LangIet al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised Phase II study. Lancet Oncol.16(1), 25–35 (2015).
   PubMed Web of Science ®Google Scholar
• Finn RS , MartinM, RugoHSet al. Palbociclib and letrozole in advanced breast cancer. N. Engl. J. Med.375(20), 1925–1936 (2016).
   PubMed Web of Science ®Google Scholar
• Cristofanilli M , TurnerNC, BondarenkoIet al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, Phase III randomised controlled trial. Lancet Oncol.17(4), 425–439 (2016).
   PubMed Web of Science ®Google Scholar
• Rugo HS , FinnRS, DiérasVet al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res. Treat.174(3), 719–729 (2019).
   PubMed Web of Science ®Google Scholar
• Turner NC , SlamonDJ, RoJet al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N. Engl. J. Med.379(20), 1926–1936 (2018).
   PubMed Web of Science ®Google Scholar
• Cristofanilli M , SlamonDJ, RoJet al. Overall survival (OS) with palbociclib plus fulvestrant in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC) analyses from PALOMA-3 [LBA2_PR]. European Society for Medical Oncology Annual Meeting.Munich, Germany (19–23 October 2018).
   Google Scholar
• Harbeck N , IyerS, TurnerNet al. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann. Oncol.27(6), 1047–1054 (2016).
   PubMed Web of Science ®Google Scholar
• Finn RS , CristofanilliM, EttlJet al. Treatment effect of palbociclib (PAL) plus endocrine therapy (ET) by prognostic and intrinsic subtype: a joint analysis of PALOMA2 and PALOMA3. J. Clin. Oncol.36(Suppl. 15), Abstract 1023 (2018).
   Web of Science ®Google Scholar
• Pfizer, Inc . Palbociclib (Ibrance®) US prescribing information 2017. (2018). https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207103s004lbl.pdf
   Google Scholar
• Hortobagyi GN , StemmerSM, BurrisHAet al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N. Engl. J. Med.375, 1738–1748 (2016).
   PubMed Web of Science ®Google Scholar
• Hortobagyi GN , StemmerSM, BurrisHAet al. Updated results from MONALEESA-2, a Phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann. Oncol.29(7), 1541–1547 (2018).
   PubMed Web of Science ®Google Scholar
• Verma S , O’ShaughnessyJ, BurrisHAet al. Health-related quality of life of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer treated with ribociclib + letrozole: results from MONALEESA-2. Breast Cancer Res. Treat.170(3), 535–545 (2018).
   PubMed Web of Science ®Google Scholar
• Tripathy D , ImSA, ColleoniMet al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised Phase III trial. Lancet Oncol.19(7), 904–915 (2018).
   PubMed Web of Science ®Google Scholar
• Im SA , LuYS, BardiaAet al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N. Engl. J. Med.381(4), 307–316 (2019).
   PubMed Web of Science ®Google Scholar
• Slamon DJ , NevenP, ChiaSet al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J. Clin. Oncol.36(24), 2465–2472 (2018).
   PubMed Web of Science ®Google Scholar
• Fasching PA , EstevaFJ, PivotXet al. Patient-reported outcomes (PROs) in advanced breast cancer (ABC) treated with ribociclib + fulvestrant: results from MONALEESA-3. Ann. Oncol.Suppl. 8, viii90–viii121 (2018).
   Google Scholar
• Slamon DJ , NevenP, ChiaSet al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal receptor-positive (HR+), human epidermal growth factor 2-negative (HER2-) advanced breast cancer (ABC) treated with fulvestrant (FUL)± ribociclib (RIB). Ann. Oncol.30(Suppl. 5), Abstract 7184 (2019).
   Google Scholar
• Yardley DA , ChanA, NuschAet al. Ribociclib + endocrine therapy in patients with hormone receptor-positive, HER2-negative advanced breast cancer presenting with visceral metastases: subgroup analysis of Phase III MONALEESA trials. Cancer Res.79 (Suppl. 4), Abstract P6-18-07 (2019).
   Web of Science ®Google Scholar
• Novartis . Ribociclib (Kisqali®) US prescribing information 2020. (2020). https://www.pharma.us.novartis.com/sites/www.pharma.us.novartis.com/files/kisqali.pdf
   Google Scholar
• Goetz MP , ToiM, CamponeMet al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J. Clin. Oncol.35(32), 3638–3646 (2017).
   PubMed Web of Science ®Google Scholar
• Sledge GW Jr , ToiMet al. MONARCH 2: abemaciclib in combination with fulvestrant in women with HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J. Clin. Oncol.35(25), 2875–2884 (2017).
   PubMed Web of Science ®Google Scholar
• Dickler MN , TolaneySM, RugoHSet al. MONARCH 1, a Phase II study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent in patients with refractory HR+/HER2- metastatic breast cancer. Clin. Cancer Res.23(17), 5218–5224 (2017).
   PubMed Web of Science ®Google Scholar
• Johnston S , MartinM, DiLeo Aet al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer5, 5 (2019).
   PubMed Web of Science ®Google Scholar
• Sledge GW , ToiM, NevenPet al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy – MONARCH 2: a randomized clinical trial. JAMA Oncol.6(1), 116–124 (2019).
   Web of Science ®Google Scholar
• Dickler MN , TolaneySM, RugoHSet al. MONARCH 1, a Phase 2 study of abemaciclib, a CDK4 and CDK6 inhibitor, as a single agent, in patients with refractory HR+/HER2- metastatic breast cancer. American Association for Cancer Research Annual Meeting.Washington DC, USA, 1–5 April 2017 ( Poster).
   Google Scholar
• European Medicines Agency . Abemaciclib (verzenios) assessment report 26 July 2018, EMA/551438/2018. (2019). https://www.ema.europa.eu/en/medicines/human/EPAR/verzenios
   Google Scholar
• Tolaney SM , DiLeo A, Llombart-CussacAet al. Impact of abemaciclib on the time to subsequent chemotherapy and the time to second disease progression across the MONARCH 2 and 3 studies. American Society of Clinical Oncology Annual Meeting.IL, USA, 1–5 June 2018 (Poster 1048).
   Google Scholar
• Kaufman PA , ToiM, NevenPet al. Health-related quality of life in MONARCH 2: abemaciclib plus fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy. Oncologist25(2), e243–e251 (2020).
   PubMed Web of Science ®Google Scholar
• Gervaso L , MonteroAJ, JiaX, KhoranaAA. Venous thromboembolism in breast cancer patients receiving cyclin-dependent kinase inhibitors. J. Thromb. Haemost.18(1), 162–168 (2020).
   PubMed Web of Science ®Google Scholar
• Eli Lilly and Company, Ltd . Abemaciclib (verzenio®) US prescribing information, September 2019. (2019). http://pi.lilly.com/us/verzenio-uspi.pdf
   Google Scholar
• Patnaik A , RosenLS, TolaneySMet al. Efficacy and safety of abemaciclib, an inhibitor of CDK4 and CDK6, for patients with breast cancer, non-small cell lung cancer and other solid tumors. Cancer Discov.6(7), 740–753 (2016).
   PubMed Web of Science ®Google Scholar
• Di Leo A , O’ShaughnessyJ, SledgeGWJret al. Prognostic characteristics in hormone receptor-positive advanced breast cancer and characterization of abemaciclib efficacy. NPJ Breast Cancer4, 41 (2018).
   PubMed Web of Science ®Google Scholar
• Inic Z , ZegaracM, InicMet al. Difference between luminal A and luminal B subtypes according to Ki-67, tumor size and progesterone receptor negativity providing prognostic information. Clin. Med. Insights Oncol.8, 107–111 (2014).
   PubMedGoogle Scholar
• Prat A , CheangMCU, MartinMet al. Prognostic significance of progesterone receptor-positive tumor cells within immunohistochemically defined luminal A breast cancer. J. Clin. Oncol.31(2), 203–209 (2013).
   PubMed Web of Science ®Google Scholar
• Gao JJ , ChengJ, BloomquistEet al. Benefit of CDK 4/6 inhibition in less common breast cancer subsets: a U.S. Food and Drug Administration pooled analysis. J. Clin. Oncol.36 (Suppl. 15), Abstract 1024 (2018).
   Web of Science ®Google Scholar
• Torres-Guzmán R , CalsinaB, HermosoAet al. Preclinical characterization of abemaciclib in hormone receptor positive breast cancer. Oncotarget8(41), 69493–69507 (2017).
   PubMedGoogle Scholar
• De Dios A , LallenaM, BuchananSG, BeckmannRP. Mechanisms of action of the CDK4 and CDK6 inhibitor abemaciclib: single-agent and combination activities in preclinical models for human cancer. Presented at: American Association for Cancer Research Annual Meeting.LA, USA, 16–20 April 2016.
   Google Scholar
• Chang JC , O’ReganR. Use of novel combination therapies in the treatment of advanced HR+/HER2- breast cancer. J. Natl Compr. Canc. Netw.16(Suppl. 1), S1–S14 (2018).
   PubMedGoogle Scholar
• Caldon CE , DalyRJ, SutherlandRL, MusgroveEA. Cell cycle control in breast cancer cells. J. Cell. Biochem.97(2), 261–274 (2006).
   PubMed Web of Science ®Google Scholar
• Finn RS , DeringJ, ConklinDet al. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitro. Breast Cancer Res.11(5), R77 (2009).
   PubMed Web of Science ®Google Scholar
• Laurenti E , FrelinC, XieSet al. CDK6 levels regulate quiescence exit in human hematopoietic stem cells. Cell Stem Cell16(3), 302–313 (2015).
   PubMed Web of Science ®Google Scholar
• Malumbres M , BarbacidM. Cell cycle, CDKs and cancer: a changing paradigm. Nat. Rev. Cancer9(3), 153–166 (2009).
   PubMed Web of Science ®Google Scholar
• Scheicher R , Hoelbl-KovacicA, BelluttiFet al. CDK6 as a key regulator of hematopoietic and leukemic stem cell activation. Blood125(1), 90–101 (2015).
   PubMed Web of Science ®Google Scholar
• Yu Q , GengY, SicinskiP. Specific protection against breast cancers by cyclin D1 ablation. Nature411(6841), 1017–1021 (2001).
   PubMed Web of Science ®Google Scholar
• Yu Q , SicinskaE, GengYet al. Requirement for CDK4 kinase function in breast cancer. Cancer Cell9(1), 23–32 (2006).
   PubMed Web of Science ®Google Scholar
• Anders CK , LeRhun E, BachelotTDet al. A Phase II study of abemaciclib in patients (pts) with brain metastases (BM) secondary to HR+, HER2- metastatic breast cancer (MBC). J. Clin. Oncol.37 (Suppl. 15), Abstract 1017 (2019).
   Web of Science ®Google Scholar
• Deng Y , MaG, LiW, WangT, ZhaoY, WuQ. CDK4/6 Inhibitors in combination with hormone therapy for HR+/HER2- advanced breast cancer: a systematic review and meta-analysis of randomized controlled trials. Clin. Breast Cancer18(5), e943–e953 (2018).
   PubMed Web of Science ®Google Scholar
• DeMichele A , ClarkAS, TanKSet al. CDK 4/6 inhibitor palbociclib (PD0332991) in Rb+ advanced breast cancer: Phase II activity, safety and predictive biomarker assessment. Clin. Cancer Res.21(5), 995–1001 (2015).
   PubMed Web of Science ®Google Scholar
• Malorni L , CuriglianoG, MinisiniAMet al. Palbociclib as single agent or in combination with the endocrine therapy received before disease progression for estrogen receptor-positive, HER2-negative metastatic breast cancer: TREnd trial. Ann. Oncol.29(8), 1748–1754 (2018).
   PubMed Web of Science ®Google Scholar