Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Poster display session

2085 - Efficacy and Safety of Abemaciclib Combined with either LY3023414 or Pembrolizumab in Stage IV NSCLC


09 Sep 2017


Poster display session


Clinical Research;  Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Non-Small Cell Lung Cancer


Pilar Garrido Lopez


Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380


P. Garrido Lopez1, J. Goldman2, K. Kelly3, E.S. Kim4, T.J. Beck5, M. Alonso Garcia6, Z. Yang7, K. Ingram8, L. Amstutz8, W.J. John8, M. Provencio Pulla9

Author affiliations

  • 1 Medical Oncology, Hospital Universitario Ramon y Cajal, 28031 - Madrid/ES
  • 2 Hematology & Oncology, University of California-Los Angeles, Santa Monica/US
  • 3 Medical Oncology, UC Davis Comprehensive Cancer Center, Sacramento/US
  • 4 Medical Oncology, Levine Cancer Institute, Charlotte/US
  • 5 Medical Oncology, Highlands Oncology Group, Fayetteville/US
  • 6 Medical Oncology, Hospital Universitario Virgen del Rocío, Sevilla/ES
  • 7 Biometrics, Eli Lilly and Company, Indianapolis/US
  • 8 Medical Affairs, Eli Lilly and Company, Indianapolis/US
  • 9 Medical Oncology, Servicio de Oncología Médica Hospital Universitario Puerta de Hierro, Madrid/ES


Abstract 2085


Abemaciclib (abema), a cyclin D kinase 4 & 6 inhibitor, has single-agent activity and an acceptable safety profile when dosed continuously in patients with previously treated metastatic NSCLC (NCT01394016). In tumor models, CDK inhibition induces an escape pathway involving PI3kinase (PI3K) and abema induces synergistic immune activation with checkpoint inhibitors. We report on activity and safety of abema plus LY3023414 (LY), a PI3K/mTOR dual inhibitor, and abema plus pembrolizumab (pembro), an anti-PD-1 antibody, in an ongoing Phase 1b open-label, 3 + 3 multicenter trial of previously treated advanced NSCLC (NCT02079636).


For escalation, Abema [100, 150 mg, or 200 mg (cohort D only)] was given orally on a continuous schedule every 12 hours (q12h) with LY at 100, 150, or 200 mg q12h (cohort D) or with pembro at 200 mg I.V. infusion q3 weeks (cohort E). Confirmatory cohorts were given 150 mg abema with 150 mg LY or 200 mg pembro. Pts were treated until progression or other discontinuation criteria were met. Responses were evaluated with RECIST v1.1. Safety assessments followed the NCI-CTCAE v4.0.


As of 01-Mar-2017, cohort D (n = 29) had 62.1% males, 37.9% ≥65 years of age, median # prior systemic therapies=3; 86.2% stage IV; 72.4% adenocarcinoma; 62.1% ECOG PS = 1. 9 pts (31%) had stable disease (SD), 3 pts had progressive disease (PD), and the status for the remaining 17 pts was unknown or under evaluation. There were 3 deaths unrelated to study drug (2 disease related and 1 stroke). 24/29 pts had a treatment emergent, related AE (TRAE), 10/24 had a Grade 3/4 TRAE. Any grade TRAEs (>30% pts) were nausea (51.7%), diarrhea (51.7%), vomiting (41.4%), and decreased appetite (31%). Cohort E had 19 pts entered (42.1% male, 42.1% ≥65 years of age, median # prior systemic therapies=2; 52.6% stage IV; 89.5% adenocarcinoma; 57.9% ECOG PS = 1). 8 pts (42.1%) had SD, 1 had PD, and the status for the remaining 10 pts was unknown or under evaluation. There were 3 disease related deaths. 15/19 pts had a TRAE, 5/15 had a G3/4 TRAE. Any grade TRAEs (>30% pts) were fatigue (n = 47.4%) and diarrhea (36.8%).


To date, stable disease as best response and acceptable safety have been observed using combinations of abema and either LY or pembro in advanced NSCLC.

Clinical trial identification


Legal entity responsible for the study

Eli Lilly and Company


Eli Lilly and Company


P. Garrido Lopez: Advisor/Board member: MSD, Pfizer, BMS, Novartis, Roche, BI, Guardant Speakers Bureau: MSD, Pfizer, BMS, Novartis, Roche Honorarium recipient: BI J. Goldman: Research grant from Eli Lilly and company Eli Lilly and Company\'s Scientific Advisory Board member. K. Kelly: Attended a Lilly advisory board in Feb 2017 that discussed Abemaciclib. E.S. Kim: Celgene - Consultant Boehringer Ingelheim - Consultant Eli Lilly - Consultant AstraZeneca – Consultant. Z. Yang, L. Amstutz, W.J. John: Full time employee of Eli Lilly and Company. K-J. Ingram: Stock ownership in Eli Lilly and Company. Employee of Eli Lilly and company. M. Provencio Pulla: Corporate-sponsored research (investigator): GI Therapeutics, Eli Lilly and Company. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.