| Added by | amaraver |
|---|---|
| Group name | EquipeAM |
| Item Type | Journal Article |
| Title | Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC: A Phase 1b Study |
| Creator | Pujol et al. |
| Author | Jean-Louis Pujol |
| Author | Johan Vansteenkiste |
| Author | Luis Paz-Ares Rodríguez |
| Author | Vanesa Gregorc |
| Author | Mark Awad |
| Author | Pasi A. Jänne |
| Author | Michael Chisamore |
| Author | Anwar M. Hossain |
| Author | Yanyun Chen |
| Author | J. Thaddeus Beck |
| Abstract | INTRODUCTION: Abemaciclib is an oral, selective small-molecule CDK 4 and 6 inhibitor. In preclinical models, abemaciclib synergized with programmed cell death protein-1 blockade to enhance antitumor efficacy. Here, we report the safety and anticancer activity of abemaciclib plus pembrolizumab in two cohorts with NSCLC. METHODS: This nonrandomized, open-label, phase 1b study included patients with previously untreated programmed death-ligand 1-positive, KRAS-mutant nonsquamous metastatic NSCLC (cohort A); squamous NSCLC after one previous platinum-containing chemotherapy regimen for metastatic disease (cohort B); and two breast cancer cohorts (disclosed separately). Patients received 150 mg abemaciclib every 12 hours plus 200 mg pembrolizumab intravenously on day 1 every 21 days. The primary objective was safety; secondary objectives included objective response rate, disease control rate, progression-free survival, and overall survival. Clinical Trial Number: NCT02779751. RESULTS: Each cohort enrolled 25 patients. Grades greater than or equal to 3 treatment-emergent adverse events in cohorts A and B were reported by 20 (80%) and 19 patients (76%), respectively. Six patients in cohort A (24.0%) and two patients in cohort B (8.0%) had a confirmed partial response; disease control rate was 56% and 64%, respectively. Median progression-free survival was 7.6 months (95% confidence interval [CI]: 1.6-not estimable) and 3.3 months (95% CI: 1.4-5.2); median overall survival was 27.8 months (95% CI: 9.9-not estimable) and 6.0 months (95% CI: 3.7-13.1) in cohorts A and B, respectively. CONCLUSIONS: The combination of abemaciclib and pembrolizumab in stage IV NSCLC resulted in greater toxicity compared with that previously reported for each individual treatment. Risk-benefit profile does not warrant further evaluation of the combination in this population. |
| Publication | JTO clinical and research reports |
| Volume | 2 |
| Issue | 11 |
| Pages | 100234 |
| Date | 2021-11 |
| Journal Abbr | JTO Clin Res Rep |
| Language | eng |
| DOI | 10.1016/j.jtocrr.2021.100234 |
| ISSN | 2666-3643 |
| Short Title | Abemaciclib in Combination With Pembrolizumab for Stage IV KRAS-Mutant or Squamous NSCLC |
| Library Catalog | PubMed |
| Extra | PMID: 34746886 PMCID: PMC8551846 |
| Tags | Abemaciclib, clinic, first, KRAS-mutant, PD-L1 positive non - small cell lung cancer, Squamous |
| Date Added | 2022/08/31 - 14:19:42 |
| Date Modified | 2022/08/31 - 14:19:59 |
| Notes and Attachments | Full Text (Attachment) PubMed entry (Attachment) |
Institut de Recherche en Cancérologie de
