RT Journal Article
T1 A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER.
A1 Goldman, Jonathan W
A1 Mazieres, Julien
A1 Barlesi, Fabrice
A1 Dragnev, Konstantin H
A1 Koczywas, Marianna
A1 Göskel, Tuncay
A1 Cortot, Alexis B
A1 Girard, Nicolas
A1 Wesseler, Claas
A1 Bischoff, Helge
A1 Nadal, Ernest
A1 Park, Keunchil
A1 Lu, Shun
A1 Taus, Alvaro
A1 Cobo, Manuel
A1 Estrem, Shawn T
A1 Wijayawardana, Sameera R
A1 Turner, Kellie
A1 Oakley, Gerard Joseph
A1 Hurt, Karla C
A1 Chiang, Alan Y
A1 Hossain, Anwar M
A1 John, William J
A1 Paz-Ares, Luis
K1 KRAS
K1 NSCLC
K1 Abemaciclib
K1 Erloitinib
K1 Platinum-resistant
AB JUNIPER compared the efficacy and safety of abemaciclib, a selective cyclin-dependent kinase 4 and 6 inhibitor, with erlotinib in patients with non-small cell lung cancer (NSCLC) harboring a Kirsten rat sarcoma (KRAS) mutation. JUNIPER was a Phase III, multicenter, randomized, open-label trial of abemaciclib versus erlotinib in patients with stage IV NSCLC and a detectable mutation in codons 12 or 13 of the KRAS oncogene, who progressed after platinum-based chemotherapy and 1 additional therapy (could include immune checkpoint inhibitor therapy). Randomized patients (3:2) received either 200 mg abemaciclib twice daily or 150 mg erlotinib once daily with best supportive care until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS); secondary endpoints included overall response rate (ORR), progression-free survival (PFS), and safety. Between December 2014 and April 2017, 453 patients were randomly assigned to receive abemaciclib (N = 270) or erlotinib (N = 183). Median OS was 7.4 months (95% confidence interval [CI]: 6.5, 8.8) with abemaciclib and 7.8 months (95% CI: 6.4, 9.5) with erlotinib (hazard ratio [HR] = 0.968 [95% CI: 0.768, 1.219]; p = .77). Median PFS was 3.6 months (95% CI: 2.8, 3.8) with abemaciclib and 1.9 months (95% CI: 1.9, 2.0) with erlotinib (HR = 0.583 [95% CI: 0.470, 0.723]; p  In this study, the primary endpoint of OS was not met; PFS and ORR were improved with manageable toxicity in the abemaciclib arm. The increases in response rates and PFS support further investigation of abemaciclib in other NSCLC subpopulations or in combination with other agents. 
PB Frontiers Research Foundation
SN 2234-943X
YR 2020
FD 2020-10-26
LK https://hdl.handle.net/10668/26828
UL https://hdl.handle.net/10668/26828
LA en
NO Goldman JW, Mazieres J, Barlesi F, Dragnev KH, Koczywas M, Göskel T, et al. A Randomized Phase III Study of Abemaciclib Versus Erlotinib in Patients with Stage IV Non-small Cell Lung Cancer With a Detectable KRAS Mutation Who Failed Prior Platinum-Based Therapy: JUNIPER. Front Oncol. 2020 Oct 26;10:578756
DS RISalud
RD Apr 19, 2025