CTIM-32 - A parallel cohort phase 2 study of regorafenib plus nivolumab for recurrent or metastatic solid tumors: results in patients with glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA)

Friday, November 17, 2023

7:30 PM - 9:30 PM PT

Location: Exhibit Hall A/B

Author(s)

MS

Matteo Simonelli

Oncology Department, IRCCS Humanitas Research Hospital
Milan, Italy
Mario Caccese

Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV-IRCCS
Padua, Veneto, Italy
DL

Delphine Larrieu-Ciron

Department of Neurology, Toulouse University Hospital
Toulouse, France
EF

Enrico Franceschi

Nervous System Medical Oncology Department, IRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy
TK

Tae Min Kim

Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Seoul, Republic of Korea
JF

Jerome Fayette

Centre Léon Bérard
Lyon, France
PF

Pierre Freres

Department of Medical Oncology, University Hospital of Liège, CHU Sart Tilman
Liege, Belgium
MR

Marie Robert

Department of Medical Oncology, Institut de Cancérologie de l'Ouest
Nantes, France
Marica Eoli

Fondazione IRCCS Carlo Besta
Milano, Lombardia, Italy
SL

Sylvie Luce

Department of Oncology, Hôpital Erasme, Université Libre de Bruxelles
Brussels, Belgium
JP

Jana L. Portnow

Department of Medical Oncology, City of Hope Beckman Research Institute
Duarte, California, United States
YH

Yuki Hirata

Ono Pharmaceutical Co., Ltd
Osaka, Japan
KE

Kengo Enya

Ono Pharmaceutical Co., Ltd
Osaka, Japan
IW

Ian Waxman

Bristol-Myers Squibb
Lawrenceville, New Jersey, United States
LJ

Lixian Jin

Bristol-Myers Squibb
Lawrenceville, New Jersey, United States
DS

Dipam Shah

Bayer HealthCare Pharmaceuticals
Whipanny, New Jersey, United States
UD

Uta Drews

Bayer AG
Berlin, Germany
ML

Marie-Aude Le Berre

Bayer HealthCare SAS
Loos, France

Poster Presenter(s)

Giuseppe Lombardi

Department of Oncology, Oncology 1, Veneto Institute of Oncology IOV-IRCCS
Padua, Veneto, Italy

Introduction: The multikinase inhibitor regorafenib improved overall survival (OS) versus lomustine in relapsed GBM in the randomized phase 2 REGOMA study. The aim of this study was to evaluate the efficacy of regorafenib combined with nivolumab in this setting (NCT04704154).

Methods: Patients aged ≥ 18 years with recurrent GBM/AA (WHO 2016 classification) after radiotherapy plus temozolomide, and an ECOG performance status (PS) of 0/1, received oral regorafenib 90 mg/day on days 1–21 and intravenous nivolumab 480 mg on day 1 of each 28-day cycle. If tolerated, the regorafenib dose could be escalated to 120 mg/day from cycle 2. Prior regorafenib treatment or immunotherapy was not allowed. The primary endpoint was objective response rate (ORR) using RANO criteria. Secondary endpoints included progression-free survival (PFS), OS, and safety (MedDRA; CTCAE v5.0).

Results: Of the 36 patients enrolled, 30 were treated and were eligible for analysis. Median age was 60 years, 63% had an ECOG PS of 1, and 90% had GBM (10% AA). All patients discontinued treatment as of the primary analysis (March 9, 2023). One patient had a best-overall partial response (ORR; 3%) and nine (30%) had stable disease. Median number of cycles of regorafenib and nivolumab infusions was three. Median PFS (RANO) was 2.7 months (80% CI 1.8, 7.3) and 6-month PFS was 31.5%. Median OS was 8.0 months (80% CI 4.6, 12.4) and 12-month OS was 33.7%. Thirteen patients (43%) had grade 3/4 treatment-emergent adverse events (TEAEs), which were drug-related in 12 patients (40%). The most common drug-related grade 3/4 TEAEs were AST increase (13%), ALT increase (10%), and hypertension (10%). There were no immune-mediated serious TEAEs or drug-related grade 5 TEAEs.

Conclusion: The efficacy results of this study do not support further evaluation of regorafenib combined with nivolumab in GBM/AA. The safety profile was acceptable and manageable.