ECE2022 Oral Communications Oral Communications 3: Thyroid 1 (6 abstracts)
Effect of age on efficacy and safety of cabozantinib vs placebo in patients with radioiodine refractory (RAI-R)-differentiated thyroid cancer (DTC) with progression after VEGFR-targeted therapy: subgroup analysis from Phase 3 COSMIC 311 study
Cosimo Durante 1 , Bruce Robinson 2 , Steven I Sherman 3 , Jolanta Krajewska 4 , Chia-Chi Lin 5 , Fernanda Vaisman 6 , Ana O Hoff 7 , Erika Hitre 8 , Daniel W Bowles 9 , Jorge Hernando 10 , Kamalika Banerjee 11 , Roman M Levytskyy 11 , Jennifer W Oliver 11 , Bhumsuk Keam 12 , Jaume Capdevila 10 & Marcia Brose 13,14
1Sapienza University of Rome, Department of Translational and Precision Medicine, Roma, Italy; 2University of Sydney School of Medicine, Sydney Medical School, Camperdown, Australia; 3The University of Texas MD Anderson Cancer Center, Department of Endocrine Neoplasia and Hormonal Disorders, Houston, United States; 4M. Sklodowska-Curie National Research Institute of Oncology, Gliwie Branch, Gliwice, Poland; 5National Taiwan University Hospital, Department of Oncology, Taiwan; 6National Institute of Cancer, Brazil; 7Instituto do Câncer do Estado de São Paulo, Department of Endocrinology, Brazil; 8National Institute of Oncology, Department of Medical Oncology and Clinical Pharmacology “B,”, Budapest, Hungary; 9University of Colorado Anschutz Medical Campus, Division of Medical Oncology, Department of Medicine, Aurora, United States; 10VHIO Vall d’Hebron Institut d’Oncologia, Barcelona, Spain; 11Exelixis Inc, Alameda, United States; 12Seoul National University Hospital Medical Research and Innovation Center, Rep. of South Korea; 13University of Pennsylvania, Abramson Cancer Center, Philadelphia, United States; 14Thomas Jefferson University Medical School, Sidney Kimmel Cancer Center, Philadelphia, Pennsylvania, United States
Background: Increasing age is associated with poorer survival in DTC [Oyer SL, 2012]. In the phase 3 COSMIC-311 trial (NCT03690388), cabozantinib, an inhibitor of VEGFR2, MET, AXL and RET, significantly improved the progression-free survival (PFS) vs placebo in previously treated patients with RAI-R DTC (HR 0.22, 96% CI 0.13-0.36; P<0.0001; median follow-up 6.2 months). The impact of age on efficacy and safety was included in the prespecified subgroup analysis.
Methods: 258 patients were randomized 2:1 to receive cabozantinib (60 mg QD) or placebo. Patients were stratified by prior lenvatinib treatment and age (younger subgroup: ≤65 y, older subgroup: >65 y). Patients with RAI-R DTC must have progressed on or after 1-2 prior VEGFR-targeted therapy. The primary endpoint of PFS and other outcomes in the extended follow-up data (8 Feb 2021) were analyzed by subgroups based on age.
Results: In the younger subgroup, 49% patients had papillary thyroid cancer (PTC) in the cabozantinib arm vs 66% in placebo, whereas 53% vs 36% had follicular thyroid cancer (FTC). In the older subgroup, 64% had PTC in the cabozantinib arm vs 57% in placebo, whereas 38% vs 43% had FTC. In the younger subgroup, 65% received prior sorafenib and 61% prior lenvatinib whereas in the older subgroup 55% received prior sorafenib and 65% prior lenvatinib. Median PFS for the cabozantinib arm was 11.1 months (95% CI 7.2-NE) with HR 0.19 (95% CI 0.12-0.32) for the younger subgroup and 11.1 months (95% CI 5.9-13.8) with HR 0.27 (95% CI 0.16-0.45) for the older subgroup. ORR with cabozantinib was 10% (95% CI 4.9%–18.9%) for the younger and 12% (95% CI 5.9%–20.8%) for the older subgroup vs 0% (95% CI 0.0-8.0) for both placebo subgroups. The discontinuation rate of cabozantinib due to AE related to study treatment was 6% both in the younger and the older subgroup and the percentage of patients with any dose reduction was 65% vs 69%. The safety profile in both age groups was similar and consistent with that of the overall population. No treatment-related grade 5 adverse events were observed.
Conclusion: This subgroup analysis demonstrates that clinical benefit with cabozantinib is maintained irrespective of age in previously treated RAIR DTC patients.
Keywords: Cabozantinib; COSMIC-311; DTC; VEGFR; age; differentiated thyroid
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Endocrine Abstracts
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