HLB announced on the 18th that
the results of the Rivoceranib Thyroid Cancer Phase 3 clinical trials will be
released at the 2020 ESMO. The announcement will cover clinical results for
Thyroid Cancer and T-cell lymphoma. Following the Esophageal Cancer, HLB
expects that the future value of Rivoceranib will also increase as it proves
the value of Rivoceranib for various cancerous species.
The abstract of the paper are as follows:
LBA89 - A randomized multicentered phase
III study to evaluate apatinib in subjects with locally advanced or metastatic
radioactive iodine-refractory differentiated thyroid cancer
Presentation Number
LBA89
Speakers
Yansong Lin (Beijing, China)
Abstract
Background
Apatinib, an oral inhibitor of vascular
endothelial growth factor receptor 2, showed clinical activity in preliminary
studies involving patients (pts) with differentiated thyroid cancer refractory
to radioactive iodine (RAIR-DTC).
Methods
In this phase III, randomized,
double-blind, multicenter trial involving pts with progressive RAIR-DTC,
eligible pts were randomized (1:1) to either 500 mg apatinib orally once daily
or placebo. The primary endpoint was progression-free survival (PFS), secondary
endpoints included objective response rate (ORR), overall survival (OS), and
safety. The planned sample size was 118 pts, with 90% power to detect a
6.2-month improvement in PFS at a two-sided alpha level of 0.05. A planned
interim analysis would be performed when 60% of expected events occurred.
Results
Between February 2017 to March 2020, 92 pts
from 20 sites were randomized to apatinib (n=46) or placebo (n=46) arms. The
pre-planned interim analysis was performed by the independent Data Monitoring
Committee (IDMC) in March 2020 upon the occurrence of 61.45% (51/83) PFS
events. The median PFS was 22.21 months (95% CI 10.91-Not Reached) in apatinib
group, and 4.47 months (95% CI 1.94-9.17) in the placebo group (HR=0.26, 95% CI
0.14-0.47, p<0.0001), and the p-value was less than the prespecified interim
efficacy margin (α=0.0085). ORR was 55.56% vs. 2.27%. The median OS was 29.9
months (95% CI 18.96-Not reached) in the placebo arm, and not reached in
apatinib arm (HR=0.42, 95% CI 0.18-0.97, p=0.0356). The most frequent
treatment-emergent ≥ grade 3 adverse events in two arms were hypertension
(34.8% vs 0%), hand-foot syndrome (17.4% vs 0%) and proteinuria (17.4% vs
2.2%). Table: LBA89
Table: LBA89 Summary of efficacy
Apatinib (N=46) Placebo (N=46)
Median PFS, months (95%CI) 22.21 (10.91- Not Reached) 4.47 (1.94-9.17)
p-value
<0.0001
HR (95% CI) 0.26 (0.14-0.47)
Median OS, months (95%CI) Not Reached (26.25 - Not Reached) 29.90 (18.96 - Not Reached)
p-value
0.0356
HR (95% CI) 0.42 (0.18-0.97)
ORR, n (%)
25 (54.35%) 1 (2.17%)
95% CI
39.01% - 69.10% 0.06% - 11.53%
p-value
<0.0001
Conclusions
Apatinib significantly prolonged the PFS,
OS, and improved ORR in pts with locally advanced or metastatic RAIR-DTC. The
toxic effects of apatinib were well tolerated by the management of adverse
events.
Clinical trial identification
NCT03048877.
Legal entity responsible for the study
The authors.
Funding
Jiangsu Hengrui Medicine, China.
Disclosure
All authors have declared no conflicts of interest.