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Globally, the incidence of thyroid cancer has risen sharply in the past three decades , especially among young adults and even adolescents
.
The mortality rate of thyroid cancer is relatively stable at a low level, or has decreased in almost all places
Globally, the incidence of thyroid cancer has risen sharply in the past three decades.
Accurately about 60% of patients with medullary thyroid cancer can detect RET gene mutations, and the proportion of RET mutations in advanced patients is as high as 90%
Pralsetinib is an oral (once a day), highly effective and highly selective drug under development that targets RET mutations
.
The results of preclinical studies have shown that pralsetinib is sensitive to RET fusion and RET activating mutations.
pralsetinib is sensitive to RET fusion and RET activating mutations.
Lancet
This study aims to evaluate the safety and anti-tumor activity of pralsetinib in patients with RET-mutant thyroid cancer
.
ARROW is a Phase 1/2 open-label study conducted in 71 locations in communities and hospitals in 13 countries, recruiting patients over 18 years of age with locally advanced or metastatic solid tumors altered by RET, including myeloid with RET mutations Thyroid and RET fusion-positive thyroid cancer, while the performance status of the Eastern Cooperative Oncology Group was 0-2
Patients who receive 400 mg of oral pralsetinib once a day are evaluated until disease progression, intolerance, withdrawal of consent, or the investigator's decision.
The primary endpoint of the second phase is overall response rate and safety
.
To evaluate the tumor response of patients with RET-mutant medullary thyroid cancer who have previously received cabozantinib and/or vandetanib, or who do not meet standard treatment conditions, and who have previously received RET fusion-positive thyroid cancer treatment Patients; To evaluate the safety of all patients with RET-modified thyroid cancer
During 2017.
03.
17-2020.
05.
22, 122 patients with RET-mutant medullary thyroid cancer and 20 patients with RET-fusion-positive thyroid cancer were enrolled
.
Among patients with baseline measurable disease who received pralsetinib before 2019.
The overall response rate of patients with RET-mutant medullary thyroid cancer who did not respond to treatment was 15/21 (71%) (95% CI 48-89), and patients who had previously received cabozantinib and/or vandetanib It was 33/55 (60%) (95% CI 46-73) and 8/9 (89%) (95% CI 52-100) in patients with RET fusion-positive thyroid cancer
Among patients with RET fusion thyroid cancer who were enrolled before 2020.
05.
22, the common (≥10%) grade 3 and above treatment-related adverse events were hypertension (24 [17%]) and neutropenia (19[ 13%]), lymphopenia (17[12%]) and anemia (14[10%])
.
Twenty-one patients (15%) reported serious treatment-related adverse events, of which the most common (≥2%) was pneumonia (5[4%])
In summary, Pralsetinib is a new, well-tolerated, effective, once-a-day oral treatment regimen, suitable for patients with RET-altered thyroid cancer
.
.
In summary, Pralsetinib is a new, well-tolerated, effective, once-a-day oral treatment regimen, suitable for patients with RET-altered thyroid cancer
.
references:
Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study.
https://doi.
org/10.
1016/S2213-8587(21)00120 -0
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