The highest total remission rate is nearly 90%! Publication of new precision treatments for lung and thyroid cancer

Today, "The Lancet-Oncology" and "The Lancet-Diabetes and Endocrinology" respectively published the importance of the RET inhibitor pralsetinib in the precise treatment of advanced non-small cell lung cancer (NSCLC) and thyroid cancer patients.

In certain patients with these two major types of cancer, pratinib brings lasting remission and benefits regardless of whether the patient has received other treatments in the past

One of the researchers, MD Anderson Cancer Center (MD Anderson Cancer Center) Dr.

"This marks another milestone in the shift to the precision medicine paradigm

Why is RET targeted therapy attracting attention?

Transfection rearrangement (RET) activating fusion and mutation are key drivers of many cancers

Currently, including surgery, radiotherapy, chemotherapy and immunotherapy, standard cancer treatments have limited efficacy for patients with RET fusion-positive solid tumors

In early clinical trials, some multi-kinase inhibitors with anti-RET activity, including cabozantinib, vandetanib and lenvatinib, have shown certain clinical activity , But has high treatment-related toxicity

Pratinib is a powerful and highly selective oral precision therapy that targets oncogenic RET mutations (including predictable drug-resistant mutations), which can specifically and powerfully inhibit RET mutations that drive many cancer types

High response rate in patients with two major cancer types

ARROW is a multi-cohort phase 1/2 clinical trial conducted in 71 clinical centers in 13 countries and regions, including China.

In the NSCLC cohort, a total of 233 patients with RET fusion-positive NSCLC were included in this analysis

In patients who have not previously received systemic treatment, pratinib treatment has achieved a 70% overall remission rate and a 11% complete remission rate

▲The median time to remission (A, B) and progression-free survival (C, D) of patients with RET fusion-positive NSCLC

The thyroid cancer cohort included 122 patients with RET-mutant medullary thyroid cancer and 20 patients with RET-fusion-positive thyroid cancer

Among patients with RET-mutated medullary thyroid cancer: the overall response rate was 71% for those who had not been treated before; among patients who had previously received cabozantinib and/or vandetinib, the overall response rate was 60%

The treatments observed in both cohorts were well tolerated

Among all 142 patients with RET variant thyroid cancer, common (≥10%) grade 3 and above TRAEs include hypertension (24 cases [17%]), neutropenia (19 cases [13%]), Lymphopenia (17 cases [12%]) and anemia (14 cases [10%]); 5 patients (4%) were discontinued due to TRAE, and 1 patient (1%) died due to TRAE

Benefit more Chinese patients

Based on the data previously published by the ARROW study, pratinib has been approved in the United States for the treatment of adult patients with metastatic RET fusion-positive NSCLC, adults with advanced or metastatic RET-mutated medullary thyroid cancer requiring systemic treatment, and adults 12 years and older Pediatric patients, as well as adults with advanced or metastatic RET fusion-positive thyroid cancer and children 12 years and older who require systemic treatment and are refractory to radioiodine (if applicable)
.

Pratinib is also the first RET inhibitor approved for marketing in China
.
In March of this year, pratinib has been approved for use in adult patients with locally advanced or metastatic NSCLC who have previously received platinum-containing chemotherapy and RET gene fusion-positive
.
Pratinib's thyroid cancer indication is also expected to accelerate its approval in China.
It was included in the proposed priority review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration in April.
The proposed indication is RET that meets specific conditions.
Patients with mutant medullary thyroid carcinoma (MTC) patients with RET fusion-positive thyroid cancer
.

Note: The original text has been deleted

Reference

[1] Justin F Gainor, et al.
, (2021).
Pralsetinib for RET fusion-positive non-small-cell lung cancer (ARROW): a multi-cohort, open-label, phase 1/2 study, The Lancet Oncology , DOI: https://doi.
org/10.
1016/S1470-2045(21)00247-3

[2] Vivek Subbiah, et al.
, (2021).
Pralsetinib for patients with advanced or metastatic RET-altered thyroid cancer (ARROW): a multi-cohort, open-label, registrational, phase 1/2 study.
The Lancet Diabetes & Endocrinology, DOI: https://doi.
org/10.
1016/S2213-8587(21)00120-0

[3] Targeted therapy pralsetinib safely effectively treats lung and thyroid cancers with RET alterations.
Retrieved June 10, 2021, from https:// CStone Pharmaceuticals.
Retrieved June 10, 2021, from https://