Hengrui Pharmaceutical CDK 4/6 Inhibitor Phase 3 clinical studies reached the main endpoint

Source: Pharmaceutical Mission Hills On December 24, Hengrui Pharmaceuticals announced that it had reached the end of a phase 3 clinical study in patients with advanced breast cancer in the study of CDK 4/6 inhibitor SHR6390 tablets.
results showed that SHR6390 combined fluoravis groups significantly extended patients' progression-free survival compared to placebo combined fluoravis groups.
Plans to submit a pre-market communication application to the Drug Review Center (CDE) of the State Drug Administration of China.
CDK 4/6 (cell cycle protein-dependent kinases 4 and 6) is a key regulatory factor driving cell division.
study found that CDK 4/6 has been expressed in many cancer cells, resulting in an out-of-control cancer cell division cycle and infinite proliferation.
clinical studies confirmed that more than half of breast cancer patients had expressed cell cycle protein D, and that the majority were estrogen-positive (HR-plus) breast cancer patients.
because the cell cycle protein D directly actes on CDK 4/6, CDK 4/6 has become an important molecular target for patients with HR-positive metastatic breast cancer.
SHR6390 is an oral, efficient and selective small molecule CDK 4/6 inhibitor developed by Hengrui Pharmaceuticals, which is a new class 1 drug.
SHR6390 is able to selectively inhibit CDK4/6 kinase activity, thereby blocking the CDK4/6-Rb signaling path, inducing cell G1 blocking, and selectively inhibiting the proliferation of RB high-expression tumor cells, and thus achieve anti-tumor effect.
The main end point of this study is a multi-center, randomized, controlled, double-blind Phase 3 clinical study called SHR6390-III-301, which aims to assess the effectiveness and safety of SHR6390 combined fluorovis group compared to placebo combined fluoravis group therapy for HR-positive, HER2-negative localized or advanced metastatic breast cancer progression after endocrine therapy. The main endpoints of the
study were progress-free survival (PFS) assessed according to the RECISTv1.1 standard, and the secondary study endpoints included progress-free lifetime (PFS), total lifetime (OS), total mitigation rate (ORR), clinical benefit rate (CBR), objective mitigation duration (DOR), and safety assessed by the Independent Imaging Assessment Board.
Photo Source: 123RF According to a press release, the study included 361 subjects in the study who received SHR6390 or placebo combined fluoravis in a random group of 2:1, one treatment cycle every 28 days, including continuous use of the drug SHR6390 or placebo for the first 3 weeks, rest for the next week (not taking the drug), treatment until the disease progresses, toxicity is not acceptable, or other conditions that require termination of treatment.
results showed that for patients with HR-positive and HER2-negative advanced breast cancer who had previously received endocrine therapy, receiving SHR6390 combined fluoravis group therapy significantly extended the patient's progression-free survival compared to placebo combined fluoravis group.
is the second most common tumor in the world and one of the most common malignancies in women.
endocrine therapy is standard for hormone-positive female breast cancer patients, but primary and secondary resistance to endocrine therapy often leads to treatment failure, and the emergence of CDK 4/6 inhibitors offers new hope for these patients.
congratulations to Hengrui Pharmaceutical CDK 4/6 inhibitors on reaching the end of the phase 3 clinical trial, and hope that the drug will be approved at an early date to provide new treatment options for patients with advanced breast cancer.
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