Roche PI3K alpha inhibitors were declared clinically and accepted for the first time in China.

The Latest announcement from the Drug Review Center (CDE) of the State Drug Administration of China shows that Roche has declared clinical trials in China and received acceptance of the new drug PI3K alpha-specific inhibitor GDC-0077 in ChinaThis is the first time the product has been declared clinical in China, and the world is being used in Phase 3 clinical trials to treat HR-positive, HER2-negative breast cancer patientsIt is worth mentioning that at present, most of the PI3K inhibitors in China are still in the 1st or 2nd clinical stage, and the target product has not yet been approved for marketGDC-0077 is a PI3K alpha-specific inhibitorIt is more selective about PI3K alpha and can lead to the degradation of the mutant PI3K alpha, resulting in a more powerful, longer-lasting inhibition effectThe study found that the overactivity of the PI3K signaling pathway was significantly related to tumor progression, increased tumor microvascular density, cancer cell chemology and aggression, so the PI3K signaling pathway was regarded by researchers as one of the key targets for the development of cancer treatment drugstwo clinical studies were registered on the Clinicaltrials website, GDC-0077One is a randomized double-blind, placebo-controlled phase 3 study that evaluated the efficacy and safety of patients with PRE-local or metastatic breast cancer who combined the product with the CDK4/6 inhibitor palbociclib and the estrogen receptor antagonist fulvestrant in PIK3CA mutant, HR-positive, HER2-negative localized advanced or metastatic breast cancerAnother phase 1 study of open labeling, dose-increasing, assessed the safety of GDC-0077 as a single drug, tolerance and pharmacokinetics with local late-stage or metastatic PIK3CA mutant hormone receptor-positive breast cancer in patients with locally advanced or metastatic PIK3CA mutant solid tumors, and when used in combination with endocrine and targeted therapy in patientsGDC-0077 showed positive activity in a Phase 2 clinical trial with CDK4/6 inhibitors and endocrine therapies, which was conducted in February, in conjunction with CDK4/6 inhibitors and endocrine therapy, with GDC-0077 showing encouraging activity, with a combined therapy with a total remission rate of 52%Currently, GDC-0077 is being used in Phase 3 clinical trials to treat HR-positive, HER2-negative breast cancer patients, four PI3K inhibitors have been approved for public market worldwide, namely Gilead's idelalisib, Bayer's Copanlisib, Verastem's duvelisib and Novartis's ALpelisib (BYL719)However, most of china's PI3K inhibitors are still in the 1st or 2nd clinical stage, away from the approval of the listing, the research and development of the target of the company has Cinda Biology, and Huang China Medicine, Zhengda Qing, Arnold Pharmaceuticals and so onthis time GDC-0077 was declared clinically and accepted in China, and is another advance in Roche's recent research and development of new drugs in China following THE TIGIT inhibitor tiragolumabWe wish this product a smooth development in subsequent clinical development and an early benefit to more patients.