Have "broad-spectrum anti-cancer" potential! Roche's 3 new drugs have been approved clinically in China

At present, China has not been approved for "unlimited cancer" therapy.
but more and more open-ended cancer therapies have entered or are entering the clinical stage.
also means that Chinese patients are expected to usher in "broad-spectrum anti-cancer" therapy in the near future, into the era of broad-spectrum anti-cancer.
: Target P13K/AKT signal path Ipatasertib is an oral-specific inhibitor that targets P13K/AKT signal path and can be combined with three subtypes of AKT.
PI3K/AKT signaling path, which promotes tumor occurrence, tumor resistance and metabolic changes, and is very active, is considered to be one of the mechanisms by which tumor cells become resistant to immuno checkpoint inhibitors.
, inhibiting pi3K/AKT signaling pathfours prevents cancer cells from growing and surviving, and may also reverse the resistance of tumor cells to immunotherapy.
this time ipasertib was approved clinically in China to be developed for AKT1/2/3 mutation-positive solid tumors.
that almost all human cancers, such as breast, colorectal and blood cancers, have PI3K/AKT signaling disorders.
AKT is also considered a new target for broad-spectrum cancer.
screenshot Source: CDE.com Previously, ipatasertib has reached one of the main endpoints in Phase 3 clinical trials in patients treating metastatic desopathic prostate cancer (mCRPC).
in patients with PTEN anti-cancer gene deficiency, ipatasertib combination therapy significantly improved radiological progression-free survival (rPFS).
In the case of triple-negative breast cancer (TNBC), the results of a Phase 1b clinical trial of TNBC, where ipatasertib was treated with a combination of atilijuta and chemotherapy, showed an objective remission rate (ORR) of 73% for combination therapy, regardless of patient PD-L1 expression levels and PIC3CA/AKT1/PTEN gene variants.
phase 2 clinical trial, called LOTUS, showed that ipatasertib reduced disease progressity and risk of death by 56 percent when treating TNBC patients screened through molecular diagnosis.
: PD-L1 inhibitor Atili pearl monoanti is an anti-PD-L1 monoclonal antibody developed by Roche-owned Genentech.
it identifies and attacks tumor cells by binding to the surface of tumor cells and the PD-L1 protein on the surface of tumor-immersed immune cells.
, the product has been approved worldwide bladder cancer, urethra cancer, non-small cell lung cancer and widespread small cell lung cancer and other adaptations.
note that several clinical trials are currently testing the efficacy of PD-L1 inhibitors in "unlimited cancer" adaptations.
this time atili zhu single resistance in China was approved clinically, the proposed development of adaptive disorders have two.
First, atili-pearl monoantigen binding yew alcohol and metformin are used in patients with previously untreated metastatic tri-negative breast cancer, and second, atili-pearl monoantigen and gisithamin are used in patients with advanced bile duodenal cancer who have not previously received systemic treatment.
Screenshot Source: CDE.Com In the case of tricyclic breast cancer, atili-pearl monoantigen was approved in the United States in March 2019 to treat adult patients with partial late stage or metastasis tristastic breast cancer that cannot be removed in the form of albumin yew alcohol.
phase 3 clinical trial called Impassion 130, the combination therapy reduced the risk of disease and death by 40 percent, with a medium PFS of up to 7.4 months (vs 4.8 months).
And early studies of metformin for the treatment of tricycline breast cancer have been published in Nature and other journals, in animal tumor models, metformin and hemoglobin, PD-1 antibodies, BCL-2 inhibitors and other combined use can have a lethal effect on breast tumor cells.
this provides a scientific basis for the use of atili-pearl monoantiformin for tri-yin breast cancer.
In the case of advanced bilial cancer, a randomized multi-center Phase 2 study published in the American Association for Cancer Research (AACR) in 2020 showed that the treatment of bile gallbladder cancer with the single-use atili-pearl monoantitor Cobitinib reached its primary endpoint and significantly extended the progression-free survival period compared to the single-use atili-pearl monotherapy.
It is worth mentioning that atiliju monoantitor has been approved in China in February this year for the first-line treatment of a wide range of small cell lung cancer, its first-line treatment of advanced non-exteteable hepatocellular carcinoma new adaptation was also approved in October this year.
: Targeting ROS1 and NTRK gene fusion Entrectinib is a specific tyrosine kinase inhibitor designed for NTRK and ROS1 gene fusion, which inhibits TRK A/B/C and ROS1 kinase activity.
NTRK gene fusion may occur in tumors originating in different parts of the body, including breast cancer, bile tube cancer, colorectal cancer, neuroendocrine cancer, non-small cell lung cancer (NSCLC), pancreatic cancer, etc.
study showed that this "unlimited cancer" precision anti-cancer therapy in the treatment of NTRK fusion positive solid tumor patients, reached 57.4% objective remission rate, and reached 54.5% intracranial objective remission rate.
The entrectinib capsule/tablet was approved in three clinical trials in CDE to develop indications for the treatment of non-removable, locally advanced or metastatic solid tumor patients carrying specific carcinogenic gene changes or potential predictive biomarkers.
Previously, the product has been approved in China for a number of clinical trials, the adaptation is: NTRK-positive solid tumor children, patients with ROS1-positive local late stage or metastasis non-small cell lung cancer patients, NTRK1/2/3 gene mutation of local late stage or metastasis solid tumor patients.
Screenshot Source: CDE.Com It's worth noting that entrectinib's "unlimited cancer" adaptation was accelerated by the FDA in August 2019 to treat adult and adolescent cancer patients with NTRK gene fusion, making it the third "unlimited cancer" cancer treatment approved by the FDA.
, the product has also been approved for use in patients with non-small cell lung cancer with the ROS1 gene mutation.
: The Drug Review Center of the State Drug Administration of China. Retrieved Nov 26, 2020, from # [2] Roche's IPATential150 study evaluating ipatasertib in combination with abiraterone and prednisone/prednisolone met one of its co-primary endpoints. Retrieved June 20, 2020, from [3] Roche's ipatasertib in combination with Tecentriq and chemotherapy shows promising anti-tumour activity in triple-negative breast cancer in early phase trial. Retrieved April 1, 2019, from [4]Japan becomes the first country to approve Roche's personalised medicine Rozlytrek. Retrieved June 18, 2019, from [5] FDA approves third oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor. Retrieved August 15, 2019, from the Roche St. Tage Immunology Joint Treatment Program was approved in China for the treatment of hepatocellular carcinoma. Retrieved Oct 28, 2020, from Roche Source: Supplied