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On August 6, local time, Roche released data from The Phase 3 clinical study IMpassion131, a phase 3 clinical study of PD-L1 inhibitor Tecentriq and cyanosis (chemotherapeutic therapy), a first-line treatment for PD-L1-positive metastatic trinegativealbreasty breast cancer (TNBC).
results showed that the study reached the primary endpoint, and that the improvement in progression-free survival (PFS) in the Tecentriq-sequoia group was statistically significant compared to the yew alcohol and placebo.
but unfortunately, the secondary end point total lifetime (OS) data is in negative trend.
IMpassion131 is a multicenter, random, double-blind phase 3 study that evaluated the efficacy and safety of Tecentriq combined sequoia alcohol in previously untreated, non-treatable locally advanced or metastatic TNBC patients.
a total of 651 people were recruited in a 2:1 ratio and treated with Tecentriq or placebo-linked yew alcohol. the main endpoint of
was PFS in the PD-L1-positive patient sist (ITT) population assessed by the researchers, and the secondary endpoint included OS, objective remission rate, and duration of remission.
it is understood that the analysis, the data is not mature, at this stage the data can not support the secondary endpoint OS.
researchers plan to continue tracking OS until the final analysis.
the safety of the Tecentriq co-use scheme is consistent with the known safety of a single drug, and no new safety signals have been found.
full results on IMpassion131 will be presented at a future medical conference.
in previous IMpassion130 studies, Tecentriq and Abraxane (the acid olp protein-combined particle suspension injection, the active ingredient is nab-yewol), showed a statistically significant improvement in PFS.
not formally tested, the therapy showed clinically significant OS improvement in patients with metastatic TNBC patients who expressed pD-L1 expression of more than 1%.
Tecentriq's co-treatment of PD-L1 expression pD-L1 is 1% of non-removable locallate or metastatic TNBC adult patients and has been approved in more than 70 countries.
breast cancer is the most common cancer in women, with more than 2 million cases diagnosed worldwide each year.
TNBC is a type of breast cancer that lacks estrogen, progesterone, and HER2 amplification to target receptor expression.
therefore, special effects that target these receptors are often ineffective in such patients. about 15 percent of breast cancer patients
are TNBC.
tNBC is more common among women under 50 than other forms of breast cancer.
the transfer of TNBC is moving fast and oS is short.
Tecentriq is a monoclonal antibody that binds to PD-L1 and activates T cells by inhibiting PD-L1, a cancer immunotherapy that has the potential to be used in combination with other immunotherapy, targeted drugs, and chemotherapy.
Roche's extensive development program for Tecentriq, including ongoing or planned phase 3 clinical studies of urinary tract cancer, skin cancer, breast cancer, gastrointestinal cancer, gynaecological cancer, and head and neck cancer, will evaluate the effectiveness of Tecentriq single drug therapy or in combination with other drugs.
Tecentriq has been approved as a single drug treatment in the United States, the European Union and other countries or in combination with other treatments for various forms of non-small cell lung cancer, small cell lung cancer, certain types of metastatic urinary tract skin cancer and PD-L1-positive metastatic trinegativeal breast cancer.
in China, Tecentriq has been approved for combined chemotherapy to treat small cell lung cancer, first-line treatment of advanced hepatocellular carcinoma has been qualified for priority review, and has opened a clinical trial of sanyin breast cancer sympathising drug.
reference source: Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with meta triplestatic-negative breast cancer.