ESMO |。 Roche releases clinically exploratory data on Early Bladder Cancer Phase 3 of Tecentriq

On December 11th Roche presented an exploratory analysis of Phase 3 clinical study IMvigor010 at the Virtual Conference of immuno-oncology (ESMO IO) of the European Medical Oncology Society.
IMvigor010 is a global Phase 3 open label, randomized, controlled study that assesses the effectiveness and safety of Tecentriq® (atezolizumab) as a muscle-immersive urethra cancer (MIUC) patient (postoperative) complementary monotherapy compared to clinical observations.
809 MIUC patients in the study group, who had a higher risk of recurrence after excision.
the researchers assessed the main endpoint of disease-free survival (DFS), which is the time from random grouping to MIUC recurrence or death.
data from IMvigor010 showed an increase in DFS in patients treated with Tecentriq compared to clinical observations (median 5.9 months compared to 4.4 months, with a risk ratio of 0.58; 95% CI: 0.43-0.79).
total survival rate (OS) of the interim analysis also showed that tecentriq treatment was more beneficial in ctDNA-positive populations, with a median OS of 25.8 months (HR=0.59; 95% CI:0.41-0.86) compared to observation (15.8 months). The main efficacy results of the
exploratory analysis are as follows: Roche notes that while these pre-set analyses are exploratory and cannot be formally tested in accordance with the statistical plan in the IMvigor010 study, the data further enhance understanding of the disease and will provide the basis for a new Phase 3 study in patients with ctDNA-positive muscle-immersive bladder cancer.
as presented at the Virtual Conference of the American Society of Clinical Oncology 2020 (ASCO20), the IMvigor010 study did not reach the main endpoint of its DFS (Tecentriq group) compared to the observations of high-risk MIUC patients in the intended treatment population. For 19.4 months, the observation group was 16.6 months (HR=0.89;95%CI:0.74-1.08; p=0.2446)).
in the interim analysis of OS, neither treatment group reached the median (HR-0.85).
addition, TecCentriq's safety data are consistent with known single-drug treatment safety data and no new safety issues have been found.
statistics, urethra cancer accounts for about 90-95% of all bladder cancer cases.
MIUC is a type of urethra cancer that has spread to the bladder, ureter, or kidney muscles.
about 25 percent of new cases of bladder cancer are diagnosed with muscle-immersive disease, with poor prognosis compared to non-MIUC.
current treatment of MIUC patients is to provide early intervention to reduce the risk of recurrence or transfer to other parts of the body.
As tumors grow, dead cells are replaced by new cells that release tumor DNA into the bloodstream, known as ctDNA, which can be used in different ways, including identifying patients with minimal tumor residues, who may benefit most from complementary treatment, as well as those who do not benefit from complementary treatment.
in MIUC, ctDNA is a powerful prognosmological marker of disease recurrence.
more treatment options are needed after surgery, as about half of MIUC patients will relapse within 2 years of surgery, and because no predictive or prognostic biomarkers are currently used in MIUC clinical practice, more personalized treatment of the disease is required.
, Roche's chief medical officer and head of global product development, says that by using ctDNA and other biomarkers, we want to gain more awareness and personalize treatments.
bladder cancer is a complex and often difficult disease to treat, but as we learn more about its biological properties, we are becoming more aware of new treatments.
as a cancer immunotherapy, Tecentriq may be used as a base combination with other immunotherapy, targeted drugs, and various chemotherapy therapies for a wide range of cancers.
Currently, the drug has been approved in the United States, the European Union and countries around the world and can be used alone or in combination with targeted therapy and/or chemotherapy to treat non-small cell lung cancer, small cell lung cancer, certain types of metastatic urethrosarcular cancer, melanoma, PD-L1 positive metastatic triple negative breast cancer and hepatocellular carcinoma.
source: Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020