Muscle-immersive urethroma (MIUC) immunotherapy! Roche Tecentriq shows strong results in ctDNA-positive patients!

December 11, 2020 // -- Roche recently presented the anti-PD-L1 therapy Tecentriq at the European Society of Oncology's Online Conference on Immuno-Oncology (ESMO IO) Common name: atezolizumab, atilijudium monoanti) as an auxiliary (postoperative) single-drug therapy to treat muscle-immersive urethrial skin cancer (MIUC) Phase III IMvigor010 study of exploratory results.
the study was conducted in a global, open-label, randomized, controlled Phase III study in MIUC patients with a high risk of recurrence after 809 routine excisions and assessed the effectiveness and safety of Tecentriq single-drug-assisted therapy and observation.
end point of the study was the researchers' assessment of disease-free survival (DFS), which was the time when skin cancer returned or died from random grouping to immersive urethra.
the results, presented at the American Society of Clinical Oncology's 2020 Annual Meeting (ASCO20) online meeting, showed that Tecentriq single-drug-assisted therapy did not achieve the main endpoint of improving DFS in high-risk MIUS patients in the intentional therapy (ITT) population compared to observation (19.19.) 4 months (Tecentriq Group) vs 16.6 months (Observation Group); HR=0.89,95%CI:0.74-1.08, p=0.2446).
analysis of total lifetime (OS), the mid-OS for both groups was not reached.
the safety of Tecentriq is consistent with the known safety of the drug and no new safety signals have been detected.
exploratory analysis published at the ESMO IO conference showed that DFS in patients in the Tecentriq treatment group showed improved DFS compared to the observation group (medium DFS: 5.9 months vs 4.4 months; HR=0.58,95%CI:0.43-0.79).
in the ctDNA-positive patient population, the OS data also benefited Tecentriq (25.8 months (Tecentriq group) vs 15.8 months (observation group); HR=0.59,95% CI:0.41-0.86).
While these pre-designated analyses are exploratory and cannot be formally tested in accordance with the statistical plan in the IMvigor010 study, the data further enhance understanding of MIUC disease and will provide insights into a new Phase III study in ctDNA-positive MIUC patients. "Bladder cancer is a complex and often difficult disease to treat, but as we continue to understand its biological characteristics, we are becoming clearer about new treatment pathways," said Dr. Levi Garraway, Roche's chief medical officer and head of global product development at
Bladder Cancer (photo source - medscape.com)
by using ctDNA and other biomarkers, we want more insights to make treatments more personalized.
are applying these findings to our clinical development program.
" currently, the goal of treating MIUC patients is to provide early intervention to reduce the risk of the disease relapsing or spreading to other parts of the body.
as the tumor grows, dead cells are replaced by new cells that release tumor DNA into the bloodstream.
, known as ctDNA, can be used in different ways, including identifying patients with tiny residual diseases (MRDs) who are most likely to benefit most from complementary treatments.
in MIUC, ctDNA is a strong prognosmological marker of disease recurrence.
MIUC patients need more treatment options after surgery, as about half of patients will relapse within 2 years of surgery, and because MIUC does not use predictive or prognostic biomarkers in current clinical practice, more personalized treatment of the disease is required.
In addition to the ongoing Phase III study of early and late bladder cancer, Roche has developed an extensive clinical trial development program for Tecentriq, including ongoing and planned Phase III studies covering a wide range of types of tumors, including lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers.
these studies are evaluating Tecentriq as a monotherapy and in combination with other drugs.
2018, more than half a million new cases of bladder cancer have been confirmed worldwide, and about 200,000 people will die from the disease.
urine cortoma (UC) is the most common type of bladder cancer, accounting for about 90 to 95 percent of all cases.
MIUC is a UC that has spread to the muscles of the bladder, ureter, or kidney.
about 25 percent of new cases of bladder cancer are diagnosed with muscle-immersive disease, with a worse prognosis than non-muscle-immersive urethra cancer (non-MIUC).
early treatment of MIUC is to reduce the risk of disease recurrence or spread to other parts of the body.
that since about half of MIUC patients will have a recurrence within 2 years of surgery, more postoperative treatment options are needed.
Tecentriq is an oncology immunotherapy whose active drug ingredient is atzolizumab, a monoclonal antibody that targets the PD-L1 protein and is designed to bind to PD-L1 on the surface of tumor cells and tumor-immersive immune cells, blocking its binding to PD-1 and B7.1 receptors.
by inhibiting PD-L1, Tecentriq is able to reactivate T cells.
the drug has the potential to be used as a base drug, combining other immunotherapy, targeted therapies and various chemotherapy options to treat multiple types of tumors.
Tecentriq has been approved as a single drug or in combination with targeted therapies and/or chemotherapy in various types of non-small cell lung and small cell lung cancer, certain types of metastatic urethra skin cancer (mUC), PD-L1 positive metastatic triple negative breast cancer (TNBC).
the original source: Roche presents exploratory data from the Phase III IMvigor010 study in early bladder cancer at the ESMO Immuno-Oncology Virtual Congress 2020