Roche Phase III IMvigor-010 Clinical Trial Fails to Meet Endpoint for Muscle-Invasive Urothelial Cancer

Roche Phase III IMvigor-010 Clinical Trial Fails to Meet Endpoint for Muscle-Invasive Urothelial Cancer

Roche announced that the Phase III IMvigor-010 study evaluating Tecentriq® (atezolizumab) as an adjuvant (post-surgery) monotherapy treatment failed to meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with the known safety profile of the medicine and no new safety signals were identified.

The Challenge

Roche sought to use the IMvigor-010 study to take on this form of cancer. Muscle-invasive urothelial (transitional cell) carcinoma is a potentially lethal condition for which an attempt at curative surgery is required. Clinical staging does not allow for accurate determination of eventual pathologic status. Muscle-invasive urothelial carcinoma is a highly progressive disease, and initiation of definitive therapy within 3 months of diagnosis is worthwhile.

In 2018, there were over half a million new cases of bladder cancer diagnosed globally, with approximately 200,000 deaths from the disease, reports Roche. Urothelial cancer is the most common type of bladder cancer, accounting for about 90–95% of all cases. MIUC is a type of urothelial cancer that has spread into the muscle of the bladder, ureter or renal pelvis. Approximately 25% of new cases of bladder cancer are diagnosed with muscle-invasive disease, which is associated with a poorer prognosis than non-MIUC.

As reported by Roche, the goal in treating MIUC early is to mitigate the risk of the disease recurring or spreading to other parts of the body. Other treatment options following surgery are needed as approximately half of people with MIUC will develop a recurrence of their disease within 2 years of surgery.

Roche Disappointment

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche reported, “Reducing the risk that muscle-invasive urothelial cancer will recur after surgery is very difficult, and we are disappointed that we were not able to significantly prolong disease-free survival.” However, Dr. Garraway noted “We remain committed to exploring the potential benefits of immunotherapy for more people with early cancers.”      

About the IMvigor010 study

IMvigor010 is a global Phase III, open-label, randomized, controlled study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq compared to observation in 809 people with MIUC, who are at high risk for recurrence following resection. The primary endpoint is DFS as assessed by investigator, which is defined as the time from randomization to invasive urothelial cancer recurrence or death.                                                                                                       

About Tecentriq

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptor. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programmed is based on our greater understanding of how the immune system interacts with tumors and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU, and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

About Roche in cancer immunotherapy

For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, they’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.