Roche announced interim results from its Phase III IMvigor130 clinical trial, indicating it met its co-primary endpoint of progression-free survival. The trial evaluated the combination of Tecentriq and platinum-based chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma compared to chemotherapy alone.
Roche announced interim results from its Phase III IMvigor130 clinical trial, indicating it met its co-primary endpoint of progression-free survival (PFS). The trial evaluated the combination of Tecentriq (atezolizumab) and platinum-based chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (mUC) compared to chemotherapy alone.
In this interim analysis, the trial met the co-primary endpoint of PFS with encouraging overall survival (OS) results, but the OS data was not yet mature and will require follow-up at the next planned analysis.
“IMvigor130 is the first positive Phase III study of a cancer immunotherapy combination in previously untreated advanced bladder cancer, an aggressive disease with high unmet need,” stated Sandra Horning, Roche’s chief medical officer and head of Global Product Development. “These results support our broad clinical development program for Tecentriq in bladder cancer, as well as our approach of combining immunotherapy with chemotherapy or other medicines to improve patient outcomes, and we look forward to discussing them with health authorities.”
The IMvigor130 trial is a multicenter, partially blinded, randomized Phase III study to evaluate the efficacy and safety of Tecentriq in combination with chemotherapy or by itself compared to chemotherapy alone in people with mUC who haven’t received previous systemic therapy for metastatic disease. It enrolled 1,213 patients who received either Tecentriq plus gemcitabine with either cisplatin or carboplatin, or Tecentriq alone, or gemcitabine with either cisplatin or carboplatin plus placebo.
Tecentriq is a checkpoint inhibitor that binds with PD-L1. It is approved in the U.S., European Union and other countries either alone or in combination with targeted therapies or chemotherapy in several types of non-small cell and small cell lung cancer, certain types of mUC, and in PD-L1-positive triple-negative breast cancer.
In the second quarter, Tecentriq brought in $450 million in sales, but it and other checkpoint inhibitors are getting clobbered by Merck’s Keytruda (pembrolizumab), which reported $2.6 billion in sales for the second quarter. This surpasses Bristol-Myers Squibb’s Opdivo (nivolumab), which brought in $1.823 billion in the second quarter.
It was in May 2017 that Roche’s Tecentriq failed in the IMvigor211 Phase III trial of the drug in locally advanced or metastatic urothelial cancer (mUC) whose disease progressed during or after receiving platinum-based chemotherapy. It failed to meet its primary endpoint of overall survival (OS) compared to chemotherapy.
The company has four ongoing Phase III clinical trials studying Tecentriq as a monotherapy or in combination with other drugs in early and advanced bladder cancer. It also has an extensive development program for the drug in lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
Last year, more than 500,000 new cases of bladder cancer were diagnosed around the world, with about 200,000 reported deaths. Urothelial carcinoma develops in the cells of the bladder lining and is the most common type of bladder cancer. It accounts for about 90% of all cases. Of those, 30% are advanced based on muscle-invasive or metastatic disease.
Roche indicated it will share the data from this most recent trial with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
