Bladder cancer: immunotherapy, keep moving forward! 2015-07-31 Global Consultation Expert Chen Haigo, Department of Urology, Shanghai Renji Hospital Editor: Wind of Yumi (Oncology Information – Contributing Editor) Editor’s own words You must remember that a few days ago, I just introduced a news which is not exactly the latest development, namely, PD-1 inhibitor Nivolumab (BMS) was approved for lung squamous cancer in Europe. In fact, immunotherapy uses the body’s own immune system to control cancer by blocking the PD-1/PD-L1 signaling pathway to cause cancer cells to die, so mechanistically it has the potential to treat many types of tumors and is expected to substantially improve overall patient survival. So today I will share with you the new progress of immunotherapy for bladder cancer. [30 years of bladder cancer treatment breakthroughs] The reason why this is a breakthrough in the history of bladder cancer treatment is that for 40 years since the 1976 article in J Urol confirmed the effectiveness of BCG vaccine for bladder cancer, the field has been moving forward. Professor Peter Johnson, chief clinician at Cancer Research UK, said: “Harnessing the action of the immune system, these new breakthrough therapies have given us many exciting results. The breakthrough in immunotherapy for the treatment of advanced bladder cancer further validates the power of this new therapy, which could be the new treatment for cancer we have been looking for for years.” A strong contender in bladder cancer immunotherapy is atezolizumab (PD-L1 inhibitor) from Roche. Roche just announced this month that results from a Phase II clinical trial – the IMvigor 210 study – met the primary study endpoint. atezolizumab was highly effective in treating locally advanced or metastatic bladder cancer. The open-label, multicenter, single-arm study enrolled patients with locally advanced or metastatic bladder cancer that had recurred after initial treatment (second-line or later). Patients were given intravenous atezolizumab 1200 mg d1 in cycles of 21 days until clinical benefit was lacking. The study showed that the benefit was more pronounced in patients with high PD-L1 expression. sandra Horning, CMO from Roche, said, “We plan to report the results at our next medical congress and will have further discussions with government agencies on how to bring this new treatment option to our patients more quickly” Also being studied in bladder cancer are two other PD inhibitors, nivolumab (Opdivo, Bristol-Myers Squibb) and pembrolizumab (Keytruda, Merck). However, according to data from GlobalData, Roche’s atezolizumab is moving faster in the bladder cancer field than these two competitors. Based on the results of the Phase Ib and Phase II studies of atezolizumab, Roche currently has a Phase III clinical study in progress, called IMvigor 211, which aims to compare the efficacy of atezolizumab with the current standard chemotherapy for recurrent bladder metastatic cell carcinoma. And another Phase III study, named IMvigor 010, is also underway to evaluate atezolizumab as adjuvant therapy for early-stage PD-L1-positive muscle-invasive bladder cancer. The development of multiple indications will give this drug “the potential to expand into multiple indications and thus become a leader in the bladder cancer treatment revolution we have been waiting so long for.” [Conclusion] Back last year, the US FDA has granted atezolizumab the status of breakthrough therapy for PD-L1 positive advanced bladder cancer. As we have mentioned before, immunotherapy has become a new hope for us to overcome those “big mountains” in the field of oncology. Bladder cancer and lung squamous cancer should only be the first step, and we wish the pioneering path of immunotherapy will go further!