Roche withdrew Tecentriq’s indication for bladder cancer in US. What about Korea?

Roche has withdrawn Tecentriq’s indication for bladder cancer in the United States, but experts predict its effects on patients in clinical practice will not be significant.

On Nov. 28, Genentech, an affiliate of Roche, said it would voluntarily withdraw Tecentriq’s U.S. indication for treating adults with locally progressive or metastatic urinary tract epithelial cancer unsuited for cisplatin.

Roche won Tecentriq’s indication for bladder cancer through a fast-track approval process in the U.S. on the premise that it would conduct a confirmation clinical trial. It then carried out a phase 3 clinical trial, IMvigor130, to primarily treat progressive bladder cancer patients who had received no treatment.

As a result, the company failed to attain its first objective of proving the overall survival (OS) period compared to chemotherapy alone.

Faced with the disappointing outcome, Roche voluntarily withdrew Tecentriq’s primary indication for bladder cancer through consultation with the U.S. Food and Drug Administration. The company plans to release detailed results of IMvigor130 by holding an academic conference later.

“Bladder cancer is a disease with high unmet needs, and I feel it regrettable that the IMvigor130 study has failed to produce statistically significant results in OS,” said Dr. Levi Garraway, Roche’s chief medical officer (CMO). “However, I am certain that Tecentriq has the benefit of treating various cancers.”

According to industry insiders, Roche’s decision is highly likely to affect Korean patients by changing Tecentriq’s applications here.

Currently, immunotherapies approved for bladder cancer in Korea also include MSD’s Keytruda (pembrolizumab), Merck’s Bavencio (avelumab), and BMS & Ono’s Opdivo (nivolumab). Besides, J&J’s Balversa (erdafitinib) is a targeted treatment for bladder cancer. Globally, there is also Astellas’ Padceb (anfotumab betodin), but it has yet to win approval here.

Among them, treatment options that bladder patients can use are limited.

That explains why the U.S. National Comprehensive Cancer Network (NCCN)’s guidelines still recommend patients fit for cisplatin-based chemotherapy as the primary treatment use combination therapy of GC (gemcitabine + cisplatin) and dose-concentrated MVAC (methotrexate + vinblastine + doxorubicin + cisplatin).

“In reality, not many patients use immunotherapies for the primary treatment of bladder cancer. However, it is also true that Tecentriq’s withdrawal has reduced options for patients who would not or cannot receive chemotherapies,” said Professor Park In-geun of the Oncology Department at Asan Medical Center. “Nevertheless, the withdrawal is unlikely to exert much influence because there are immunotherapies that provide insurance benefits and those that can be used as primary maintenance treatment without insurance benefits.”

In response to the U.S. development, Roche Korea said, “We will discuss closely with the global headquarters and the Ministry of Food and Drug Safety to decide whether to maintain Tecentriq’s domestic indication. Furthermore, we will find the best ways to minimize the impact on Korean bladder cancer patients treated with Tecentriq.”