Bladder cancer patients and their families have faced years, and even decades, of waiting for a breakthrough in bladder cancer treatment. For some patients, the results of two clinical trials will provide a chance at survival.

The FDA recently approved drug combinations investigated in two early-phase clinical trials (CheckMate-901 and EV-302). Tumors either stopped growing or shrank in approximately 67% of patients treated with pembrolizumab plus enfortumab compared to 44% of patients treated with platinum-based chemotherapy.

Thirty percent of patients who received pembrolizumab plus enfortumab compared favorably against 12% of patients in the chemotherapy group.

Patients Now Have an Option

Advanced bladder cancer patients now have the option of being treated with Keytruda (pembrolizumab), an immunotherapy drug combined with Padcev (enfortumab vedotin). This combination has proven to be very powerful.

The patients who enrolled in the two trials had cancers that had metastasized (spread) to other body parts and could not be surgically removed. Both studies investigated immunotherapy drugs. Researchers reported the two trial results in Madrid at the October ESMO Annual Meeting. The announcement of a doubling in survival prompted the crowd to give a standing ovation.

The CheckMate-901 Trial

In the CheckMate trial funded by Bristol-Meyers Squibb, 600 patients with advanced bladder cancer were enrolled and received basic chemotherapy alone or combined with Opdivo (nivolumab), an immunotherapy drug.

In an eighteen-month follow-up of patients receiving pembrolizumab plus enfortumab, the team reported that this group survived a median of thirty-one months compared to sixteen months.

EV-302 is The Second Trial

Enfortumab, an antibody-drug conjugate, plus pembrolizumab, was investigated in the EV-302 trial funded by Astellas Pharma and Seagen, and presented as a basic chemotherapy regimen. The antibody-drug enfortumab is a therapy whereby an antibody transports a deadly payload into cancerous bladder cells.

It should be noted that patients who received the new combination had a longer life span than the patients who were treated with chemotherapy. For example, complete remission was triple the length of time for people receiving chemotherapy as a single agent. One-fifth of people receiving nivolumab were reported to have survived for almost five years.

Each group, however, reported side effects related to treatment such as:

• numbness or pain in feet and hands
• skin reactions
• nausea
• fatigue
• decrease in white and red blood cells

To give a better perspective, Dr. Andrea Apolo at NCI’s Genitourinary Branch said that the discovery of these two successful treatments is a monumental accomplishment.

The doctor acknowledged that to reach this milestone, there were many failed attempts, but now the future looks brighter for their patients.