How Was BALVERSA™ Studied?

  1. About BALVERSA™
  2. How Was BALVERSA™ Studied?

BALVERSA™ Clinical Study Details

BALVERSA™ was studied in 87 adults with advanced bladder cancer who had tried at least 1 chemotherapy

In the clinical trial for BALVERSA™, all patients had a tumor that tested positive for a certain type of abnormal FGFR gene. Everyone started on an 8-mg once-daily dose of BALVERSA™.

After about 2 weeks, all patients had a blood test to measure their phosphate levels. People with higher phosphate levels stayed at the 8-mg dose, while those with lower levels increased their dose to 9 mg once a day.

People stayed on BALVERSA™ until their tumors started to grow or until they had side effects that were too severe.

In the study, BALVERSA™ helped reduce the growth of tumors in patients who had an objective response

Remember, each person is different, so the results you see with BALVERSA™ may not be the same as in the study.

  • 32.2% of patients (28 out of 87) experienced a certain amount of tumor shrinkage (called an “objective response rate,” or ORR) 87 people were included in the assessment of ORR2.3% (2 out of 87) had a complete response and 29.9% (26 out of 87) had a partial response
  • Patients who had an objective response had their tumor shrinkage last for a median of 5.4 months. This means that for 50% of the patients, the response lasted for 5.4 months or longer, and for the other 50% of the patients, it was shorter than 5.4 months

See glossary for definitions of “objective response rate,” “complete response,” “partial response,” and “median.”