Reporter and Curator: Dr. Sudipta Saha, Ph.D.
A large clinical trial has shown that pembrolizumab (Keytruda), an immunotherapy drug, nearly doubles the cancer-free survival time for patients with high-risk, muscle-invasive bladder cancer following surgery. The study, published on September 15, 2024, in The New England Journal of Medicine, was led by NIH researchers and demonstrated that pembrolizumab outperforms traditional observation methods post-surgery. Patients receiving pembrolizumab had a median cancer-free survival of 29.6 months, compared to 14.2 months for the observation group.
The trial enrolled 702 participants, some of whom had previously undergone cisplatin-based chemotherapy (neoadjuvant therapy). Pembrolizumab was administered every three weeks for a year. The drug was well tolerated, with common side effects including fatigue, itching, diarrhea, and thyroid issues.
Interestingly, the benefit of pembrolizumab was seen regardless of the tumor’s PD-L1 status.
- Patients with PD-L1-positive tumors had a median cancer-free survival of 36.9 months.
- Patients with PD-L1-negative tumors experienced 17.3 months cancer-free.
These results suggest that PD-L1 status should not be the sole factor in selecting patients for this therapy.
While overall survival rates were similar between the pembrolizumab and observation groups, many patients in the observation group began taking nivolumab once it was approved, complicating survival comparisons. Researchers are continuing to explore other treatment combinations and biomarkers to better personalize adjuvant therapy for bladder cancer patients.
References:
https://www.nejm.org/doi/full/10.1056/NEJMoa2401726
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