Following bladder removal surgery, Keytruda (pembrolizumab) has demonstrated a significant increase in cancer-free survival for patients battling high-risk bladder cancers. The study, published in the New England Journal of Medicine, highlights the potential of Keytruda as a post-operative treatment option to delay cancer recurrence and improve patient outcomes.
Improved Cancer-Free Survival with Pembrolizumab
The trial involved 702 patients with high-risk bladder cancers who had undergone bladder removal. A significant portion (two-thirds) had also received pre-operative cisplatin. Patients were then randomized to receive either post-surgical Keytruda every three weeks for a year or were simply monitored. After a four-year follow-up, the Keytruda group showed an average cancer-free survival of nearly 30 months, compared to just over 14 months in the monitoring group.
Dr. Andrea Apolo, lead investigator and senior investigator in the Genitourinary Malignancies Branch of the Center for Cancer Research at the National Cancer Institute (NCI), stated, “This study shows that pembrolizumab can offer patients another treatment option to help keep their disease from coming back.” She added, “Extending the time that these patients are cancer-free makes a big difference in their quality of life.”
Impact of PD-L1 Expression
The study also revealed that the effectiveness of Keytruda was influenced by the PD-L1 status of the tumor. Patients with PD-L1-positive tumors experienced an even greater benefit, with cancer-free survival rising to almost 37 months on average, compared to 21 months in the monitoring group. Even in patients with PD-L1-negative tumors, Keytruda improved cancer-free survival to 17.3 months, a notable increase from the 9-month average in the monitoring group.
Current Treatment Landscape and the Role of Immunotherapy
High-risk bladder cancers with muscle invasion are typically treated with bladder removal surgeries, often followed by cisplatin chemotherapy to eliminate residual cancer cells. However, many patients cannot tolerate cisplatin due to its side effects, leaving them with limited options beyond close monitoring for recurrence. Immunotherapy drugs, such as Opdivo (nivolumab), have emerged as a valuable post-operative treatment. Opdivo received FDA approval in 2021 for post-surgical use against high-risk bladder cancers. This trial supports the use of Keytruda, a drug in the same class, as another effective strategy.
The findings suggest that Keytruda can provide a significant clinical benefit, particularly for patients who cannot tolerate cisplatin, offering them a chance to extend their cancer-free survival and improve their quality of life.
