The study published by Professor Andrea Necchi in the international journal The Lancet Oncology, titled “Neoadjuvant sacituzumab govitecan plus pembrolizumab, followed by adjuvant pembrolizumab, in patients with muscle-invasive bladder cancer (SURE-02): a single-arm, phase 2 study,” evaluated a new treatment strategy for muscle-invasive bladder cancer. The current standard treatment involves chemotherapy before surgery followed by removal of the bladder, but about half of patients cannot receive—or choose not to undergo—chemotherapy.
For this reason, researchers tested an alternative approach in the SURE-02 study conducted at the IRCCS Ospedale San Raffaele in Milan. The treatment combines two innovative drugs: pembrolizumab, an immunotherapy that stimulates the immune system to attack cancer cells, and sacituzumab govitecan, a targeted therapy that delivers chemotherapy directly to tumor cells.
The study included 49 patients with non-metastatic bladder cancer who were not eligible for standard chemotherapy. After four cycles of treatment, the tumor response was assessed: some patients underwent bladder removal surgery, while others chose a bladder-preserving approach with a repeat endoscopic procedure. All patients then continued treatment with pembrolizumab.
After about 14 months of follow-up, 39% of patients showed no signs of cancer. All of these patients remained free of metastases, although in two cases the tumor recurred in the bladder.
Serious side effects were limited (16% of patients), most commonly diarrhea, and no treatment-related deaths occurred.
In summary, the combination of pembrolizumab and sacituzumab govitecan before surgery may represent a promising bladder-preserving strategy, achieving complete remission in about 4 out of 10 patients. However, larger studies with longer follow-up are needed to confirm these results.
