New class of drug leads to 30% reduced risk of death for cancer patients

Pharma News: A new type of drug that helps target chemotherapy directly to cancer cells has been found to significantly increase survival of patients with the most common form of bladder cancer, according to results from a phase III clinical trial.

Urothelial cancer (UC) is the most common type of bladder cancer (90% of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra. Globally, approximately 549,000 new cases of bladder cancer and 200,000 deaths are reported annually.

Currently, sequenced platinum-based chemotherapy and PD-1/PD-L1 inhibition are the standard of care for patients with advanced UC. Intrinsic and acquired resistance do occur with chemotherapy, and durable responses to immune checkpoint inhibition occur only in a minority of patients.

“Treatment after platinum-based chemotherapy and immune checkpoint inhibitors is challenging,” said Thomas Powles, MD, PhD, FCRP, of Barts Cancer Centre, Queen Mary University of London, who presented results of the EV-301 trial at the 2021 American Society of Clinical Oncology’s Genitourinary Cancers Symposium. “Overall survival [OS] is short, [and] therapeutic options are also limited. In this setting, new therapeutic agents supported by randomized trials are needed.”

The clinical trial involved 608 patients in 19 countries and tested Padcev (enfortumab vedotin), developed by Astellas Pharma and Seagen, in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and an immunotherapy drug called a PD-1/L1 inhibitor. It found that:

• The risk of death was 30% lower with Padcev than with standard chemotherapy (docetaxel, vinflunine or paclitaxel), with a median survival of approximately 13 months for Padcev.
• Median progression-free survival (PFS) was 5.6 months for Padcev vs. 3.7 months for chemotherapy (p < 0.00001)
• Overall response rate (RR), the percentage of patients with either complete or partial response, was 40.6% for Padcev vs. 17.9% of patients in the chemotherapy arm (p < 0.001)
• The side effects of the drug were manageable and overall similar to chemotherapy.

“This new type of drug has led to a survival advantage in bladder cancer which has been difficult to achieve in this difficult disease. It reduced the death rate by 30% and beat chemotherapy in every setting, so this really is a big deal,” added Dr Powles.

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