Trodelvy shows promise as a potential treatment option for patients with advanced or metastatic bladder cancer who have progressed after checkpoint inhibitor therapy.
Trodelvy (sacituzumab govitecan) demonstrated a relatively high response rate with rapid responses in patients with locally advanced (cancer that has spread beyond its original size) or metastatic (disease that spread to other areas) urothelial cancer, a type of bladder cancer, according to a study.
In the TROPHY-U-01 trial published in the Journal of Clinical Oncology, at a median follow-up of 9.3 months, patients demonstrated an overall response rate (percentage of people whose disease shrinks or disappears after treatment) of 32%, a clinical benefit rate (the percentage of patients who show improvement in their cancer after treatment) of 42%, median duration of response (the time from treatment until the disease progresses or the patient dies) of 5.6 months, median progression-free survival (how long a person lives without their disease getting worse) of 5.6 months and a median overall survival (the time from the start of treatment when a patient with cancer is still alive) of 13.5 months.
Patients that were included in the study had locally advanced or metastatic urothelial cancer whose disease progressed or recurred after a checkpoint inhibitor (this blocks certain proteins that cancer cells use to evade the immune response) and who were ineligible for cisplatin.
Some of the factors that determined whether a patient was ineligible for cisplatin included moderate functional impairment (assessed by the ECOG performance score), impaired kidney or heart function, and significant hearing loss or peripheral neuropathy (nerve pain, numbness, tingling, swelling or muscle weakness.
This trial included 38 patients (61% men) with a median age of 72.5 years. Among patients in the trial, 66% (25 patients) has visceral metastasis (disease that spread within the body cavity such as the abdomen or chest), of whom 29% (11 patients) had disease that metastasized to the liver. Fifty percent of patients received previous platinum-based chemotherapy as either neoadjuvant (first step to shrink a tumor before the main treatment) or adjuvant therapy (additional treatment given after the initial treatment to lower the risk for recurrence).
Patients in the study were treated with Trodelvy on days one and eight of a 21-day cycle. Treatment continued until disease progression, informed consent withdrawal and unacceptable side effects. Patients were allowed a five-week maximum break (decided upon by their cancer team) from treatment to recover from any harmful side effect.
The primary focus of the study was overall response rate. Secondary endpoints included duration of response, clinical benefit rate, progression-free survival and safety.
All 38 patients in the trial experienced at least one side effect from the treatment. Of note, 33 (87%) had at least a grade 3 (severe) side effect. The most common treatment-induced side effects of any grade included diarrhea (66%), fatigue (50%), nausea (53%), hair loss (50%), neutropenia (lower-than-normal number of neutrophils, a type of white blood cell; 45%), constipation (40%), leukopenia (low levels of leukocytes, a type of white blood cell; 34%) and decreased appetite (32%). These treatment-related side effects resulted in the interruption of Trodelvy treatment in 61% of patients, dose reduction in 37% and the discontinuation of Trodelvy in 21% of patients. Treatment discontinuation was attributed to diarrhea (2 patients), febrile neutropenia (fever with a low levels of neutrophils; 1 patient), colitis (inflammation of the colon; 1 patient), vomiting (1 patient), nausea (1 patient), fever (1 patient), weakness (1 patient), pneumonia (1 patient), sepsis (an extreme immune response to an infection that may lead to organ failure, tissue damage or death if not immediately treated; 1 patient) and maculopapular rash (a skin rash with a combination of flat, discolored areas and raised bumps; 1 patient).
“ [Trodelvy] demonstrated a relatively high [overall response rate] with manageable toxicity profile in cisplatin-ineligible patients with progression after [checkpoint inhibitors]. These data warrant further evaluation of [Trodelvy] (alone and in combinations) in [locally advanced]/mUC,” study authors concluded.
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