Among patients with advanced bladder cancer who are potentially ineligible for platinum-based chemotherapy, initial treatment with Keytruda has consistent antitumor activity and safety, regardless of the variable definitions of platinum ineligibility used, according to study findings published in Cancer.
In this analysis, patients from KEYNOTE-052 (370 patients) and LEAP-011 (242 patients) who were deemed potentially platinum ineligible, were evaluated with median follow‐ups of 56.3 months and 12.8 months, respectively.
Group 1 demonstrated an objective response rate (ORR) of 26.2%, with a median progression-free survival (PFS) of 2.7 months and a median overall survival (OS) of 10.1 months. Group 2 showed an ORR ranging from 23.5% to 33.3%, with a median PFS between 2.1 and 4.4 months and a median OS between 9.1 and 10.1 months. Group 3 exhibited an ORR range of 25.7% to 27.9%, with a median PFS ranging from 2.1 to 2.8 months and a median OS between 9.0 and 10.6 months.
“Results from this exploratory post hoc analysis suggest that [Keytruda] monotherapy remains a feasible and effective treatment option in patients ineligible for platinum‐based chemotherapy and support its use in select patients with advanced/unresectable [bladder cancer] in the frontline setting,” the study authors wrote.
Group 1 included patients with an ECOG performance score of 2 (unable to carry out any work activities), a measure of a patient's functional ability. Group 2 included patients with an ECOG score of 2 and at least one of the following: aged 80 years or older, kidney dysfunction or visceral disease. Group 3 included patients with any two other factors, regardless of their ECOG score.
Regarding safety, the number of patients who experienced treatment-related side effects was the same across all groups. Similarly, the frequency of severe side effects, treatment-related deaths and treatment discontinuations due to side effects were comparable among the groups.
In addition, one patient died from myositis, one from grade 3 (severe) thyroiditis, one from grade 3 hepatitis, one from grade 3 pneumonia, one from grade 4 (life-threatening) myocarditis and one from renal failure.
According to the study, a global standardized definition of platinum ineligibility currently does not exist. This analysis compared patients who were deemed platinum ineligible based on multiple varying criteria definitions.
The study authors also discussed Padcev (enfortumab vedotin-ejfv) plus Keytruda, and its approval as a first-line treatment for patients with advanced bladder cancer ineligible for cisplatin-based chemotherapy, based on EV-103 and EV-302 trials. The confirmed ORR was 64.5% with Padcev plus Keytruda and 45.2% with Padcev alone.
READ MORE: FDA APPROVES PADCEV-KEYTRUDA COMBO FOR ADVANCED BLADDER CANCER
“The approval of [Padcev] in combination with [Keytruda] in the first‐line setting (regardless of cisplatin eligibility) could alter the decision calculus around treatment options for patients who are platinum ineligible,” the study authors wrote. “Although the vast majority of patients are anticipated to be eligible to receive [Padcev] plus [Keytruda], a subset of patients who are deemed ineligible for platinum‐based chemotherapy and [Padcev] plus [Keytruda] may still benefit from [Keytruda] monotherapy.”
Patients were to receive 200 milligrams of Keytruda intravenously, meaning into the vein, every 3 weeks.
The trial’s main focuses included ORR, PFS, OS and safety.
Reference
“Efficacy and safety of pembrolizumab in patients with advanced urothelial carcinoma deemed potentially ineligible for platinum‐containing chemotherapy: Post hoc analysis of KEYNOTE‐052 and LEAP‐011Title” by Dr. Peter H. O’Donnell, et al., Cancer.
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