medwireNews: A review of trial records has identified a high rate of all-grade pneumonitis in people with metastatic urothelial carcinoma receiving enfortumab vedotin (EV).
The researchers explain that pneumonitis was not considered an adverse event of special interest in the EV-201 and EV-301 trials of the antibody–drug conjugate for metastatic urothelial cancer.
But they “unexpectedly encountered 2 grade 5 pneumonitis events that had not been reported at that time” and therefore “decided to closely review the records and CT [computed tomography] findings of a subset of patients treated with EV to determine the incidence, severity, and clinical outcomes of EV-related pneumonitis.”
The analysis focused on 64 EV-treated participants of the two trials recruited from one of eight institutions in South Korea. Participants were aged a median of 67 years, the majority (80%) were men, and all had previously received anti-PD-1 or anti-PD-L1 therapy, with the final dose administered a median of 5.6 weeks before the start of EV.
As reported in the European Journal of Cancer, 18 (28.1%) of these patients experienced pneumonitis of any grade at a median of 13.1 weeks from EV initiation. The majority (77.8%) of the events were of grade 1 or 2, with just 22.2% of grade 3 or worse.
Eleven patients with pneumonitis presented with symptoms, most commonly dyspnea (50.0%), fever (22.2%), and cough (16.7%), while the remaining seven were asymptomatic at the time of detection of the initial radiologic abnormality.
A third of the patients received corticosteroid treatment for pneumonitis, 22.2% discontinued EV permanently, and 11.1% died “despite high-dose steroid treatment and ventilator care,” report Jae Lyun Lee (University of Ulsan College of Medicine, Seoul, Republic of Korea) and co-investigators.
The authors caution that they “could not rule out the relationship with prior immunotherapy administration,” but “recommend that patients presenting with non-specific pulmonary symptoms while receiving EV should be evaluated with a chest CT to rule out the possibility of pneumonitis to prevent further lung damage.”
They continue: “As EV is becoming a turning point in the therapeutic landscape of [metastatic urothelial carcinoma], clinician awareness and early recognition of EV-related pneumonitis is essential to protect patients from potential serious adverse events.”
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