EV-302: Patient-Reported Outcomes Show Improved Survival, Quality of Life

A recent study evaluating patient-reported outcomes from the phase 3 EV-302 trial demonstrated that the combination of enfortumab vedotin and pembrolizumab (EV+P) offers significant benefits for patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). This combination nearly doubled the median progression-free survival and overall survival compared with the standard platinum-based chemotherapy (PBC). The patient-reported outcomes (PROs) from this trial were presented at the 2024 American Society of Clinical Oncology Annual Meeting and shed light on how these treatments impact patients’ quality of life (QOL).

The EV-302 trial involved 886 patients who were randomly assigned to receive either EV+P or PBC, which consisted of gemcitabine combined with cisplatin or carboplatin. The trial utilized 2 main tools for PRO assessments: the EORTC Quality of Life Questionnaire (EORTC QLQ-C30) and the Brief Pain Inventory Short Form. Patients completed these assessments at the start of the trial, weekly for the first 12 weeks, and every 3 weeks thereafter, continuing through the survival follow-up period, including after any disease progression.

Out of the 886 participants, 731 patients completed the baseline PRO questionnaires, with 376 in the EV+P group and 355 in the PBC group. Compliance with the PRO assessments was higher in the EV+P group, remaining above 70% through week 29, while compliance in the PBC group dropped after week 17.

The median time to pain progression for patients treated with EV+P was 14.2 months, compared with 10.0 months for those receiving PBC. Although the difference did not reach statistical significance (hazard ratio [HR], 0.92; P=.48), the results indicated a trend toward better pain management with EV+P. Additionally, at week 26, patients in the EV+P group reported a greater reduction in worst pain scores compared with those in the PBC group (−0.61 vs −0.03).

Patients experiencing moderate to severe pain at baseline showed meaningful improvements when treated with EV+P. These patients maintained a significant reduction in worst pain from week 3 through week 26 of the trial.

QOL was evaluated using the EORTC QLQ-C30 Global Health Status/Quality of Life (GHS/QOL) scale. Patients treated with EV+P initially experienced a slight worsening in GHS/QOL scores at week 3, but their scores returned to baseline levels from weeks 4 through 26. In contrast, patients undergoing PBC treatment saw a continuous decline in their GHS/QOL scores from week 1 through week 17, with their scores only returning to baseline after this period.

The time to confirmed deterioration (TTCD) of GHS/QOL was also measured, with the EV+P group showing a median TTCD of 5.9 months compared with 3.2 months in the PBC group.

Overall, the EV-302 trial findings highlight that patients treated with EV+P experience improved survival without detriment to their QOL and functioning. These results support the clinical value of EV+P as a treatment for patients with la/mUC, offering a viable option that not only extends survival but also helps maintain a better QOL. Despite some lower-than-expected compliance rates, especially after disease progression in the PBC group, the positive outcomes associated with EV+P underscore its potential as a beneficial treatment strategy for this patient population.