Early Quality-of-Life Declines With Adjuvant Imfinzi and Imjudo in Resected RCC

Adjuvant therapy with Imfinzi (durvalumab) and Imjudo (tremelimumab-actl) in patients with resected renal cell carcinoma was associated with early reductions in patient-reported quality of life, according to findings presented at the 2026 ASCO Genitourinary Cancers Symposium.

Participants receiving the combination therapy reported meaningful declines in overall health, role functioning, fatigue, and insomnia at week 16. Although many early deficits improved by month 15, new declines emerged in cognitive function and pain, emphasizing the need to consider patient-reported outcomes alongside disease-free survival when evaluating the overall impact of treatment.

“These findings should be considered alongside the disease-free survival benefit when interpreting the trial results,” lead study author and presenter Dr. Sophie Merrick emphasized at the conference. She is a senior clinical research fellow at the University College London, MRC Clinical Trials Unit, in England.

RAMPART trial shows disease-free survival benefit

RAMPART is an international, investigator-led, open-label, phase 3 trial evaluating adjuvant immune checkpoint therapy versus active monitoring in patients with resected renal cell carcinoma at intermediate or high risk of recurrence. Patients were randomized in a 3:2:2 ratio to active monitoring (340 patients), Imfinzi monotherapy (225 patients), or Imfinzi plus Imjudo (225 patients).

In the intention-to-treat population, Imfinzi and Imjudo improved disease-free survival compared with active monitoring. Three-year disease-free survival was 81% with Imfinzi plus Imjudo versus 73% in the active monitoring arm (hazard ratio, 0.65).

“Evaluating quality of life is essential to understanding the overall impact of treatment,” Merrick said, emphasizing the need to understand the patient experience.

Study design and patient-reported outcomes assessment

The RAMPART quality-of-life sub-study was conducted as an optional component in English-speaking countries, including the United Kingdom and Australia. Patient-reported outcomes were collected using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire at baseline, week 16, and month 15, with a 7-day recall period.

A total of 329 participants consented to the sub-study, of whom 254 (104 receiving Imfinzi plus Imjudo, 150 active monitoring) completed baseline and at least one follow-up questionnaire, making them eligible for analysis. Analyses were exploratory and adjusted for baseline score and sex, with no correction for multiple testing.

The primary outcome was change in overall health and quality of life from baseline to month 15. Secondary outcomes included change from baseline to week 16, changes in five functional domains, nine symptom and single-item scales, and the proportion of participants experiencing improvement, stability, or deterioration in overall quality of life at each time point.

Baseline characteristics of patients enrolled in the sub-study were broadly similar to those of the overall trial population. Within the sub-study cohort, baseline characteristics between the Imfinzi plus Imjudo arm and the active monitoring arm were generally balanced. A slightly higher proportion of patients in the Imfinzi plus Imjudo arm were male (74% versus 68%).

Regarding performance status, 88% and 12% of patients in the Imfinzi plus Imjudo arm had an ECOG performance status of 0 and 1 compared with 80% and 20% in the active monitoring arm, respectively.

Safety and tolerability of the combination

Safety data from the Imfinzi plus Imjudo arm mirrored previous reports of adjuvant checkpoint therapy. Any-grade side effects occurred in 97% of Imfinzi plus Imjudo participants versus 63% in the active monitoring group. Grade 3 or higher side effects occurred in 40% of Imfinzi plus Imjudo recipients compared with 8% in active monitoring. Treatment discontinuation due to side effects was reported in 32% of patients receiving Imfinzi plus Imjudo, and 36% required systemic corticosteroids.

Serious side effects were reported in 34% of the Imfinzi plus Imjudo arm and 6% of the active monitoring arm. Treatment-related deaths were rare, occurring in less than 1% of participants. Common immune-related side effects included fatigue, diarrhea, colitis, pneumonitis, hypothyroidism, and dermatologic toxicity. These events were largely manageable but are relevant to interpreting early declines in patient-reported quality of life, particularly in functional and symptom domains.

Trends in quality of life and symptom burden

Change in overall health and quality of life from baseline to month 15 showed no statistically significant or clinically meaningful difference between treatment arms. Among the subset of participants who completed the QLQ-C30 questionnaire at both baseline and month 15, 59 patients in the Imfinzi plus Imjudo arm and 77 patients in the active monitoring arm were evaluable.

At week 16, patients receiving Imfinzi plus Imjudo reported clinically meaningful reductions in overall health and quality of life, role functioning, and higher fatigue and insomnia scores compared with active monitoring. The odds of a large reduction in quality of life at week 16 were significantly higher with Imfinzi plus Imjudo.

By month 15, many early deficits improved, with overall health and role functioning approaching baseline levels. However, new, clinically meaningful declines in cognitive function and pain were observed.

Limitations

The quality-of-life sub-study was limited by its optional design and open-label nature. Additionally, analyses were exploratory and conducted in a subset of the overall trial population. Completion rates declined over time, although follow-up was similar between arms.

References

1. “Patient-reported outcomes in resected renal cell carcinoma: Active monitoring vs. durvalumab and tremelimumab in the RAMPART trial,” by Dr. Sophie Merrick, et al. Thw Journal of Clinical Oncology.

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