Among patients with metastatic renal cell carcinoma (mRCC) who responded to frontline Bavencio (avelumab) and Inlyta (axitinib), updated phase 2 TIDE-A study findings presented at the 2025 Genitourinary Cancers Symposium supported the feasibility of maintenance Bavencio with Inlyta treatment interruption.
Glossary:
Progression-free survival (PFS): time a patient lives without disease worsening.
Overall survival (OS): time from diagnosis or treatment start until death.
Objective response rate (ORR): percentage of patients with partial or complete response to treatment.
Partial responses (PR): reduction in tumor size, but not complete remission.
Disease control rate: percentage of patients with stable, partial, or complete response.
Hepatic metastases: cancer spread to the liver.
ECOG performance status of 0 or 1: scale of daily activity ability (0 = fully active, 1 = some limitations).
Bulky or symptomatic disease: large cancer-causing noticeable symptoms.
Findings showed that at a median follow-up of 31.7 months, patients in the overall population (75 patients) achieved a median progression-free survival (PFS) of 27.9 months. The median overall survival (OS) was not reached (NR), and the 24-month OS rate was 85%.
Among the patients who interrupted Inlyta at week 36 (29 patients), the median PFS and OS were both NR; the 24-month PFS and OS rates were 58% and 82%, respectively. The median duration of first Bavencio maintenance was 16 weeks.
“This analysis with a longer follow-up confirmed the feasibility of [Vascular endothelial growth factor, VEGF, tyrosine kinase inhibitors, TKI] interruption and the high response rate after VEGFR TKI reintroduction in patients receiving [Bavencio] maintenance,” lead study author Dr. Daniela Arduini, of Fondazione Policlinico Universitario "Agostino Gemelli" IRCCS, and colleagues wrote in a poster presentation of the data.
Following Inlyta interruption, five patients remained on Bavencio monotherapy without disease progression. One patient discontinued Bavencio due to side effects after 35.8 months of maintenance. Two patients continued Bavencio despite evidence of disease progression, and 21 patients restarted Inlyta.
Among patients who restarted Inlyta, the objective response rate (ORR) was 50%, with partial responses (PR) in 10 patients, stable disease in eight patients and progressive disease in two. The median PFS following Inlyta reintroduction was 17.2 months.
“The progression during maintenance with [Bavencio] alone did not affect the response to the subsequent TKI reintroduction. This strategy warrants further investigation in a randomized trial,” study authors added.
Trail Enrollment Criteria and Design
TIDE-A enrolled patients with metastatic RCC who had measurable disease, an ECOG performance status of 0 or 1, no bulky or symptomatic disease and no hepatic metastases.
Patients were excluded if they received prior systemic therapy for advanced RCC; received prior adjuvant or neoadjuvant treatment; had an active seizure disorder or evidence of active brain metastases, spinal cord compression, or carcinomatous meningitis; or had a history of another malignancy within two years prior to enrollment, with the exception of adequately treated non-melanoma skin cancer or carcinoma in situ.
All enrolled patients initially received combination therapy with Bavencio at 800 milligrams (mg) once every two weeks plus Inlyta at 5 mg twice per day for 36 weeks. At week 36, patients underwent tumor evaluation, and those who achieved a PR — defined as a tumor volume reduction of at least 30% from baseline — discontinued Inlyta and continued Bavencio monotherapy at 800 mg once every two weeks until disease progression.
If disease progression occurred during Bavencio maintenance — defined as a tumor volume increase of at least 20% from the week 36 assessment — Inlyta was reintroduced at the same dose and discontinued again upon patients achieving a new PR. Patients who had stable disease at week 36 continued combination therapy until disease progression. Those with progressive disease at week 36 stopped all treatment.
The trial’s primary end goal was ORR at eight weeks following Inlyta discontinuation and initiation of Bavencio maintenance after 36 weeks of combination therapy. Secondary end goals included PFS, ORR for the combination period, disease control rate, OS, safety and patient-reported outcomes.
Reference
“Updated results of the TIDE-A study evaluating avelumab plus intermittent axitinib in previously untreated patients with metastatic renal cell carcinoma (mRCC),” by Dr. Arduini D, et al., J Clin Oncol.
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