- FDA sets June 19, 2026, as the target action date for WELIREG and KEYTRUDA review.
- Phase 3 LITESPARK-022 trial shows 28% reduction in RCC recurrence risk.
- KEYTRUDA and WELIREG combination improves disease-free survival in RCC.
- Safety profile consistent with previous studies; no new safety signals observed.
Trial Results
The Phase 3 LITESPARK-022 trial evaluated the combination of KEYTRUDA and WELIREG in patients with clear cell renal cell carcinoma (RCC) post-nephrectomy. The trial demonstrated a 28% reduction in the risk of disease recurrence or death compared to KEYTRUDA monotherapy. The median disease-free survival (DFS) was not reached in either arm, but the estimated 24-month DFS rate was 80.7% for the combination therapy versus 73.7% for KEYTRUDA plus placebo.
Regulatory Review
Based on these findings, the U.S. FDA has accepted priority review applications for the combination of WELIREG and KEYTRUDA, or KEYTRUDA QLEX, for adjuvant treatment in RCC patients with a clear cell component at increased risk of recurrence. The FDA has set a target action date of June 19, 2026, under the Prescription Drug User Fee Act (PDUFA).
Safety Profile
The safety profile of the KEYTRUDA and WELIREG combination was consistent with previous studies. Grade ≥3 treatment-emergent adverse events (TEAEs) occurred in 52.1% of patients receiving the combination therapy, compared to 30.2% in the KEYTRUDA plus placebo group. Common Grade ≥3 TEAEs included anemia, increased alanine aminotransferase (ALT), and hypoxia. Grade 5 treatment-emergent and treatment-related adverse events were similar between the treatment arms.
