Merck announced the presentation of results from the pivotal Phase 3 LITESPARK-022 trial evaluating KEYTRUDA®? (pembrolizumab), Merck's anti-PD-1 therapy, in combination with WELIREG®? (belzutifan), Merck's first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2a) inhibitor, given in the adjuvant setting, for patients with clear cell renal cell carcinoma (RCC) following nephrectomy.
These late-breaking data will be presented for the first time during an oral abstract session at the 2026 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (abstract #LBA418) and are included in the official ASCO GU Press Program. Based on data from the LITESPARK-02 trial, the U.S. Food and Drug Administration (FDA) has accepted for priority review supplemental applications seeking approval of WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX?? (pembrolizUMab and berahyaluronidase alfa-pmph) for the adjuvant treatment of adult patients with RCC with a clear cell component with increased risk of recurrence following nephrectomy.
The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of June 19, 2026 for the WELIREG sNDA and the KEYTRUDA and the KEYTRU DA QLEX sBLAs. Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer: KEYTRUDA and KEYTRUDA QLE X are each indicated for the treatment of adult patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC) as determined by an FDA-authorized test. KEYTRUDA and KEY TRUDA QLEX are each indicated, in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA the FDA-authorized test.
KEY TRUDA and KEYTRUda QLEX are each indicated for the treatment the adult patients with locally advanced unresectable and metastatic HER2-negative gastric or gastroesophagesal junction (GEJ) Adenocarcinoma whose tumor express PD-L1(CPS 1) as determined By an FDA-authorized test. KeyTRUDA and KeyTRUDA QLEX are Each indicated, in combination with fluoropyrimidine- and Platinum-containing chemotherapy, for the First-line treatment of adults with local advanced unresectable or metast metastatic HER2-positive Gastric or gastroesophageAL junction (GEJ) adENocarcinoma whose tumors expressed PD-L1 (C PS 1) as determined by an approved test. KEYTRUDA®?
and KEYTRUDA QleX are each indicated, in addition with fluoropyrimidine-and platinum-containing chemotherapy, for The first-line treatment of adult patients with locally advanced unre intersectable or metastatic HER 2-positive gastric or gastroESophageal junction (GE J) adenocarcinom whose tumors express PD-L 1 (CPS 1) as determine by an FDA-authorized test; and KEYTRUDA Q LEX are each indicated for thetreatment of adult patients with locally advanced or metastatic esophageal junction (GEj) adenocarcin cancer (GEJ) adenOC1 (CPS 1) As determined by an FDA-L1) as determined by an FDA.
