Dr Choueiri on the Background of the Phase 3 LITESPARK-022 Trial in ccRCC

Toni K. Choueiri, MD, the director of the Lank Center for Genitourinary Oncology and the medical director of International Strategic Initiatives at Dana-Farber Cancer Institute, as well as the Jerome and Nancy Kohlberg Professor of Medicine at Harvard Medical School, discussed the background data that led to the initiation of the phase 3 LITESPARK-022 trial (NCT05239728) of belzutifan (Welireg) plus pembrolizumab (Keytruda) for the adjuvant treatment of patients with clear cell renal cell carcinoma (ccRCC) after nephrectomy.

Prior findings from the phase 3 KEYNOTE-564 trial (NCT03142334) demonstrated that pembrolizumab was effective and offered an overall survival (OS) benefit vs placebo for the treatment of patients with ccRCC with an increased risk of disease recurrence following surgery, Choueiri began. Belzutifan is a HIF-2α inhibitor that is well tolerated and approved by the FDA for the treatment of patients with advanced RCC following treatment with a PD-1 or PD-L1 inhibitor and a VEGF TKI, he continued. Therefore, investigators were interested in combining the 2 agents in the adjuvant setting in LITESPARK-022, he concluded.

The primary end point of LITESPARK-022 was investigator-assessed disease-free survival. OS was a key secondary end point and safety was also assessed as a secondary end point.

Disclosures: Choueiri reported holding a leadership position with ASCO; having stock and other ownership Interests with Abalytics Oncology, Bicycle Therapeutics, Curesponse, Faron Pharmaceuticals, Inndura, Osel, Pionyr, Precede Bio, Primium, and Tempest Therapeutics; receiving honorariafrom Alkermes, Analysis Group, Aravive, Arcus Biosciences, ASCO, AstraZeneca, Bayer, Bristol-Myers Squibb, Clinical Care Options, Eisai, EMD Serono, ESMO, Exelixis, Foundation Medicine, Gilead Sciences, Gilead Sciences, GlaxoSmithKline, Harborside Press, HiberCell, Infinity Pharmaceuticals, Ipsen, Janssen Oncology, Kanaph Therapeutics, Lancet Oncology, Lilly, MashupMD, Merck, Michael J. Hennessy Associates, Navinata Health, NCCN, NiKang Therapeutics, Novartis, Peloton Therapeutics, Pfizer, PlatformQ Health, Precede Bio, Prometheus, Roche/Genentech, Sanofi/Aventis, Scholar Rock, Tempest Therapeutics, The New England Journal of Medicine, and UpToDate; holding consulting or advisory roleswith alkermes, Analysis Group, Aravive, Arcus Biosciences, ASCO, AstraZeneca, Bayer, Bicycle Therapeutics, Bristol-Myers Squibb, Caris Life Sciences, Clinical Care Options, Curesponse, Eisai, EMD Serono, ESMO, Exelixis, Foundation Medicine, Gilead Sciences, Gilead Sciences, GlaxoSmithKline, Harborside Press, Infinity Pharmaceuticals, Ipsen, Janssen Oncology, Kanaph Therapeutics, Lancet Oncology, Lilly, Merck, Michael J. Hennessy Associates, Navinata Health, NCCN, Neomorph, NiKang Therapeutics, Novartis, Peloton Therapeutics, Pfizer, PlatformQ Health, Precede Bio, Prometheus, Roche/Genentech, Sanofi/Aventis, Scholar Rock, Tempest Therapeutics, The New England Journal of Medicine, and UpToDate; receiving research fundingfrom Agensys (Inst), Arcus Biosciences (Inst), AstraZeneca (Inst), AVEO (Inst), Bayer (Inst), Bristol-Myers Squibb (Inst), Calithera Biosciences (Inst), Eisai (Inst), Exelixis (Inst), GlaxoSmithKline (Inst), Ipsen (Inst), Merck (Inst), NiKang Therapeutics (Inst), Novartis (Inst), Peloton Therapeutics (Inst), Pfizer (Inst), Roche (Inst), Roche/Genentech (Inst), Seattle Genetics/Astellas (Inst), Takeda (Inst), and TRACON Pharma (Inst); holding patents, royalties, or other Intellectual Propertyfor International Patent Application No. PCT/US2018/058430, entitled “Biomarkers of Clinical Response and Benefit to Immune Checkpoint Inhibitor Therapy (Inst), ctDNA technologies, International Patent Application No. PCT/US2018/12209, entitled “PBRM1 Biomarkers Predictive of Anti-Immune Checkpoint Response (Inst); and receiving travel, accommodations, and/or expenses from Alexion Pharmaceuticals, alligent, Analysis Group, AstraZeneca, Bayer, Bristol-Myers Squibb, Cerulean Pharma, Clinical Care Options, Corvus Pharmaceuticals, Eisai, EMD Serono, ESMO, Exelixis, Foundation Medicine, GlaxoSmithKline, Harborside Press, HERON, Ipsen, Kidney Cancer Association, Lancet Oncology, Lilly, Lpath, Merck, Michael J. Hennessy Associates, Navinata Health, NCCN, Novartis, Peloton Therapeutics, Pfizer, PlatformQ Health, Prometheus, Roche/Genentech, Sanofi/Aventis, The New England Journal of Medicine, and UpToDate.