Dr Choueiri on Adjuvant Belzutifan Plus Pembrolizumab in ccRCC After Nephrectomy

“The primary end point of disease-free survival was met with an HR of 0.72. This is the first study that builds on [prior data with] adjuvant pembrolizumab [in this patient population].”

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 findings from 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 after nephrectomy.

The primary end point of LITESPARK-022 was investigator-assessed disease-free survival (DFS). Overall survival represented the key secondary end point and safety was also assessed as a secondary end point.

At a median follow-up of 28.4 months (range, 15.0-40.1), data from the trial showed that patients who received the combination (n = 921) achieved a median DFS that was not reached (NR; 95% CI, 36.9 months to NR); the median DFS was also NR (95% CI, NR-NR) among patients who received pembrolizumab plus placebo (n = 920). These findings conferred a HR for DFS of 0.72 (95% CI, 0.59-0.87; P = .0003), meeting the primary end point of the trial, Choueiri noted.

In terms of safety, there was a higher rate of toxicity in the combination arm compared with the placebo arm, Choueiri explained. However, the overall adverse effect profile of the combination was manageable and there was not a significant amount of treatment discontinuation in either arm, he concluded.

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.