1691P - Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Updated efficacy and safety results from CheckMate 67T

Background

CheckMate 67T (NCT04810078) is a multicenter, randomized, open-label, phase 3 trial of NIVO SC vs IV in previously treated pts with advanced/metastatic ccRCC. In the primary data analysis (min. 8 months follow-up), NIVO SC demonstrated noninferiority of the co-primary pharmacokinetic endpoints and key powered secondary efficacy endpoint (objective response rate [ORR] by blinded independent central review [BICR]) vs NIVO IV (ASCO GU 2024). Safety outcomes and health-related quality of life (ASCO 2024) were consistent between NIVO SC and NIVO IV. We report updated efficacy, safety, and immunogenicity data after a min. 15 month follow-up.

Methods

Pts were randomized 1:1 to receive NIVO SC 1200 mg + recombinant human hyaluronidase PH20 Q4W or NIVO IV 3 mg/kg Q2W until disease progression, unacceptable toxicity, withdrawal of consent, completion of 2 years’ treatment, or death. ORR by BICR was a key powered secondary endpoint. Other secondary objectives included safety, efficacy, and immunogenicity outcomes.

Results

A total of 495 pts were randomized to NIVO SC (n = 248) or NIVO IV (n = 247). With longer follow-up, additional responses were observed leading to an increased ORR in both arms (table). Safety reported with NIVO SC was similar or numerically lower than NIVO IV across safety categories. Study drug toxicity led to 3/2 deaths with NIVO SC/IV, which includes one additional death in the IV arm since the primary analysis. Updated anti-NIVO antibody (ANA) analyses with longer follow-up are shown in the table. Table: 1691P

Conclusions

Efficacy and safety profiles of NIVO SC in this analysis are comparable to those of NIVO IV, consistent with the primary analysis. Immunogenicity data were consistent with the primary analysis. These updated results continue to support NIVO SC as a new option to improve pt experience and healthcare efficiency.

Clinical trial identification

NCT04810078.

Editorial acknowledgement

Professional medical writing assistance was provided by Elizabeth Haygreen, PhD, and Tina Allen, BSc, both of Spark (a division of Prime, New York, USA), funded by Bristol Myers Squibb.

Legal entity responsible for the study

Bristol Myers Squibb.

Funding

Bristol Myers Squibb.

Disclosure

L. Albiges: Financial Interests, Institutional, Other, Consulting: Astellas, BMS, Eisai, Ipsen, Janssen, MSD, Novartis, Pfizer, Roche, Merck, Amgen; Financial Interests, Personal, Other, Honoraria: Novartis; Non-Financial Interests, Principal Investigator, Clinical trial steering committee: Pfizer, BMS, Aveo, AstraZeneca, MSD; Non-Financial Interests, Principal Investigator: Ipsen; Non-Financial Interests, Other, Clinical trial steering committee: Roche, Exelixis; Non-Financial Interests, Member: ASCO; Non-Financial Interests, Other, Medical Steering Committee: Kidney Cancer Association; Non-Financial Interests, Other, Member of the Renal Cell Carcinoma Guidelines Panel: European Association of Urology (EAU). M.T. Bourlon de los Rios: Financial Interests, Personal and Institutional, Advisory Board: BMS, MSD, Ipsen, Eisai, Janssen, Astellas/Asofarma; Financial Interests, Personal and Institutional, Invited Speaker: BMS, MSD, Ipsen, Eisai, Janssen, Astellas/Asofarma; Financial Interests, Personal and Institutional, Leadership Role: BMS, MSD, Ipsen, Eisai, Janssen, Astellas/Asofarma; Financial Interests, Personal and Institutional, Local PI: BMS, MSD, Janssen; Financial Interests, Personal and Institutional, Steering Committee Member: BMS, Janssen. M. Chacon: Non-Financial Interests, Institutional, Other, PI and other - member of the steering committee: Alexander Fleming Institute. J. Mota: Other, Personal, Invited Speaker, Non-financial and Financial Interests: Adium, Bayer, AstraZeneca, Amgen, Ipsen; Other, Personal, Expert Testimony, Non-financial and Financial Interests: Adium, Bayer; Other, Personal, Other, Non-financial and Financial Interests: Adium, Bayer, Ipsen; Other, Personal and Institutional, Invited Speaker, Non-financial and Financial Interests: Johnson & Johnson Innovative Medicine, Merck Sharp Dohme, BMS, Pfizer, Astellas; Other, Personal and Institutional, Local PI, Non-financial and Financial Interests: Johnson & Johnson Innovative Medicine, Merck Sharp Dohme, BMS; Other, Personal and Institutional, Other, Non-financial and Financial Interests: Johnson & Johnson Innovative Medicine, Merck Sharp Dohme, Astellas; Other, Personal and Institutional, Advisory Board, Non-financial and Financial Interests: Johnson & Johnson Innovative Medicine, Astellas; Other, Personal, Local PI, Non-financial and Financial Interests: Bayer, AstraZeneca, Lilly, Amgen; Other, Personal, Coordinating PI, Non-financial and Financial Interests: Bayer; Other, Personal, Funding, Non-financial and Financial Interests: Bayer; Other, Personal and Institutional, Expert Testimony, Non-financial and Financial Interests: Pfizer, Astellas, Libbs, Eurofarma; Other, Institutional, Non remunerated activity, Non-financial and Financial Interests: Roche; Other, Personal, Advisory Board, Non-financial and Financial Interests: Ipsen; Non-Financial Interests, Personal and Institutional, Funding: RPH Radiofarmacia. M. Burotto: Other, Personal, Invited Speaker: BMS; Other, Personal, Advisory Role: MSD, Roche. M.D.A. Luz: Financial Interests, Personal, Invited Speaker: Ipsen, Astellas, Janssen, Sanofi, Bayer; Financial Interests, Institutional, Research Grant: Amgen, Ferring, Astra-Zeneca, ProScan, Janssen, Bayer, GSK, Active Biotech; Financial Interests, Personal, Advisory Board: ProScan, Janssen, Astellas; Financial Interests, Personal, Other, Travel expenses: Janssen, Astra-Zeneca, Pfizer, Bayer. J. Menezes: Financial Interests, Personal, Invited Speaker: BMS, AstraZeneca. E.P. Yanez Ruiz: Non-Financial Interests, Institutional, Non financial benefits: University. M. Maruzzo: Financial Interests, Personal, Advisory Board: Astellas, Jannsen, Ipsen, MSD, Merck Serono, BMS. S. Bracarda: Non-Financial Interests, Personal, Advisory Board, Plus travel support: Bayer, Pfizer, MSD; Non-Financial Interests, Personal, Advisory Board: Astellas, Janssen, BMS, Roche-Genentech, Ipsen, Novartis(AAA), AstraZeneca, Merck, Gilead; Non-Financial Interests, Personal, Advisory Board, (Compensated): Indicon, Genenta; Financial Interests, Personal, Steering Committee Member: BMS. M. Breckenridge: Financial Interests, Personal, Full or part-time Employment: BMS. Z. Yu: Financial Interests, Institutional, Full or part-time Employment: BMS. H. Vezina: Financial Interests, Personal, Full or part-time Employment: BMS; Financial Interests, Personal, Stocks/Shares: BMS. S. George: Financial Interests, Personal, Advisory Board, advisor/consultant: BMS, Bayer, Pfizer, Exelixis, Sanofi/ Genzyme, Seattle Genetics, EMD Serono, Eisai, Merck, Aveo, QED therapeutics; Financial Interests, Personal, Advisory Board, Advisor/consultant: Novartis, AstraZeneca; Financial Interests, Institutional, Local PI: Pfizer, Merck, Agensys, Novartis, BMS, Bayer, Eisai, Seattle Genetics, Surface Oncology, Exelixis, Aravive, Aveo, Gilead. All other authors have declared no conflicts of interest.