KEY TAKEAWAYS
- The phase 1/2 CheckMate 8KX study aimed to investigate NIVO SC ± the permeation enzyme PH20 (rHuPH20).
- Primary endpoint: NIVO SC ± rHuPH20 pharmacokinetics. Secondary endpoint: Safety, immunogenicity. Exploratory endpoint: Patient-reported outcomes, efficacy.
- NIVO SC showed well-characterized pharmacokinetics, good tolerance, and patient preference over IV administration and supports the ongoing CheckMate 67T study.
In this study, researchers explored the potential of subcutaneous (SC) administration of NIVO, a groundbreaking immuno-oncology therapy aiming to ease treatment challenges for patients and healthcare professionals.
Extended follow-up analyses from CheckMate 8KX (NCT03656718) were presented by the researchers that examined NIVO SC ± recombinant human hyaluronidase PH20 (rHuPH20).
Patients with various advanced solid tumors, including NSCLC, melanoma, renal cell carcinoma, and colorectal cancer, participated if they hadn’t received immune checkpoint inhibitors before and were suitable for NIVO monotherapy.
Primary goals encompassed understanding NIVO SC ± rHuPH20’s pharmacokinetics through non-compartmental analyses. Secondary aims involved assessing the safety and immunogenicity of NIVO SC, while patient-reported outcomes and effectiveness were exploratory.
Among 139 treated patients with a median age of 66 years (24–93), mainly with ECOG performance status 0 (38.1%) or 1 (61.9%), received treatment. NSCLC was the most common tumor type (27.3%), with 56.1% having one prior therapy.
Few patients developed anti-drug antibodies, none of which were neutralizing. Overall response rate details will be shared. Patients expressed strong satisfaction with SC administration, preferring it over IV, and reported minimal discomfort with SC injections.
The study provided a comprehensive understanding of NIVO SC’s pharmacokinetics, showing good tolerance similar to NIVO IV. Patients showed a strong preference for SC administration over IV infusion, reporting high satisfaction. These findings bolster the assessment of NIVO SC + rHuPH20 in the CheckMate 67T ongoing phase 3 study.
Source: https://jitc.bmj.com/content/11/Suppl_1/A701
Clinical Trials: https://clinicaltrials.gov/study/NCT03656718
https://clinicaltrials.gov/study/NCT04810078
Lonardi S, Ługowska I, O’Donnell A, et al616 Pharmacokinetics and safety of a subcutaneous formulation of nivolumab (NIVO SC) monotherapy: updated results from the phase 1/2 CheckMate 8KX studyJournal for ImmunoTherapy of Cancer 2023;11:doi: 10.1136/jitc-2023-SITC2023.0616
