Abstract 739P
Background
Subcutaneous (SC) NIVO co-formulated with rHuPH20 may benefit patients (pts), healthcare practitioners (HCPs), and healthcare resource utilization. In the phase 1/2 international multi-tumor CheckMate 8KX study, the pharmacokinetics and exposures of SC NIVO + rHuPH20 were characterized across multiple doses and treatment was well tolerated. Here, we present pt preference for SC vs intravenous (IV) NIVO.
Methods
Pts with advanced/metastatic tumors across approved NIVO monotherapy indications (and hepatocellular carcinoma) were enrolled. Pts in part A received 1 cycle (C) of NIVO SC 720 mg + rHuPH20. In part B C1, the first 10 pts received NIVO SC 960 mg + rHuPH20 and the next 35 were randomized 1:1 to NIVO SC 720 mg or NIVO SC 960 mg. From C2, pts in parts A and B received NIVO IV 480 mg every 4 weeks (Q4W) and some transitioned to part C, 1200 mg NIVO SC + rHuPH20 Q4W. Pts in part D received NIVO SC 1200 mg + rHuPH20 Q4W. An 8-item pt experience and preference questionnaire (PEPQ) was administered by site interview immediately after NIVO on C1 day (D)1 and C2D1 in part A and B, and C1D1 of part C and D.
Results
190 PEPQ responses were received from 103 pts. Baseline characteristics were well balanced. Across parts A-C, most pts preferred SC vs IV injection (21%-71% vs 4%-28%) and pts on all regimens (including part D) were very satisfied with SC injection (78%-100%). On a scale of 0 to 10 (no to worst pain/discomfort), pts reported minimal pain/discomfort associated with SC injection (mean [SD] score: part A, C1D1 0.6 [0.7], C2D1 0.3 [0.5]; part B [across all dose regimens], C1D1 0.1-0.3 [0.2-0.5], C2D1 0-0.3 [0-0.9]; part C, 1 [0.8]; part D, 1.3 [1.6]). Overall, 90%-100% pts were not bothered by duration of SC administration; 27%-80% said NIVO injection took less time than expected, 20%-64% an acceptable time, or 5%-14% longer than expected. Most pts reported no negative impact on time available to talk to a HCP (86%-100%) or interact/socialize with non-HCPs (86%-100%).
Conclusions
Overall, fewer pts preferred IV vs SC NIVO; most pts were very satisfied and reported minimal pain/discomfort associated with SC injection in this prespecified exploratory analysis.
Clinical trial identification
NCT03656718.
Editorial acknowledgement
Professional medical writing assistance was provided by Russell Craddock, PhD, of Parexel, and was funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
S. Lonardi: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Bristol Myers Squibb, Daiichi-Sankyo, GlaxoSmithKline, Incyte, Lilly, Merck Serono, MSD, Servier; Financial Interests, Personal, Invited Speaker: Pierre-Fabre; Financial Interests, Institutional, Coordinating PI: Amgen, AstraZeneca, Bayer, Bristol Myers Squibb, Lilly, Merck Serono, Roche. B.M. Bennett: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb. M. Dixon: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb; Financial Interests, Personal, Stocks/Shares: Bristol Myers Squibb.