Abstract 58P
Background
IV amivantamab (ami) is approved in multiple EGFR-mutant (EGFRm) advanced NSCLC settings. In PALOMA-3, SC ami reduced administration-related reactions (ARRs) and demonstrated noninferior PK and efficacy vs IV ami. PALOMA-2 (NCT05498428) is a bridging study evaluating SC ami-based regimens in various EGFRm NSCLC settings; Cohorts 1 and 6 showed promising efficacy and safety for 1st line ami SC Q2W + lazertinib in EGFRm NSCLC. Here we report initial experiences of switching to SC after IV ami monotherapy (mono).
Methods
PALOMA-2 Cohort 4 enrolled participants (pts) previously receiving ami IV Q2W as part of standard of care, an expanded access program, or rollover from a long-term extension study for ≥8 wks without dose reduction or evidence of progressive disease. Ami SC Q2W (1600 mg; ≥80 kg: 2240 mg) was administered by manual abdominal injection. Primary endpoint was safety; patient-reported treatment satisfaction per the modified therapy administration satisfaction questionnaire was a secondary endpoint.
Results
As of 24 Oct 2024, 25 pts were dosed with SC ami mono after switching from IV ami. Median age was 66 y, 58% female and 54% Asian. Median IV ami treatment duration was 3.1 mo. Median SC treatment duration was 7.4 mo, with a median follow-up from 1st SC ami dose of 9.7 mo. Safety profile after IV to SC switch was consistent with prior reports of the SC ami profile, with fewer ARRs vs historical IV data. Most adverse events (AEs) were EGFR/MET-related and grade 1–2. Most common AEs were paronychia (44%; gr≥3: 4%), rash-related (40%; gr≥3: 12%), and hypoalbuminemia (40%; gr≥3: 4%). No ARRs were reported; 1 pt discontinued ami due to a treatment-related AE (interstitial lung disease). PK simulations show exposures of IV vs SC for Q2W dose regimens were noninferior (90% CI lower bound ≥0.8), which further supports the IV to SC switch for reduced dose levels. Most pts found SC ami convenient (83%) and few preferred prior IV over SC (8%) during Cycle 1 of SC administration.
Conclusions
The safety profile of pts switching to SC ami mono was similar to the known SC ami profile, with fewer ARRs vs historical IV data in pts with EGFRm advanced NSCLC. SC ami was convenient and preferred by pts. Based on these initial findings, switching from IV to SC ami is feasible and safe.
Clinical trial identification
NCT05498428.
Editorial acknowledgement
Medical writing assistance was provided by Courtney Guenther, PhD, of Lumanity Communications Inc, and was funded by Johnson & Johnson.
Legal entity responsible for the study
Janssen Research & Development, LLC, a Johnson & Johnson Company.
Funding
Janssen Research & Development, LLC, a Johnson & Johnson Company.
Disclosure
J. Han: Financial Interests, Personal, Advisory Board: Novartis, Lantern, Takeda, Janssen, Merk, Pfizer, Amgen, AstraZeneca, Oncobix, AbbVie; Financial Interests, Personal, Invited Speaker: AstraZeneca, Janssen, Merk, Roche, Yuhan, Pfizer, Norvatis. J. Zhang: Financial Interests, Personal, Other, All support for the present manuscript: Janssen; Financial Interests, Personal, Research Grant: AbbVie, AstraZeneca, BeiGene, BridgeBio, BMS, Nilogen, Novartis, Genentech, Hengrui, InnoCare Pharma, Janssen, Kahr Medical, Eli Lilly, Merck, Mirati; Financial Interests, Personal, Other, Consulting Fees: AstraZeneca, Lilly, BMS, Mirati, Fosun, Novocure, Hengrui, Sanofi; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Regeneron, MJH Life Sciences, Sanofi, Novartis; Financial Interests, Personal, Advisory Board: Hengrui; Financial Interests, Personal, Other, Patent: Application Serial No 63/705,859, with a filing date of October 10, 2024. C.H. Andrade Teixeira: Financial Interests, Personal, Other, Travel: Daiichi Sankyo, Janssen, MSD; Financial Interests, Personal, Invited Speaker: Janssen, MSD, AstraZeneca, Roche; Financial Interests, Personal, Advisory Role: MSD, AstraZeneca, Lilly. N. Girard: Financial Interests, Personal, Advisory Board: AstraZeneca, BMS, MSD, Roche, Pfizer, Janssen, Regeneron, AbbVie, Amgen, Lilly, Takeda, Owkin, Leo Pharma, Daiichi Sankyo, Ipsen, Pierre Fabre, Beigene; Financial Interests, Personal, Invited Speaker: AstraZeneca, BMS, Pfizer, Amgen, MSD, Sanofi, Gilead, Janssen; Financial Interests, Personal, Officer: Edimark; Financial Interests, Institutional, Research Grant, Local: Roche, Sivan, Janssen; Financial Interests, Institutional, Funding: BMS, Leo Pharma; Financial Interests, Institutional, Research Grant: MSD; Other, Personal, Other, Family member is an employee: AstraZeneca. N. Peled: Financial Interests, Personal, Other, All support for the present manuscript: Johnson & Johnson; Financial Interests, Personal, Other, Consulting Fees: Johnson & Johnson; Financial Interests, Personal, Invited Speaker: Johnson & Johnson. S. Scott: Financial Interests, Personal, Other, Consulting Fees: Amgen, AstraZeneca, Foundation Medicine, Genentech/Roche, Regeneron, Tempus; Financial Interests, Personal, Research Grant: Mirati Therapeutics, Bristol Myers Squibb, Janssen. M. Gutierrez: Financial Interests, Personal, Other, Clinical trial support to the institution, stock/stock options: COTA, OMI. A. Bulotta: Financial Interests, Personal, Speaker’s Bureau: BMS, MSD, AstraZeneca, Eli Lilly; Financial Interests, Personal, Advisory Board: BMS, AstraZeneca, Roche. J.L. Tan: Financial Interests, Personal, Invited Speaker: MSD, Boehringer Ingelheim, Pfizer; Financial Interests, Personal, Other, Support for attending WCLC 2023: MSD. D. Botesteanu, A. Alhadab, J. Mahoney, M. Wang, J. Zhang, J. Schuchard, M. Baig: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. F.A. Duarte: Financial Interests, Personal, Invited Speaker: Roche, Novartis, MSD, Merck Sharp & Dohme Corp, BMS, Johnson & Johnson, Lilly, AstraZeneca; Financial Interests, Personal, Expert Testimony: Takeda, Pfizer, Johnson & Johnson, Daiichi; Financial Interests, Personal, Other, Travel: Takeda, Pfizer, Johnson & Johnson, AstraZeneca, Daiichi. All other authors have declared no conflicts of interest.