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Amivantamab SC, RYBREVANT, LAZCLUZE - PALOMA-2 study

Last updated: 03/26/2025
 
  • RYBREVANT (amivantamab-vmjw) is a low fucose, fully human IgG1-based bispecific antibody with immune cell-directing activity that targets EGFR mutations and MET mutations and amplifications in NSCLC.1
  • Amivantamab for SC administration is a coformulation of amivantamab with rHuPH20.2
  • LAZCLUZE (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor.3

PALOMA-2 study

  • PALOMA-2 (NCT05498428) is an ongoing, phase 2, open-label, international, parallel-cohort study evaluating the efficacy and safety of a SC formulation of amivantamab with chemotherapy and/or lazertinib in patients with EGFR-mutated advanced NSCLC (N=520). The primary endpoint is investigator-assessed ORR.4,5

Cohorts 1 and 6

  • Interim efficacy, safety, and PK results were reported for amivantamab SC plus lazertinib with either recommended (cohort 1, n=68) or mandatory (cohort 6, n=58) prophylactic anticoagulation in treatment-naïve patients with EGFR-mutated (Exon19del or Exon 21 L858R) advanced NSCLC.4
    • At a median follow-up of 8.6 months, the investigator-assessed ORR was 75% (95% CI, 63-85) in cohort 1 and 80% (95% CI, 65-90) in cohort 6.
    • The most common TEAEs (≥20%) were associated with EGFR and MET inhibition and were primarily grade 1-2 in severity.
    • The ARR (MedDRA preferred term) rate was 15% in all patients.
    • The VTE rate was 18% in cohort 1 and 7% in cohort 6.
    • TRAEs leading to discontinuation of all agents were reported in 9% of patients.
    • Mean (%CV) amivantamab coformulation Ctrough on C2D1 were 328 (32) µg/mL in cohort 1 and 373 (27) µg/mL in cohort 6.

Cohort 4

  • Initial safety and PK results were reported for patients switching from RYBREVANT IV to amivantamab SC (cohort 4). Patients in cohort 4 previously received RYBREVANT IV for ≥8 weeks without dose reduction or evidence of PD, as part of standard of care, an expanded access program, or rollover from a long-term extension study.6
    • At a median follow-up of 9.7 months, the safety profile of amivantamab SC after switching from RYBREVANT IV was consistent with previous reports of amivantamab SC monotherapy, with no new safety signals; no ARRs were reported.
    • The most common AEs associated with EGFR and MET inhibition were paronychia (44%) and hypoalbuminemia (40%), respectively.
    • The simulated PK exposures of amivantamab IV were noninferior to amivantamab SC for the Q2W dose regimen, meeting the predefined noninferiority criteria for efficacy (lower bound of the GMR 90% CI ≥0.8 for Cavg and Ctrough) and safety (upper bound of the GMR 90% CI ≤1.25 for Cmax).
    • Most patients receiving amivantamab SC by C1 were satisfied (79%), found it convenient (83%), and preferred it (63%) over RYBREVANT IV.

Note: AE, adverse event; ARR, administration-related reaction; C, cycle; Cavg, average concentration; Cmax, maximum concentration; CI, confidence interval; Ctrough, trough concentration; CV, coefficient of variation; D, day; EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion; GMR, geometric mean ratio; IgG1, immunoglobulin G1; IV, intravenous; MedDRA, Medical Dictionary for Regulatory Activities; MET, mesenchymal-epithelial transition; NSCLC, non-small cell lung cancer; ORR, objective response rate; PD, progressive disease; PK, pharmacokinetics; Q2W, every 2 weeks; rHuPH20, recombinant human hyaluronidase PH20; SC, subcutaneous; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event; VTE, venous thromboembolism.

Overview4,5

PALOMA-2 (NCT05498428) is an ongoing, phase 2, open-label, international, parallel-cohort study designed to assess the efficacy and safety of amivantamab SC with chemotherapy and/or lazertinib in patients with EGFR-mutated advanced NSCLC.

Key inclusion criteria4-6

  • Adults (age ≥18 years) with locally advanced or metastatic NSCLC
  • ≥1 measurable lesion per RECIST v1.1 (all cohorts except cohort 4)
  • ECOG PS 0 or 1
  • Brain metastases if present must be stable
  • Adequate organ functions

Study design4-6

Efficacy results4

Cohorts 1 (n=68) and 6 (n=45)

INV- and ICR-assessed ORR (confirmed and unconfirmed responses)

Endpoint Cohort 1
(n=68) 		Cohort 6
(n=45) 		Overall
(N=113)
INV ICR INV ICR INV ICR
ORR, % (95% CI) 75 (63- 85) 81 (70 -89) 80 (65 -90) 76 (61 -87) 77 (68 -84) 79 (70 -86)

Median follow-up was 10 months for cohort 1, 6.1 months for cohort 6, and 8.6 months overall.

Safety results4,6

Cohorts 1 (n=68) and 6 (n=57)4

  • The most common TEAEs (≥20%) were associated with EGFR and MET inhibition and were primarily grade 1-2 in severity.
  • ARRs were reported in 15% (19/125) of patients, with 90% of ARRs reported in C1 (on or after C1D1 but before the next dose).
  • Median time to ARR onset (defined as the start of ARR minus the start of the last injection prior to this event) was 2.3 hours (range, 0.3-7.2).
  • TRAEs leading to the discontinuation of all agents were reported in 9% (11/125) of patients.

Cohort 4 (n=25)6

  • The most common AEs associated with EGFR and MET inhibition were paronychia (44%) and hypoalbuminemia (40%), respectively.
  • TRAE (interstitial lung disease) leading to discontinuation of amivantamab SC was reported in 1 patient.
  • No ARRs were reported.

PK4,6

Cohorts 1 (n=50) and 6 (n=42)4

  • Consistent with historic IV levels (mean [%CV], 317 [32] µg/mL from the MARIPOSA study), mean (%CV) amivantamab coformulation Ctrough concentrations on C2D1 were as follows:
  • Cohort 1 (n=50): 328 (32) µg/mL
  • Cohort 6 (n=42): 373 (27) µg/mL

Cohort 46

  • The PK exposures of amivantamab IV were noninferior to amivantamab SC for the Q2W dose regimen, meeting the predefined noninferiority criteria for efficacy (lower bound of the GMR 90% CI ≥0.8 for Cavg and Ctrough) and safety (upper bound of the GMR 90% CI ≤1.25 for Cmax).

Note: AE, adverse event; ARR, administration-related reaction; C, cycle; Cavg, average concentration; Cmax, maximum concentration; CI, confidence interval; Ctrough, trough concentration; CV, coefficient of variation; D, day; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion; Exon20ins, Exon 20 insertion; GMR, geometric mean ratio; ICR, independent central review; INV, investigator; IV, intravenous; MET, mesenchymal-epithelial transition; NSCLC, non-small cell lung cancer; ORR, objective response rate; PK, pharmacokinetics; PO, orally; Q2W, every 2 weeks; Q3W, every 3 weeks; Q4W, every 4 weeks; QD, once daily; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SC, subcutaneous; SC-CF, subcutaneous coformulation with recombinant human hyaluronidase PH20; TEAE, treatment-emergent adverse event; TRAE, treatment-related adverse event; US, United States.

  • PALOMA-2 (NCT05498428) is an ongoing, phase 2, open-label, international, parallel-cohort study designed to assess the efficacy and safety of amivantamab SC with chemotherapy and/or lazertinib in patients with EGFR-mutated advanced NSCLC.4,5
  • Amivantamab SC, coformulated with rHuPH20, is administered by manual injection in the abdomen at 1600 mg (or 2240 mg if BW ≥80 kg) on D1 and D15 of each 28-day cycle.4-6

PALOMA-2 study design4-6

PALOMA-2 (ClinicalTrials.gov Identifier: NCT05498428); data cutoff date: January 6, 2024.
aReceived first-line regimen.
bb1600 mg (2240 mg if BW ≥80 kg) QW for the first 4 weeks, then Q2W for cohorts 1, 4, and 6; 28-day cycle.
c1600 mg (2240 mg if BW ≥80 kg) on C1D1, then 2400 mg (3360 mg if BW ≥80 kg); 21-day cycle.
dExperienced disease progression on or after osimertinib treatment.
ePatients previously received amivantamab IV 1050 mg (1400 mg if BW ≥80 kg) for ≥8 weeks without dose reduction or evidence of PD, as part of standard of care, an expanded access program, or rollover from a long-term extension study.
f3520 mg (4640 mg if BW ≥80 kg); 28-day cycle.
gExperienced disease progression on or after amivantamab plus lazertinib.
hFor cohort 4, results were based on the resimulation of the PALOMA-3 study using the final population PK model, in which patients received amivantamab IV or SC at DL0, DL(-1), and DL(-2); PK samples were not collected in PALOMA-2 cohort 4.
iTreatment satisfaction was assessed using the mTASQ, a 12-item questionnaire measuring the impact of treatment mode (SC administration) on physical functioning; psychological functioning; and activities of daily living, convenience, and satisfaction. Assessment was performed at screening (before amivantamab IV to SC switch) and after amivantamab SC administration at C1D1, C3D1, and EOT. The modified questionnaire specifies that the injection will take place in the “skin.”

  • Interim efficacy, safety, and PK results were reported for amivantamab SC plus lazertinib with either recommended (cohort 1) or mandatory (cohort 6) prophylactic anticoagulation in treatment-naïve patients with EGFR-mutated (Exon19del or Exon 21 L858R) advanced NSCLC.4

Demographics and baseline disease characteristics4

Characteristic Characteristic Cohort 1
(n=68) 		Cohort 6
(n=58) 		Total
(n=126)
Median age, years (range) 58 (28-85) 62 (34-83) 59 (28-85)
Female, n (%) 42 (62) 34 (59) 76 (60)
Race, n (%)
Asian 45 (66) 40 (69) 85 (67)
White 19 (28) 16 (28) 35 (28)
Othera 4 (6) 2 (3) 6 (5)
ECOG PS 1, n (%) 48 (71) 43 (75) 91 (72)
History of smoking, n (%) 15 (22) 18 (31) 33 (26)
History of brain metastases, n (%) 20 (29) 18 (31) 38 (30)
EGFR mutation,b n (%)
Exon19del 45 (66) 34 (59) 79 (63)
Exon 21 L858R 24 (35) 24 (41) 48 (38)
Adenocarcinoma subtype, n (%) 65 (96) 57 (98) 122 (97)

aIncludes Black or African American and American Indian/Alaska Native.
bPatients could be included in >1 category.

Primary endpoint4

  • At a median follow-up of 8.6 months, the investigator-assessed ORR with amivantamab SC plus lazertinib was 77% (95% CI, 68-84) for both cohorts 1 and 6.
    • In cohort 1 (median follow-up, 10 months; n=68) and cohort 6 (median follow-up, 6.1 months; n=45), the investigator-assessed ORR was 75% (95% CI, 63-85) and 80% (95% CI, 65-90), respectively.

Secondary endpoints4

  • The ICR-assessed ORR reported with amivantamab SC plus lazertinib was comparable with previous reports of RYBREVANT IV plus lazertinib.
    • The overall ICR-assessed ORR was 79% (95% CI, 70-86; cohort 1, 81% [95% CI, 70-89]; cohort 6, 76% [95% CI, 61-87]).
  • The investigator-assessed best response, TTR, and DOR in confirmed responders were evaluated across cohorts 1 and 6.

Investigator-assessed best response, TTR, and DOR4

Parameters Confirmed responders
(n=111)
Best response,a n
CR 0
PR 75
SD 33
PD 2
Median TTR, months (range) 1.9 (1.4-5.3)
Median DOR,a,b months NE

aPatients without postbaseline tumor assessment were excluded.
bn=75.

  • AEs reported with amivantamab SC plus lazertinib were consistent with previous reports of RYBREVANT IV plus lazertinib. The most common TEAEs (≥20%) were associated with EGFR and MET inhibition and were primarily grade 1-2 in severity.4
  • ARRs were reported in 15% (19/125) of patients.4
    • ARRs (90%; 18/20) were mostly reported in C1 (on or after C1D1 but before the next dose).
    • One patient reported 2 ARRs (1 on C1D1 and 1 on C1D9).
    • Median time to ARR onset (defined as the start of ARR minus the start of the last injection prior to this event) was 2.3 hours (range, 0.3-7.2).
  • TRAEs leading to the discontinuation of all agents were reported in 9% (11/125) of patients.4
  • In the safety-evaluable set, 48 (71%) patients in cohort 1 and 57 (100%) patients in cohort 6 received prophylactic anticoagulation (apixaban, rivaroxaban, dalteparin, or enoxaparin as included in the national treatment guidelines; please refer to individual product labels for complete Prescribing Information).4
  • VTE was reported in 13% (16/125) of all patients, with 18% (12/68) in cohort 1 and 7% (4/57) in cohort 6.4
    • Most VTEs were grade 1-2 in severity; no grade 5 events were reported.
    • No VTEs led to dose reductions.
  • Of the 12 patients in the prophylactic anticoagulation group who reported VTE, 11 (92%) developed VTE after discontinuing prophylactic anticoagulation.4
    • Median onset time of VTE after discontinuing prophylactic anticoagulation was 70 days (range, 2-185).

VTE and bleeding events based on prophylactic anticoagulation use4

n (%) Any prophylactic
anticoagulation
(n=105) 		No prophylactic
anticoagulation
(n=20) 		Total
(n=125)
Any VTEa 12 (11) 4 (20) 16 (13)
Grade ≥3 0 1 (5) 1 (1)
Grade 5 0 0 0
Any VTE leading to death 0 0 0
Any VTE leading to any discontinuation 0 0 0
Grade ≥3 bleedingb 2 (2)c 0 2 (2)

aVTE AEs were identified using the SMQ for “Embolic and Thrombotic events, Venous (SMQ),” and the preferred term was “Thrombosis” or “Embolism.”
bBleeding AE terms were identified using the SMQ for “Hemorrhage Terms (Excl Laboratory Terms)” (narrow scope).
cOne patient had been on rivaroxaban 10 mg PO daily since D1 and developed chronic pigmented purpura on D67, which resolved on D79; another patient had been on rivaroxaban 10 mg PO daily since D1 and developed grade 3 subarachnoid hemorrhage on D76, which remained unresolved.

  • Consistent with historic IV levels (mean [%CV], 317 [32] µg/mL from the MARIPOSA study), mean (% CV) amivantamab coformulation Ctrough on C2D1 were as follows4:
    • Cohort 1 (n=50): 328 (32) µg/mL
    • Cohort 6 (n=42): 373 (27) µg/mL
  • Initial safety and PK results were reported for patients switching from RYBREVANT IV to amivantamab SC (cohort 4).6
  • Of the 26 patients enrolled in cohort 4, 25 were switched from RYBREVANT IV to amivantamab SC.6
  • At the data cutoff date of October 24, 2024,6
    • Median follow-up from the first amivantamab SC dose was 9.7 months.
    • Median treatment duration was 3.1 months for prior RYBREVANT IV and 7.4 months for amivantamab SC.
    • In total, 64% of patients continued to receive amivantamab SC.

Demographics and baseline disease characteristics6

Characteristic Cohort 4
(n=26)
Median age, years (range) 66 (41-83)
Female, n (%) 15 (58)
Race, n (%)
Asian 14 (54)
White 10 (38)
Not reporteda 2 (8)
ECOG PS, n (%); n=25
0 9 (36)
1 16 (64)
History of smoking, n (%) 10 (38)
History of brain metastases, n (%) 8 (31)
EGFR mutation,b n (%); n=23
Exon 21 L858R 3 (13)
Exon20ins 21 (91)
Adenocarcinoma histology, n (%) 24 (92)

aPatient either declined to answer the question or was not able to identify a race.
bPatients could be included in ≥1 category.

  • The safety profile of amivantamab SC after switching from RYBREVANT IV was consistent with previous reports of amivantamab SC monotherapy, with no new safety signals reported.6
  • The most common AEs associated with EGFR and MET inhibition were paronychia (44%) and hypoalbuminemia (40%), respectively.6
  • The incidence of rash (grouped term, including rash, rash maculo-papular, acne, dermatitis acneiform, rash pustular, and skin lesions) was 40% (n=10), with grade ≥3 events reported in 12% of patients (n=3).6
  • TRAE (interstitial lung disease) leading to discontinuation of amivantamab SC was reported in 1 patient.6
  • No ARRs (defined per the MedDRA preferred term and referred to as infusion-related reactions in prior IV studies) were reported.6
  • Patient-reported treatment satisfaction was evaluated for RYBREVANT IV at screening vs amivantamab SC at C1.6

Patient-reported treatment satisfaction6

Patient responses to mTASQ, % RYBREVANT IV at screening
(n=25) 		Amivantamab SC at C1D1
(n=24)
Convenience over timea,b
Inconvenient or very inconvenient 24 0
Neither convenient nor inconvenient 32 17
Convenient or very convenient 44 83
Feeling restricted over timea,c
Quite a bit 4 0
A little bit or somewhat 72 46
Not at all 24 54
Bothered by the time it takes for infusion/injectiona,d
Quite bothered 28 0
A little or moderately bothered 60 33
Not at all bothered 12 67

aThe mTASQ for IV injection was completed at screening.
bBased on patient responses to mTASQ item #6, “How convenient is it for you to get your SC injection?”
cBased on patient responses to mTASQ item #5, “When receiving the SC injection, how restricted did you feel?”
dBased on patient responses to mTASQ item #7, “How bothered are you by the amount of time it takes to have the SC injection?”

PROs by C16

  • In total, 96% of patients were compliant with the mTASQ assessments.
  • Most patients receiving amivantamab SC were satisfied (79%), found it convenient (83%), and preferred it (63%) over RYBREVANT IV.
  • In total, 54% and 67% of patients receiving amivantamab SC (n=24) vs 24% and 12% receiving RYBREVANT IV (n=25), respectively, reported feeling unrestricted and unbothered by the time required for treatment administration.
  • Most patients experienced mild or no injection-site symptoms with amivantamab SC:
    • Mild or no pain: 71%
    • Mild or no swelling: 83%
    • Mild or no redness: 88%
  • Among patients receiving amivantamab SC, severe injection-site pain was reported in 8% at C1, with none reported at C3.
  • Population PK simulations were conducted for amivantamab IV vs SC exposures for the Q2W dose regimen at DL0, DL(-1), and DL(-2).6
  • The simulated PK exposures of amivantamab IV were noninferior to amivantamab SC for the Q2W dose regimen, meeting the predefined noninferiority criteria for efficacy (lower bound of the GMR 90% CI ≥0.8 for Cavg and Ctrough) and safety (upper bound of the GMR 90% CI ≤1.25 for Cmax).6

PK simulations for the Q2W regimen6,a

PK endpoint Amivantamab IV (GM [CV%]) Amivantamab SC (GM [CV%]) SC/IV GMR (90% CI)
DL0 DL(-1) DL(-2) DL0 DL(-1) DL(-2) DL0 DL(-1) DL(-2)
Cavg,C2 362 (25) 229 (26) 98 (31) 396 (28) 245 (29) 148 (30) 1.09
(1.05-1.14) 		1.07
(1.03-1.12) 		1.52
(1.44-1.59)
Cavg,ss 245 (27) 148 (27) 57 (32) 275 (32) 160 (33) 89 (33) 1.12
(1.07-1.18) 		1.08
(1.03-1.14) 		1.56
(1.48-1.64)
Ctrough,max 305 (27) 191 (27) 80 (33) 367 (28) 227 (28) 138 (29) 1.2
(1.15-1.26) 		1.19
(1.14-1.24) 		1.72
(1.64-1.81)
Ctrough,ss 139 (40) 76 (41) 22 (50) 198 (38) 109 (40) 55 (42) 1.42
(1.34-1.51) 		1.43
(1.34-1.53) 		2.55
(2.38-2.74)
Cmax,max 696 (21) 457 (21) 218 (26) 486 (28) 306 (29) 189 (30) 0.7
(0.67-0.73) 		0.67
(0.64-0.7) 		0.87
(0.83-0.91)
Cmax,ss 534 (20) 344 (21) 160 (25) 343 (31) 205 (32) 118 (32) 0.64
(0.62-0.67) 		0.6
(0.57-0.62) 		0.74
(0.71-0.77)

aIV: DL0, 1050 mg (≥80 kg, 1400 mg); DL(-1), 700 mg (≥80 kg, 1050 mg); DL(-2), 350 mg (≥80 kg, 700 mg);
SC: DL0, 1600 mg (≥80 kg, 2240 mg); DL(-1), 1050 mg (≥80 kg, 1600 mg); DL(-2), 700 mg (≥80 kg, 1050 mg).
Note: PK noninferiority criteria to ensure comparable efficacy (lower bound of the GMR 90% CI ≥0.8 for Cavg and Ctrough) and safety (upper bound of the GMR 90% CI ≤1.25 for Cmax) were met for all DLs.

AE Adverse event GM Geometric mean
ALT Alanine aminotransferase GMR Geometric mean ratio
ARR Administration-related reaction ICR Independent central review
AST Aspartate aminotransferase IgG1 Immunoglobulin G1
BW Body weight INV Investigator
C Cycle IV Intravenous
Cavg Average concentration max Maximum
CBR Clinical benefit rate MedDRA Medical Dictionary for Regulatory Activities
CI Confidence interval MET Mesenchymal-epithelial transition
Cmax Maximum concentration mTASQ Modified Therapy Administration Satisfaction Questionnaire
CR Complete response NE Not estimable
Ctrough Trough concentration NSCLC Non-small cell lung cancer
CV Coefficient of variation ORR Objective response rate
D Day OS Overall survival
DL Dose level PD Progressive disease
DOR Duration of response PFS Progression-free survival
ECOG PS Eastern Cooperative Oncology Group performance status PK Pharmacokinetics
EGFR Epidermal growth factor receptor PO Orally
EOT End of treatment PR Partial response
Exon19del Exon 19 deletion PRO Patient-reported outcome
Exon20ins Exon 20 insertion Q2W Every 2 weeks
Q3W Every 3 weeks SD Stable disease
Q4W Every 4 weeks SMQ Standardized MedDRA query
QD Once daily ss Steady state
QW Once a week TEAE Treatment-emergent adverse event
RECIST v1.1 Response Evaluation Criteria in Solid
Tumors version 1.1 		TRAE Treatment-related adverse event
rHuPH20 Recombinant human hyaluronidase PH20 TTR Time to response
SC Subcutaneous US United States
SC-CF Subcutaneous coformulation with
recombinant human hyaluronidase PH20 		VTE Venous thromboembolism

A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 26 March 2025.

  1. Moores SL, Chiu ML, Bushey BS, et al. A novel bispecific antibody targeting EGFR and cMet is effective against EGFR inhibitor-resistant lung tumors. Cancer Res. 2016;76(13):3942-3953.
  2. Leighl NB, Akamatsu H, Lim SM, et al. Subcutaneous versus intravenous amivantamab, both in combination with lazertinib, in refractory epidermal growth factor receptor-mutated non-small cell lung cancer: primary results from the phase III PALOMA-3 study. J Clin Oncol. 2024;42(30):3593-3605.
  3. Cho BC, Felip E, Hayashi H, et al. MARIPOSA: phase 3 study of first-line amivantamab + lazertinib versus osimertinib in EGFR-mutant non-small cell lung cancer. Future Oncol. 2022;18(6):639-647.
  4. Lim SM, Tan JL, Dias JM, et al. Subcutaneous amivantamab and lazertinib as first-line treatment in patients with EGFR mutated advanced non-small cell lung cancer (NSCLC): interim results from the phase 2 PALOMA-2 study. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; May 31-June 4, 2024; Chicago, IL.
  5. Janssen Research & Development, LLC. A phase 2, open-label, parallel cohort study of subcutaneous amivantamab in multiple regimens in patients with advanced or metastatic solid tumors including EGFR-mutated non-small cell lung cancer. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2025 March 26]. Available from: https://clinicaltrials.gov/study/NCT05498428 NLM Identifier: NCT05498428.
  6. Lim SM, Han JY, Zhang J, et al. Subcutaneous after intravenous amivantamab in advanced NSCLC: initial results from PALOMA-2. Poster presented at: European Lung Cancer Congress (ELCC); March 26-29, 2025; Paris, France.