- 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 an investigational coformulation with rHuPH20.2
- LAZCLUZE (lazertinib) is a third-generation EGFR tyrosine kinase inhibitor.3
PALOMA-3 Study
-
PALOMA-3 (NCT05388669) is an ongoing, phase 3, open-label, international, randomized study evaluatingthe PK, efficacy, and safety of amivantamab SC plus lazertinib (n=206) vs RYBREVANT IV plus lazertinib (n=212) in patients with EGFR-mutated (Exon19del or Exon 21 L858R) locally advanced or metastatic NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy (N=418). The noninferior coprimary PK endpoints were Ctrough and AUCD1-D15.2,4 The key secondary endpoints were ORR and PFS. OS was a predefined exploratory endpoint.2
- The GMRs for Ctrough at predose (C2D1), Ctrough at steady state (C4D1), and C2 AUCD1-D15 for amivantamab SC and IV administration were 1.15 (90% CI, 1.04-1.26), 1.43 (90% CI, 1.27-1.61), and 1.03 (90% CI,0.98-1.09), respectively.2
- ORR was 30% in the amivantamab SC plus lazertinib group and 33% in the RYBREVANT IV plus lazertinib group, and the median PFS was 6.1 and 4.3 months, respectively. OS was longer in the amivantamab SC plus lazertinib vs RYBREVANT IV plus lazertinib group (HR for death, 0.62; 95% CI, 0.42-0.92; nominal P=0.02).2
- Grade ≥3 AEs were reported in 52% of patients in the amivantamab SC plus lazertinib group and 56% ofpatients in the RYBREVANT IV plus lazertinib group.2
- All-grade IRRs were reported by 13% of patients in the amivantamab SC plus lazertinib group and 66% of patients in the RYBREVANT IV plus lazertinib group. The VTE rate was 9% in the amivantamab SC plus lazertinib group and 14% in the RYBREVANT IV plus lazertinib group.2
- Median administration time was reduced to 4.8 minutes with SC administration from 5 hours (first infusion) with IV administration.2
- Healthcare resource utilization parameters were lower with amivantamab SC vs RYBREVANT IV on C1D1 and C3D1.5
- Patient time in chair was lower with amivantamab SC vs RYBREVANT IV on C1D1 (0.4 vs 6.5 hours) and C3D1 (0.6 vs 3.4 hours).
- Active healthcare provider time was lower with amivantamab SC vs RYBREVANT IV on C1D1 (5.6 vs 7.6 hours) and C3D1 (2.3 vs 4.4 hours).
- Patient time in treatment room was lower with amivantamab SC vs RYBREVANT IV on C1D1 (4.7 vs 7.0 hours) and C3D1 (1.5 vs 3.9 hours).
- Patients receiving amivantamab SC reported minimal moderate to very severe injection-site symptoms (pain [C1D1, 14%; C3D1, 16%], swelling [C1D1, 5%; C3D1, 6%], and redness [C1D1, 5%; C3D1, 6%]).5
- Patients receiving amivantamab SC were satisfied (C1D1, 86%; C3D1, 90%), were likely to prefer it over IV (C1D1, 77%; C3D1, 81%), and indicated that they would recommend it to other patients (C1D1,78%; C3D1, 81%).5
Note: AE, adverse event; AUCD1-D15, area under the concentration-time curve from D1 to D15; C, cycle; CI, confidence interval; Ctrough, trough concentrations; D, day; EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion; GMR, geometric mean ratio; HR, hazard ratio; IgG1, immunoglobulin G1; IRR, infusion-related reaction; IV, intravenous; MET, mesenchymal-epithelial transition; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; SC, subcutaneous; VTE, venous thromboembolism.
Overview2,4
PALOMA-3 (NCT05388669) is an ongoing phase 3, open-label, international, randomized study designed to assess the PK, efficacy, and safety of amivantamab SC plus lazertinib vs RYBREVANT IV plus lazertinib in patients with EGFR-mutated (Exon19del or Exon 21 L858R) locally advanced or metastatic NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy
Eligibility Criteria2,4
Inclusion criteria:
- Age ≥18 years
- Locally advanced or metastatic NSCLC
- Disease progression on or after osimertinib and platinum-based chemotherapy (irrespective of order)
- EGFR Exon19del or Exon 21 L858R
- ≥1 measurable lesion per RECIST v1.1
- ECOG PS 0-1
Exclusion criteria:
- Symptomatic or progressive brain metastasis
- Untreated leptomeningeal disease
- Uncontrolled pain
- Radiation in the past 7 days
- History of ILD
Study Design2,4
PK2
PK Endpointa | Amivantamab SC (n=206) |
RYBREVANT IV (n=212) |
GMR (90% CI) |
---|---|---|---|
Mean Ctrough, μg/mL (%CV) | |||
C2D1 (predose) | 365 (33) |
314 (32) |
1.15 (1.04-1.26) |
C4D1 (steady state) | 224 (39) | 162 (42) | 1.43 (1.27-1.61) |
Mean C2 AUCD1-D15, μg·h/mL (% CV) | 142,236 (31) | 135,552 (24) | 1.03 (0.98-1.09) |
aThe PK population for evaluating the coprimary PK endpoints included all patients who received all doses without dose modifications prior to the respective endpoint and who provided the PK samples necessary to derive each parameter. |
Efficacy Results2
Endpoints | Amivantamab SC (n=206) |
RYBREVANT IV (n=212) |
---|---|---|
ORR, % (95% CI) | 30 (24-37) |
33 (26-39) |
Median OS, months (95% CI) | 12.9 (12.9-NE) |
NE (10.2-NE) |
Median PFS, months (95% CI) | 6.1 (4.3-8.1) |
4.3 (4.1-5.7) |
- OS was longer in the amivantamab SC plus lazertinib vs RYBREVANT IV plus lazertinib group (HR for death, 0.62; 95% CI, 0.42-0.92; nominal P=0.02).
Safety Results2
- Grade ≥3 AEs were reported in 52% of patients in the amivantamab SC plus lazertinib group and 56% of patients in the RYBREVANT IV plus lazertinib group.
- All-grade IRRs were reported by 13% of patients in the amivantamab SC plus lazertinib group and 66% of patients in the RYBREVANT IV plus lazertinib group.
- The VTE rate was 9% in the amivantamab SC plus lazertinib group and 14% in the RYBREVANT IV plus lazertinib group.
Note: % CV, % coefficient of variation; AE, adverse event; AUCD1-D15, area under the concentration-time curve from D1 to D15; C, cycle; CI, confidence interval; Ctrough, trough concentrations; D, day; ECOG PS, Eastern Cooperative Oncology Group performance status; EGFR, epidermal growth factor receptor; Exon19del, Exon 19 deletion; GMR, geometric mean ratio; HR, hazard ratio; ILD, interstitial lung disease; IRR, infusion-related reaction; IV, intravenous; NE, not estimable; NSCLC, non-small cell lung cancer; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PK, pharmacokinetics; PO, orally; Q2W, every 2 weeks; QD, once daily; QW, once a week; RECIST v1.1, Response Evaluation Criteria in Solid Tumors version 1.1; SC, subcutaneous; VTE, venous thromboembolism.
- PALOMA-3 (NCT05388669) is an ongoing phase 3, open-label, international, randomized study designed to assess the PK, efficacy, and safety of amivantamab SC plus lazertinib vs RYBREVANT IV plus lazertinib in patients with EGFR-mutated (Exon19del or Exon 21 L858R) locally advanced or metastatic NSCLC with disease progression on or after osimertinib and platinum-based chemotherapy.2,4
PALOMA-3 Study Design2,4
PALOMA-3 (ClinicalTrials.gov Identifier: NCT05388669) enrollment period: August 2022 to October 2023; data cutoff date: January 3, 2024.2
aAll patients were required to undergo brain imaging at baseline; subsequent imaging was performed Q6W in patients with baseline brain metastases or as clinically indicated.
bFor calculating the primary and key secondary outcomes, a sample size of 400 patients was estimated to provide >95% power with a 1-sided alpha of 0.05 allocated to each of the coprimary endpoints and 80% power with a 1-sided alpha of 0.025 allocated to ORR. A hierarchical testing approach at a 2-sided alpha of 0.05 was used for the coprimary endpoints (noninferiority), followed by ORR (noninferiority) and PFS (superiority), which used a combined 2-sided alpha of 0.05.
CTwo definitions of the same endpoint were used per regional health authority guidance.
dSC amivantamab was co-formulated with rHuPH20 at a concentration of 160 mg/mL.
eC1 for IV: D1, D2 (D2 applies to IV split dose only [350 mg on D1 and the remainder on D2]), D8, D15, and D22; C1 for SC: D1, D8, D15, and D22; after C1 for all: D1 and D15 (28-day cycles).
f2240 mg if BW ≥80 kg.
g1400 mg if BW ≥80 kg.
- A total of 418 patients were randomized to receive amivantamab SC plus lazertinib (n=206) or RYBREVANT IV plus lazertinib (n=212).2
Patient Disposition2
Disposition, n (%) | Randomized (N=418) | |
---|---|---|
Amivantamab SC + Lazertinib (n=206) |
RYBREVANT IV + Lazertinib (n=212) |
|
Received treatment | 206 (100) | 210 (99) |
Treatment ongoinga | 92 (45) | 96 (46) |
Discontinued treatment | 114 (55) | 114 (54) |
PD | 85 (41) | 83 (40) |
AE | 23 (11) | 25 (12) |
Withdrawal by patient | 4 (2) | 5 (2) |
Physician decision | 2 (1) | 1 (0.5) |
aData cutoff date: January 3, 2024. |
Demographics and Baseline Disease Characteristics2
Characteristic | ||
---|---|---|
Amivantamab SC + Lazertinib (n=206) |
RYBREVANT IV + Lazertinib (n=212) |
|
Median age, years (range) | 61 (35-82) | 62 (29-81) |
<65 years, n (%) | 133 (65) | 120 (57) |
≥65 to <75 years, n (%) | 55 (27) | 70 (33) |
≥75 years, n (%) | 18 (9) | 22 (10) |
Male/female, n (%) | 68 (33)/138 (67) | 71 (33)/141 (67) |
Median BW, kg (range) | 61.8 (35-130) | 60.1 (33-150) |
<80 kg/≥80 kg, n (%) | 184 (89)/22 (11) | 184 (87)/28 (13) |
Race, n (%) | ||
Asian | 126 (61) | 129 (61) |
White | 78 (38) | 77 (36) |
Black or African American | 1 (0.5) | 3 (1) |
Multiple | 0 | 1 (0.5) |
Not reported | 1 (0.5) | 2 (0.9) |
Region, n (%)a | ||
North America | 19 (9) | 30 (14) |
South America | 11 (5) | 17 (8) |
Europe | 38 (18) | 40 (19) |
Asia | 126 (61) | 120 (57) |
Oceania | 12 (6) | 5 (2) |
aRussia was counted as part of Europe; Turkey and Israel were counted as part of Asia. |
Coprimary PK Endpoints (Noninferiority)
- The GMRs for Ctrough and C2 AUCD1-D15 were estimated for amivantamab SC and IV administration.2
GMRs for SC vs IV Administration2
PK Endpointa | Amivantamab SC (n=206) |
Amivantamab IV (n=212) |
GMR (90% CI) |
---|---|---|---|
Mean Ctrough, μg/mL (%CV) | |||
C2D1 (predose) | 365 (33) | 314 (32) | 1.15 (1.04-1.26) |
C4D1 (steady state) | 224 (39) | 162 (42) | 1.43 (1.27-1.61) |
Mean C2 AUCD1-D15, μg·h/mL (% CV) | 142,236 (31) | 135,552 (24) | 1.03 (0.98-1.09) |
aThe PK population for evaluating the coprimary PK endpoints included all patients who received all doses without dose modifications prior to the respective endpoint and who provided the PK samples necessary to derive each parameter. |
- Treatment-emergent anti-amivantamab antibodies were reported in 1 (0.6%) patient in the amivantamab SC group and none in the RYBREVANT IV group.2
- Treatment-emergent anti-rHuPH20 antibodies were reported in 15 (8%) patients in the amivantamab SC group.2
- The ORR, best responses, and DCR were evaluated for the amivantamab SC plus lazertinib and RYBREVANT IV plus lazertinib groups.2
Key Efficacy Endpoints2
Endpointa | Amivantamab SC + Lazertinib (n=206) |
RYBREVANT IV + Lazertinib (n=212) |
---|---|---|
ORR, % (95% CI)b | ||
All responders | 30 (24-37) | 33 (26-39) |
RR (95% CI) | 0.92 (0.70-1.23) | |
Confirmed responders | 27 (21-33) | 27 (21-33) |
Best response, n (%) | ||
CRc | 1 (0.5) | 1 (0.5) |
PRc | 61 (30) | 68 (32) |
SD | 93 (45) | 81 (38) |
PD | 37 (18) | 42 (20) |
NE | 14 (7) | 20 (9) |
DCR, % (95% CI)d | 75 (69-81) | 71 (64-77) |
Median TTR, months (range) | 1.5 (1.2-6.9) | 1.5 (1.2-9.9) |
aThe efficacy population included all the patients who had undergone randomization. |
- Median DOR among confirmed responders was 11.2 months (95% CI, 6.1-NE) in the amivantamab SC plus lazertinib group and 8.3 months (95% CI, 5.4-NE) in the RYBREVANT IV plus lazertinib group.2
- In total, 29% of patients in the amivantamab SC plus lazertinib group and 14% in the RYBREVANT IV plus lazertinib group had a DOR of ≥6 months.
- Median PFS was 6.1 months (95% CI, 4.3-8.1) in the amivantamab SC plus lazertinib group and 4.3 months (95% CI, 4.1-5.7) in the RYBREVANT IV plus lazertinib group (HR, 0.84; 95% CI, 0.64-1.10; P=0.20).2
- The PFS rates in the amivantamab SC plus lazertinib and RYBREVANT IV plus lazertinib groups, respectively, were 50% (95% CI, 43-58) and 42% (95% CI, 35-50) at 6 months and 37% (95% CI, 28-46) and 20% (95% CI, 8-35) at 12 months.
- ORR across predefined subgroups was evaluated for the amivantamab SC plus lazertinib and RYBREVANT IV plus lazertinib groups.2
ORR Across Predefined Subgroups2
Subgroup | RR (95% CI) | No. of Responders/No. of Patients (%) | |
---|---|---|---|
Amivantamab SC + Lazertinib | RYBREVANT IV + Lazertinib | ||
All randomized patients | 0.92 (0.7-1.23) | 62/206 (30) | 69/212 (33) |
Age | |||
<65 years | 0.95 (0.63-1.43) | 35/133 (26) | 38/120 (32) |
≥65 years | 0.9 (0.56-1.44) | 27/73 (37) | 31/92 (34) |
<75 years | 0.93 (0.69-1.26) | 57/188 (30) | 63/190 (33) |
≥75 years | 0.86 (0.28-2.61) | 5/18 (28) | 6/22 (27) |
Sex | |||
Female | 0.87 (0.61-1.24) | 43/138 (31) | 51/141 (36) |
Male | 1.09 (0.59-1.99) | 19/68 (28) | 18/71 (25) |
Race | |||
Asian | 0.81 (0.54-1.19) | 36/126 (29) | 46/129 (36) |
Non-Asian | 1.16 (0.69-1.96) | 26/79 (33) | 23/81 (28) |
BW | |||
<80 kg | 0.89 (0.65-1.22) | 53/184 (29) | 61/184 (33) |
≥80 kg | 1.16 (0.47-2.86) | 9/22 (41) | 8/28 (29) |
ECOG PS | |||
0 | 0.98 (0.54-1.76) | 19/58 (33) | 20/61 (33) |
1 | 0.9 (0.63-1.29) | 43/148 (29) | 49/151 (32) |
History of smoking | |||
Yes | 1.18 (0.68-2.08) | 23/65 (35) | 20/67 (30) |
No | 0.82 (0.56-1.19) | 39/141 (28) | 49/145 (34) |
EGFR mutation | |||
Exon19del | 0.75 (0.51-1.11) | 35/135 (26) | 48/138 (35) |
Exon 21 L858R | 1.32 (0.78-2.25) | 27/71 (38) | 21/74 (28) |
History of brain metastases | |||
Yes | 1.07 (0.63-1.83) | 24/71 (34) | 23/73 (32) |
No | 0.85 (0.58-1.25) | 38/135 (28) | 46/139 (33) |
Last therapy | |||
Osimertinib | 0.81 (0.48-1.36) | 22/91 (24) | 28/96 (29) |
Chemotherapy | 1 (0.68-1.45) | 40/115 (35) | 41/116 (35) |
- Median OS was 12.9 months (95% CI, 12.9-NE) in the amivantamab SC plus lazertinib group and NE (95% CI, 10.2-NE) in the RYBREVANT IV plus lazertinib group (HR, 0.62; 95% CI, 0.42-0.92; nominal P=0.02; endpoint was exploratory and not part of hierarchical hypothesis testing).2
- The OS rates in the amivantamab SC plus lazertinib and RYBREVANT IV plus lazertinib groups, respectively, were 85% (95% CI, 79-89) and 75% (95% CI, 68-80) at 6 months and 65% (95% CI, 52-74) and 51% (95% CI, 37-64) at 12 months.
- At a median follow-up of 7 months (range, 0.1-14.4), the median treatment duration was 4.7 months (range, 0.1-13.2) in the amivantamab SC plus lazertinib group and 4.1 months (range, 0-13.2) in the RYBREVANT IV plus lazertinib group. The incidence of AEs reported across both groups was consistent with previous reports of RYBREVANT IV plus lazertinib.2
Safety Summary2
AE, n (%) | Amivantamab SC + Lazertinib (n=206) |
RYBREVANT IV + Lazertinib (n=210) |
---|---|---|
Any AEs | 204 (99) | 209 (99) |
Grade ≥3 AEs | 107 (52) | 118 (56) |
Serious AEs | 59 (29) | 64 (30) |
AEs leading to death | 7 (3) | 10 (5) |
Any AE leading to treatment | ||
Interruptions of any agenta | 127 (62) | 127 (60) |
Reductions of any agent | 63 (31) | 52 (25) |
Discontinuations of any agent | 26 (13) | 29 (14) |
aExcluding infusion/administration-related reactions. |
- The median time to treatment discontinuation was 6.7 months (95% CI, 4.9-8.4) in the amivantamab SC plus lazertinib group and 5.6 months (95% CI, 4.2-6.9) in the RYBREVANT IV plus lazertinib group (HR, 0.86; 95% CI, 0.66-1.12).2
- Treatment-related AEs leading to discontinuation were reported in 9% of patients in the amivantamab SC plus lazertinib group and 12% in the RYBREVANT IV plus lazertinib group.2
- The dose reduction rate was 31% in the amivantamab SC plus lazertinib group and 25% in the RYBREVANT IV plus lazertinib group; the corresponding rates due to grade ≥3 AEs were 3% and 4%, respectively.2
- Rash was the leading cause of dose reductions in the amivantamab SC plus lazertinib and RYBREVANT IV plus lazertinib groups (8% vs 4%), with the similar incidence of all-grade rash (46% vs 43%) and grade ≥3 rash (3% vs 4%) in both groups.2
- The median duration of rash was 31 days in the amivantamab SC plus lazertinib group and 44 days in the RYBREVANT IV plus lazertinib group.2
- The most common grade ≥3 AE was dermatitis acneiform, reported in 9% of patients in the amivantamab SC plus lazertinib group and 6% of patients in the RYBREVANT IV plus lazertinib group.2
AE of Special Interest: IRR-Related Events
- All-grade IRRs were reported in 13% of patients in the amivantamab SC plus lazertinib group and 66% of patients in the RYBREVANT IV plus lazertinib group.2
- No grade 4-5 events were reported.
- Most IRRs were reported during C1.
Summary of IRRs2
Parameters | Amivantamab SC + Lazertinib (n=206) |
RYBREVANT IV + Lazertinib (n=210) |
---|---|---|
All-grade IRRs, % | 13 | 66 |
Grade ≥3 IRRs, n (%) | 1 (0.5) | 8 (4) |
IRRs leading to discontinuations, n (%) | 0 | 4 (2) |
- The incidence rates of infusion-related AEs ranged between 0% and 6% in the amivantamab SC plus lazertinib group and 2% and 20% in the RYBREVANT IV plus lazertinib group.2
AE of Special Interest: VTE2
- The incidence of VTE was 9% in the amivantamab SC plus lazertinib group and 14% in the RYBREVANT IV plus lazertinib group, with pulmonary embolism and deep vein thrombosis being the most common.2
- Among all VTE cases, most occurred in the first 4 months (amivantamab SC plus lazertinib vs RYBREVANT IV plus lazertinib, 74% vs 67%).
- VTE was reported in 10% (32/335) of patients receiving prophylactic anticoagulation and 21% (17/81) of patients not receiving prophylactic anticoagulation.2
AE of Special Interest: VTE2
n (%) | Amivantamab SC + Lazertinib (n=206) |
RYBREVANT IV + Lazertinib (n=210) |
---|---|---|
Any VTEa | 19 (9) | 30 (14) |
Grade 1 | 1 (0.5) | 7 (3) |
Grade 2 | 16 (8) | 16 (8) |
Grade 3 | 2 (1) | 6 (3) |
Grade 4 | 0 | 1 (0.5) |
Grade 5 | 0 | 0 |
Any VTE leading to death | 0 | 0 |
Any VTE leading to discontinuation of any agent | 0 | 2 (1) |
aVTE events include pulmonary embolism, deep vein thrombosis, embolism venous, venous thrombosis limb, embolism, thrombosis, subclavian vein thrombosis, superficial vein thrombosis, pulmonary infarction, and venous thrombosis. |
- Overall, 80% and 81% of patients in the amivantamab SC plus lazertinib and RYBREVANT IV plus lazertinib groups, respectively, received prophylactic anticoagulation.2
Concomitant Anticoagulants2
Anticoagulant Use, n (%) | Amivantamab SC + Lazertinib (n=206) |
RYBREVANT IV + Lazertinib (n=210) |
---|---|---|
Patients with ≥1 concomitant anticoagulant | 164 (80) | 171 (81) |
Antithrombotic agents | ||
Direct factor Xa inhibitors | 132 (64) | 143 (68) |
Rivaroxaban | 89 (43) | 76 (36) |
Apixaban | 38 (18) | 54 (26) |
Edoxaban | 7 (3) | 17 (8) |
Heparin group | 48 (23) | 45 (21) |
Enoxaparin | 39 (19) | 35 (17) |
Heparin | 4 (2) | 2 (1) |
Tinzaparin | 3 (2) | 2 (1) |
Low molecular weight heparin | 3 (2) | 1 (0.5) |
Bemiparin | 2 (1) | 3 (1) |
Nadroparin | 1 (0.5) | 2 (1) |
Dalteparin | 0 | 1 (0.5) |
Other antithrombotic agents | 1 (0.5) | 3 (1) |
Fondaparinux | 1 (0.5) | 3 (1) |
Direct thrombin inhibitors | 0 | 1 (0.5) |
Dabigatran | 0 | 1 (0.5) |
Vitamin K antagonists | 0 | 1 (0.5) |
Warfarin | 0 | 1 (0.5) |
- At C1D1, median administration time was reduced to 4.8 minutes (range, 0-18) with SC administration from 5 hours (range, 0.2-9.9) for the first infusion with IV administration.2
- The patient-reported treatment satisfaction was evaluated for amivantamab SC vs RYBREVANT IV administration at C1D1, C3D1, and EOT.2,5
Patient-Reported Treatment Satisfaction2,5
Responsea | Amivantamab SCb | RYBREVANT IVb | Nominal P-Value |
---|---|---|---|
C1D1c | n=193 | n=195 | |
Unrestrictedd, % | 66 | 29 | <0.001 |
Unbotherede, % | 69 | 30 | |
Convenient or very convenient, % | 85 | 52 | |
C3D1 | n=146 | n=125 | |
Unrestrictedd, % | 60 | 42 | 0.004 |
Unbotherede, % | 71 | 45 | <0.001 |
EOTf | n=61 | n=55 | |
Convenient or very convenient, % | 85 | 35 | <0.001 |
aResponse categories on the mTASQ convenience question included “very convenient,” “convenient,” “neither convenient nor inconvenient,” “inconvenient,” and “very Inconvenient.” The mTASQ is an 11-item questionnaire measuring the impact of each mode of treatment administration on 5 domains: physical impact, psychological impact, impact on activities of daily living, convenience, and satisfaction. |
- Patients receiving amivantamab SC reported minimal moderate to very severe injection-site symptoms (pain [C1D1, 14%; C3D1, 16%], swelling [C1D1, 5%; C3D1, 6%], and redness [C1D1, 5%; C3D1, 6%]).2
- Patients receiving amivantamab SC were satisfied (C1D1, 86%; C3D1, 90%), were likely to prefer it over IV (C1D1, 77%; C3D1, 81%) and indicated that they would recommend it to other patients (C1D1, 78%; C3D1, 81%).2
AE | Adverse event | mTASQ | modified Therapy Administration Satisfaction Questionnaire |
---|---|---|---|
ALT | Alanine aminotransferase | NE | Not estimable |
AST | Aspartate aminotransferase | NSCLC | Non-small cell lung cancer |
AUCD1-D15 | Area under the concentration-time curve from C2 D1 to D15 | ORR | Objective response rate |
BW | Body weight | OS | Overall survival |
C | Cycle | PD | Progressive disease |
CI | Confidence interval | PFS | Progression-free survival |
CR | Complete response | PK | Pharmacokinetics |
Ctrough | Trough concentrations | PO | Orally |
%CV | % Coefficient of variation | PR | Partial response |
D | Day | PRO | Patient-reported outcome |
DCR | Disease control rate | QD | Once daily |
DOR | Duration of response | QW | Once a week |
ECOG PS | Eastern Cooperative Oncology Group performance status | Q2W | Every 2 weeks |
EGFR | Epidermal growth factor receptor | Q6W | Every 6 weeks |
EOT | End of treatment | RECIST v1.1 | Response Evaluation Criteria in Solid Tumors version 1.1 |
Exon19del | Exon 19 deletion | R | Randomization |
GMR | Geometric mean ratio | RR | Relative risk |
HR | Hazard ratio | rHuPH20 | Recombinant human hyaluronidase PH20 |
IgG1 | Immunoglobulin G1 | SC | Subcutaneous |
ILD | Interstitial lung disease | SD | Stable disease |
IRR | Infusion-related reaction | TTR | Time to response |
IV | Intravenous | VTE | Venous thromboembolism |
MET | Mesenchymal-epithelial transition |
A literature search of MEDLINE®, Embase®, BIOSIS Previews®, and Derwent Drug File (and/or other resources, including internal/external databases) was conducted on 03 September 2024.
- 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.
- 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.
- 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.
- Janssen Research & Development, LLC. A phase 3, open-label, randomized study of lazertinib with subcutaneous amivantamab compared with intravenous amivantamab in patients with EGFR-mutated advanced or metastatic non-small cell lung cancer after progression on osimertinib and chemotherapy. In: ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). 2000- [cited 2024 September 03]. Available from: https://clinicaltrials.gov/study/NCT05388669 NLM Identifier: NCT05388669
- Alexander M, Cheng Y, Lee S-H, et al. Subcutaneous vs intravenous amivantamab: patient satisfaction and resource utilization results from the PALOMA-3 Study. Oral Presentation presented at: International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer (WCLC); September 7-10, 2024; San Diego, CA.