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DRUG:

amivantamab SC (Ami-LC)

i
Other names: Ami-LC, Ami-HC, CNTO-4424, JNJ-611, JNJ-61186372, JNJ61186372, CNTO4424, JNJ611, CNTO 4424, JNJ 611, JNJ 61186372
Associations
Company:
J&J
Drug class:
EGFR inhibitor, c-MET inhibitor
Related drugs:
Associations
14d
New P2 trial • Combination therapy • Metastases
|
carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
1m
Trial completion date
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
2ms
Efficacy and Safety of Amivantamab in Advanced or Metastatic EGFR-Mutant Non-Small Cell Lung Cancer: A Systematic Review. (PubMed, J Clin Med)
Infusion-related reactions (IRRs) ranged from 42% to 78% among patients that received amivantamab intravenously, while a 13% IRR rate was found in a group of patients that received amivantamab subcutaneously. Current evidence suggests that amivantamab is an effective treatment option for patients with advanced or metastatic NSCLC with EGFR mutations. Amivantamab-based combinations may prolong survival both in the treatment of naïve patients and those who have progressed on chemotherapy or tyrosine kinase inhibitors.
Review • Journal • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Rybrevant (amivantamab-vmjw) • amivantamab SC (Ami-LC)
5ms
Subcutaneous versus Intravenous Amivantamab, both in Combination with Lazertinib, in Refractory EGFR-mutated NSCLC: Primary Results from the Phase 3 PALOMA-3 Study. (PubMed, J Clin Oncol)
Subcutaneous amivantamab-lazertinib demonstrated noninferiority to intravenous amivantamab-lazertinib, offering a consistent safety profile with reduced infusion-related reactions, increased convenience, and prolonged survival.
P3 data • Journal • Combination therapy
|
EGFR (Epidermal growth factor receptor)
|
Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
6ms
Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
6ms
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1, N=160, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting
Enrollment closed
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
7ms
Subcutaneous amivantamab vs intravenous amivantamab, both in combination with lazertinib, in refractory EGFR-mutated, advanced non-small cell lung cancer (NSCLC): Primary results, including overall survival (OS), from the global, phase 3, randomized controlled PALOMA-3 trial. (ASCO 2024)
PALOMA-3 (NCT05388669) evaluated SC ami+laz vs IV ami+laz for pharmacokinetics (PK), efficacy, and safety among pts with EGFR Ex19del or L858R-mutated advanced NSCLC and disease progression on osimertinib and platinum-based chemotherapy. SC ami demonstrated noninferior PK and ORR compared to IV. Unexpectedly, DoR, PFS, and OS were longer in the SC arm vs IV, suggesting that the route of administration or formulation may affect outcomes. The safety profile was improved for SC ami, with lower IRR and VTE rates.
Combination therapy • Late-breaking abstract • P3 data • Clinical • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
8ms
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1, N=166, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Jan 2024 --> Oct 2024
Trial primary completion date • Metastases
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
9ms
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1, N=166, Recruiting, Janssen Research & Development, LLC | Trial completion date: Feb 2025 --> Oct 2025
Trial completion date • Metastases
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
11ms
Enrollment change • Metastases
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
11ms
Trial completion date • Metastases
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
11ms
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1, N=116, Recruiting, Janssen Research & Development, LLC | Active, not recruiting --> Recruiting | Phase classification: P1b --> P1 | Trial completion date: Oct 2024 --> Feb 2025
Enrollment open • Phase classification • Trial completion date • Metastases
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
11ms
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
12ms
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
1year
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1b, N=125, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | Trial primary completion date: Oct 2023 --> Jan 2024
Enrollment closed • Trial primary completion date • Metastases
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
1year
A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
P3, N=418, Active, not recruiting, Janssen Research & Development, LLC | Recruiting --> Active, not recruiting | Trial completion date: Feb 2024 --> Oct 2024
Enrollment closed • Trial completion date • Metastases
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
1year
Enrollment change • Metastases
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
1year
Trial primary completion date • Metastases
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
over1year
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1b, N=196, Recruiting, Janssen Research & Development, LLC | Trial primary completion date: Apr 2023 --> Oct 2023
Trial primary completion date
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
over1year
Subcutaneous amivantamab (ami) in patients (pts) with advanced solid malignancies: The PALOMA study—Updated safety and identification of the recommended phase 2 dose. (ASCO 2023)
Ami SC was well tolerated with meaningful reductions in administration time and TEAEs. Ami SC provided a quantitative and qualitative improvement in the symptoms of IRRs vs historical IV rates. The identified RP2D for ami SC on the Q2W schedule achieved similar exposure as the approved IV dose.
P2 data • Clinical • Metastases
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
amivantamab SC (Ami-LC)
over1year
Enrollment change • Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
over1year
Trial primary completion date • Metastases
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
almost2years
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
almost2years
Enrollment open • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
almost2years
Enrollment change • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
2years
Enrollment open • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
2years
Trial completion date • Metastases
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
2years
Trial completion date
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
over2years
New P2 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR exon 20 mutation
|
Tagrisso (osimertinib) • carboplatin • pemetrexed • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
over2years
New P3 trial
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
|
Tagrisso (osimertinib) • Rybrevant (amivantamab-vmjw) • Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
almost3years
Enrollment change
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR exon 20 insertion • EGFR exon 20 mutation
|
Lazcluze (lazertinib) • amivantamab SC (Ami-LC)
over3years
[VIRTUAL] Subcutaneous delivery of amivantamab in patients with advanced solid malignancies: PALOMA, an open-label, multicenter, dose escalation phase 1b study. (ASCO 2021)
To mitigate infusion related reactions (IRR), medication with steroid, paracetamol, and antihistamine will be given pre-infusion and as clinically indicated post-infusion . Blood samples will be collected to assess PK, pharmacodynamics, and immunogenicity . A Study Evaluation Team composed of investigators and sponsor representatives will review safety and PK data to make decisions about dose escalation and cohort expansion throughout the conduct of the study.
P1 data • Clinical
|
MET (MET proto-oncogene, receptor tyrosine kinase)
|
EGFR mutation • MET amplification • MET mutation
|
Rybrevant (amivantamab-vmjw) • amivantamab SC (Ami-LC)
almost4years
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1b, N=80, Recruiting, Janssen Research & Development, LLC | Not yet recruiting --> Recruiting
Clinical • Enrollment open
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
amivantamab SC (Ami-LC)
4years
PALOMA: A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies (clinicaltrials.gov)
P1b, N=80, Not yet recruiting, Janssen Research & Development, LLC | Trial completion date: Sep 2024 --> Dec 2024
Clinical • Trial completion date
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
amivantamab SC (Ami-LC)
4years
Clinical • New P1 trial
|
EGFR (Epidermal growth factor receptor) • MET (MET proto-oncogene, receptor tyrosine kinase)
|
amivantamab SC (Ami-LC)