JOHNSON & JOHNSON
'Despite significant advances in the treatment of EGFR-mutated non-small cell lung cancer, the progression-free survival rate with the current first-line therapies remains low,' said
MARIPOSA (NCT04487080) is a randomised, Phase 3 study evaluating amivantamab in combination with lazertinib compared to osimertinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations.4 The MARIPOSA study met its primary endpoint, resulting in statistically significant and clinically meaningful improvement in progression-free survival (PFS) for amivantamab plus lazertinib versus osimertinib, as assessed by blinded independent central review (BICR).1 The safety profile of amivantamab plus lazertinib was consistent with prior reports of the combination, with mostly Grade 1 or 2 adverse events (AEs).1
'Lung cancer remains the leading cause of cancer death worldwide and high unmet needs remain for patients with certain oncogenic driver mutations,' said
The pivotal data from the MARIPOSA study were featured in a Late-Breaking Presidential Symposium session (Abstract #LBA14) at the 2023
About the MARIPOSA Study
MARIPOSA (NCT04487080), which enrolled 1,074 patients, is a randomised, Phase 3 study evaluating amivantamab in combination with lazertinib versus osimertinib and versus lazertinib alone in first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR ex19del or L858R substitution mutations.1,5 The primary endpoint of the study is PFS (using RECIST v1.1 guidelines(++)) as assessed by BICR.1 Secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DOR), second progression free survival (PFS2) and intracranial PFS.1
The MARIPOSA study required all patients to have serial brain imaging with MRIs in order to detect or monitor brain metastases, a measure not implemented in most prior studies for EGFR-mutated NSCLC.1 The primary endpoint of PFS in MARIPOSA included these central nervous system (CNS) events detected by serial brain MRIs.1 Extracranial PFS, which may more closely approximate what would be seen in other trials, was also explored in MARIPOSA.1
About Lazertinib
Lazertinib is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the efficacy and safety of lazertinib from the Phase 3 study LASER301 was published in
About Amivantamab
Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications.5,6,7,8,9
The
For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using amivantamab please refer to the Summary of Product Characteristics.12
In line with EMA regulations for new medicines and those given conditional approval, amivantamab is subject to additional monitoring.
About Non-Small Cell
In
The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.15 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.15,15 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.16,17,18,19 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.20 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR TKIs is less than 20 percent.21,22 Patients with EGFR ex19del or L858R mutations have a real-world five-year OS of 19 percent.23 In addition, it has been demonstrated that approximately 50 percent of patients with NSCLC will develop brain metastases which are a substantial contributor to overall cancer mortality.
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of amivantamab and lazertinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of
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