JOHNSON & JOHNSON
RARITAN - The Janssen Pharmaceutical Companies of
Investigators assessed efficacy using overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), clinical benefit rate, duration of response and the safety profile of amivantamab and lazertinib,3 in the 91 patients treated with the combination across dose escalation and expansion cohorts3. The study results were presented at the
The CHRYSALIS study is an open-label, global, multi-center study evaluating the safety, pharmacokinetics and efficacy of amivantamab as a monotherapy and in combination with lazertinib in adult patients with advanced NSCLC.5 Exon 19 deletion and L858R mutations are common, accounting for 85-90 percent of all EGFR mutations in NSCLC.6 In the study, 91 patients with NSCLC harboring EGFR exon 19 deletion or L858R mutations received the combination of amivantamab intravenously and lazertinib orally.3 The study enrolled 26 patients in dose escalation and identified a combination dose that was equivalent to monotherapy doses of both products.3 Additionally, 20 treatment-naive patients with EGFR-mutated NSCLC were enrolled to further examine the safety, efficacy and tolerability in the first-line setting and 45 patients who had relapsed on osimertinib but were chemotherapy-naive were enrolled to examine safety and efficacy in the resistance setting.3
In the treatment-naive group, 20 patients receiving the combination of amivantamab and lazertinib achieved a 100 percent ORR (95 percent CI, 83 - 100).3 The median follow-up and treatment duration at the time of data cut-off was seven months (3 - 10).3 Among 45 osimertinib-relapsed, chemotherapy-naive patients, the combination of amivantamab and lazertinib resulted in a 36 percent ORR (95 percent CI, 22 - 51), with one complete response and 15 partial responses.3 The clinical benefit rate for these patients was 60 percent (95 percent CI; 44 - 74).3 Biomarker and central nervous system analyses and efficacy by mechanism of osimertinib resistance are ongoing and will be presented at a future medical meeting.
'Despite treatment advancements, lung cancer remains the leading cause of cancer deaths globally, and there are opportunities to improve treatment options for patients with non-small cell lung cancer with genetic factors such as EGFR mutations,' said
For the 91 treated patients, the majority of treatment-related adverse events (AEs) experienced were Grade 1-2.3 A low incidence of Grade 3 treatment-related AEs occurred, which included rash (four percent), hypoalbuminemia (two percent), increased gamma glutamyltransferase (one percent), hyponatremia (one percent), paronychia (one percent) and interstitial lung disease (one percent) were observed.3 Related AEs leading to treatment discontinuation occurred in six percent of patients.3 Infusion-related reaction occurred predominantly at first infusion and did not impact subsequent dosing.3
The results from the CHRYSALIS study have led to new studies to further evaluate the potential of amivantamab and lazertinib combination therapy. The Phase 3 MARIPOSA study (NCT04487080) will assess the amivantamab and lazertinib combination against osimertinib in untreated advanced EGFR-mutated NSCLC,4 and Phase 2 trial, CHRYSALIS-2, (NCT04077463) has been initiated to examine the combination in patients who have progressed after treatment with osimertinib and chemotherapy.7
'We are committed to advancing our understanding of the biology of lung cancer in order to develop targeted therapies that address specific patient populations, such as those with EGFR-mutated non-small cell lung cancer,' said
About Amivantamab
Amivantamab, formerly JNJ-61186372, is an investigational EGFR-MET bispecific antibody with immune cell-directing activity that targets activating and resistance EGFR mutations and MET mutations and amplifications.3,5 In
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.9 Interim safety and efficacy results from the lazertinib Phase 1-2 study were published in The Lancet Oncology in 2019. In 2018,
About Non-Small Cell
Worldwide, lung cancer is the most common cancer, and NSCLC makes up 80-85 percent of all lung cancers.10,11 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.12 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase that helps cells grow and divide.13 EGFR mutations are present in 10 to 15 percent of patients with NSCLC and occur in 40 to 50 percent of Asian patients who have NSCLC adenocarcinoma.14,15,16 The five-year survival rate for patients with metastatic NSCLC is currently 24 percent.17
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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