New Amivantamab Data from CHRYSALIS Study Show Robust Clinical Activity and Durable Responses in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer and EGFR Exon 20 Insertion Mutations

January 28, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced new data from the Phase 1 CHRYSALIS study, which evaluated amivantamab in patients with metastatic or unresectable non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy.1 These data were presented for the first time in an oral presentation at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore. The key findings showed robust activity and durable responses with a tolerable and manageable safety profile (Abstract #3031) in patients with NSCLC and EGFR exon 20 insertion mutations, a mutation for which no targeted therapies are currently approved.1,2,3Amivantamab is an investigational, fully-human EGFR and MET bispecific antibody with immune cell-directing activity that targets tumors with activating and resistance EGFR and MET mutations and amplifications.4,5,6,7 Janssen has filed regulatory submissions in the U.S. and Europe seeking approval of amivantamab for the treatment of patients with NSCLC and EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.8 These applications mark the first-ever regulatory submissions for a treatment for patients with NSCLC and EGFR exon 20 insertion mutations.9“Th...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Source: Medscape Infectious Diseases Headlines - Category: Infectious Diseases Tags: Infectious Diseases News Source Type: news
AbstractMore than 12 months have passed since the World Health Organization (WHO) declared Coronavirus Disease 19 (COVID-19), caused by the SARS-CoV2 virus, to be a pandemic on 11 March 2020. The entire world scientific community agrees that at this time vaccine is the most promising weapon to combat the infection and the severity of the disease. According to the document “Draft landscape of COVID-19 candidate vaccines” by WHO, 272 vaccines against SARS-CoV-2 virus are in development, although only four of these, produced by Pfizer-BioNTech (Pfizer, Inc. and BioNTech), Moderna, AstraZeneca, and Janssen companie...
Source: Dermatology and Therapy - Category: Dermatology Source Type: research
September 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced preliminary results from the Phase 1b CHRYSALIS-2 (NCT04077463) study evaluating RYBREVANT® (amivantamab-vmjw) in combination with lazertinib in the treatment of patients with non-small cell lung cancer (NSCLC) characterized by epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib and platinum chemotherapy.[i] While previously reported results have demonstrated durable responses with RYBREVANT® in combination with ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
September 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced a new analysis from the CHRYSALIS (NCT02609776) study evaluating RYBREVANT® (amivantamab-vmjw) monotherapy and a combination regimen with lazertinib in advanced non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations who progressed after osimertinib.[1] The analysis showed higher activity and longer duration of response (DOR) in patients treated with the combination therapy, demonstrating the potential benefit of targeting the extracellular (outer) and cataly...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
August 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANTTM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. The initial data showed anti-tumor activity in patients with METex14 mutations and a safety profile consistent with reported experience at the approved CHRYSALIS Phase 2 dose (RYBREVANTTM 1050 mg [
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
May 21, 2021 (HORSHAM, P.A.) – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of RYBREVANTTM (amivantamab-vmjw) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.[1] RYBREVANTTM is the first fully-human, bispecific antibody approved for the treatment of patients with NSCLC th...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
May 19, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced updated data from the Phase 1 CHRYSALIS study showing treatment with amivantamab in combination with lazertinib led to a median duration of response (DOR) of 9.6 months in chemotherapy-naïve patients with non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 19 deletion or L858R mutations whose disease had progressed after treatment with osimertinib.[1] These data, which will be presented in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) Annual M...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
January 12, 2021 (RARITAN, N.J.) – The Janssen Pharmaceutical Companies of Johnson &Johnson announced today that eight company-sponsored presentations, including two oral presentations, will be featured at the International Association for the Study of Lung Cancer’s (IASLC) 2020 World Conference on Lung Cancer (WCLC) Singapore taking place virtually January 28-31, 2021. The presentations include updated data from the Phase 1 CHRYSALIS study (NCT02609776) evaluating amivantamab in patients with NSCLC and EGFR exon 20 insertion mutations and two studies that characterize the high unmet need and lack of standa...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
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