Non-Small Cell Lung Cancer (NSCLC)

European Commission Approves LORVIQUA® (lorlatinib) as a First-Line Treatment for ALK-Positive Advanced Lung Cancer

Retrieved on: 
Friday, January 28, 2022
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, the CROWN Trial of LORVIQUA, Non-Small Cell Lung Cancer (NSCLC), LORVIQUA® (lorlatinib), Pfizer Oncology, Pfizer: Breakthroughs That Change Patients’ Lives, THE CROWN TRIAL OF LORVIQUA, NON-SMALL CELL LUNG CANCER (NSCLC), LORVIQUA® (LORLATINIB), PFIZER ONCOLOGY, PFIZER: BREAKTHROUGHS THAT CHANGE PATIENTS’ LIVES

LORVIQUA is a TKI that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of ALK.

Key Points: 
  • LORVIQUA is a TKI that has been shown to be highly active in preclinical lung cancer models harboring chromosomal rearrangements of ALK.
  • LORVIQUA was specifically developed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.
  • First-line ceritinib versus platinum-based chemotherapy in advanced ALKrearranged non-small-cell lung cancer (ASCEND-4): a randomised, open-label, phase 3 study.
  • Patterns of metastatic spread and mechanisms of resistance to crizotinib in ROS1-positive non-small-cell lung cancer.

Janssen Receives Positive CHMP Opinion for RYBREVANT® (amivantamab) for the Treatment of Patients with Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations After Failure of Platinum-Based Therapy

Retrieved on: 
Friday, October 15, 2021
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Amivantamab, the CHRYSALIS Study, Non-Small Cell Lung Cancer (NSCLC), the Janssen Pharmaceutical Companies of Johnson & Johnson, AMIVANTAMAB, THE CHRYSALIS STUDY, NON-SMALL CELL LUNG CANCER (NSCLC), THE JANSSEN PHARMACEUTICAL COMPANIES OF JOHNSON & JOHNSON

HSR19-082: Epidemiological Findings and Outcomes in Non-Small Cell Lung Cancer Patients with Exon 20 Insertion Mutations: A Meta-Analysis.

Key Points: 
  • HSR19-082: Epidemiological Findings and Outcomes in Non-Small Cell Lung Cancer Patients with Exon 20 Insertion Mutations: A Meta-Analysis.
  • 13 Janssen Submits European Marketing Authorisation Application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
  • RYBREVANT (amivantamab-vmjw) Receives FDA Approval as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
  • Comparative clinical outcomes for patients with NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations.

U.S. FDA Expands Approval of Pfizer’s LORBRENA® as First-Line Treatment for ALK-Positive Metastatic Lung Cancer

Retrieved on: 
Thursday, March 4, 2021
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Chemical compounds, Drugs, Orphan drugs, Breakthrough therapy, Lung cancer, Clinical medicine, Tyrosine kinase receptors, Anaplastic lymphoma kinase, Non-small-cell lung carcinoma, Lorlatinib, Treatment of lung cancer, Ceritinib, the CROWN Trial, Non-Small Cell Lung Cancer (NSCLC), LORBRENA® (lorlatinib), Pfizer Oncology, Pfizer: Breakthroughs That Change Patients’ Lives

LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Key Points: 
  • LORBRENA is now indicated for adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.
  • AEs leading to dose interruptions and dose reductions occurred in 49% and 21% of people treated with LORBRENA, respectively.
  • Based on the CROWN data, the FDA has also converted the accelerated approval to full approval.
  • LORBRENA is approved in the U.S. for the treatment of adults with metastatic NSCLC whose tumors are ALK-positive as detected by an FDA-approved test.

Janssen: 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

Retrieved on: 
Friday, January 29, 2021
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Lung cancer, Organic compounds, Chemical compounds, Quinazolines, Aromatic compounds, Tyrosine kinase receptors, Tyrosine kinase inhibitors, Chloroarenes, Non-small-cell lung carcinoma, Epidermal growth factor receptor, T790M, Icotinib, the Phase 1 CHRYSALIS Study21, Amivantamab, Non-Small Cell Lung Cancer (NSCLC), the Janssen Pharmaceutical Companies of Johnson & Johnson

8 Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.

Key Points: 
  • 8 Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
  • 9 Janssen Submits European Marketing Authorisation Application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations.
  • HSR19-082: Epidemiological Findings and Outcomes in Non-Small Cell Lung Cancer Patients with Exon 20 Insertion Mutations: A Meta-Analysis.
  • Comparative Clinical Outcomes for Patients with NSCLC Harboring EGFR Exon 20 Insertion Mutations and Common EGFR Mutations.

Janssen Submits European Marketing Authorisation Application for Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Monday, December 28, 2020
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Johnson & Johnson, Quinazolines, Companies, Organic compounds, Health, Epidermal growth factor receptor, Oncogenes, Non-small-cell lung carcinoma, Cilag, Janssen Pharmaceutica, Lung cancer, Janssen Biotech, Amivantamab, Non-Small Cell Lung Cancer (NSCLC), the Janssen Pharmaceutical Companies of Johnson & Johnson

Janssen Research & Development, LLC; Janssen-Cilag, S.A. and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points: 
  • Janssen Research & Development, LLC; Janssen-Cilag, S.A. and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • EGFR exon 20 insertions in advanced non-small cell lung cancer: A new history begins.
  • Antitumor Activity of Amivantamab (JNJ-61186372), an EGFRMET Bispecific Antibody, in Diverse Models of EGFR Exon 20 InsertionDriven NSCLC.
  • Targeting EGFR exon 20 insertion mutations in non-small cell lung cancer.

TROPION-Lung05 Phase 2 Trial of Datopotamab Deruxtecan Initiated in Patients with Advanced or Metastatic NSCLC with Actionable Genomic Alterations

Retrieved on: 
Monday, December 14, 2020
Oncology, Health, Clinical trials, Research, Pharmaceutical, Science, Companies, Clinical medicine, Health care, Immunology, Breakthrough therapy, Trastuzumab deruxtecan, Antineoplastic drugs, AstraZeneca, Trastuzumab, Daiichi Sankyo, Targeted therapy, Non-small-cell lung carcinoma, TROPION-Lung05, Non-Small Cell Lung Cancer (NSCLC), TROP2, Datopotamab Deruxtecan (Dato-DXd; DS-1062), Daiichi Sankyo

Many patients with NSCLC will ultimately develop resistance to available targeted therapies, and treatment options for advanced NSCLC are limited, said Cristian Massacesi, Senior Vice President, Head of Late Stage Development Oncology R&D, AstraZeneca.

Key Points: 
  • Many patients with NSCLC will ultimately develop resistance to available targeted therapies, and treatment options for advanced NSCLC are limited, said Cristian Massacesi, Senior Vice President, Head of Late Stage Development Oncology R&D, AstraZeneca.
  • TROPION-Lung05 provides an opportunity to evaluate datopotamab deruxtecan, a targeted ADC approach with promise in this patient population.
  • Datopotamab deruxtecan (Dato-DXd; DS-1062) is one of three lead DXd antibody drug conjugates (ADCs) in the oncology pipeline of Daiichi Sankyo.
  • Daiichi Sankyo is responsible for manufacturing and supply of trastuzumab deruxtecan and datopotamab deruxtecan.

TROPION-Lung01 Head-to-Head Phase 3 Trial Initiated to Evaluate Datopotamab Deruxtecan Versus Docetaxel in Previously Treated Patients with Advanced or Metastatic NSCLC Without Actionable Genomic Alterations

Retrieved on: 
Monday, December 14, 2020
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Drugs, Clinical medicine, Breakthrough therapy, Health sciences, Lung cancer, Orphan drugs, Monoclonal antibodies, Non-small-cell lung carcinoma, Docetaxel, Trastuzumab deruxtecan, Atezolizumab, TROPION-Lung01, Non-Small Cell Lung Cancer (NSCLC), TROP2, Datopotamab Deruxtecan (Dato-DXd; DS-1062), Daiichi Sankyo

This head-to-head trial will determine whether targeting TROP2 with datopotamab deruxtecan will improve survival as compared to the standard therapy used in this setting.

Key Points: 
  • This head-to-head trial will determine whether targeting TROP2 with datopotamab deruxtecan will improve survival as compared to the standard therapy used in this setting.
  • TROPION-Lung01 was initiated following the encouraging clinical activity of datopotamab deruxtecan in patients with heavily pre-treated advanced NSCLC observed in the ongoing TROPION-PanTumor01 phase 1 trial, which completed enrollment of patients with lung cancer in October of 2020.
  • This global, multicenter, randomized, open-label phase 3 trial will evaluate the efficacy and safety of datopotamab deruxtecan (6.0 mg/kg) versus docetaxel (75 mg/m2) in patients with advanced or metastatic NSCLC without actionable genomic alterations and with progression on or after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy received either in combination or sequentially.
  • Approximately 590 patients will be randomized into two arms in a 1:1 ratio to receive either datopotamab deruxtecan or docetaxel.

Janssen Submits Application to U.S. FDA Seeking Approval of Amivantamab for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Thursday, December 3, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Organic compounds, Chemical compounds, Quinazolines, Cancer, Tyrosine kinase inhibitors, Epidermal growth factor receptor, Oncogenes, Non-small-cell lung carcinoma, Lung cancer, T790M, KRAS, Amivantamab, the Amivantamab Expanded Access Program Protocol (EAP), Non-Small Cell Lung Cancer (NSCLC), the Janssen Pharmaceutical Companies of Johnson & Johnson

Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab.

Key Points: 
  • Companion diagnostics to identify patients with EGFR exon 20 insertion mutations have been an integral part of the development program for amivantamab.
  • 7 Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer.
  • 14 Chen D, Song Z, Cheng G. Clinical efficacy of first-generation EGFRTKIs in patients with advanced nonsmallcell lung cancer harboring EGFR exon 20 mutations.
  • Real-World Treatment Patterns and Survival in Non-Small Cell Lung Cancer Patients with EGFR Exon 20 Insertion Mutations.

BeiGene Announces that RATIONALE 303 Trial of Tislelizumab in Non-Small Cell Lung Cancer Met the Primary Endpoint of Overall Survival at Interim Analysis

Retrieved on: 
Tuesday, November 17, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Monoclonal antibodies, Drugs, Clinical medicine, Tislelizumab, Medicine, Immune system, Programmed cell death protein 1, Cancer immunotherapy, PD-1 and PD-L1 inhibitors, Breakthrough therapy, Non-Small Cell Lung Cancer (NSCLC), Tislelizumab, the Tislelizumab Clinical Program, BeiGene

The safety profile of tislelizumab was consistent with the known risks of tislelizumab, with no new safety signals identified.

Key Points: 
  • The safety profile of tislelizumab was consistent with the known risks of tislelizumab, with no new safety signals identified.
  • The RATIONALE 303 trial is the third Phase 3 trial of tislelizumab in NSCLC that has achieved a positive outcome at interim analysis, and more importantly, marks the first global pivotal trial with a positive outcome in the tislelizumab clinical program, demonstrating BeiGenes capabilities in global clinical development.
  • A total of 805 patients were randomized 2:1 to either the tislelizumab arm or the docetaxel arm in 10 countries.
  • Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcR on macrophages.

Janssen Presents Findings from Global, Multi-Centre Trial Examining Amivantamab in Combination with Lazertinib in Patients with EGFR-Mutated Non-Small Cell Lung Cancer

Retrieved on: 
Monday, September 21, 2020
Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Lung cancer, Health, Cancer, Breakthrough therapy, Johnson & Johnson, Janssen Pharmaceutica, Cilag, Osimertinib, Non-small-cell lung carcinoma, Janssen Biotech, Small-cell carcinoma, Amivantamab, Lazertinib, Non-Small Cell Lung Cancer (NSCLC), the Janssen Pharmaceutical Companies of Johnson & Johnson

Janssen Research & Development, LLC, Janssen-Cilag S.A. and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.

Key Points: 
  • Janssen Research & Development, LLC, Janssen-Cilag S.A. and Janssen Biotech, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
  • A Study of Amivantamab and Lazertinib Combination Therapy Versus Osimertinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer (MARIPOSA).
  • A Study of Lazertinib as Monotherapy or in Combination With JNJ-61186372 in Participants With Advanced Non-small Cell Lung Cancer.
  • 8 Janssen Announces U.S. FDA Breakthrough Therapy Designation Granted for JNJ-6372 for the Treatment of Non-Small Cell Lung Cancer.