Tyrosine kinase receptors

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

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.

First Patients Tested with InVisionFirst®-Lung in EORTC Sponsored Phase II NSCLC Study

Retrieved on: 
Wednesday, January 20, 2021

The aim of this academic trial, announced in 2019 and being supported by Pfizer, is to examine the resistance to lorlatinib in ALK positive NSCLC patients.

Key Points: 
  • The aim of this academic trial, announced in 2019 and being supported by Pfizer, is to examine the resistance to lorlatinib in ALK positive NSCLC patients.
  • While in the past these patients were known to respond well to ALK inhibition therapies, such as lorlatinib, drug resistance in patients has been increasing.
  • A total of 100 patients will be involved in two study designs run in parallel across 30 participating EORTC sites across Europe.
  • The Phase II study is a single arm, multicenter study.

Canadian Pathology Quality Assurance Leverages Diaceutics’ DXRX Platform to Advance NTRK IHC Proficiency Testing

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Monday, January 18, 2021

Diaceutics PLC , (AIM: DXRX), today announces a strategic partnership with Canadian Pathology Quality Assurance (CPQA) to advance the development of Neurotrophic Tropomyosin Receptor Kinase (NTRK) IHC proficiency testing globally.

Key Points: 
  • Diaceutics PLC , (AIM: DXRX), today announces a strategic partnership with Canadian Pathology Quality Assurance (CPQA) to advance the development of Neurotrophic Tropomyosin Receptor Kinase (NTRK) IHC proficiency testing globally.
  • Globally, more labs are now testing for NTRK which means there is a growing demand for a robust Proficiency Testing (PT) program in this area.
  • CPQA has identified the need to source Formalin-Fixed Paraffin-Embedded (FFPE) tissue blocks from laboratories to enable them to build a small tissue microarray for the purposes of NTRK IHC proficiency testing and the development of NTRK IHC validation assistance.
  • John Garratt, Director, CPQA said: We are looking forward to taking advantage of Diaceutics extensive network facilitated through DXRX.

Phase 2 FIGHT Trial Results Presented at ASCO GI Validate Importance of FGFR2b Overexpression and Reinforce Potential of Bemarituzumab Plus Chemotherapy as a Frontline Targeted Treatment for FGFR2b+ Gastric and GEJ Cancers

Retrieved on: 
Friday, January 15, 2021

Stomatitis (31.6% vs 13.0%) and elevated transaminases (34.2% vs 19.5%) were also more common in the bemarituzumab arm.

Key Points: 
  • Stomatitis (31.6% vs 13.0%) and elevated transaminases (34.2% vs 19.5%) were also more common in the bemarituzumab arm.
  • Ocular events are common in therapies targeting FGFR and were also reported in the FIGHT trial.
  • To participate in the conference call, please dial (877) 878-2269 (domestic) or (253) 237-1188 (international) and refer to conference ID: 2063209.
  • Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b.

Pfizer’s XALKORI® (crizotinib) Approved by FDA for ALK-positive Anaplastic Large Cell Lymphoma in Children and Young Adults

Retrieved on: 
Thursday, January 14, 2021

The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.

Key Points: 
  • The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
  • XALKORI is indicated for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive.
  • The safety and efficacy of XALKORI have not been established in older adults with relapsed or refractory, systemic ALK-positive ALCL.
  • Targeting ALK With Crizotinib in Pediatric Anaplastic Large Cell Lymphoma and Inflammatory Myofibroblastic Tumor: A Childrens Oncology Group Study.

AstraZeneca to Showcase Transformative Data Across Diverse Pipeline at World Conference on Lung Cancer

Retrieved on: 
Wednesday, January 13, 2021

1 39 abstracts at WCLC 2020 will feature AstraZeneca medicines and pipeline molecules, of which 24 are company-sponsored or supported.

Key Points: 
  • 1 39 abstracts at WCLC 2020 will feature AstraZeneca medicines and pipeline molecules, of which 24 are company-sponsored or supported.
  • Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU.
  • In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients.
  • EGFR mutation testing in lung cancer: a review of available methods and their use for analysis of tumor tissue and cytology samples.

New Research Data Across DXd ADC Portfolio at WCLC Showcases Daiichi Sankyo’s Continued Commitment in Lung Cancer

Retrieved on: 
Wednesday, January 13, 2021

New Data from Rare EGFR Alterations;

Key Points: 
  • New Data from Rare EGFR Alterations;
    Trastuzumab deruxtecan in HER2 mutated metastatic non-small cell lung cancer; interim results of DESTINY-Lung01 (ENCORE)
    Smit, et al.
  • Each ADC is engineered using Daiichi Sankyos proprietary and portable DXd ADC technology to target and deliver chemotherapy inside cancer cells that express a specific cell surface antigen.
  • In May 2020, ENHERTU received a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) for gastric cancer, including GEJ adenocarcinoma.
  • The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer.

Zentalis Pharmaceuticals Announces the Initiation of Multiple Early-Stage Clinical Trials

Retrieved on: 
Wednesday, January 6, 2021

At Zentalis, our primary focus is to rapidly bring novel and transformative medicines to patients diagnosed with a wide variety of cancers, said Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals.

Key Points: 
  • At Zentalis, our primary focus is to rapidly bring novel and transformative medicines to patients diagnosed with a wide variety of cancers, said Dr. Anthony Sun, Chairman and Chief Executive Officer at Zentalis Pharmaceuticals.
  • These data will provide key insight needed for future trials, laying the foundation to continue to advance the investigation of ZN-c5, ZN-c3 and ZN-d5.
  • Zentalis is currently conducting a Phase 1/2 clinical trial of ZN-c5 in patients with ER+/HER2- advanced or metastatic breast cancer as a monotherapy.
  • Zentalis Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapeutics targeting fundamental biological pathways of cancers.

Hummingbird Bioscience Announces Collaboration with Tempus to Harness AI-driven Precision Medicine to Accelerate Clinical Development of HMBD-001 In HER3 Driven Cancers

Retrieved on: 
Monday, December 14, 2020

[1]

Key Points: 
  • [1]
    HMBD-001 is a uniquely differentiated anti-HER3 neutralizing antibody that was developed using Hummingbird's proprietary Rational Antibody Discovery platform.
  • HMBD-001 has been immune-engineered to bind with high affinity to the HER3 dimerization interface and block HER3 growth signals to the cancer.
  • Most importantly, HMBD-001 uniquely blocks HER3 in both open and closed conformations, and in the presence or absence of high concentrations of NRG1.
  • Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare.

SEngine Precision Medicine Presents Data Summarizing Predictive Value of PARIS® Test in Breast Cancer Patients at 2020 San Antonio Breast Cancer Symposium

Retrieved on: 
Wednesday, December 9, 2020

SEATTLE, Dec. 09, 2020 (GLOBE NEWSWIRE) -- SEngine Precision Medicine , a precision oncology company revolutionizing cancer therapies by pre-testing drugs on patient-derivedtumor organoids, today presented data from a study summarizing the predictive value of the PARIS Test in breast cancer tumors as a poster session (PS04/01) at the 2020 San Antonio Breast Cancer Symposium, taking place virtually from December 8-11, 2020.

Key Points: 
  • SEATTLE, Dec. 09, 2020 (GLOBE NEWSWIRE) -- SEngine Precision Medicine , a precision oncology company revolutionizing cancer therapies by pre-testing drugs on patient-derivedtumor organoids, today presented data from a study summarizing the predictive value of the PARIS Test in breast cancer tumors as a poster session (PS04/01) at the 2020 San Antonio Breast Cancer Symposium, taking place virtually from December 8-11, 2020.
  • This study highlighted the utility of the PARIS Test, a CLIA certified functional drug sensitivity assay, to support clinical decision making in heterogeneous disease such as breast cancer.
  • Showed high genomic concordance between known actionable biomarkers, such as PIK3CA and FGFR1/FGFR2, and PARIS Test organoid drug sensitivity.
  • This commitment is exemplified by this exciting data utilizing our PARIS Test across the breast cancer spectrum that showed a very strong predictive value between PARIS Test drug responses and clinical benefit.