ALK inhibitor

AmoyDx® Pan Lung Cancer PCR Panel Receives MHLW Approval as Companion Diagnostic for 9 Targeted Therapies for Use in Patients with Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Wednesday, June 30, 2021

The AmoyDx PLC Panel has received approval for four driver genes (EGFR, ALK, ROS1, and BRAF) for nine associated targeted therapies in NSCLC.

Key Points: 
  • The AmoyDx PLC Panel has received approval for four driver genes (EGFR, ALK, ROS1, and BRAF) for nine associated targeted therapies in NSCLC.
  • With its high sensitivity and short turnaround time, The AmoyDx PLC Panel is expected to be an important clinical diagnostic in guiding treatment opportunities for NSCLC patients.
  • We are pleased to collaborate with AmoyDx and PREMIA in obtaining approval of the AmoyDx PLC Panel in Japan.
  • Detection of EGFR gene mutations, ALK fusion gene, ROS1 fusion gene, and BRAF gene mutations in nucleic acids extracted from cancer tissue

Turning Point Therapeutics Granted FDA Orphan Drug Designation for TPX-0022 in Gastric Cancer

Retrieved on: 
Thursday, June 17, 2021

We are pleased to receive this designation for TPX-0022 as we work to develop it as a potentially differentiated option for patients affected by MET-driven gastric cancer.

Key Points: 
  • We are pleased to receive this designation for TPX-0022 as we work to develop it as a potentially differentiated option for patients affected by MET-driven gastric cancer.
  • There are currently no approved MET inhibitors for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma.
  • Orphan Drug Designation is granted by the FDA to assist in the development of drug candidates that may offer therapeutic benefits for diseases with a prevalence of fewer than 200,000 patients annually.
  • The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.

AnHeart and Innovent Releases Preliminary Results from the Phase II TRUST Trial of Taletrectinib in ROS1 Fusion Positive NSCLC at the ASCO 2021 Annual Meeting

Retrieved on: 
Monday, June 7, 2021

The results were as follows:

Key Points: 
  • The results were as follows:
    In the crizotinib pre-treated patients (n=5), the ORR was 60% (3/5); and the DCR was 100% (5/5).
  • Our team is highly focused on completing patient enrollment for this phase II TRUST trial in Q3 2021, said Bing Yan, MD, Co-founder and Chief Medical Officer of AnHeart.
  • We sincerely thank the patients, their families and investigators in the TRUST trial and look forward to bringing taletrectinib to all ROS1 fusion positive patients in the near future upon approval.
  • Taletrectinib has shown good efficacy and safety results, which offers hope to patients with ROS1 fusion positive non-small cell lung cancer."

Lantern Pharma Announces Publication Detailing Preclinical Results of Drug Candidate, LP-184, in a Spectrum of Drug-Resistant Lung Cancers in the Journal Oncotarget

Retrieved on: 
Monday, April 26, 2021

The manuscript is titled \' The acylfulvene alkylating agent, LP-184, retains nanomolar potency in non-small cell lung cancer carrying otherwise therapy-refractory mutations\' .

Key Points: 
  • The manuscript is titled \' The acylfulvene alkylating agent, LP-184, retains nanomolar potency in non-small cell lung cancer carrying otherwise therapy-refractory mutations\' .
  • Existing targeted therapies, such as EGFR or ALK inhibitors, only work in specific, genetically defined patient subsets.
  • "\nThis publication in Oncotarget highlights LP-184\'s nanomolar in vitro potency in primary and metastatic NSCLC models.
  • Lantern Pharma has developed a genomic signature that is believed to predict response in tumors that will be responsive to LP-184.

Worldwide Anaplastic Lymphoma Kinase ALK Inhibitors Industry to 2026 - Featuring Astellas Pharma, AstraZeneca ad Pfizer Among Others

Retrieved on: 
Thursday, April 22, 2021

b'DUBLIN, April 22, 2021 /PRNewswire/ -- The "Global Anaplastic Lymphoma Kinase ALK Inhibitors Market, Drug Sales, Price & Clinical Trials Insight 2026" report has been added to ResearchAndMarkets.com\'s offering.\nThe global anaplastic lymphoma kinase inhibitor market is going to witness high growth during the forecast period which is mainly attributed to the rise in prevalence of anaplastic lymphoma kinase positive cancers and high research and development activities in this sector.

Key Points: 
  • b'DUBLIN, April 22, 2021 /PRNewswire/ -- The "Global Anaplastic Lymphoma Kinase ALK Inhibitors Market, Drug Sales, Price & Clinical Trials Insight 2026" report has been added to ResearchAndMarkets.com\'s offering.\nThe global anaplastic lymphoma kinase inhibitor market is going to witness high growth during the forecast period which is mainly attributed to the rise in prevalence of anaplastic lymphoma kinase positive cancers and high research and development activities in this sector.
  • The characterization of anaplastic lymphoma kinase (ALK) gene and their role in the development and progression of ALK positive cancer has transformed the cancer therapeutics market.
  • The global anaplastic lymphoma kinase inhibitor market is going to witness high growth rate and is expected to double in next 5 years.
  • In addition to this, several emerging ALK inhibitors along with their clinical trials are also provided in the report.\n'

Nuvalent Appoints Christopher Turner, M.D., as Chief Medical Officer

Retrieved on: 
Tuesday, March 23, 2021

CAMBRIDGE, Mass., March 23, 2021 /PRNewswire/ --Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Christopher Turner, M.D., as Chief Medical Officer.

Key Points: 
  • CAMBRIDGE, Mass., March 23, 2021 /PRNewswire/ --Nuvalent, Inc., a biotechnology company creating precisely targeted therapies for clinically proven kinase targets in cancer, today announced the appointment of Christopher Turner, M.D., as Chief Medical Officer.
  • "Chris is a dedicated physician and drug developer who has guided the early development, global registration studies, and marketing approval of multiple kinase inhibitor therapies for patients with cancer," said James Porter, Ph.D., Chief Executive Officer of Nuvalent.
  • "I am delighted to welcome him to the Nuvalent team, where his clinical vision and proven leadership will help drive the progression of our robust pipeline through multiple near-term clinical milestones."
  • Nuvalent is advancing a robust pipeline with parallel lead programs in ROS1-positive and ALK-positive NSCLC, along with multiple discovery-stage research programs.

Turning Point Therapeutics to Present New Preclinical Data For Three Drug Candidates at American Association For Cancer Research Annual Meeting

Retrieved on: 
Wednesday, March 10, 2021

For MET/SRC/CSF1R inhibitor, TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors.

Key Points: 
  • For MET/SRC/CSF1R inhibitor, TPX-0022, the company will present preclinical data demonstrating potential utility in combination with immune checkpoint inhibitors.
  • For its newest drug candidate, ALK-inhibitor TPX-0131, Turning Point will present preclinical potency data against ALK resistance mutations and in-vivo data demonstrating brain tissue penetration.
  • Turning Point Therapeuticsis a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies.
  • Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics drug candidates, the results, conduct, progress and timing of Turning Point Therapeutics pre-clinical studies and plans regarding future development activities.

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.

Turning Point Therapeutics Granted FDA Breakthrough Therapy Designation for Repotrectinib Treatment in Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer Who Have Not Been Treated with a ROS1 Tyrosine Kinase Inhibitor

Retrieved on: 
Tuesday, December 8, 2020

Turning Point plans to present updated TRIDENT-1 Phase 2 study data from patients with TKI-naive ROS1-positive NSCLC during a mini-oral presentation at the World Conference on Lung Cancer on Jan. 31, 2021.

Key Points: 
  • Turning Point plans to present updated TRIDENT-1 Phase 2 study data from patients with TKI-naive ROS1-positive NSCLC during a mini-oral presentation at the World Conference on Lung Cancer on Jan. 31, 2021.
  • Breakthrough therapy designation is granted by the FDA to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition.
  • The companys lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors.
  • The company is driven to develop therapies that mark a turning point for patients in their cancer treatment.

Results from Phase 3 CROWN Trial of Pfizer’s LORBRENA® (lorlatinib) in Previously Untreated ALK-Positive Lung Cancer Published in the New England Journal of Medicine

Retrieved on: 
Thursday, November 19, 2020

Grade 3 or 4 AEs occurred in 72% of people treated with LORBRENA and 56% of people treated with XALKORI.

Key Points: 
  • Grade 3 or 4 AEs occurred in 72% of people treated with LORBRENA and 56% of people treated with XALKORI.
  • LORBRENA was specifically developed to inhibit tumor mutations that drive resistance to other ALK inhibitors and to penetrate the blood brain barrier.
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
  • Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to initiating LORBRENA.