ILD

BriaCell Showcases Data Demonstrating Unmatched Progression-Free Survival (PFS) and Clinical Efficacy in Antibody-Drug Conjugate (ADC) Resistant and Central Nervous System (CNS) Metastatic Breast Cancer at the 2024 AACR

Retrieved on: 
Tuesday, April 9, 2024
HER2, ILD, CPI, Survival, Progression-free survival, Central nervous system, Patient, CNS, History, Death, Eribulin, Spacecraft, MD, CBR, TPC, EMBRACE, Life, BCT, AACR, TSX, Therapy, Breast cancer, Safety, Poster, CMO, PFS, ADC, PD-1, Pharmaceutical industry

“ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.

Key Points: 
  • “ADCs are the latest treatments for very difficult-to-treat advanced metastatic breast cancer.
  • To our knowledge, there are no effective treatment options in this patient population for whom the progression-free survival prognosis is only a few weeks.
  • BriaCell will be monitoring ADC resistant patients in its ongoing pivotal Phase 3 study of Bria-IMT™ and CPI in advanced metastatic breast cancer.
  • Eribulin monotherapy versus treatment of physician’s choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study.

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

Retrieved on: 
Saturday, April 6, 2024
Research, Women, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, Oncology, Orbis, Urinary tract infection, Cardiac arrest, Stomatitis, Patient, Stroke, Lung cancer, University, Acute kidney injury, Neoplasm, Therapy, Anemia, Vomiting, Pleural effusion, Cellulitis, Shock (mechanics), Periodic breathing, Colorectal cancer, Abdominal pain, Safety, Immunohistochemistry, Fatigue, ADC, Daiichi Sankyo, Food, IHC, Sepsis, NSCLC, Appetite, Biliary tract, Constipation, NCCN, MD, Priority review, Fatality, Pneumonitis, HER2, ILD, Medication, Pneumonia, AstraZeneca, COVID-19, Biomarker, Diarrhea, Bleeding, MD Anderson Cancer Center, Nausea, Upper respiratory tract infection, Pharmaceutical industry

The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .

Key Points: 
  • The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .
  • In DESTINY-PanTumor02, efficacy was assessed in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.
  • In DESTINY-Lung01, efficacy was assessed in a subgroup of patients (n=17) with centrally confirmed HER2 positive (IHC 3+) non-small cell lung cancer (NSCLC).
  • In DESTINY-CRC02, efficacy was assessed in the subgroup of patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
Wednesday, March 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

Data from Brainomix's Collaboration with AstraZeneca Shows its AI-Powered e-Lung Better Identifies Lung Fibrosis Patients at Risk of Decline

Retrieved on: 
Wednesday, March 27, 2024
AJRCCM, Medical research, ILD, AstraZeneca, ATS, Survival, Data science, Critical Care Medicine (journal), Partnership, Risk, Boehringer Ingelheim, Royal Brompton Hospital, Patient, American Journal, Lung, WRVS, Biopharmaceutical, Biomarker, Vital capacity, American Thoracic Society, Idiopathic pulmonary fibrosis, IPF, Clinical trial, Tralokinumab, Idiopathic disease, FVC

The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).

Key Points: 
  • The study was an analysis of AstraZeneca's Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF).
  • The patient data from the trial was processed with Brainomix's e-Lung tool.
  • The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
  • WRVS was also able to predict both short- and long-term outcomes of the patients, including lung function decline and survival.

Third Pole Therapeutics Announces Successful Completion of Feasibility Study with eNOfit™ Portable Inhaled Nitric Oxide Delivery System

Retrieved on: 
Tuesday, February 27, 2024
Oxygen, Pulmonary hypertension, Blood pressure, Blood, FDA, Quality of life, Gestational sac, Nitric oxide, Travel, Carbon, Lung, Medicine, Rest, Fatigue, Third Pole, Death, ILD, Patient, Artery, Heart, UCLA, Tissue, EFS, COPD

This study evaluated eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD).

Key Points: 
  • This study evaluated eNOfit™, a miniaturized, portable inhaled nitric oxide (iNO) generator and delivery system for the ambulatory treatment of patients suffering from pulmonary hypertension (PH) associated with Interstitial Lung Disease (ILD).
  • “The successful completion of our EFS which validated the safe and practical use of our eNOfit™ system, enables us to confidently move into larger randomized placebo-controlled safety and efficacy studies.
  • Importantly, this value creating milestone will trigger the final funding of Third Pole’s Series B investment round.” said Bill Athenson, CEO of Third Pole.
  • Inhaled nitric oxide relaxes smooth muscle within the pulmonary vasculature, increasing the diameter of pulmonary arteries and decreasing their resistance to blood flow.

aTyr Pharma Announces Expanded Access Program (EAP) for EFZO-FIT™ Clinical Trial Participants

Retrieved on: 
Wednesday, February 21, 2024
SAN, Sarcoidosis, Scar, Small RNA, Pi, ATyr Pharma, FDA, Inflammation, Food, Scleroderma, Risk, Myelocyte, Health, Safety, Principal investigator, Expanded access, Neuropilin, Systemic scleroderma, ILD, OLE, Patient, Fibrosis, Clinical trial, EAP, Pharmaceutical industry

SAN DIEGO, Feb. 21, 2024 (GLOBE NEWSWIRE) --  aTyr Pharma, Inc. (Nasdaq: LIFE) (aTyr or the Company), a clinical stage biotechnology company engaged in the discovery and development of first-in-class medicines from its proprietary tRNA synthetase platform, today announced plans to initiate an Individual Patient Expanded Access Program (EAP) for its lead therapeutic candidate, efzofitimod, for patients with pulmonary sarcoidosis. The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.

Key Points: 
  • Individual Patient EAP allows access to efzofitimod for patients who complete the Phase 3 EFZO-FIT™ study in pulmonary sarcoidosis.
  • Company initiating program based on blinded EFZO-FIT™ study investigator and patient participant feedback.
  • The Individual Patient EAP is intended to allow access for patients who complete the Phase 3 EFZO-FIT™ study and wish to receive treatment with efzofitimod outside of the clinical trial.
  • “We are pleased to make efzofitimod available to patients beyond the duration of the EFZO-FIT™ clinical trial through this Individual Patient EAP,” said Sanjay S. Shukla, M.D., M.S., President and Chief Executive Officer of aTyr.

TAGRISSO® (osimertinib) demonstrated overwhelming efficacy benefit for patients with unresectable, Stage III EGFR-mutated lung cancer in LAURA Phase III trial

Retrieved on: 
Monday, February 19, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, NSCLC, Fever, Progression-free survival, PFS, AstraZeneca, Heart, Periodic breathing, QT interval, MD, Chemoradiotherapy, Cough, Pemetrexed, Winship Cancer Institute, QT, OS, Electrolyte, Cardiomyopathy, Lung cancer, Safety, Emory University, CRT, LAURA, ILD, Patient, LVEF, Brain, Pharmaceutical industry

In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.

Key Points: 
  • In addition, TAGRISSO plus chemotherapy was recently approved in the US based on the FLAURA2 Phase III trial.
  • Interstitial lung disease (ILD)/pneumonitis occurred in 4% of the 1813 TAGRISSO-treated patients; 0.4% of cases were fatal.
  • TAGRISSO is the only targeted therapy to improve patient outcomes in both early-stage disease in the ADAURA Phase III trial and late-stage disease in the FLAURA Phase III trial and FLAURA2 Phase III trial .
  • AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

RYBREVANT® (amivantamab-vmjw) in Combination With Chemotherapy Is the First FDA Approved Therapy for First-line Treatment of Patients With Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Retrieved on: 
Friday, March 1, 2024
NSCLC, Progression-free survival, PFS, EGFR, Neoplasm, Magnesium, Diarrhea, FDA, Amivantamab, Food, Cancer, Johnson & Johnson, Nausea, Vomiting, Edema, Risk, ICAN, Constipation, Potassium, IRR, Lung cancer, Toxicity, Neutrophil, Prognosis, COVID-19, NCCN, Fatigue, Death, JNJ, NYU Langone Health, ILD, Drug, Patient, Rash, National Comprehensive Cancer Network, Survival, PAPILLON, Mutation, Appetite, Stomatitis, Pharmaceutical industry

RARITAN, N.J., March 1, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that following a priority review, the U.S. Food and Drug Administration (FDA) has approved RYBREVANT® (amivantamab-vmjw) in combination with chemotherapy (carboplatin-pemetrexed) for the first-line treatment of 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.1 This FDA action converts the May 2021 accelerated approval of RYBREVANT® to a full approval based on the confirmatory Phase 3 PAPILLON study.

Key Points: 
  • The approval of RYBREVANT plus chemotherapy heralds a promising new first-line treatment option for patients newly diagnosed with non-small cell lung cancer where their driver mutation is an EGFR exon 20 insertion," said Marcia Horn**, Executive Director of the Exon 20 Group and CEO of ICAN, International Cancer Advocacy Network.
  • We've seen first-hand the extended survival that Exon 20 Group patients experienced on RYBREVANT plus chemotherapy in the PAPILLON study, and we're delighted that this historic treatment option, which specifically targets the EGFR exon 20 insertion mutation, has been approved."
  • "RYBREVANT plus chemotherapy is the first targeted approach approved for the first-line treatment of patients with NSCLC with EGFR exon 20 insertion mutations.
  • We look forward to building on this latest milestone as we continue to accelerate our transformative lung cancer portfolio."

BriaCell Announces Strong Clinical Data in Breast Cancer Patients; Reports Another Notable Responder Case

Retrieved on: 
Wednesday, February 7, 2024
Survival, Breast cancer, PFS, Literature, Patient, Pain, TSX, ADC, Therapy, Quality of life, HLA, Spacecraft, Liver disease, Liver, BCT, ILD, Pharmaceutical industry

exhibited clinical outcomes) Phase 2 advanced breast cancer patients treated with BriaCell’s Bria-IMT™ regimen – the same formulation being used in BriaCell’s open pivotal Phase 3 study.

Key Points: 
  • exhibited clinical outcomes) Phase 2 advanced breast cancer patients treated with BriaCell’s Bria-IMT™ regimen – the same formulation being used in BriaCell’s open pivotal Phase 3 study.
  • Additionally, a disease control rate of 50% was reported in similarly treated evaluable patients who had failed prior antibody-drug conjugate (ADC) therapy.
  • “This data provides further encouragement to us as we continue our pivotal Phase 3 study enrollment.
  • No cases of Interstitial Lung Disease (ILD) with Bria-IMT™ (a well-documented serious side effect of ADCs) reported in this group of patients.

AnaMar Announces US and EU Orphan Drug Designation for AM1476 for Treating Systemic Sclerosis

Retrieved on: 
Monday, February 5, 2024
Inflammation, Systemic scleroderma, Biomarker, Patient, Diagnosis, FDA, EMA, Marketing, Scleroderma, Interstitial lung disease, Skin, Pulmonary fibrosis, Disability, Disease, Fibrosis, European Medicines Agency, Death, ODD, Autoimmune disease, ILD, Organ dysfunction, Pharmaceutical industry

AM1476 offers a unique dual-action approach to treat both skin and lung manifestations of systemic sclerosis.

Key Points: 
  • AM1476 offers a unique dual-action approach to treat both skin and lung manifestations of systemic sclerosis.
  • Systemic sclerosis is a chronic, progressive, autoimmune disease characterized by inflammation and fibrosis, i.e.
  • AnaMar's Chief Executive Officer, Dr. Ulf Ljungberg, said: “We are delighted with the FDA’s and EMA’s decisions to grant orphan drug designation to AM1476 for SSc.
  • Orphan drug designation provides certain benefits, including the potential for extensive marketing exclusivity following regulatory approval, reduction in regulatory fees and, in the case of EU, a centralized approval process.