Anaplastic lymphoma kinase

Nuvectis Pharma, Inc. Reports First Quarter 2024 Financial Results and Business Highlights

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Mardi, mai 7, 2024
FDA, Mayo Clinic, Nature Communications, Anaplastic lymphoma kinase, Cholangiocarcinoma, Research, Disease, Clinical professor, Patient, AACR, ALK, EGFR, NSCLC, Ovarian cancer, AstraZeneca, Platinum, Lung cancer, Pharmaceutical industry

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "Our clinical development programs for NXP800 and NXP900 continued to advance nicely in the first quarter of 2024.

Key Points: 
  • Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis, commented, "Our clinical development programs for NXP800 and NXP900 continued to advance nicely in the first quarter of 2024.
  • For NXP800, we announced encouraging preliminary data from the Phase 1b study in platinum resistant, ARID1a-mutated ovarian cancer.
  • Cash, and cash equivalents were $19.5 million as of March 31, 2024, compared to $19.1 million as of December 31, 2023.
  • Net loss for the first quarter of 2024 fiscal year included $1.3 million in non-cash stock-based compensation.

Pfizer Highlights Progress in Accelerating Breakthrough Cancer Medicines at ASCO 2024 Annual Meeting

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Lundi, avril 29, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, PFS, Brentuximab vedotin, Triple-negative breast cancer, Lung cancer, MBC, ASCO, Lymphoma, PFE, Metastasis, ALK, Breast cancer, Learning, CRS, Food, Colorectal cancer, Abstract, RRMM, Rituximab, ADC, HR, CDK4, De novo, Spacecraft, DLBCL, Tucatinib, Anaplastic lymphoma kinase, Safety, Crizotinib, Pembrolizumab, Survival, EZH2, Pros, Inc., Neoplasm, Progression-free survival, Recurrence, PAL, Biologics license application, HRR, Hodgkin lymphoma, Patient, Society, Cyclin-dependent kinase 4, Cytokine release syndrome, Annual general meeting, APLS, PBC, Lenalidomide, B-cell lymphoma, Pharmaceutical industry

Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) highlights its progress in advancing new potential standards of care in Oncology at the 2024 American Society of Clinical Oncology (ASCO®) Annual Meeting, taking place May 31 to June 4 in Chicago.
  • “We are excited to participate in our first ASCO Annual Meeting following the creation of Pfizer’s new Oncology organization, where we will highlight our efforts to accelerate breakthrough medicines that help people with cancer live better and longer lives,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer.
  • An oral presentation on extended duration of response from the Phase 3 MOUNTAINEER trial adds to the positive profile of TUKYSA in colorectal cancer.
  • Those interested in learning more can visit www.Pfizer.com/apls to access the summaries starting Friday, May 24.

FDA Approves Genentech's Alecensa as First Adjuvant Treatment for People With ALK-Positive Early-Stage Lung Cancer

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Jeudi, avril 18, 2024
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Phase, Cancer, Anaplastic lymphoma kinase, Risk, Food, ROG, Death, Recurrence, Roche, Disease, Patient, Neoplasm, Biomarker, ALK, NSCLC, Alectinib, Lung cancer, Pharmaceutical industry

Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor.

Key Points: 
  • Alecensa is now the first and only ALK inhibitor approved for people with ALK-positive early-stage NSCLC who have undergone surgery to remove their tumor.
  • “At Genentech, our goal is to give patients the best chance of cure by bringing effective, targeted treatments to early-stage disease before their cancer has spread.
  • In an exploratory analysis, an improvement of central nervous system (CNS)-disease-free survival (DFS) was observed (HR=0.22; 95% CI: 0.08-0.58).
  • Alecensa is a kinase inhibitor currently approved as first- and second-line treatment for ALK-positive metastatic NSCLC.

Nuvectis Pharma's NXP900 Demonstrates Robust Activity in Non-Small Cell Lung Cancer Cell Lines

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Lundi, avril 8, 2024
EGFR, Patient, Anaplastic lymphoma kinase, Research, Alectinib, Active ingredient, Lung cancer, AACR, AstraZeneca, ALK, Vaccine

Fort Lee, NJ, April 08, 2024 (GLOBE NEWSWIRE) -- Nuvectis Pharma, Inc. (NASDAQ: NVCT) today recapped poster highlights from the 2024 American Association for Cancer Research (AACR) conference demonstrating highly synergistic antiproliferative activity in epidermal growth factor receptor (EGFR)-resistant non-small cell lung cancer (NSCLC) cells of NXP900 in combination with osimertinib, the active ingredient in TagrissoTM, an EGFR inhibitor approved for the treatment of NSCLC. The data reported, which confirms data previously published by the research team at Astra Zeneca, demonstrated that the combination reverses resistance to osimertinib versus osimertinib alone.

Key Points: 
  • The data reported, which confirms data previously published by the research team at Astra Zeneca, demonstrated that the combination reverses resistance to osimertinib versus osimertinib alone.
  • In addition, NXP900 demonstrated potent, single agent, antiproliferative activity in anaplastic lymphoma kinase (ALK)-resistant NSCLC cells and synergistic effects in combination with alectinib in alectinib sensitive cells.
  • Alectinib is the active ingredient in AlecensaTM, an ALK inhibitor approved for the treatment of NSCLC.
  • Moreover, effective inhibition of signaling pathways associated with osimertinib and alectinib resistance were observed in the respective cell lines tested.

Promising Intracranial Anti-Tumor Activity and Safety Data for Ivonescimab in NSCLC Patients with Brain Metastases Featured at ELCC 2024

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Vendredi, mars 22, 2024
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, SMMT, Intraparenchymal hemorrhage, Sun, EGFR, Central European Time, Metastasis, ELCC, Progression-free survival, Anaplastic lymphoma kinase, Constipation, Brain, Drug, HKEX, Safety, Anemia, Phase, Summit, TKI, Time in Europe, PFS, ALK, Pharmaceutical industry

The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.

Key Points: 
  • The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.
  • This analysis consisted of the 35 patients with advanced or metastatic NSCLC who had asymptomatic brain metastases at baseline; 28 patients were treated with ivonescimab plus chemotherapy in AK112-201, and seven patients were treated with monotherapy ivonescimab in AK112-202.
  • Patients across both cohorts experienced an intracranial response rate of 34%, and eight patients (23%) experienced a complete response by RANO criteria.
  • The most frequent TEAEs were anemia and decreased neutrophil counts in squamous patients and anemia and constipation in non-squamous patients.

Intracranial Anti-Tumor Activity and Safety of Ivonescimab in NSCLC Patients with Brain Metastases to be Featured at ELCC 2024

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Jeudi, mars 14, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, SMMT, Sun, EGFR, Central European Time, ELCC, NSCLC, Anaplastic lymphoma kinase, Drug, HKEX, Safety, Phase, Summit, TKI, Time in Europe, ALK, Pharmaceutical industry

Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.

Key Points: 
  • Summit Therapeutics Inc. (NASDAQ: SMMT) (“Summit,” “we,” or the “Company”) today announced that data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, will be presented at the 2024 European Lung Cancer Congress (ELCC 2024) in Prague, Czech Republic.
  • Two posters featuring updated ivonescimab data will be displayed on Friday, March 22 from 12:00 to 12:45pm Central European Time.
  • The first poster, “Intracranial Activity of Ivonescimab Alone or in Combination with Platinum Doublet Chemotherapy in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) and Brain Metastases” includes data from patients with asymptomatic brain metastases at baseline.
  • These patients were enrolled in either AK112-202 (NCT04900363), in which ivonescimab is delivered as monotherapy, or AK112-201 (NCT04736823), in which ivonescimab is delivered in combination with platinum doublet chemotherapy, both of which are Phase II clinical trials for patients with advanced or metastatic NSCLC.

U.S. Food and Drug Administration (FDA) Has Accepted the New Drug Application (NDA) for Ensartinib

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Mercredi, mars 13, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Brain, NSCLC, New Drug Application, Patient, JAMA Oncology, NDA, Anaplastic lymphoma kinase, Crizotinib, Safety, File, Holding, Food, ALK, PDUFA, Pharmaceutical industry

Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).

Key Points: 
  • Xcovery Holdings, Inc. , an oncology focused pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for ensartinib, an Anaplastic Lymphoma Kinase (ALK) inhibitor for the treatment of adult patients with metastatic ALK-positive non-small cell lung cancer (NSCLC).
  • The filing is based on the results of the eXalt3, a randomized global phase III study designed to evaluate the efficacy and safety of ensartinib vs crizotinib in the first-line treatment of ALK-positive NSCLC.
  • The FDA granted the application Standard Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024.
  • In the clinical trials, the drug has demonstrated robust and durable responses in ALK-positive NSCLC patients (both systemically and in the brain), with an extensively studied and well manageable safety profile.

Genprex Collaborators to Present Positive Preclinical Data on the Use of Reqorsa® and on NPRL2 Gene Therapy Utilizing Non-Viral Oncoprex® Delivery System for the Treatment of Lung Cancers at the 2024 AACR Annual Meeting

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Mercredi, mars 6, 2024
Glioblastoma, NSCLC, Diabetes, Lung, Lung cancer, Metabolism, EGFR, Osteosarcoma, MD, Neoplasm, FDA, Cancer, Glycolysis, Food, Growth, Anaplastic lymphoma kinase, Pembrolizumab, AACR, Cell, Apoptosis, Date, Osimertinib, Agonal respiration, Mitochondrion, Breast, University, Nanoparticle, Food and Drug Administration, NPRL2, Patient, ATP, Clinical trial, Gene, Disease, TUSC2, Trial of the century, Mesothelioma, Research, ALK, Vaccine

AUSTIN, Texas, March 6, 2024 /PRNewswire/ -- Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, today announced that its research collaborators will present at the upcoming 2024 American Association for Cancer Research (AACR) Annual Meeting being held April 5-10, 2024 in San Diego, California. The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company's non-viral Oncoprex® Delivery System for the treatment of lung cancer.

Key Points: 
  • The collaborators will present positive preclinical data from studies of its lead product candidate, Reqorsa® Immunogene Therapy (quaratusugene ozeplasmid), as well as NPRL2 gene therapy, which both utilize the Company's non-viral Oncoprex® Delivery System for the treatment of lung cancer.
  • In this humanized mouse model, researchers investigated the anti-tumor immune responses to NPRL2 gene therapy in pembrolizumab resistant KRAS/STK11mt NSCLC.
  • "Today's bolus of compelling data validates the potential of REQORSA and the ONCOPREX Delivery System as innovative cancer treatments.
  • We look forward to continuing to evaluate the ONCOPREX Delivery System using both REQORSA and NPRL2 as potential treatments for lung cancer."

Stage IV lung cancer survivor, disparities cancer researcher, family physician appointed as Karmanos' new associate center director

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Mardi, novembre 28, 2023
School, ALK, Research, FACP, Education, AdventHealth, Indiana University–Purdue University Indianapolis, American Academy, Anaplastic lymphoma kinase, Karmanos Cancer Institute, Patient, Faculty, Doctorate, Teacher, Family medicine, AIM center, Psychiatry, Teaching, Medical school, Lung cancer, Pleasure, University, FAAFP, Public health, University of Aleppo, WSU, Society, Methodology, Nursing, Science, Medicine, Philosophy, Indiana University, Karmanos

DETROIT, Nov. 28, 2023 /PRNewswire/ -- The Barbara Ann Karmanos Cancer Institute welcomes Morhaf Al Achkar, M.D., Ph.D., MSCR, FAAFP, as the associate center director for Education. Dr. Al Achkar brings over 10 years of experience in education and teaching, research, and clinical family. He also brings valuable personal experience to his new role as a seven-year stage IV lung cancer survivor.

Key Points: 
  • He also brings valuable personal experience to his new role as a seven-year stage IV lung cancer survivor.
  • My responsibilities at Karmanos center around advancing education and training initiatives for the cancer center community.
  • Additionally, I am deeply passionate about enhancing the cancer care experience for our patients and addressing health disparities."
  • Additionally, Dr. Al Achkar has spent five years as an attending family medicine physician and assistant professor at Indiana University.

Merck and Eisai Provide Update on Two Phase 3 Trials Evaluating KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) in Patients With Certain Types of Metastatic Non-Small Cell Lung Cancer

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Vendredi, septembre 22, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, MSD, Docetaxel, Senior, Hepatocellular carcinoma, RCC, Lenvatinib, Pembrolizumab, OS, MRK, Lung cancer, Head, Multimedia, NSCLC, Biomarker, PFS, Merck & Co., LEAP, Cancer, Patient, EGFR, Anaplastic lymphoma kinase, ROS1, Esophageal cancer, Stomach, Pemetrexed, NYSE, ORR, ALK, Pharmaceutical industry, Medical imaging, EU, Eisai, Merck

At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA plus LENVIMA with chemotherapy compared to KEYTRUDA with chemotherapy.

Key Points: 
  • At the study’s final analysis, there was not an improvement in OS for patients treated with KEYTRUDA plus LENVIMA with chemotherapy compared to KEYTRUDA with chemotherapy.
  • Earlier interim analyses did not demonstrate a statistically significant improvement in PFS or objective response rate (ORR), a key secondary endpoint.
  • At the final analysis of the study, there was not an improvement in OS for patients who received KEYTRUDA plus LENVIMA compared to docetaxel.
  • Results from the LEAP-006 and LEAP-008 trials do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.