Dor

ENHERTU® Demonstrated Strong and Durable Tumor Responses in Previously Treated HER2 Mutant Advanced Lung Cancer in DESTINY-Lung02 Phase 2 Trial

Retrieved on: 
Monday, September 11, 2023
Biotechnology, FDA, Health, Clinical Trials, Oncology, Neutropenia, Belfer Center for Science and International Affairs, Central nervous system, American Journal of Clinical Oncology, Progression-free survival, HER2, DCR, OS, Journal of Thoracic Oncology, International Association, Lung cancer, ILD, Pneumonitis, NSCLC, Lung, Doctor of Philosophy, AstraZeneca, PFS, Journal, Dor, MD, Patient, Daiichi Sankyo, Anemia, CR, ADC, CRS, Diagnosis, R, George M. Low Center for Industrial Innovation, Conference, ORR, Disease, Dana–Farber Cancer Institute, Medical imaging, Copper, Pharmaceutical industry, Bachelor of Medicine, Bachelor of Surgery

Results from the primary analysis of the DESTINY-Lung02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) continued to demonstrate strong and durable tumor responses in previously treated patients with HER2 mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC).

Key Points: 
  • Results from the primary analysis of the DESTINY-Lung02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) continued to demonstrate strong and durable tumor responses in previously treated patients with HER2 mutant unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC).
  • Median OS was 19.5 months (95% CI: 13.6-NE) in the 5.4 mg/kg arm and not reached (95% CI: 12.1-NE) in the 6.4 mg/kg arm.
  • Baseline central nervous system metastases were present in 34.3% of patients in the 5.4 mg/kg arm and 44.0% of patients in the 6.4 mg/kg arm.
  • Median follow-up was 11.5 months (range 1.1-20.6) in the 5.4 mg/kg arm and 11.8 months (range 0.6-21.0) in the 6.4 mg/kg arm.

ADC Therapeutics Announces Updates on ZYNLONTA® LOTIS Clinical Trial Programs at the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023)

Retrieved on: 
Thursday, August 31, 2023
Lymphoma, Loncastuximab tesirine, Abstract, Polatuzumab vedotin, Society, Progression-free survival, Follicular lymphoma, Diffuse large B-cell lymphoma, DLBCL, Safety, SOHO, Doctor of Philosophy, B-cell lymphoma, Nanakaly Hospital for Hematology & Oncology, Mosunetuzumab, Dor, The Year's Best Science Fiction: Eleventh Annual Collection, ADC, Poster, Trial of the century, Therapy, NYSE, ORR, Medical device, Pharmaceutical industry, Fine chemical, Rituximab, MD, Patient

LAUSANNE, Switzerland, Aug. 30, 2023 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today announced that two ZYNLONTA® (loncastuximab tesirine-lpyl) abstracts have been accepted for presentation at the Eleventh Annual Meeting of the Society of Hematologic Oncology (SOHO 2023), which will be held in Houston, Texas from September 6-9, 2023.

Key Points: 
  • For LOTIS-5, the Phase 3 study evaluating the combination of ZYNLONTA with rituximab, we are encouraged by the updated safety run-in results being presented at SOHO 2023.
  • It is the confirmatory trial for accelerated approval for 3L+ and would also support potential label expansion into 2L+ in combination with rituximab.
  • Dosing arms include ZYNLONTA (loncastuximab tesirine-lpyl) plus polatuzumab vedotin, as well as ZYNLONTA (loncastuximab tesirine-lpyl) plus glofitamab and mosunetuzumab, t-cell-engaging bispecific monoclonal antibodies (BsAbs).
  • Combining these agents with different mechanisms of action has the potential to have increased activity compared to either agent alone.

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

Retrieved on: 
Tuesday, August 15, 2023
Neutropenia, Exercise, REMS, Genotype, US Foods, Radiation, EAP, Private investment in public equity, Liver disease, HLA, Mitigation, PIPE, DCR, RECIST, Delcath Systems, Uveal melanoma, National Comprehensive Cancer Network, Toxicity, Mum, Aplastic anemia, Vaccine, Lung, NCCN, HDS, PHP, Incidence, Overseas Private Investment Corporation, Bleeding, Dor, Patient, Lymph, Microsoft Access, Anemia, Liver, FDA, Melphalan, Liver failure, Death, Thrombocytopenia, ORR, Food, Medical imaging, Dietary supplement, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Key Points: 
  • mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year.
  • National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases.
  • HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.
  • "FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma," said Gerard Michel, Delcath's Chief Executive Officer.

Cyolo’s Newly-Formed Security Research Team Presents Critical Vulnerability Findings at BSides Las Vegas 2023

Retrieved on: 
Tuesday, August 8, 2023
Networks, Security, Data Management, Technology, Software, OT, Learning, Disclosure, Research, RDP, Heel, PDF, Knowledge, Ecosystem, Dor, Risk management

Cyolo , provider of the fastest and most secure zero-trust access solution for enterprise IT and OT, today announced the launch of its recently formed Security Research Team and the details surrounding its upcoming technical session at BSides Las Vegas 2023 .

Key Points: 
  • Cyolo , provider of the fastest and most secure zero-trust access solution for enterprise IT and OT, today announced the launch of its recently formed Security Research Team and the details surrounding its upcoming technical session at BSides Las Vegas 2023 .
  • Cyolo’s recently launched security research team continuously monitors and analyzes the latest security trends, tactics, and techniques to proactively identify and mitigate potential access vulnerabilities.
  • By joining Cyolo and researching this area, I feel that I can really make an impact and benefit the entire cybersecurity ecosystem,” said Dor Dali, Head of Security Research at Cyolo.
  • If interested in learning more about recent vulnerabilities and the repercussions you may face, join Dor Dali’s presentation, held on Tuesday, August 8, 2023, at 2:30 p.m. PT at BSides Las Vegas.

Arcus Biosciences Reports Second-Quarter 2023 Financial Results and Provides a Pipeline Update

Retrieved on: 
Monday, August 7, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Pancreatic cancer, Docetaxel, Partnership, G-7, PD, Progression-free survival, Survival, American Society of Clinical Oncology, Cancer, G&A, Research, CD73, Inflammation, RPF, DCO, Second, PFS, Lung, ASCO, KIT, Dor, HIV disease progression rates, Patient, Administration, Risk, Annual general meeting, TIGIT, Financial toxicity, Research and development, R, PD-1, Death, Society, NYSE, ORR, Safety, Pharmaceutical industry, Vaccine, Cryptocurrency

At the time of data cutoff (DCO), February 7, 2023, safety and efficacy were evaluated in all patients treated (n=150).

Key Points: 
  • At the time of data cutoff (DCO), February 7, 2023, safety and efficacy were evaluated in all patients treated (n=150).
  • Arcus initiated ARC-25, a Phase 1 trial in cancer patients for AB598, its anti-CD39 antibody, in the second quarter of 2023.
  • Arcus now expects cash utilization between $290 million and $325 million for the year ended December 31, 2023.
  • Net Loss was $75 million for the second quarter 2023, compared to $67 million for the same period in 2022.

Allogene Therapeutics Reports Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Wednesday, August 2, 2023
European Medicines Agency, AACR, B-cell lymphoma, Kite Pharma, CD19, Investment, CD70, RCC, ICML, Multiple myeloma, Infection, American Society of Clinical Oncology, Lymphoma, Anti-CD19 immunotoxin, Cancer, Licensure, CTA, GAAP, FC, Cytopenia, Equity, PFS, UNIVERSAL, EMA, ASCO, Hematological Cancer Research Investment and Education Act, CAR, Incidence, ATM, PIN, 2023 International Conference on Climate Resilient Pakistan, Dor, Cytokine release syndrome, Patient, IVD, Research, American Association for Cancer Research, Therapy, Society, Conference, ORR, News, BCMA, Life insurance, Pharmaceutical industry, Medical imaging, Vaccine

Research and development expenses were $62.0 million for the second quarter of 2023, which includes $6.9 million of non-cash stock-based compensation expense.

Key Points: 
  • Research and development expenses were $62.0 million for the second quarter of 2023, which includes $6.9 million of non-cash stock-based compensation expense.
  • General and administrative expenses were $18.5 million for the second quarter of 2023, which includes $9.7 million of non-cash stock-based compensation expense.
  • Net loss for the second quarter of 2023 was $78.0 million, or $0.53 per share, including non-cash stock-based compensation expense of $16.6 million.
  • Allogene will host a live conference call and webcast today at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss financial results and provide a business update.

ENHERTU® Demonstrated Clinically Meaningful Progression-Free Survival and Overall Survival Across Multiple HER2 Expressing Advanced Solid Tumors in DESTINY-PanTumor02 Phase 2 Trial

Retrieved on: 
Thursday, July 27, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Progression-free survival, HER2, Survival, ILD, Medicine, Interstitial lung disease, AstraZeneca, PFS, ASCO, Dor, MD, Patient, Daiichi Sankyo, Cancer, ADC, Biliary tract, Society, ORR, Safety, Medical imaging

Topline results from the primary analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2 expressing advanced solid tumors, two secondary endpoints of the trial.

Key Points: 
  • Topline results from the primary analysis of the ongoing DESTINY-PanTumor02 phase 2 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients across multiple HER2 expressing advanced solid tumors, two secondary endpoints of the trial.
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE:4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • The DESTINY-PanTumor02 phase 2 trial is evaluating the efficacy and safety of ENHERTU in patients with previously treated locally advanced, unresectable or metastatic HER2 expressing solid tumors not eligible for curative therapy, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other cancers.
  • These data will be presented at an upcoming medical meeting and will support ongoing discussions with global health authorities.

Journal of Clinical Oncology Publishes Results of Corcept’s Phase 2 Trial of Relacorilant in Women With Platinum-Resistant Ovarian Cancer

Retrieved on: 
Tuesday, June 27, 2023
Bevacizumab, Doctor of Pharmacy, University, Obstetrics, American Journal of Clinical Oncology, Progression-free survival, Associate professor, American Society of Clinical Oncology, OS, Woman, Doctor of Philosophy, JCO, PFS, European Institute of Oncology, ASCO, Control, Journal, IRCCS, Dor, University of Milano-Bicocca, HIV disease progression rates, Risk, CORT, Death, Society, PARK, Chair, Pharmaceutical industry, MD, Gynaecology, Patient

Patients who would have met the eligibility requirements for Corcept’s confirmatory Phase 3 ROSELLA trial did especially well.

Key Points: 
  • Patients who would have met the eligibility requirements for Corcept’s confirmatory Phase 3 ROSELLA trial did especially well.
  • “The benefits experienced by patients in the intermittent dosing group are meaningful especially given the simple, oral dosing and favorable safety profile of relacorilant.
  • Our single goal is to replicate the great results seen in our phase 2 trial,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer.
  • “We believe relacorilant has the potential to become a new standard of care for all patients with platinum-resistant ovarian cancer.”

Latest Data of InnoCare’s Orelabrutinib Presented at the 17th International Conference on Malignant Lymphoma (ICML)

Retrieved on: 
Friday, June 16, 2023
Oncology, Health, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, Rituximab, IRC, Independent Review Committee, POLARIS, Classification, Progression-free survival, ICML, Lymphoma, Lenalidomide, BTK, PFS, SSE, HKEX, International Conference on Population and Development, Dor, Patient, MCL, Hospital, Abstract, Conference, ORR, Safety, Fine chemical, Pharmaceutical industry

InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, today announced the latest clinical data of its Bruton Tyrosine Kinase (BTK) inhibitor orelabrutinib at the 17th International Conference on Malignant Lymphoma (ICML).

Key Points: 
  • InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company, today announced the latest clinical data of its Bruton Tyrosine Kinase (BTK) inhibitor orelabrutinib at the 17th International Conference on Malignant Lymphoma (ICML).
  • Among the enrolled Chinese patients, the majority had late-stage diseases, with the stage IV accounting for 75.9%.
  • The 12-month PFS rate was 84.3% and the rate of overall survival (OS) was 91.5% at 12 months.
  • The preliminary data indicated that the orelabrutinib plus lenalidomide and rituximab exerted synergistic antitumor activity, with a good safety profile in the treatment of MCL.

Kura Oncology Presents Late-Breaking Clinical Data for Menin Inhibitor Ziftomenib at 2023 European Hematology Association (EHA) Congress

Retrieved on: 
Sunday, June 11, 2023
Postcholecystectomy syndrome, Menin, Continuity, Venetoclax, Crystal structure, Cancer, Mutation, Massachusetts General Hospital, Kura, MEN1, Acute myeloid leukemia, Congress, Mixed-phenotype acute leukemia, AML, Dor, Patient, KURA, EHA, IDH, FLT3, SCT, CRi, Hospital, Poster, Safety, Disease, Pharmaceutical industry

The updated clinical data are being featured during a late-breaking oral session today at the 2023 European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.

Key Points: 
  • The updated clinical data are being featured during a late-breaking oral session today at the 2023 European Hematology Association (EHA) Annual Congress in Frankfurt, Germany.
  • Notably, 33% (2/6) of patients with FLT3 co-mutations and 50% (4/8) of patients with IDH co-mutations achieved a CR on ziftomenib.
  • Two patients underwent a stem cell transplant (SCT) and remain in remission as of the data cutoff, including one on post-SCT ziftomenib maintenance therapy.
  • “The clinical data presented today continue to demonstrate the ability of ziftomenib to drive durable responses as a monotherapy in heavily pretreated patients with NPM1-mutant AML.