Shanghai Chest Hospital

Zai Lab Announces Approval of AUGTYRO™ (repotrectinib) for Patients with ROS1-positive NSCLC by China’s NMPA

Retrieved on: 
måndag, maj 13, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, New Drug Application, National Medical Products Administration, Patient, HKEX, TKI, NMPA, NDA, Safety, Shanghai Jiao Tong University, NSCLC, Shanghai Chest Hospital, Pharmaceutical industry

The approval is based on the pivotal TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated repotrectinib in TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC.

Key Points: 
  • The approval is based on the pivotal TRIDENT-1 study, an open-label, single-arm, Phase 1/2 trial that evaluated repotrectinib in TKI-naïve and TKI-pretreated patients with ROS1-positive NSCLC.
  • “We are pleased with NMPA’s approval of AUGTYRO for the treatment of patients with ROS1-positive NSCLC in China.
  • The topline efficacy and safety data of Chinese subpopulation is consistent with that of global population, demonstrating robust response rates and durable clinical activity in patients with ROS1-positive NSCLC.
  • Treatment with AUGTYRO was generally well tolerated with a manageable safety profile.

Junshi Biosciences Announces JAMA Publication of Results from NEOTORCH, a Randomized Phase 3 Trial of Perioperative Toripalimab plus Chemotherapy for Patients with Resectable Non-Small Cell Lung Cancer

Retrieved on: 
torsdag, januari 18, 2024
Patient, EFS, ASCO, Diagnosis, Trial of the century, Society, American Medical Association, Lung cancer, NSCLC, Shanghai Chest Hospital, JAMA, Journal, Safety, Shanghai Jiao Tong University, Medical device

NEOTORCH is a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of toripalimab in combination with perioperative platinum-based chemotherapy vs chemotherapy alone in patients with resectable stage II or III NSCLC.

Key Points: 
  • NEOTORCH is a randomized, double-blind, placebo-controlled phase 3 trial evaluating the efficacy and safety of toripalimab in combination with perioperative platinum-based chemotherapy vs chemotherapy alone in patients with resectable stage II or III NSCLC.
  • NEOTORCH is the world’s first phase III clinical study of a anti-PD-1 monoclonal antibody for NSCLC perioperative treatment (including neoadjuvant and adjuvant) with positive EFS results.
  • As a phase 3 clinical study of perioperative treatment, NEOTORCH enrolled the largest sample of resectable stage III NSCLC patients in China.
  • We anticipate that toripalimab will guide China’s perioperative lung cancer treatment into a new era.

Junshi Biosciences Announces Approval of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Resectable NSCLC Patients

Retrieved on: 
tisdag, januari 2, 2024
Immunotherapy, Lung cancer, Survival, Risk, ASCO, Shanda, Mortality, Shanghai Chest Hospital, Trial of the century, EFS, Society, Recurrence, Cisplatin, Cancer, MPR, HR, Death, Pemetrexed, World Health Organization, National Medical Products Administration, Patient, Diagnosis, Safety, Paclitaxel, NSCLC, PCR, Pharmaceutical industry

This is the first approved perioperative therapy for lung cancer in China and the second worldwide.

Key Points: 
  • This is the first approved perioperative therapy for lung cancer in China and the second worldwide.
  • In the same year, the number of lung cancer deaths in China amounted to 715,000, accounting for 23.8% of all cancer deaths in China.
  • Amongst these patients, 20%-25% are surgically resectable at first diagnosis, but even after radical surgical treatment, 30%-55% of these patients suffer from post-surgical recurrence and death.
  • One of the first domestic pharmaceutical companies to initiate clinical trials for perioperative immunotherapy, Junshi Biosciences entered the perioperative immunotherapy arena very early on and now holds the broadest spectrum of indications in China.

Phanes Therapeutics Announces the Appointment of Internationally Renowned Oncologist Prof. Shun Lu to its Clinical Advisory Board

Retrieved on: 
torsdag, september 14, 2023
Commissioner, The Lancet, Investment-specific technological progress, Society, PNAS, MCMC, PI, CAB, IAC, Nivolumab, American Society of Clinical Oncology, Shanghai Jiao Tong University, Oncology, Editorial board, Journal of Thoracic Oncology, Clinical Cancer Research, Lung cancer, Tel Aviv University, Doctor of Philosophy, Committee, ASCO, JAMA Oncology, Melvin Mooney Distinguished Technology Award, Journal, MD, SAN, EGFR, Drug discovery, CSCO, Editor-in-chief, Shanghai Chest Hospital, Therapy, MD Anderson Cancer Center, Pharmaceutical industry, Science, Bevacizumab, Savolitinib, Tislelizumab

SAN DIEGO, Sept. 14, 2023 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, today announced that Professor Shun Lu, an internationally renowned oncologist and professor at Shanghai Jiao Tong University Chest Hospital, has joined the Company's Clinical Advisory Board (CAB).

Key Points: 
  • SAN DIEGO, Sept. 14, 2023 /PRNewswire/ -- Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, today announced that Professor Shun Lu, an internationally renowned oncologist and professor at Shanghai Jiao Tong University Chest Hospital, has joined the Company's Clinical Advisory Board (CAB).
  • "We are excited to have Professor Lu joining our Clinical Advisory Board," said Rita Laeufle, MD, PhD, Phanes' Chief Medical Officer. "
  • Professor Lu is a leading clinician-scientist in the field of lung cancer.
  • He also served on the International Affairs Committee (IAC) of American Clinical Oncology Society (2008-2011) and MCMC Working Group (2008-2016).

Allist and ArriVent Announce Interim Results from Ongoing Phase 1b Trial with Furmonertinib at the 2023 World Conference on Lung Cancer

Retrieved on: 
söndag, september 10, 2023
WCLC, IRC, Diarrhea, Dead on arrival, Lung cancer, Trae tha Truth, International Association, NSCLC, Patient, EGFR, Phases of clinical research, Anemia, Corr, Shanghai Chest Hospital, Conference, Safety, Pharmaceutical industry

The median duration of response were 15.2 months, 13.1 months, and 9.7 months in the treatment-naïve 240 mg, previously treated 240 mg, and previously treated 160 mg patient groups, respectively.

Key Points: 
  • The median duration of response were 15.2 months, 13.1 months, and 9.7 months in the treatment-naïve 240 mg, previously treated 240 mg, and previously treated 160 mg patient groups, respectively.
  • Anti-tumor responses were observed across near-loop, far-loop and helical EGFR exon 20 insertion mutations.
  • A well-tolerated safety profile has been observed to-date in the FAVOUR study.
  • The trial is currently enrolling patient in the US, China and other countries.

Junshi Biosciences Announces Acceptance of the Supplemental New Drug Application for Toripalimab as Perioperative Treatment for Operable NSCLC Patients

Retrieved on: 
onsdag, april 12, 2023
Survival rate, IDMC, Cancer, Lung cancer, NSCLC, Cisplatin, Immunotherapy, Trial of the century, ASCO, SSE, HKEX, Patient, National Medical Products Administration, EFS, Diagnosis, Mortality, Shanghai Chest Hospital, Recurrence, Death, III, Pemetrexed, World Health Organization, Disease, Pharmaceutical industry

“This newly applied indication for operable NSCLC patients will open the door to the clinical application of toripalimab in the early stages of the disease,”said Dr. Jianjun ZOU, President of Global Research and Development at Junshi Biosciences.

Key Points: 
  • “This newly applied indication for operable NSCLC patients will open the door to the clinical application of toripalimab in the early stages of the disease,”said Dr. Jianjun ZOU, President of Global Research and Development at Junshi Biosciences.
  • “The Neotorch study has created a new model of perioperative immunotherapy for NSCLC in China, enabling the use of immunotherapy throughout the preoperative, postoperative, and consolidation maintenance processes.
  • Neotorch is the world’s first phase III registered study demonstrating that perioperative treatment with anti-PD-1 monoclonal antibody significantly extends EFS of patients with operable NSCLC.
  • Results of the interim analysis showed that, compared with chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment for stage III operable NSCLC patients and toripalimab monotherapy for consolidation therapy thereafter could significantly extend EFS of patients.

Junshi Biosciences Announces Toripalimab as Perioperative Treatment for Operable NSCLC Patients Met Primary Endpoint in Phase 3 Clinical Study

Retrieved on: 
onsdag, januari 18, 2023
NSCLC, Large-cell lung carcinoma, Independent Review Committee, Survival rate, Shanghai Chest Hospital, World Health Organization, IRC, DFS, New Drug Application, Lung cancer, IDMC, Trial of the century, Blind, Death, Safety, HKEX, Pemetrexed, SSE, Immune system, Patient, Diagnosis, Survival, Cisplatin, Mortality, Cancer, Research, Chain reaction, EFS, Recurrence, III, Paclitaxel, Pharmaceutical industry

The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.

Key Points: 
  • The Independent Data Monitoring Committee (IDMC) has determined that the primary endpoint of event-free survival (“EFS”) has met the pre-defined efficacy boundary.
  • Junshi Biosciences will communicate with regulatory authorities regarding matters related to the supplemental New Drug Application in the near future.
  • Perioperative I-O therapy covering the whole process, including pre- and post-surgery, is expected to be a better treatment model for patients.
  • Based on the interim analysis, compared with chemotherapy alone, toripalimab in combination with chemotherapy as perioperative treatment for phase III operable NSCLC patients and toripalimab monotherapy for consolidation therapy thereafter may significantly extend EFS of patients.

New Study Shows Virtual Bronchoscopic Navigation With Fused Fluoroscopy and Vessel Mapping Using Broncus Archimedes System is Safe and Effective in Obtaining High Biopsy Yield in Lung Tumors

Retrieved on: 
fredag, mars 25, 2022
Biotechnology, Health, Surgery, Oncology, Risk, Blood, Marketing, Therapy, Cell, Lung, Temple University Hospital, Diagnosis, First Affiliated Hospital of Xinjiang Medical University, Biopsy, Archimedes, University of Pennsylvania, Shanghai Chest Hospital, Pulmonology, Planner, Respiratory disease, Pneumothorax, VBN, TBNA, Â, MD, Houston Methodist Hospital, Temple University, Fluoroscopy, Trial of the century, Beth Israel Deaconess Medical Center, Chair, Degenerative disease, Guangzhou Medical University, Lung cancer, University, Patient, Medical device, Medical imaging, Medicine

The prospective, single-arm, multicenter study of 104 patients studied biopsy yield (biopsy forceps and/or needle), sampling yield (including cytologic sampling) and diagnostic yield using the Archimedes System to guide bronchoscopic transparenchymal nodule access (BTPNA) and guided transbronchial needle aspiration (TBNA).

Key Points: 
  • The prospective, single-arm, multicenter study of 104 patients studied biopsy yield (biopsy forceps and/or needle), sampling yield (including cytologic sampling) and diagnostic yield using the Archimedes System to guide bronchoscopic transparenchymal nodule access (BTPNA) and guided transbronchial needle aspiration (TBNA).
  • The Archimedes VBN System combines fused fluoroscopy, real-time bronchoscopy and virtual bronchoscopic navigation for 3D views and access to nodules anywhere in the lung, with the ability to avoid major blood vessels through vessel mapping.
  • In this study, BTPNA showed a superior biopsy yield when compared to todays bronchoscopic diagnostic approaches.
  • Its lung cancer diagnostic and therapeutic portfolio includes the Archimedes System, Archimedes Lite Virtual Bronchoscopic Navigation (VBN) System, Archimedes Planner and FleXNeedle.

DGAP-News: Lisen Imprinting Diagnostics Announces a Revolutionary Early Diagnostic Method for Lung Cancer

Retrieved on: 
måndag, december 20, 2021
Medical school, Shanghai Chest Hospital, Degenerative disease, Fudan University, Cancer, Diagnosis, Lung cancer, Allele, Biomarker, Critical Care Medicine (journal), Breast, First Department, Survival, Institute, Lung, Prostate, Johns Hopkins University, CEO, Research, Gene, Neoplasm, Patient, Mortality, Paper, Respiratory Medicine, Department, R, Carcinoma, Ohio State University, Second Affiliated Hospital of Xinjiang Medical University, PA, Impact, Technology, Medical imaging, Southeast University, Lisen Imprinting Diagnostics, Inc., Imprinted Genes, LISEN IMPRINTING DIAGNOSTICS, INC., IMPRINTED GENES

WUXI, CHINA & PHILADELPHIA, PA / ACCESSWIRE / December 15, 2021 / Lisen Imprinting Diagnostics ("LisenID" or "the company") announces an innovative and ground-breaking epigenetics-based diagnostic solution for early lung cancer detection.

Key Points: 
  • WUXI, CHINA & PHILADELPHIA, PA / ACCESSWIRE / December 15, 2021 / Lisen Imprinting Diagnostics ("LisenID" or "the company") announces an innovative and ground-breaking epigenetics-based diagnostic solution for early lung cancer detection.
  • The present study particularly focused on lung cancer, which has the highest reported mortality among all cancers.
  • This method could greatly improve the diagnostic performance of preoperative cytopathology, promote the early diagnosis and treatment of lung cancer, and increase the survival of lung cancer patients.
  • During preoperative detection, the diagnostic model can accurately distinguish benign lung diseases from lung cancer demonstrating far superior diagnostic sensitivity than cytopathology, particularly for early lung cancer and small lung nodules.

BeyondSpring Pharmaceuticals Announces Positive Final Phase 3 DUBLIN-3 Data with the Plinabulin/Docetaxel Combination versus Docetaxel Alone in 2nd/3rd Line Non-Small Cell Lung Cancer Patients with EGFR Wild Type at the European Society for Medical Oncolo

Retrieved on: 
måndag, september 20, 2021
Therapy, Overalls, Â, NMPA, CIN, APC, Respiratory Medicine, Safety, ESMO, SE, File, Medicine, Neutropenia, Form 20-F, Investor, U.S. Securities and Exchange Commission, Webcast, Data, DP, Knowledge, HR, Survival, Incidence, PFS, Fourth grade, Shanghai Chest Hospital, Docetaxel, Cancer, Patient, NDA, NASDAQ, FDA, Company, PD-1, Large-cell lung carcinoma, European Society for Medical Oncology, PDUFA, OS, B cell, Forward-looking statement, NEW, GLOBE, Department, ITT, Congress, HSPC, Oncology, NSCLC, U.S. FDA, Priority review, MOA, Quality of life, EGFR, Medical imaging, Typesetting, Pharmaceutical industry, Silviculture

ET today at the ESMO Congress in Paris, and the Company will host a conference call at 10:00 a.m.

Key Points: 
  • ET today at the ESMO Congress in Paris, and the Company will host a conference call at 10:00 a.m.
  • This includes the final intention-to-treat (ITT) dataset from the Companys DUBLIN-3 Phase 3 registrational trial of its first-in-class lead asset, plinabulin, in combination with docetaxel vs. docetaxel alone for the treatment of 2nd/3rd line non-small cell lung cancer (NSCLC) patients with EGFR wild type.
  • Plinabulin is a selective immunomodulating microtubule-binding agent (SIMBA), which is a potent antigen presenting cell (APC) inducer.
  • The DUBLIN-3 Phase 3 trial is a randomized, active controlled, single blind to patients, global trial that enrolled 559 patients in 2nd and 3rd line NSCLC, EGFR wild type, with a measurable lung lesion.