Journal of Thoracic Oncology

MAIA Biotechnology Announces 100% Disease Control in Second-Line Non-Small Cell Lung Cancer Demonstrating Impressive Positive Preliminary Efficacy Data for Ongoing THIO-101 Phase 2 Trial

Retrieved on: 
Tuesday, October 24, 2023
Oncology, Health, Other Health, General Health, Clinical Trials, Pharmaceutical, Biotechnology, NSCLC, Journal of Thoracic Oncology, NYSE, DCR, DCR Workforce, SOC, Overalls, Cancer, Patient, Pharmaceutical industry

MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today reported positive preliminary efficacy data from its ongoing Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®).

Key Points: 
  • MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, today reported positive preliminary efficacy data from its ongoing Phase 2 clinical trial, THIO-101, evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo®).
  • 100% Preliminary DCR observed in second-line and 88% in third-line, in highly difficult-to-treat patients who already progressed through previous lines of treatment.
  • DCRs across all dose levels met the pre-determined statistical requirements earlier than expected to proceed to next stage of the trial.
  • “We have also observed unprecedented high DCRs in third-line, with an 88% control rate, with treatment of THIO followed by cemiplimab.

ENHERTU® Approved in the EU as the First HER2 Directed Therapy for Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Monday, October 23, 2023
Oncology, Health, Genetics, Clinical Trials, Pharmaceutical, Biotechnology, CR, Female, Neoplasm, ERBB2, Lymphocytopenia, NSCLC, AstraZeneca, Journal of Thoracic Oncology, DOR, Thrombocytopenia, Vomiting, Hypokalemia, HER2, Diarrhea, Lung cancer, News, Nausea, Pneumonia, Transaminase, Lung, ADC, Disease, Daiichi Sankyo, TSE, Immunotherapy, ORR, Anemia, Leukopenia, Safety, European, Patient, Diagnosis, Neutropenia, Mutation, Fatigue, Pharmaceutical industry, Medical imaging, MD, EU

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).

Key Points: 
  • 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).
  • In DESTINY-Lung02, ENHERTU (5.4 mg/kg) demonstrated a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI]: 39.0-59.1) in patients with previously treated advanced or metastatic HER2 mutant NSCLC as assessed by blinded independent central review (BICR).
  • Grade 5 adverse reactions occurred in 1.4% of patients, including interstitial lung disease (1.0%).
  • Following approval in the EU, an amount of $75 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment in HER2 mutant non-small cell lung cancer.

AnHeart Therapeutics’ Investigational Medicine Taletrectinib Shrank Tumors in More Than 90 Percent of People With ROS1-Positive Non-Small Cell Lung Cancer Who Were ROS1 TKI Naïve in Global Pivotal TRUST-II Trial

Retrieved on: 
Saturday, October 21, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TKI, ROS1, NSCLC, Corr, Journal of Thoracic Oncology, NMPA, Food, Lung cancer, Dizziness, National Medical Products Administration, Doctor of Philosophy, Incidence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lung, Disease, Medicine, Interim, Brain, European Society of Gynaecological Oncology, Cancer, Patient, IRC, Pharmaceutical industry

Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).

Key Points: 
  • Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).
  • Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain.
  • Median progression-free survival (IRC-assessed) was not reached for TKI naïve patients and was 11.7 months for TKI pre-treated patients, respectively.
  • In both trials, taletrectinib shrank tumors in almost every ROS1 TKI naïve person and more than half of people previously treated with a ROS1 TKI, and the responses were durable.

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

Retrieved on: 
Thursday, 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).

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.

Foundation Medicine Awards Grant to Moffitt Cancer Center and LUNGevity to Help Remove Barriers to Information About Personalized Oncology for Black Patients

Retrieved on: 
Monday, July 31, 2023
Nursing, Surgery, Women, Hospitals, Men, Practice Management, Managed Care, Consumer, Health, Oncology, DNA, Moffitt, Clinical trial, Health equity, Journal of Thoracic Oncology, Cancer, Research, NSCLC, COMPASS, Doctor of Philosophy, H. Lee Moffitt Cancer Center & Research Institute, Organization, Literature, Community, Patient, Risk, Outreach, Medicine, Neoplasm, Foundation Medicine, MPH, Engagement, Geography, Pharmaceutical industry, Black, MD

Foundation Medicine, Inc ., a pioneer in molecular profiling for cancer, today announced a grant to Moffitt Cancer Center (Moffitt) and LUNGevity Foundation to help fund their COMPASS initiative.

Key Points: 
  • Foundation Medicine, Inc ., a pioneer in molecular profiling for cancer, today announced a grant to Moffitt Cancer Center (Moffitt) and LUNGevity Foundation to help fund their COMPASS initiative.
  • Compared to white patients, Black patients are more likely to present with NSCLC and have a lower 5-year relative survival rate compared to white patients (20% vs 22%).1 This is likely due to multiple barriers that contribute to notable disparities in treatment for Black patients.
  • Foundation Medicine requested applications that included collaboration between two separate organizations, recognizing that addressing disparities in oncology care requires multi-stakeholder partnerships.
  • ​We are proud to support Moffitt and LUNGevity with their work on the COMPASS initiative to remove more barriers to Black patients’ access to personalized oncology care.”

Median Technologies Announces Onboarding of All Academic Sites Involved in the Pivotal Validation Plan for iBiopsy® LCS CADe/CADx SaMD

Retrieved on: 
Monday, July 17, 2023
Health Technology, Other Health, Technology, Radiology, Oncology, Biometrics, Medical Devices, Hospitals, Clinical Trials, Science, Biotechnology, Software, Other Science, Health, Research, CE marking, Medical device, CT, MT, CMS, University, Brag, Centers for Medicare & Medicaid Services, Intervention, LCS, Journal of Thoracic Oncology, Cancer, Lung cancer, University of Pennsylvania, Perelman School of Medicine at the University of Pennsylvania, Lung, Pulmonology, MD Anderson Cancer Center, Medicare, MD, Lalit Vachani, Patient, Clinical research, MRMC, University of Pennsylvania Health System, Diagnosis, Hospital of the University of Pennsylvania, AI, Mortality, Hospital, FDA, Respiratory Medicine, Disease, Pharmaceutical industry, Medical imaging

For the purposes of its pivotal validation plan, Median Technologies has signed clinical research agreements with world-class academic healthcare institutions, which are leading healthcare centers for the management of lung cancer patients.

Key Points: 
  • For the purposes of its pivotal validation plan, Median Technologies has signed clinical research agreements with world-class academic healthcare institutions, which are leading healthcare centers for the management of lung cancer patients.
  • Median’s pivotal validation plan is composed of a pivotal standalone performance study (MT-LCS-002) and an international Multi-Reader Multi-Case (MRMC) pivotal clinical trial (MT-LCS-004).
  • Data quality is compulsory for the proper conduct of our pivotal validation plan” said Fredrik Brag, CEO and Founder of Median Technologies.
  • Now that we have onboarded all the sites, we are on track for the launch of our iBiopsy® LCS CADe/CADx SaMD pivotal validation plan.

Hummingbird Diagnostics Announces Publication of miLung Small RNA-Based Blood Test for Early Detection of Lung Cancer in the Journal of Thoracic Oncology

Retrieved on: 
Tuesday, July 11, 2023
Oncology, Health, Infectious Diseases, Other Health, General Health, Biotechnology, Journal of Thoracic Oncology, Beth Israel Deaconess Medical Center, Thorax, National Lung Screening Trial, Lung cancer, RNA, Lung, Doctor of Philosophy, ASCO, Journal, NLST, American Society of Clinical Oncology, Machine learning, Reading, Mortality, Hospital, Trial of the century, Massachusetts General Hospital, Society, Medical imaging

Hummingbird Diagnostics GmbH, a leader in reading blood-based small RNAs for early disease detection and characterization, today announced a publication in the Journal of Thoracic Oncology following a poster presentation at the American Society for Clinical Oncology (ASCO) 2023 Annual Meeting on the miLung small RNA blood test for early-stage lung cancer detection.

Key Points: 
  • Hummingbird Diagnostics GmbH, a leader in reading blood-based small RNAs for early disease detection and characterization, today announced a publication in the Journal of Thoracic Oncology following a poster presentation at the American Society for Clinical Oncology (ASCO) 2023 Annual Meeting on the miLung small RNA blood test for early-stage lung cancer detection.
  • Screening was performed on stabilized whole blood samples from 1,384 individuals meeting National Lung Screening Trial (NLST) lung cancer eligibility criteria (age 55-74, pack-years ≥30) by leveraging ultra-deep small RNA sequencing.
  • The miLung small RNA blood test is noninvasive and identifies specific small RNAs, molecular biomarkers associated with lung cancer in whole blood samples that can be drawn at the point of care.
  • “Early cancer detection remains the most effective strategy to reduce mortality associated with lung cancer,” commented Jochen Kohlhaas, Founder and Chief Executive Officer of Hummingbird Diagnostics.

Datopotamab Deruxtecan Combinations Showed Encouraging Tumor Responses in Patients with Advanced Non-Small Cell Lung Cancer in TROPION-Lung02 Phase 1b trial

Retrieved on: 
Monday, June 5, 2023
Oncology, Health, Hospitals, Clinical Trials, Pharmaceutical, Biotechnology, Progression-free survival, DCR, AGAS, Journal of Thoracic Oncology, Platinum, Trae Waynes, Outer ring road, ILD, NSCLC, Lung cancer, Immunotherapy, AstraZeneca, PFS, Lung, ALK, Dor, HIV disease progression rates, MD, Patient, Stomatitis, EGFR, DXD, Division, Daiichi Sankyo, Anemia, Internal medicine, Nausea, ADC, Merck, Spacecraft, Merck & Co., Pembrolizumab, PD-L1, ORR, TSE, Fatigue, Disease, Pharmaceutical industry, Medical imaging

In patients receiving triplet datopotamab deruxtecan plus pembrolizumab and platinum chemotherapy, an ORR of 49% was observed (95% CI: 37-61).

Key Points: 
  • In patients receiving triplet datopotamab deruxtecan plus pembrolizumab and platinum chemotherapy, an ORR of 49% was observed (95% CI: 37-61).
  • Disease control rates (DCR) of 84% and 87% were observed in the doublet and triplet cohorts, respectively.
  • Grade 3 or greater treatment-related adverse events (TRAEs) occurred in 31% of patients receiving doublet therapy and 58% of patients receiving triplet therapy.
  • As of the April 7, 2023 data cut-off, 36% and 46% of patients remained on the doublet and triplet therapy, respectively.

Panbela Announces Clinical Trial with Moffitt Cancer Center for Phase I/II Program in STK11 Mutant Non-Small Cell Lung Cancer

Retrieved on: 
Monday, May 22, 2023
Moffitt, Therapy, MSN, Polyamine, Eflornithine, Survival, Clinical trial, Journal of Thoracic Oncology, PBLA, NSCLC, Doctor of Philosophy, Patient, Immune system, H. Lee Moffitt Cancer Center & Research Institute, Phase, Pharmaceutical industry, STK11

MINNEAPOLIS, May 22, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC).

Key Points: 
  • MINNEAPOLIS, May 22, 2023 (GLOBE NEWSWIRE) -- Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, today announced it has entered into a clinical trial agreement with Moffitt Cancer Center for a Phase I/II program in STK11 mutant non-small cell lung cancer (NSCLC).
  • The initial goal of the Phase I trial will be to ascertain the maximum tolerated dose of eflornithine, while evaluating efficacy and then moving into a Phase II efficacy trial.
  • We anticipate data from the Phase I trial by the end of this year with a look to start the Phase II trial at the end of the year or early 2024.
  • We know that STK11 mutant tumors have reduced levels of T cells that direct immune surveillance, and they can avoid immune detection.