WCLC

HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC

Retrieved on: 
Thursday, March 28, 2024

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 27, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). If approved, the new label indication for savolitinib will be expanded to include treatment-naïve patients in China.

Key Points: 
  • Savolitinib was previously granted conditional approval in China for the treatment of patients with NSCLC with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
  • Savolitinib was launched and is marketed under the brand name ORPATHYS® by our partner, AstraZeneca for this patient population, representing the first selective MET inhibitor approved in China.
  • More than a third of the world’s lung cancer patients are in China and, among those with NSCLC globally, approximately 2-3% have tumors with MET exon 14 skipping alterations.
  • The data from this study provide confirmatory evidence for savolitinib as a targeted treatment option for treatment-naïve or previously treated patients with MET exon 14 skipping alteration NSCLC.

IO Biotech Announces 2023 Fourth-Quarter and Year-End Results

Retrieved on: 
Tuesday, March 5, 2024

“In 2023, we reached a significant milestone in our pivotal Phase 3 trial evaluating our lead therapeutic cancer vaccine, IO102-IO103, in combination with KEYTRUDA, completing enrollment in this trial in mid-November,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech.

Key Points: 
  • “In 2023, we reached a significant milestone in our pivotal Phase 3 trial evaluating our lead therapeutic cancer vaccine, IO102-IO103, in combination with KEYTRUDA, completing enrollment in this trial in mid-November,” said Mai-Britt Zocca, Ph.D., President and CEO of IO Biotech.
  • The company expanded its Board of Directors with the appointment of Helen Collins, MD in November 2023.
  • Cash and cash equivalents as of December 31, 2023 were $143.2 million, compared to $142.6 million at December 31, 2022.
  • During the three months ended December 31, 2023, the company used cash, cash equivalents and restricted cash of $22.9 million from operating and investing activities.

PrognomiQ's Latest Research Demonstrates the Potential of its Multi-omics Liquid Biopsy Platform in Early-Stage Detection of Lung Cancer

Retrieved on: 
Monday, January 8, 2024

SAN MATEO, Calif., Jan. 8, 2024 /PRNewswire/ -- PrognomiQ – a healthcare company focused on harnessing the power of multi-omics data to transform the early detection, treatment selection and recurrence monitoring of cancer and other complex diseases – today announced promising results from the largest, deep multi-omics study conducted to date. The study, published online in medRxiv, focused on subjects at risk for lung cancer, demonstrating the power of multi-omics to deliver both high sensitivity and high specificity in the detection of early-stage lung cancer.

Key Points: 
  • The study, published online in medRxiv , focused on subjects at risk for lung cancer, demonstrating the power of multi-omics to deliver both high sensitivity and high specificity in the detection of early-stage lung cancer.
  • These encouraging data stem from a 2,513-subject case-control study which analyzed the molecular differences between the peripheral blood plasma of lung cancer subjects and non-cancer controls, many of whom were at high-risk for lung cancer.
  • Given the focus on high-risk populations in this study, the team focused on prioritizing high sensitivity, particularly for early-stage cancer.
  • These findings add to the body of research previously presented in 2023 on lung cancer detection at both the American College of Chest Physicians (CHEST) and the World Conference on Lung Cancer (WCLC), and on pancreatic cancer detection at the American Association of Cancer Research (AACR) annual conferences.

IO Biotech Announces 2023 Third Quarter Results

Retrieved on: 
Monday, November 13, 2023

“Our focus for 2023 has been to successfully execute multiple clinical trials for our novel, investigational therapeutic cancer vaccine, IO102-IO103.

Key Points: 
  • “Our focus for 2023 has been to successfully execute multiple clinical trials for our novel, investigational therapeutic cancer vaccine, IO102-IO103.
  • Encouraging preliminary data from this basket trial were presented at the IASLC 2023 World Conference on Lung Cancer (WCLC) in September 2023 and at the ESMO Congress in October 2023.
  • General and administrative expenses were consistent at $5.8 million for the three months ended September 30, 2023 and 2022, respectively.
  • Cash and cash equivalents as of September 30, 2023, were $165.5 million, compared to $142.6 million at December 31, 2022.

Vergent Bioscience Initiates Phase 2, Multi-Center VISUALIZE Study Evaluating Efficacy of Tumor-targeted Fluorescent Imaging Agent VGT-309 in Lung Cancer Surgeries

Retrieved on: 
Wednesday, December 13, 2023

Vergent Bioscience , a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that the company has enrolled the first patients in a Phase 2, multi-center study evaluating the efficacy and safety of VGT-309 in patients with cancer in the lung.

Key Points: 
  • Vergent Bioscience , a clinical-stage biotechnology company developing tumor-targeted imaging agents, announced that the company has enrolled the first patients in a Phase 2, multi-center study evaluating the efficacy and safety of VGT-309 in patients with cancer in the lung.
  • The international VISUALIZE study will assess the potential of Vergent’s tumor-targeted fluorescent imaging agent to improve the visibility of difficult-to-find and previously undetected tumors during minimally invasive and robotic-assisted surgical procedures, and reduce the possibility that cancer is left behind.
  • Investigators at six clinical trial sites in the United States and Australia plan to enroll 100 patients.
  • “We look forward to expanding on our previous studies to further evaluate this agent and its ability to facilitate the complete removal of tumor during surgery.”

Apollomics Announces Two New Cohorts in Global Phase 2 SPARTA Study of Vebreltinib in Non-Small Cell Lung Cancer and Other Solid Tumors with MET Dysregulation

Retrieved on: 
Tuesday, October 31, 2023

The second new cohort, labeled F, will evaluate vebreltinib monotherapy in histology-agnostic solid tumors with wild type MET gene that have high expression of c-MET and hepatocyte growth factor (HGF).

Key Points: 
  • The second new cohort, labeled F, will evaluate vebreltinib monotherapy in histology-agnostic solid tumors with wild type MET gene that have high expression of c-MET and hepatocyte growth factor (HGF).
  • Dr. Bindiya Patel and Dr. Siddhartha Devarakonda presented this study during a poster session on September 11, 2023, at the World Conference on Lung Cancer (WCLC) in Singapore.
  • A link to the WCLC poster is available under the Investors tab of the Apollomics website at https://www.apollomicsinc.com .
  • It works by inhibiting the aberrant activation of the HGF/c-MET axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies such as osimertinib.

IO Biotech Announces New Data Related to its IO102-IO103 Therapeutic Cancer Vaccine Presented Today at the IASLC 2023 World Conference on Lung Cancer

Retrieved on: 
Tuesday, September 12, 2023

Jonathan Riess, MD, lead investigator of the trial at the UC Davis Comprehensive Cancer Center, presented encouraging early clinical and biomarker data supporting the combination treatment for patients with metastatic non-small cell lung cancer (NSCLC).

Key Points: 
  • Jonathan Riess, MD, lead investigator of the trial at the UC Davis Comprehensive Cancer Center, presented encouraging early clinical and biomarker data supporting the combination treatment for patients with metastatic non-small cell lung cancer (NSCLC).
  • Available biomarker results for some patients show vaccine-specific T cell expansion and complete clearance or considerable drop of ctDNA, indicating activity of the treatment after just 21 days.
  • As of the data cut-off in July 2023, 25 patients had been enrolled in the lung cohort of this basket trial.
  • Abstract Title: Ph 2 Trial of IO102-IO103 Vaccine Plus Pembrolizumab: Preliminary Results for the First-line Treatment of Lung Adenocarcinoma

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

Retrieved on: 
Sunday, September 10, 2023

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.

Exai Bio Presents Data Further Validating its Liquid Biopsy Platform at the 2023 World Conference on Lung Cancer

Retrieved on: 
Tuesday, September 12, 2023

Exai Bio today announced non-small cell lung cancer (NSCLC) data further validating that its novel RNA- and generative AI-based liquid biopsy platform detected early-stage disease with high accuracy.

Key Points: 
  • Exai Bio today announced non-small cell lung cancer (NSCLC) data further validating that its novel RNA- and generative AI-based liquid biopsy platform detected early-stage disease with high accuracy.
  • These results will be presented today at the 2023 World Conference on Lung Cancer (WCLC).
  • OncRNAs are transcribed and actively secreted from cancer cells and are stable and abundant in the blood of cancer patients.
  • Exai’s universal platform can be used across multiple cancer care settings such as screening and early detection, monitoring, molecular residual disease and therapy selection.

Novocure Highlights Use of Tumor Treating Fields Therapy in Treatment of Non-Small Cell Lung Cancer at 2023 World Conference on Lung Cancer

Retrieved on: 
Friday, September 8, 2023

Novocure (NASDAQ: NVCR) today announced its participation in the upcoming International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) from September 9 – 13, 2023 in Singapore.

Key Points: 
  • Novocure (NASDAQ: NVCR) today announced its participation in the upcoming International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) from September 9 – 13, 2023 in Singapore.
  • Novocure will take part in presentations and symposia throughout the event and will exhibit several posters exploring the use of Tumor Treating Fields (TTFields) therapy in the treatment of lung cancer, including a new post-hoc analysis of data from its LUNAR trial in metastatic non-small cell lung cancer.
  • The LUNAR trial was designed to evaluate the use of TTFields therapy together with standard systemic therapies for the treatment of metastatic non-small cell lung cancer, following progression on or after platinum-based therapy.
  • “This analysis further elucidates the promising results from the LUNAR trial and the potential benefit of utilizing TTFields therapy for the treatment of metastatic non-small cell lung cancer,” Dr. Leal said.