Tislelizumab

BeiGene Receives FDA Approval for TEVIMBRA® for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma After Prior Chemotherapy

Retrieved on: 
Thursday, March 14, 2024
Cardiology, Biotechnology, Pharmaceutical, Oncology, General Health, Health, FDA, Clinical Trials, Civil service commission, Glucose, Survival, ALT, DSM-IV codes, Associate, Blas, Medicine, Patient, Esophageal cancer, Committee, Sodium, Alkaline phosphatase, University, Cancer, EMA, BGNE, Quality of life, Tislelizumab, Lung cancer, Section, European Medicines Agency, Lymphocyte, ITT, European Commission, Anemia, Division, ESCC, Fatigue, University of Southern California, BLA, Food, Pharmaceutical industry

TEVIMBRA will be available in the U.S. in the second half of 2024.

Key Points: 
  • TEVIMBRA will be available in the U.S. in the second half of 2024.
  • The FDA is also reviewing Biologics License Applications (BLAs) for tislelizumab as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC and patients with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.
  • BeiGene has launched more than 17 potentially registration-enabling trials with TEVIMBRA, of which 11 Phase 3 randomized trials and four Phase 2 trials have already had positive readouts.
  • More than 900,000 patients have been prescribed TEVIMBRA globally to date.

BeiGene to Present Clinical and Preclinical Data from Broad Portfolio and Pipeline at AACR Annual Meeting 2024

Retrieved on: 
Wednesday, March 6, 2024
Science, Other Science, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Therapy, Macrophage, Tislelizumab, Marketing, Form 10-K, Annual report, Safety, TIS, Patient, Intellectual property, Immunoglobulin G, Cancer, Pharmaceutical industry

It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Key Points: 
  • It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.
  • BeiGene is a global oncology company that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide.
  • With a broad portfolio, we are expediting development of our diverse pipeline of novel therapeutics through our internal capabilities and collaborations.
  • We are committed to radically improving access to medicines for far more patients who need them.

BeiGene’s Biologics License Application for TEVIMBRA® (tislelizumab) for First-Line Gastric or Gastroesophageal Junction Cancers Accepted by FDA

Retrieved on: 
Tuesday, February 27, 2024
Biotechnology, FDA, Health, Pharmaceutical, Oncology, Incidence, Progression-free survival, European Commission, Tislelizumab, Anemia, Quality of life, Food, File, ESCC, BLA, Nausea, Vomiting, BGNE, Platelet, Safety, Stomach, Civil service commission, Death, Patient, Survival, Biologics license application, Appetite, Cancer, Pharmaceutical industry

“In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.

Key Points: 
  • “In clinical trials, TEVIMBRA has demonstrated its potential to improve survival for patients with gastric and gastroesophageal junction cancer.
  • Median progression-free survival for TEVIMBRA plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).
  • The safety profile for TEVIMBRA in combination with chemotherapy was manageable and in line with the known safety profile of anti-PD-1 antibodies.
  • A BLA for the treatment of patients with advanced or metastatic ESCC after prior chemotherapy is also under review by the FDA.

BeiGene Receives Positive CHMP Opinion for Tislelizumab as Treatment for Non-Small Cell Lung Cancer

Retrieved on: 
Monday, February 26, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, NSCLC, Carboplatin, European Commission, EMA, JAMA Oncology, EGFR, Committee, Tislelizumab, MAA, Neoplasm, FDA, Quality of life, Cancer, Food, ESCC, Pemetrexed, BGNE, European, Lung cancer, Civil service commission, CHMP, European Medicines Agency, Paclitaxel, Patient, Journal, Survival, ALK, Pharmaceutical industry

As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.

Key Points: 
  • As monotherapy for the treatment of adult patients with locally advanced or metastatic NSCLC after prior platinum-based therapy.
  • Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.
  • Tislelizumab is also under review by the FDA as a first-line treatment for patients with unresectable, recurrent, locally advanced, or metastatic ESCC.
  • BeiGene has launched more than 17 potentially registration-enabling trials with tislelizumab with over 13,000 patients enrolled to-date, of which 15 have already reported positive readouts.

Enhancing Leadership in Gynecology, Asieris Pharmaceuticals Appoints Sophia Cao to Lead the Newly-Established Women's Health Business Unit, Accelerating Strategic Expansion

Retrieved on: 
Tuesday, January 9, 2024
Action plan, E pluribus unum, Woman, Bladder cancer, Marketing, Health, Elimination, Society, Cancer, Cervical cancer, Infection, World Health Organization, Diagnosis, NMIBC, Comparison, Cervical weakness, Multimedia, Death, ASCO, Breast cancer, Eli Lilly, Tislelizumab, Prevalence, MIBC, Neoadjuvant therapy, HPV, Human papillomavirus infection, LSIL, New Drug Application, NMPA, National Health Commission, Central China, Kidney cancer, Women's health, National Cancer Center, PD-1, WHO, Mortality, HSIL, Conditional sentence, Internet, Weak topology, Patient, Senior, State Council, NDA, Incidence, Head, National Medical Products Administration, Miscarriage

This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.

Key Points: 
  • This strategic move is designed to enhance the company's focus on genitourinary diseases and strengthen its position in women's health.
  • Asieris Pharmaceuticals will leverage both in-house discoveries and external partnerships to enrich its gynecological portfolio, thereby reinforcing its leadership in women's health.
  • In November 2020, the World Health Organization (WHO) released a Global Strategy to Accelerate the Elimination of Cervical Cancer.
  • To further deliver its strategic vision and commitment in the realm of women's health, Asieris Pharmaceuticals has announced the establishment of the Women's Health Business Unit.

Deka Biosciences Adds Industry Veterans to its Executive Leadership Team and Board of Directors

Retrieved on: 
Tuesday, December 19, 2023
Atlas Venture, Therapeutic index, Atlas, Yale University, Cytokine, Science, Drug discovery, Medical school, Sutro Biopharma, Research, Chemistry, BeiGene, Tislelizumab, Acquisition, EGFR, File, Inflammation, Physician, Juno Therapeutics, MBA, College, Blinatumomab, Therapy, Columbia University, Lisocabtagene maraleucel, Cancer, University, Head, Feinberg School of Medicine, BMS, Harvard College, Surgeon, Medicine, Biogen, FACP, Pharmaceutical industry

GERMANTOWN, Md., Dec. 19, 2023 /PRNewswire/ -- Deka Biosciences ("Deka") today announced the appointments of Stanley Frankel, M.D., FACP, as senior clinical advisor, interim chief medical officer and scientific advisory board member, and Stuart Chaffee, Ph.D. as an independent director and chairman of the Board. Deka is a privately held biotech company developing next-generation cytokine therapies to treat cancer and inflammatory diseases based on a patient's individual immune response. Deka's lead asset, DK210 (EGFR), is currently being evaluated for the treatment of multiple solid tumors in a Phase 1 clinical trial.

Key Points: 
  • Deka is a privately held biotech company developing next-generation cytokine therapies to treat cancer and inflammatory diseases based on a patient's individual immune response.
  • Dr. Frankel joins Deka as a hematologist-oncologist with over 20 years of industry experience, including the research, clinical development, and commercialization of immuno-oncology and cellular therapies.
  • He is a non-executive director at Precision Biosciences and a member of the board of directors at Myeloid Therapeutics.
  • Earlier in his career, Dr. Chaffee served in several roles at Biogen across finance, business development, program leadership, and corporate strategy.

PureTech Presents Data from Phase 1 Trial of LYT-200 Targeting Galectin-9 in Solid Tumors at the ESMO Immuno-Oncology Congress 2023

Retrieved on: 
Thursday, December 7, 2023
Oncology, Health, FDA, General Health, Clinical Trials, Pharmaceutical, Biotechnology, UCLA, Neck, The, Tislelizumab, Apoptosis, BeiGene, Head, Colorectal cancer, Acute myeloid leukemia, PureTech Health, Carcinoma, Mortality, ESMO, Patient, LSE, PRTC, Bone marrow, Pharmaceutical industry, Medicine

LYT-200 is an anti-galectin-9 antibody being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene, in metastatic solid tumors, including urothelial and head and neck cancers.

Key Points: 
  • LYT-200 is an anti-galectin-9 antibody being evaluated as a monotherapy and in combination with tislelizumab, an anti-PD-1 antibody developed by BeiGene, in metastatic solid tumors, including urothelial and head and neck cancers.
  • LYT-200 is also in development for the treatment of hematological malignancies, such as acute myeloid leukemia.
  • The monotherapy arm of the trial has been completed, and the clinically relevant dose was selected for the Phase 2 portion of the trial.
  • The poster titled “Phase 1/2 Trial of Galectin-9 Antibody LYT-200 +/- Tislelizumab” will be presented today at The ESMO Immuno-Oncology Congress 2023, which is taking place in Geneva, Switzerland.

BeiGene Announces Late-Breaking Data at ESMO Showing Tislelizumab plus Chemotherapy Significantly Improved Overall Survival at Final Analysis in First-Line Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

Retrieved on: 
Tuesday, October 17, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, SSE, Congress, Abstract, ORR, Tislelizumab, Cisplatin, OS, PD-L1, XELOX, BGNE, Survival, CEST, ESMO, ITT, Oxaliplatin, Kuwait Cancer Control Center, PFS, European Society for Medical Oncology, European Society of Gynaecological Oncology, FP, Patient, Sun, Pharmaceutical industry, BeiGene

BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced results from the final analysis of the Phase 3 RATIONALE 305 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) in the intent-to-treat (ITT) population as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).

Key Points: 
  • BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, today announced results from the final analysis of the Phase 3 RATIONALE 305 trial showing tislelizumab plus chemotherapy significantly improved overall survival (OS) in the intent-to-treat (ITT) population as a first-line treatment for patients with advanced gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).
  • Study results will be featured as a late-breaking oral presentation on October 21 at 5:25 p.m. CEST at the European Society for Medical Oncology (ESMO) Congress 2023 (Abstract #LBA80).
  • “These data show that tislelizumab plus chemotherapy resulted in significant overall survival improvement compared with chemotherapy alone in the intent-to-treat patient group.
  • Median progression-free survival (PFS) for tislelizumab plus chemotherapy was 6.9 months vs. 6.2 months respectively; (HR: 0.78 [95% CI: 0.67, 0.90]).

BeiGene Announces the Phase 3 RATIONALE 315 Trial Met Primary Endpoints of Major Pathological Response Rate and Event-Free Survival for Tislelizumab Plus Chemotherapy in Patients with Resectable Non-Small Cell Lung Cancer (NSCLC)

Retrieved on: 
Tuesday, October 17, 2023
Research, FDA, Clinical Trials, Biotechnology, Health, Pharmaceutical, Other Science, Science, Oncology, SSE, Congress, NSCLC, Abstract, Tislelizumab, BeiGene, BGNE, CEST, ESMO, EFS, Rollcage Stage II, Neoadjuvant therapy, European Society for Medical Oncology, PCR, European Society of Gynaecological Oncology, Patient, MPR, Medical imaging, Dentistry, Pharmaceutical industry

The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy.

Key Points: 
  • The tislelizumab plus chemotherapy regimen also showed a statistically significant improvement in pathological complete response (pCR), the key secondary endpoint, after neoadjuvant therapy versus chemotherapy.
  • In the study, 56.2% of NSCLC patients treated with tislelizumab in combination with chemotherapy before surgery achieved MPR, compared to 15.0% of patients treated with chemotherapy alone (difference: 41.1%; 95% CI: 33.2-49.1, p
  • "Lung cancer remains the most common type of cancer and the leading cause of cancer-related death worldwide.
  • These results add to the growing evidence suggesting the potential benefits of tislelizumab in treating patients with NSCLC.”

PureTech to Present at Two Upcoming Investor Conferences

Retrieved on: 
Tuesday, October 17, 2023
Biotechnology, General Health, Other Health, Health, Pharmaceutical, PureTech Health, Clostridioides difficile infection, Schizophrenia, OTC, U.S. Department of Defense Strategy for Operating in Cyberspace, Food, KarXT, Anxiety, Fragile X-associated tremor/ataxia syndrome, Inflammation, Central nervous system, Tislelizumab, Epilepsy, IPF, KRTX, University, AML, Myenteric plexus, Ulcerative colitis, University of California, Davis, Idiopathic pulmonary fibrosis, FDA, Therapy, PRTC, Acute myeloid leukemia, LSE, Clinical trial, Bone marrow, Fast Track, Depression, New Drug Application, Head, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Fibrosis, Vedanta, DSM-IV codes, CNS, Daphne, Office of Inspector General, U.S. Department of Health and Human Services, Patient, Pharmaceutical industry, Management, Yolo Akili, FXTAS

PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that members of the management team will participate in fireside chats at two upcoming investor conferences.

Key Points: 
  • PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company dedicated to changing the lives of patients with devastating diseases, today announced that members of the management team will participate in fireside chats at two upcoming investor conferences.
  • “Recently, we have been increasing our focus on our central nervous system (CNS) programs, including LYT-300 and LYT-310, that originated from our Glyph™ technology platform.
  • If approved, KarXT, invented at PureTech, will be the third therapeutic candidate to be taken from inception at PureTech to FDA regulatory approval.
  • PureTech will not move forward with the contemplated plan of merger with Gelesis and will instead focus on other strategic business initiatives.