Brentuximab vedotin

Corbus Announces Dosing of First Patient in U.S. Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC

Retrieved on: 
Tuesday, April 2, 2024
MUC, Brentuximab vedotin, Patient, Doctor of Philosophy, Clinical trial, Safety, Pharmacokinetics, ADC, Shijiazhuang Pharma Group, Pharmaceutical industry

NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4.

Key Points: 
  • NORWOOD, Mass., April 02, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, announced today the first patient in the U.S. has been dosed in the Phase 1 clinical trial of CRB-701 (SYS6002), a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4.
  • The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose.
  • “The initiation of our clinical trial is a significant milestone for Corbus and builds on the encouraging CRB-701 data presented by our development partner CSPC Pharmaceutical Group at ASCO-GU 2024 from the phase 1 study in China,” said Yuval Cohen, PhD.
  • Chief Executive Office of Corbus.

Pfizer Announces Positive Overall Survival in Phase 3 Trial of ADCETRIS® Regimen in Patients with Relapsed/​Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Retrieved on: 
Tuesday, March 12, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Rituximab, Survival, Lymphoma, Inc., Disease, Patient, PFE, Brentuximab vedotin, Lenalidomide, Safety, CD30, PFS, Food, FDA, DLBCL, Pharmaceutical industry

Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).

Key Points: 
  • Positive outcomes were also observed in key secondary endpoints, including progression free survival (PFS) and overall response rate (ORR).
  • The safety and tolerability of ADCETRIS in the ECHELON-3 trial were consistent with what has been previously presented for patients with relapsed/refractory DLBCL treated with ADCETRIS in clinical trials.
  • “This is the third Phase 3 study in a type of lymphoma to demonstrate an overall survival benefit for an ADCETRIS combination.
  • Pfizer plans to share the ECHELON-3 data with the U.S. Food and Drug Administration (FDA) to potentially support regulatory filing in the U.S.

Pfizer Oncology Hosts Innovation Day, Highlighting Fully Integrated Organization, Robust Portfolio, and Strategic Priorities to Drive Long-Term Sustainable Growth

Retrieved on: 
Thursday, February 29, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, NSCLC, Acquisition, Breast cancer, Head, Recurrence, Boshoff, CREST, MBC, Encorafenib, Growth, HR, Spacecraft, PFE, Prostate, Metastasis, Pembrolizumab, Lung, ADC, Monoclonal antibody, Webcast, Patient, Lymphoma, Multiple myeloma, Brentuximab vedotin, PD-L1, Cancer, Fine chemical

A replay of the webcast and related materials, including the presentations and a summary and transcript, will be made available on the Pfizer investor relations website at www.pfizer.com/investors .

Key Points: 
  • A replay of the webcast and related materials, including the presentations and a summary and transcript, will be made available on the Pfizer investor relations website at www.pfizer.com/investors .
  • “With the completion of the Seagen acquisition in 2023, Pfizer has significantly expanded its Oncology organization to amplify its efforts to advance new standards of care and improve outcomes for patients,” said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer.
  • Pfizer’s Oncology portfolio is focused on three core scientific modalities: small molecules, antibody drug conjugates (ADCs), and bispecific antibodies, including other immuno-oncology biologics.
  • Please read full Prescribing Information , including BOXED WARNING, for ELREXFIOTM (elranatamab-bcmm).

Bicycle Therapeutics Reports Recent Business Progress and Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 20, 2024
Biotechnology, General Health, Pharmaceutical, Health, Toxicity, Growth, Ovarian cancer, Radiopharmaceutical, Patient, Anal cancer, Bicycle, McKinsey & Company, Head, Cervical cancer, EV, Neoplasm, ATM, Therapy, Food and Drug Administration, TNBC, Net, Former, CMC, Thromboxane A2, Immune system, NSCLC, MUC, Peripheral neuropathy, SunOpta, Safety, Ovary, Participation, Knowledge, Novartis, Lazard, BRC, FDA, Cancer, Food, Pembrolizumab, Government, ADC, Brentuximab vedotin, CD137, Pharmaceutical industry

Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent corporate updates.

Key Points: 
  • Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent corporate updates.
  • We continue to demonstrate our ability to develop highly differentiated, precision-guided therapeutics that may offer greater tolerability and lead to enhanced benefit for patients,” said Kevin Lee, Ph.D., CEO of Bicycle Therapeutics.
  • Validating the company’s Bicycle® Radio Conjugates (BRC™) pipeline and partner for success, with updates expected from its wholly owned BRC program by mid-2024.
  • Advancing the company’s Bicycle Tumor-Targeted Immune Cell Agonist® (Bicycle TICA®) immune-oncology pipeline through innovative partnerships.

CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting Antibody Drug Conjugate Demonstrates Encouraging Safety and Efficacy in Patients with Nectin-4 Positive Tumors in First-In-Human Study Presented at ASCO-GU 2024

Retrieved on: 
Friday, January 26, 2024
MMAE, Neoplasm, Patient, PST, Yale school, CSPC, Shijiazhuang Pharma Group, Yale School of Medicine, ADC, Rash, Peripheral neuropathy, Brentuximab vedotin, ASCO, MUC, Poster, Society, Cervical cancer, Safety, EV, GU, Corbus, Urology, Tab, Trial of the century, Pharmaceutical industry

The poster is titled Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate by DingWei Ye, et al and is being presented today at the poster session between 11:30 am-1pm PST.

Key Points: 
  • The poster is titled Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate by DingWei Ye, et al and is being presented today at the poster session between 11:30 am-1pm PST.
  • The poster will also be available on the Corbus website at the start of the poster presentation.
  • We are grateful to CSPC for the work that has gone into conducting this ongoing study and to the clinicians and study participants."
  • Dose escalation and expansion are ongoing and additional data presentations are planned for later this year.

European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Retrieved on: 
Friday, January 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Patient, Carcinoma, CHMP, Progression-free survival, European Medicines Agency, Bladder cancer, Brentuximab vedotin, Survival, Civil service commission, European Commission, Pfizer, PFE, EMA, Food, PFS, Safety, Pembrolizumab, Type, Inc., Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240125523192/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240125523192/en/
    “The EV-302 pivotal trial demonstrated the benefits of combining PADCEV with pembrolizumab for advanced bladder cancer.
  • Patients with bladder cancer in Europe face poor outcomes at the advanced stage, and innovative therapies that extend survival are needed.
  • If approved, the combination would be the first alternative to a chemotherapy-based treatment for this patient population.
  • The EMA’s Committee for Medicinal Products for Human Use (CHMP) and subsequently the European Commission (EC) are expected to share their opinions and decisions on the Type II variation application in calendar year 2024.

Multiple New Analyses Reinforce the Role of BAVENCIO® (avelumab) First-Line Maintenance as a Standard of Care in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Monday, January 22, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Senior, Roger Hawkins (drummer), Tamas, Patient, Carcinoma, MD, Merck Group, ADC, OS, Health care, UC, Bladder cancer, Brentuximab vedotin, ASCO, CUP, Survival, Society, READY, Quality of life, Experiment (probability theory), Safety, PRO, Merck Serono, Toxicity, Doctor of Philosophy, BMI, Merck, BSC, Czech, Pharmaceutical industry

Data include real-world studies that confirm median overall survival (OS) of approximately 30 months in patients without progression after first-line chemotherapy.

Key Points: 
  • Data include real-world studies that confirm median overall survival (OS) of approximately 30 months in patients without progression after first-line chemotherapy.
  • These and other analyses will be presented at the 2024 American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium, January 25-27, in San Francisco.
  • “Avelumab in the first-line maintenance setting is a standard of care for patients with locally advanced or metastatic bladder cancer, with a well-established efficacy and safety profile and supported by years of real-world experience.
  • READY CUP Italy Real-World Study: The prospective, noninterventional compassionate use program (CUP) provided Italian patients with locally advanced or metastatic UC early access to BAVENCIO first-line maintenance before reimbursement.

Multiple New Analyses Reinforce the Role of BAVENCIO® (avelumab) First-Line Maintenance as a Standard of Care in Patients with Locally Advanced or Metastatic Urothelial Carcinoma

Retrieved on: 
Monday, January 22, 2024
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Senior, Roger Hawkins (drummer), Tamas, Patient, Carcinoma, MD, ADC, OS, UC, Bladder cancer, Brentuximab vedotin, ASCO, CUP, Survival, Society, READY, Quality of life, Experiment (probability theory), Safety, PRO, Toxicity, Doctor of Philosophy, BMI, Physical property, BSC, Czech, Pharmaceutical industry

Data include real-world studies that confirm median overall survival (OS) of approximately 30 months in patients without progression after first-line chemotherapy.

Key Points: 
  • Data include real-world studies that confirm median overall survival (OS) of approximately 30 months in patients without progression after first-line chemotherapy.
  • These and other analyses will be presented at the 2024 American Society of Clinical Oncology’s annual Genitourinary Cancers Symposium, January 25-27, in San Francisco.
  • “Avelumab in the first-line maintenance setting is a standard of care for patients with locally advanced or metastatic bladder cancer, with a well-established efficacy and safety profile and supported by years of real-world experience.
  • READY CUP Italy Real-World Study: The prospective, noninterventional compassionate use program (CUP) provided Italian patients with locally advanced or metastatic UC early access to BAVENCIO first-line maintenance before reimbursement.

Corbus Pharmaceuticals Announces Abstract Accepted for Presentation at 2024 ASCO GU

Retrieved on: 
Monday, December 18, 2023
CSPC, Conference, AACR, Food, ASCO, Carcinoma, Society, Brentuximab vedotin, Patient, ADC, MMAE

NORWOOD, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today announced that the Phase 1, first-in-human clinical data from a dose escalation study being carried out by its partner CSPC in China with CRB-701 (SYS6002) has been accepted for presentation at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) , to be held January 25-27, 2024 in San Francisco, CA and online.

Key Points: 
  • NORWOOD, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a precision oncology company with a diversified portfolio, today announced that the Phase 1, first-in-human clinical data from a dose escalation study being carried out by its partner CSPC in China with CRB-701 (SYS6002) has been accepted for presentation at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) , to be held January 25-27, 2024 in San Francisco, CA and online.
  • CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting nectin-4, that contains a third generation, site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload.
  • Pre-clinical data demonstrating differentiation from enfortumab vedotin was recently presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
  • Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer.

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Retrieved on: 
Friday, December 15, 2023
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Cisplatin, NYSE, PFE, Food, Platinum, Progression-free survival, Carcinoma, ADC, ESMO, Patient, PFS, Astellas Pharma, Pembrolizumab, PD-1, Brentuximab vedotin, Survival, Death, Pfizer, Congress, OS, Inc., Confidence interval, Pharmaceutical industry, Dietary supplement

This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.

Key Points: 
  • This combination is the first approved to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line la/mUC.
  • Findings from EV-302 were presented at the European Society for Medical Oncology (ESMO) Congress 2023 .
  • “In the Phase 3 EV-302 study, the combination of PADCEV and pembrolizumab demonstrated survival benefit for patients with advanced bladder cancer, nearly doubling median OS and median PFS compared with chemotherapy.
  • Our network is thrilled that the FDA has approved a new treatment option, and we are excited about the hope it will provide to members of the bladder cancer patient community.”