VEGFR

Takeda Receives Positive CHMP Opinion for Fruquintinib in Previously Treated Metastatic Colorectal Cancer

Retrieved on: 
Vendredi, avril 26, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, European Commission, CHMP, European, BSC, Patient, EMA, Committee, VEGFR, Marketing, VEGF

The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland.

Key Points: 
  • The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland.
  • If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.1,2
    “People living with metastatic colorectal cancer in the European Union currently have limited treatment options, which can lead to poor outcomes.
  • The trial investigated fruquintinib plus best supportive care (BSC) versus placebo plus BSC in patients with previously treated mCRC.
  • Adverse reactions leading to treatment discontinuation occurred in 20% of patients treated with fruquintinib plus BSC versus 21% of those treated with placebo plus BSC.

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

Retrieved on: 
Vendredi, avril 5, 2024
IOV, Tao, Medicine, Savolitinib, VEGFR, Immunotherapy, Patient, MMAE, ERK, Relapse, Neoplasm, University, Huachung University, Cisplatin, Lymphoid leukemia, Lymphoma, Chongqing Medical University, Cholangiocarcinoma, Tyrosine-protein kinase SYK, Classification, Efficacy, MET, ADC, Cardiotoxicity, Nanjing Medical University, Non-receptor tyrosine kinase, Safety, Ferroptosis, Macrophage, Pancreatic cancer, Dual role, National Taiwan University Hospital, GPR34, Oncology, Guangzhou Medical University, MD Anderson Cancer Center, Daratumumab, HCM, NPM1, MLL, 301 Hospital, Acute leukemia, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
  • Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia.
  • Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models.
  • Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo.

HUTCHMED Reports 2023 Full Year Results and Provides Business Updates

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Mercredi, février 28, 2024
Neoplasm, RMB, SHPL, Net, EZH2, Growth, FC, Tax, Follicular lymphoma, FX, Fast Track, TCFD, Ethics, Marketing, RCC, Health, CER, Sintilimab, ITP, Disclosure, Plasma protein binding, Lancet, MET, Completeness, D-19, Paclitaxel, Met, NDA, NSCLC, EGFR, NRDL, Atopic dermatitis, ESG, CRC, PD-1, Completion, Phases of clinical research, Task force, Half-life, Chills, Potential, Breakthrough therapy, NMPA, Investment, FGFR, Research, PFS, AstraZeneca, EMA, ADS, Annual report, ASCO, FDA, Carbon accounting, VEGFR, Lung, COVID-19, Alopecia areata, PMDA, Lilly, Patient, Cancer, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”, the “Company” or “we”) (Nasdaq/AIM:​HCM; HKEX:​13), the innovative, commercial-stage biopharmaceutical company, today reports its financial results for the year ended December 31, 2023 and provides updates on key clinical and commercial developments. HUTCHMED to host results call and webcasts today at 7:30 a.m. EST / 12:30 p.m. GMT / 8:30 p.m. HKT in English, and at 8:30 a.m. HKT in Chinese (Putonghua) on Thursday, February 29, 2024.

Key Points: 
  • HUTCHMED is committed to progressively embedding sustainability into all aspects of our operations and creating long-term value for our stakeholders.
  • The 2023 Sustainability Report will be published alongside our 2023 Annual Report in April 2024 and will include further information on HUTCHMED sustainability initiatives and their performance.
  • Net Income attributable to HUTCHMED for 2023 was $100.8 million compared to Net Loss attributable to HUTCHMED of $360.8 million in 2022.
  • The net income attributable to HUTCHMED in 2023 was $0.12 per ordinary share / $0.59 per ADS49, compared to net loss attributable to HUTCHMED of $0.43 per ordinary share / $2.13 per ADS in 2022.

AVEO Oncology Announces Publication of Long-Term Survival in Patients With Relapsed/Refractory Advanced Renal Cell Carcinoma Treated With Tivozanib: Analysis of the Phase III TIVO-3 Trial in The Oncologist

Retrieved on: 
Mardi, février 6, 2024
OS, Vanderbilt-Ingram Cancer Center, VEGFR, Survival, IO, TKI, Renal cell carcinoma, Division, RCC, MD, PFS, Safety, Patient, Progression-free survival, Sorafenib, Arm, Disease, ITT, Assistant, Oncology, LG Chem, Doctor of Philosophy, Pharmaceutical industry

The trial included a predefined subgroup of patients (26%) who were previously treated with both an immuno-oncology (IO) therapy and a VEGFR TKI.

Key Points: 
  • The trial included a predefined subgroup of patients (26%) who were previously treated with both an immuno-oncology (IO) therapy and a VEGFR TKI.
  • “For patients with relapsed or refractory advanced renal cell carcinoma, long-term progression-free survival is a vital measure of the value of anticancer therapy,” commented Michael Bailey, President and CEO of AVEO Oncology.
  • The trial randomized 350 patients to receive FOTIVDA (1.5 mg once daily) or sorafenib (400 mg twice daily).
  • The intent-to-treat (ITT) population included 175 patients in each arm; the safety population included 173 patients in the FOTIVDA arm and 170 in the sorafenib arm.

HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses

Retrieved on: 
Vendredi, décembre 1, 2023
Stomach, Hepatocellular carcinoma, VEGFR, Cervical cancer, PD-1, Renal cell carcinoma, Endometrial cancer, Sintilimab, HCC, GC, RCC, Patient, Safety, EMC, NSCLC, BSC, Pharmaceutical industry

These presentations will report results from the cervical cancer and NSCLC patient cohorts of the basket clinical trial in China of fruquintinib plus sintilimab.

Key Points: 
  • These presentations will report results from the cervical cancer and NSCLC patient cohorts of the basket clinical trial in China of fruquintinib plus sintilimab.
  • Data from the EMC and RCC cohorts of this trial led to the initiation of registration enabling programs.
  • This combination treatment showed promising antitumor activity in advanced cervical cancer and NSCLC patients, particularly for patients with PD-L1 positive status.
  • Fruquintinib is a selective oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3.

HiberCell Announces Successful Completion and Interim Results of Phase 1 Study of Novel PERK Inhibitor, HC-5404, in Solid Tumors and Maps Forward Path as Monotherapy and in Combinations

Retrieved on: 
Lundi, novembre 27, 2023
MTD, Metastasis, AACR, Survival, Index, VEGFR, CCR, Diarrhea, PDX, Fatigue, Nausea, Renal cell carcinoma, Research, TKI, PD, Medicine, Neoplasm, RCC, Clinical Cancer Research, Xerostomia, Publication, Patient, Safety, Pharmaceutical industry

“We are excited to announce the successful completion of our Phase 1 monotherapy study of HC-5404 along with the two publications in Clinical Cancer Research,” said Jonathan Lanfear, President and CEO.

Key Points: 
  • “We are excited to announce the successful completion of our Phase 1 monotherapy study of HC-5404 along with the two publications in Clinical Cancer Research,” said Jonathan Lanfear, President and CEO.
  • “We are encouraged by the safety profile, dose-dependent exposure, and pathway engagement, as well as the preliminary signals of efficacy observed in our Phase 1 trial.
  • This provides a forward path for Ph1b/Ph2 studies in multiple indications/combinations as outlined in our publications in Clinical Cancer Research.
  • HiberCell is seeking partners to advance HC-5404 in combination with an antiangiogenic VEGFR TKI in the solid tumor metastatic setting.

Exelixis Announces Encouraging Results from Expansion Cohort of Phase 1b STELLAR-001 Trial Evaluating Zanzalintinib in Patients with Advanced Kidney Cancer at IKCS 2023

Retrieved on: 
Vendredi, novembre 10, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, City, Exelixis, Patient, TKI, CST, VEGFR, Immunotherapy, HIV disease progression rates, Pharmaceutical industry

Exelixis, Inc. (Nasdaq: EXEL) today announced initial results from an expansion cohort of STELLAR-001 evaluating single-agent zanzalintinib in patients with previously treated clear cell renal cell carcinoma (ccRCC).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced initial results from an expansion cohort of STELLAR-001 evaluating single-agent zanzalintinib in patients with previously treated clear cell renal cell carcinoma (ccRCC).
  • STELLAR-001 is a phase 1b trial evaluating zanzalintinib alone and in combination with atezolizumab in patients with locally advanced or metastatic solid tumors.
  • The findings are being presented today at 2:35 p.m. CST during the Oral Abstracts session at the 2023 International Kidney Cancer Symposium (IKCS): North America.
  • Eighty-one percent of patients were intermediate risk by International Metastatic RCC Database Consortium.

Merck’s WELIREG® (belzutifan) Significantly Improved Progression-Free Survival and Objective Response Rates Versus Everolimus in Certain Previously Treated Patients With Advanced Renal Cell Carcinoma (RCC)

Retrieved on: 
Samedi, octobre 21, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, NYSE, ESMO, Progression-free survival, Congress, MRK, PFS, European Society for Medical Oncology, HIV disease progression rates, RCC, Risk, ORR, VEGFR, Patient, Death, Everolimus, Pharmaceutical industry, Merck

Treatment-related adverse events (TRAEs) occurred in 89% of patients who received WELIREG (n=331) versus 89.4% of patients who received everolimus (n=322).

Key Points: 
  • Treatment-related adverse events (TRAEs) occurred in 89% of patients who received WELIREG (n=331) versus 89.4% of patients who received everolimus (n=322).
  • Grade ≥3 TRAEs occurred in 38.7% of patients who received WELIREG versus 39.4% of patients who received everolimus.
  • Adverse events led to discontinuation of study treatment in 5.9% of patients who received WELIREG and 14.7% who received everolimus.
  • Treatment-related adverse events led to death in 0.3% of patients who received WELIREG (n=1) and 0.6% of patients who received everolimus (n=2).

Takeda and HUTCHMED Announce Publication of Phase 3 FRESCO-2 Results in The Lancet

Retrieved on: 
Vendredi, juin 16, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Priority review, CRC, Progression-free survival, TAK, European Medicines Agency, New Drug Application, OS, NDA, Medicines and Healthcare products Regulatory Agency, PFS, Marketing, EMA, Patient, PMDA, VEGFR, BSC, MAA, European Society of Gynaecological Oncology, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, HCM, Food, Pharmaceutical industry, Takeda, Lancet

Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that results of the Phase 3 FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in The Lancet.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ( HUTCHMED ) today announced that results of the Phase 3 FRESCO2 study evaluating fruquintinib in patients with previously treated metastatic colorectal cancer (CRC) were published in The Lancet.
  • The publication provides details of the FRESCO-2 study results as of June 24, 2022.
  • Summary results from this cut-off date were presented on September 12, 2022, at the European Society for Medical Oncology Congress 2022 (ESMO22).
  • In March 2023, HUTCHMED and Takeda closed an exclusive license agreement to further the global development, commercialization and manufacture of fruquintinib outside of China.

Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency

Retrieved on: 
Jeudi, juin 15, 2023
General Health, Health, Pharmaceutical, Clinical Trials, Oncology, Priority review, CRC, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Marketing, Progression-free survival, TAK, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, JAMA, NDA, PFS, EMA, American Medical Association, VEGF, HKEX, Journal, Prescription Drug User Fee Act, Patient, Physician, PMDA, VEGFR, European, PDUFA, BSC, MAA, FDA, HCM, Pharmaceutical industry, EU, Takeda

Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (HUTCHMED) today announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) (HUTCHMED) today announced that the European Medicines Agency (EMA) has validated and accepted for regulatory review the marketing authorization application (MAA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (CRC).
  • “We are thrilled to have submitted the marketing authorization application to the EMA, bringing us one step closer to potentially offering this innovative therapy to patients with advanced disease.
  • FRESCO-2 is a global Phase 3 multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan and Australia investigating fruquintinib plus best supportive care (BSC) vs placebo plus BSC in patients with previously treated metastatic CRC.
  • Submission of an NDA to the Japan Pharmaceuticals and Medical Devices Agency (PMDA) is also planned in 2023.