BIRC

Servier Receives Regulatory Filing Acceptances from FDA and EMA for Vorasidenib in the Treatment of IDH-Mutant Diffuse Glioma

Retrieved on: 
Wednesday, February 21, 2024

BOSTON and SURESNES, France, Feb. 21, 2024 /PRNewswire/ -- Servier, a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves, today announced the FDA filing acceptance and priority review for a New Drug Application (NDA) for vorasidenib, as well as the EMA granting accelerated assessment for the vorasidenib Marketing Authorization Application (MAA). This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma. If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of August 20, 2024, while the European Commission approval is anticipated in the second half of 2024.

Key Points: 
  • This innovative targeted therapy is an oral, selective, highly brain-penetrant dual inhibitor of mutant isocitrate dehydrogenase 1 and 2 (IDH1/2) enzymes for the treatment of IDH-mutant diffuse glioma.
  • If approved, vorasidenib would become a first-in-class targeted therapy for patients with IDH-mutant gliomas and would mark Servier's sixth approval across IDH-mutant cancers.
  • "In the realm of glioma treatment, innovation has been stagnant for nearly a quarter-century, posing challenges for patients who, post-surgery, may opt to defer treatment due to concerns around potential toxic side effects.
  • "This promising outcome brings hope to patients grappling with IDH-mutant diffuse gliomas, offering a potential breakthrough for those eagerly awaiting a new therapeutic option."

Exelixis Announces Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, February 6, 2024

In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.

Key Points: 
  • In 2023, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.2 billion.
  • Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2023, Exelixis earned $40.7 million and $148.5 million, respectively, in royalty revenues.
  • In October 2023, detailed results were presented from the phase 3 CABINET pivotal trial at the 2023 ESMO Congress.
  • Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year of 2023 and provide a general business update during a conference call beginning at 5:00 p.m.

Exelixis Announces Detailed Results of Phase 3 CONTACT-02 Pivotal Trial Evaluating Cabozantinib in Combination with Atezolizumab in Metastatic Castration-Resistant Prostate Cancer Presented at ASCO GU 2024

Retrieved on: 
Thursday, January 25, 2024

The detailed findings are being presented during Oral Abstract Session A: Prostate Cancer at 7:55 a.m. PST on January 25 at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU).

Key Points: 
  • The detailed findings are being presented during Oral Abstract Session A: Prostate Cancer at 7:55 a.m. PST on January 25 at the American Society of Clinical Oncology 2024 Genitourinary Cancers Symposium (ASCO GU).
  • The PFS analysis was conducted in the first 400 randomized patients in the intent-to-treat (PFS ITT) population and per protocol.
  • While a trend toward OS improvement was observed, the data were immature and did not meet the threshold for statistical significance.
  • The PFS benefit and the trend for an OS benefit were observed across subgroups of high-risk populations, as presented in Table 1.

Exelixis Announces Initiation of the STELLAR-305 Phase 2/3 Pivotal Trial Evaluating Zanzalintinib in Combination with Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer

Retrieved on: 
Monday, December 4, 2023

Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Key Points: 
  • Exelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
  • Patients must not have received prior systemic therapy for recurrent or metastatic disease.
  • Patients will be randomized 1:1 to receive zanzalintinib in combination with pembrolizumab or placebo in combination with pembrolizumab.
  • Secondary endpoints include PFS per RECIST 1.1 by investigator and objective response rate and duration of response per RECIST 1.1 by BIRC and by investigator.

87.5% ORR | Abbisko presented two clinical updates of Pimicotinib at the 2023 CTOS Annual Meeting

Retrieved on: 
Tuesday, November 7, 2023

SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib(ABSK021)were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.

Key Points: 
  • SHANGHAI, Nov. 6, 2023 /PRNewswire/ -- Abbisko Therapeutics Co., Ltd. ("Abbisko Therapeutics" hereafter) announced that two major clinical updates of its CSF-1R inhibitor pimicotinib(ABSK021)were presented at the 2023 Connective Tissue Oncology Society Annual Meeting, which is held in Ireland from November 1 to 4, 2023.
  • The two clinical updates include reporting the design of the pivotal global multi-center phase III clinical trial and the further update of the phase Ib clinical trial of pimicotinib.
  • In 2023, the U.S. FDA conferred Breakthrough Therapy Designation and the European Medicines Agency granted Priority Medicine Designation upon Pimicotinib treatment of TGCT.
  • Here, we report the phase 1b safety and efficacy results of Pimicotinib in TGCT patients over a 1-year follow-up.

Avistone Announces Phase II Results for Vebreltinib, a c-Met Tyrosine Kinase Inhibitor (TKI) at the European Society for Clinical Oncology (ESMO) Congress

Retrieved on: 
Monday, October 23, 2023

METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC.

Key Points: 
  • METex14 is an independent prognostic factor associated with poorer survival rates in patients with NSCLC.
  • As of August 9, 2022, 113 patients were enrolled in the China study, among whom 52 patients had METex14 skipping mutations (Cohort 1).
  • Avistone is an oncology company focused on developing innovative therapies for patients with significant unmet medical needs globally.
  • Avistone has an extensive pipeline of targeted therapies including two clinical-stage drug candidates and several ongoing programs in the pre-clinical development stage.

Servier Presents Transformational Data from Pivotal Phase 3 INDIGO Trial of Vorasidenib in Recurrent or Residual Grade 2 IDH-Mutant Diffuse Glioma

Retrieved on: 
Sunday, June 4, 2023

BOSTON, June 4, 2023 /PRNewswire/ -- Servier, a leader in oncology committed to bringing innovative therapies to the patients we serve, today presented results from the pivotal Phase 3 INDIGO clinical trial investigating vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes in patients with residual or recurrent isocitrate dehydrogenase 1 or 2 (IDH1/2) mutant low-grade glioma who have been treated with surgery only. INDIGO succeeded in meeting its primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The data were presented as a late breaking abstract during the plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO), and simultaneously published in the New England Journal of Medicine.

Key Points: 
  • We look forward to working with the FDA on its review of vorasidenib as a potential therapy in IDH-mutant diffuse glioma."
  • INDIGO is a registration-enabling Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment.
  • Of the 331 patients, 172 had oligodendroglioma (88 vorasidenib; 84 placebo) and 159 patients had astrocytoma (80 vorasidenib; 79 placebo).
  • Servier is working to determine timelines for submission of a New Drug Application (NDA) for vorasidenib to the FDA.

ACE-Breast-02 Pivotal Phase 3 Study of Ambrx’s ARX788 for the Treatment of HER2 Positive Metastatic Breast Cancer Achieves Positive Results

Retrieved on: 
Wednesday, March 1, 2023

ACE-Breast-02 is a randomized, controlled pivotal Phase 3 clinical trial of humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) in the treatment of HER2 positive patients with locally advanced or metastatic breast cancers in China.

Key Points: 
  • ACE-Breast-02 is a randomized, controlled pivotal Phase 3 clinical trial of humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) in the treatment of HER2 positive patients with locally advanced or metastatic breast cancers in China.
  • The trial enrolled 441 HER2 positive breast cancer patients who have been previously treated with taxane and trastuzumab.
  • The positive results from this large Phase 3 study provide further support for our rationale to develop ARX788 globally in HER2 positive breast cancer patients.”
    ARX788 is an anti-HER2 ADC currently being studied broadly in breast cancer, gastric/GEJ cancer and other solid tumor clinical trials with our partner NovoCodex.
  • The United States Food and Drug Administration (FDA) has granted Fast Track Designation for ARX788 in HER2 positive metastatic breast cancer and Orphan Drug Designation for ARX788 in gastric cancer.

Junshi Biosciences Announces Submission of a Marketing Authorization Application for Toripalimab to the UK Medicines and Healthcare Products Regulatory Agency

Retrieved on: 
Thursday, November 24, 2022

Junshi Biosciences also submitted a MAA to the European Medicines Agency (EMA) for toripalimab for the same indications in mid-November.

Key Points: 
  • Junshi Biosciences also submitted a MAA to the European Medicines Agency (EMA) for toripalimab for the same indications in mid-November.
  • Within a single month, we were able to submit marketing authorization applications for toripalimab to two major European regulatory agencies, said Dr. Patricia Keegan, Chief Medical Officer of Junshi/TopAlliance Biosciences.
  • In Europe, toripalimab was designated as an orphan medicinal product by the European Commission (EC) for the treatment of NPC.
  • Junshi Biosciences has more than 3,100 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou).

Junshi Biosciences and Coherus Announce Publication of Positive Results from CHOICE-01, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer, in the Journal of Clinical Onc

Retrieved on: 
Wednesday, October 12, 2022

At the interim OS analysis, the toripalimab arm had a significantly longer OS than the placebo arm (median OS not reached vs 17.1 months).

Key Points: 
  • At the interim OS analysis, the toripalimab arm had a significantly longer OS than the placebo arm (median OS not reached vs 17.1 months).
  • The CHOICE-01 study was a multi-center, randomized double-blind, placebo-controlled phase 3 study conducted in 59 centers across China.
  • 465 treatment-nave advanced NSCLC patients without EGFR/ALK mutations were randomized to receive either toripalimab plus chemotherapy (n=309) or placebo plus chemotherapy (n=156).
  • The trial was conducted in full conformance with the ICH E6 guidelines for Good Clinical Practice and the principles of the Declaration of Helsinki.