Corr

FDA Grants Breakthrough Therapy Designation to Sunvozertinib for the First-Line Treatment of Patients with advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations

Retrieved on: 
Sunday, April 7, 2024
PART, EGFR, Mutation, BTD, NSCLC, Disease, Progression-free survival, Patient, Heel, Corr, NDA, Breakthrough, Non-Euclidean geometry, Doctor of Philosophy, CDE, Society, ESMO, Safety, ASCO, FDA, Annual general meeting, Food, Pharmaceutical industry

SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.

Key Points: 
  • SHANGHAI, April 7, 2024 /PRNewswire/ -- Dizal (688192.SH) today announced that the U.S. Food and Drug Administration ("FDA") has granted Breakthrough Therapy Designation (BTD) to its sunvozertinib as the first-line treatment for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (Exon20ins) mutations.
  • This Breakthrough Therapy Designation (BTD) approval was based on results from the global multi-center phase I/II study (WU-KONG1).
  • This new BTD will enable us work more closely with the FDA and accelerate its clinical development and regulatory submission."
  • Affecting roughly 2%-4% of NSCLC patients, EGFR Exon20ins mutations have been difficult to treat due to their unique spatial conformation, diverse mutation subtypes, and high heterogeneity.

Immatics Announces Full Year 2023 Financial Results and Corporate Update

Retrieved on: 
Thursday, March 21, 2024
Ovarian cancer, Head, Uterine cancer, GSK, Patient, Dendreon, Commercial, Cancer, Bristol Myers Squibb, Neoplasm, Melanoma, TCR, Therapy, Research, MAGEA4, Sarcoma, GMP, Safety, Pharmacokinetics, Amgen, QC, CDMO, Development, Prevalence, Half-life, RECIST, Senior, FDA, Lung cancer, Administration, Conference, Entrepreneurship, Bank, Corr, Messenger, Protein, Pharmacology, Uveal melanoma, Pharmaceutical industry

“Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.

Key Points: 
  • “Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.
  • For IMA203CD8 GEN2, Immatics cleared dose level 4a (DL4a, up to ~1.6x109 TCR-T cells) in December 2023, which is currently intended to be the target dose for further development.
  • A next data update for both Phase 1b cohorts with IMA203 GEN1 and IMA203CD8 GEN2 is planned for 2H 2024.
  • On September 11, 2023, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology.

Draft revised consolidated 3-year work plan for the Methodology Working Party (MWP)

Retrieved on: 
Wednesday, February 14, 2024
Real-World Evidence, ACT, Data science, CMD, Toxicity, Budesonide, Paliperidone palmitate, Drug development, E20, RWE, ETF, Human, Pharmacology, Machine learning, Quantitative systems pharmacology, Register, Radiopharmaceutical, Legislation, QST, M12, CAT, Salt, Pharmacoepidemiology, Dasatinib, Algorithm, M13, Azacitidine, Methylphenidate, Clinical trial, Health, M&S, Methodology, PBPK, HMA, Adverse drug reaction, European, CHMP, HTA, Biomarker, Big data, Digoxin, Betahistine, Multi, Therapy, Medication package insert, Simulation, LALA, ADR, US FDA, Language, RWD, Corr, PBBM, WPS, SAWP, Committee, Pharmacovigilance, Peptide, ICH, CPS, Contribution, Good, QSP, Model, Epidemiology, Artificial intelligence, RPS, Research, Reproduction, PRAC, EMA, Health Canada, AI, Cross, Gastrointestinal tract, Paliperidone, Communication, Risk, Melatonin, MWP, CP, Medicine, Patient, Biostatistics, Pharmacokinetics, Oligonucleotide, E21, M14, Q&A, Drug, M15, Medical device

Industry level .................................................................................................. 13

Key Points: 
    • Industry level .................................................................................................. 13

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 2/14

      1.

    • A reflection paper
      (RP) on the clinical pharmacology package for oligonucleotides is a prioritised activity in the MWP work

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 3/14

      plan, and it is envisaged that something similar may be needed for other emerging treatment
      modalities (e.g., peptides).

    • Guideline work led by other working parties
      ?

      Revision of the guideline on the requirements for clinical documentation for orally inhaled
      products (CPMP/EWP/4151/00 Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 4/14

      The planned concept papers (CPs) will formulate problem statements for potential workshops and
      subsequent guidance documents will be informed and enriched by the outcome of discussions of
      workshops to be held in 2024.

    • Guideline work led by other working parties and committees
      ?

      Revision of Guidance on the investigation of medicinal products in the term and preterm
      neonate (EMEA/536810/2008).

    • There is a need for
      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 5/14

      new guidance in these areas to ensure these novel approaches meet the required evidentiary
      standards and facilitate their evaluation.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 6/14

      ?

      Revision of Guideline on clinical evaluation of diagnostic agents (CPMP/EWP/1119/98/Rev.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 7/14

      ?

      Provide appropriate support to the EU network for generic and hybrid medicines including
      product-specific requirements.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 8/14

      2.3.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on physiologically
      based biopharmaceutics modelling (PBBM).

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 9/14

      ?

      In order to support adequate evaluation of all methodology MWP will aim to facilitate an
      increase in presence and visibility in relevant committees of methodological expertise from
      across the EU network such as CHMP, PRAC, PDCO, CMD(h), ETF and CAT.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 10/14

      ?

      Product Specific Bioequivalence Guidelines (PSBGLs) (multiple) in liaison with CMD(h): for
      2024, azacitidine, budesonide (LALA GIT), trametinib, dabrafenib, paliperidone palmitate (3M
      depot) and melatonin have been prioritised as the next in series for drafting.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 11/14

      4.2.

    • ?

      Cross disciplinary work with Quality Working Party and other stakeholders on PBBM model
      assessment.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 12/14

      ?

      To deliver an improved access to raw data (e.g.

    • ?

      Propose regulatory research priorities for funders in across the activities of Methodology
      Working Party, including in the big data area.

    • ?

      Establish key communication points in national competent authorities and build a resource of
      key messages and communication materials on regulation and methodology.

    • The timing of workshops may need to be arranged according to the

      Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 13/14

      specific needs of the guidance ? either before the guidance is finalised to gather views and
      expertise; or once it is finalised for training purposes.

    • Revised consolidated 3-year work plan for the Methodology Working Party (MWP)
      EMA/CHMP/58124/2023

      Page 14/14

TUKYSA® (tucatinib) in Combination with Antibody-Drug Conjugate ado-Trastuzumab Emtansine Improves Progression-Free Survival in Patients with Previously Treated HER2-Positive Metastatic Breast Cancer

Retrieved on: 
Wednesday, December 6, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Genetics, Clinical Trials, Capecitabine, Trastuzumab, Senior, Food, Progression-free survival, RECIST, National Comprehensive Cancer Network, Tablet, Breast cancer, Brain, Taxane, Patient, Research and development, PFS, Corr, Division, FDA, Hematology, University, Development, HR, Tucatinib, HER2, Inc., Confidence interval, News, Professor, HIV disease progression rates, Medical imaging, Medicinal plants, Seagen

Seagen Inc. (Nasdaq: SGEN) today announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®).

Key Points: 
  • Seagen Inc. (Nasdaq: SGEN) today announced data from the Phase 3 HER2CLIMB-02 clinical trial of TUKYSA® (tucatinib) in combination with the antibody-drug conjugate ado-trastuzumab emtansine (Kadcyla®).
  • The combination showed a statistically significant improvement in progression-free survival (PFS), the study’s primary endpoint, in patients with unresectable locally advanced or metastatic human epidermal growth factor receptor 2-positive (HER2-positive) breast cancer who had been previously treated with trastuzumab and a taxane, compared to those who received placebo plus ado-trastuzumab emtansine.
  • Discontinuations due to adverse events were more common in the combination arm of the trial, but no new safety signals were observed for the combination.
  • Please see Important Safety Information at the end of this news release for TUKYSA (tucatinib) tablets.

Jazz Pharmaceuticals Presents Updated Phase 2a Data at SABCS 2023 Showcasing Potential of Zanidatamab in HER2+/HR+ Metastatic Breast Cancer

Retrieved on: 
Friday, December 8, 2023
Trastuzumab, Research, Progression-free survival, RECIST, Fulvestrant, Breast cancer, Jazz Pharmaceuticals, Patient, PFS, Part, Corr, DOR, MBC, DCR, Pertuzumab, HER2, Cancer, Vall d'Hebron University Hospital, BS 5839 Part 1, Metastasis, HR, Pharmaceutical industry, Medical imaging, MD

DUBLIN, Dec. 8, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive (HER2+)/HR-positive (HR+) metastatic breast cancer (mBC) as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • DUBLIN, Dec. 8, 2023 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive (HER2+)/HR-positive (HR+) metastatic breast cancer (mBC) as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • Patients treated with the combination regimen received a median of four prior systemic regimens in the metastatic setting (range, 1-12).
  • Recommended doses of the zanidatamab plus palbociclib and fulvestrant combination therapy were determined in Part 1 of the study.
  • Patients treated with the combination regimen achieved a cORR of 35% and DCR of 91%.

Innovent Presents Clinical Data Update of IBI351 (KRAS G12C Inhibitor) Monotherapy in Lung Cancer and Colorectal Cancer at ESMO Asia Congress 2023

Retrieved on: 
Friday, December 1, 2023
NDA, National Medical Products Administration, Principal, Priority review, Trae tha Truth, Ophthalmology, Dor, Safety, HKEX, Senior, Colorectal cancer, CRC, NMPA, Patient, PFS, Weakness, Corr, FDA, Lung cancer, LBA, IRRC, DCR, New Drug Application, Ceylonosticta anamia, ORR, Trial of the century, Cancer, Anemia, Congress, OS, Mutation, Itch, Hospital, NSCLC, Pharmaceutical industry, Palladium, Phosphorus

As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:

Key Points: 
  • As data cutoff date (June 13, 2023), a total of 116 NSCLC subjects were enrolled and evaluable:
    IBI351 demonstrated encouraging antitumor activity.
  • IBI351 as a selective covalent irreversible KRAS G12C inhibitor, its monotherapy has demonstrated outstanding efficacy and manageable safety in advanced colorectal cancer with KRAS G12C mutation.
  • Dr. Hui Zhou, Senior Vice President of Innovent, stated: "We are pleased to present our clinical development updates at the 2023 ESMO Asia Congress.
  • We will continue to explore the clinical development of IBI351 monotherapy and combination therapy in the fields of lung cancer, colorectal cancer and other solid tumors to benefit more cancer patients ."

Immatics Reports Interim Clinical Data from ACTengine® IMA203 and IMA203CD8 TCR-T Monotherapies Targeting PRAME in an Ongoing Phase 1 Trial

Retrieved on: 
Wednesday, November 8, 2023
Patient, FDA, Research, Pharmacology, Uveal melanoma, Regenerative Medicine Advanced Therapy, Uterine cancer, NSCLC, International Congress on Tuberculosis, Corr, Cmax, Ovarian cancer, Nivolumab, Infrared spectroscopy correlation table, TCR, Appendix, CMC, Neurotoxicity, Lung, SD, DLT, Cytokine release syndrome, Melanoma, ORR, Cell therapy, Triple-negative breast cancer, CET, PRAME, Safety, CRS, Society, Melanoma Research, Diagnosis, Today, Cytopenia, BRAF, Pharmaceutical industry, Vaccine, Medical imaging, MD

The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.

Key Points: 
  • The update is focused on IMA203 GEN1 in melanoma at the recently defined recommended Phase 2 dose (RP2D) and the first clinical data for IMA203CD8 GEN2.
  • In line with previous results, IMA203 GEN1 monotherapy was well tolerated at total doses up to 10x109 TCR-T cells infused.
  • The presentation is available on Immatics’ website – covering the complete data set including Phase 1a, Phase 1b Cohort A and the deprioritized Cohort B (IMA203 GEN1 combined with nivolumab).
  • Discussions with FDA to align on patient populations, trial design and CMC aspects concerning the planned Phase 2 trial are ongoing.

Arcus Biosciences Reports Third Quarter 2023 Financial Results and Provides a Pipeline Update

Retrieved on: 
Tuesday, November 7, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, GI, Corr, NYSE, TIGIT, PD-1, Society, Lung, Cancer, TAP, Annual general meeting, Pancreatic cancer, ORR, CD73, Patient, OS, ASCO, Pharmaceutical industry

Financial Results for Third Quarter 2023:

Key Points: 
  • Financial Results for Third Quarter 2023:
    Cash, Cash Equivalents and Marketable Securities were $950 million as of September 30, 2023, compared to $1.1 billion as of December 31, 2022.
  • Revenues were $32 million for the third quarter 2023, compared to $33 million for the same period in 2022.
  • For third quarter 2023 and 2022, Arcus recognized reimbursements of $33 million and $41 million, respectively, for shared expenses from its collaborations, primarily the Gilead collaboration.
  • Net Loss was $71 million for the third quarter 2023, compared to $65 million for the same period in 2022.

LianBio Announces Presentation of Data from Phase 2a Study of Infigratinib in Patients with Gastric Cancer at ESMO Congress 2023

Retrieved on: 
Wednesday, October 25, 2023
Gene amplification, Corr, Stomach, NMPA, ESMO, Trae tha Truth, FGFR2, ATP, DOR, DCR, MOS, FGFR, Congress, Safety, National Medical Products Administration, Disease, Oncology, Hepatotoxicity, RECIST, European Society for Medical Oncology, GC, GEJ, Death, Pharmaceutical industry, Patient

1527P)

Key Points: 
  • 1527P)
    The study enrolled 21 GC and GEJ patients with FGFR2 gene amplification.
  • Among 20 evaluable patients who had post-baseline assessments, cORR was 25.0% (95% CI: 8.7–49.1) and DCR was 80.0% (95% CI: 56.3–94.3).
  • “China has an acute need for new effective treatment options as there is a disproportionately higher number of patients with gastric cancer in the region.”
    FGFR pathway aberrations are common in multiple cancer types, including gastric cancer.
  • Infigratinib received Breakthrough Therapy Designation from the China National Medical Products Administration (NMPA) for the treatment of gastric cancer.

AnHeart Therapeutics’ Investigational Medicine Taletrectinib Shrank Tumors in More Than 90 Percent of People With ROS1-Positive Non-Small Cell Lung Cancer Who Were ROS1 TKI Naïve in Global Pivotal TRUST-II Trial

Retrieved on: 
Saturday, October 21, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, TKI, ROS1, NSCLC, Corr, Journal of Thoracic Oncology, NMPA, Food, Lung cancer, Dizziness, National Medical Products Administration, Doctor of Philosophy, Incidence, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Lung, Disease, Medicine, Interim, Brain, European Society of Gynaecological Oncology, Cancer, Patient, IRC, Pharmaceutical industry

Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).

Key Points: 
  • Taletrectinib shrank tumors in 57% of patients who had previously been treated with a ROS1 TKI (TKI pre-treated).
  • Taletrectinib also showed robust intracranial activity in the subgroup of patients with disease that had spread to the brain.
  • Median progression-free survival (IRC-assessed) was not reached for TKI naïve patients and was 11.7 months for TKI pre-treated patients, respectively.
  • In both trials, taletrectinib shrank tumors in almost every ROS1 TKI naïve person and more than half of people previously treated with a ROS1 TKI, and the responses were durable.