Taxane

Ovarian Cancer Opportunity Assessment and Forecast Report 2024: Sales of ImmunoGen's Elahere Represent the Most Impactful Driver of Growth - ResearchAndMarkets.com

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Mercoledì, Aprile 10, 2024
Genetics, Health, Oncology, Cancer, Ovarian cancer, Taxane, PBF, Risk, PARP, Recurrence, Bevacizumab, Gemcitabine, ICIS, Therapy, Patent, Patient, WMH, ImmunoGen, Mirvetuximab soravtansine, VEGF, Growth, Pharmaceutical industry

This report includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 7MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for Ovarian Cancer.

Key Points: 
  • This report includes an assessment of the disease epidemiology and 10-year patient-based forecast (PBF) across the 7MM for marketed and late-stage pipeline therapies, with a launch date assessment by market for Ovarian Cancer.
  • Ovarian cancer patients generally respond well to platinum-based chemotherapy and achieve complete remission in the initial setting.
  • Major drivers of growth in the Ovarian Cancer market across the 7MM over the forecast period include the following:
    The sales of ImmunoGen's Elahere represent the most impactful driver of growth for the ovarian cancer market.
  • Voluntary withdrawals and generic erosion upon the patent expiries of the PARP inhibitors will temper sales growth during the forecast period in the ovarian cancer market.

Cellworks Personalized Therapy Biosimulation Study Produces Superior OS and DFS Predictions for Gastroesophageal Cancer Patients

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Lunedì, Marzo 11, 2024
Technology, Biotechnology, Health, Other Health, Pharmaceutical, Oncology, Research, Software, General Health, Genetics, Health Technology, Science, Data Management, Clinical Trials, Biopsy, OS, HER2, Cancer, Radiation, Kingdom of Poland, Anthracycline, Survival, Disease, Neoadjuvant therapy, CBM, International Cancer Genome Consortium, TNM, University, Patient, Rated R, NGS, Biomarker, MSI, Artificial intelligence, Standard of care, DFS, TRI, MD, Medicine, TRG, Platinum, Publication, Biosimulation, OGA, Whole genome sequencing, PD-L1, Taxane, Medical imaging

The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).

Key Points: 
  • The study also showed a significant association between a patient’s TRI score and disease-free survival (DFS) and tumor regression grade (TRG).
  • Despite progress in gastroesophageal cancer therapy, only a small proportion of patients attain long-term survival.
  • This study concluded that TRI scores for gastroesophageal adenocarcinoma patients predict OS and DFS beyond clinical factors.
  • These results highlight the clinical value of employing Cellworks biosimulation for personalized therapy selection and warrant additional clinical evaluation.

Agendia Presents Data at Miami Breast 2024 Demonstrating MammaPrint® + BluePrint®’s Ability to Further Stratify Tumor Categories in Hormone-Positive Breast Cancer, Highlighting Response to Different Chemotherapy Regimens

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Venerdì, Marzo 8, 2024
Research, Genetics, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, Gene expression profiling, Breast cancer, Neoplasm, Taxane, Woman, Transcriptome, MD, MBCC, Cyclophosphamide, Anthracycline, PCR, MammaPrint, Risk, Conference, Symantec Endpoint Protection, AC-T, Patient, MP, Diagnosis, Triple-negative breast cancer, Blueprint, TC, Medical imaging

The first poster, titled MammaPrint® and BluePrint® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.

Key Points: 
  • The first poster, titled MammaPrint® and BluePrint® predict anthracycline chemosensitivity in patients with HR+HER2-early-stage breast cancer enrolled in FLEX, (Audeh, W., et al.
  • ), investigates the associations between MammaPrint and BluePrint classifications, therapy regimen, and the likelihood of achieving a pathologic Complete Response (pCR).
  • The second poster, titled Prediction of chemotherapy benefit by MammaPrint® in patients with HR+HER2-early-stage breast cancer from real-world evidence studies (Audeh, W., et al.
  • Taken together, these findings indicate the utility of MammaPrint to predict neoadjuvant and adjuvant chemotherapy benefit in this patient population.

Orion and MSD Announce Initiation of Two Phase 3 Trials Evaluating ODM-208/MK5684 in Certain Patients with Metastatic Castration-Resistant Prostate Cancer

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Venerdì, Gennaio 5, 2024
MSD, Patient, CYP11A1, Orion, HRT, Hormone replacement therapy, Prostate cancer, Orion Corporation, Merck & Co., Research, Corporation, Merck, OS, Taxane, Development, Senior, Pharmaceutical industry

Orion Corporation (“Orion”) and MSD (known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada) have initiated two pivotal Phase 3 clinical trials evaluating ODM-208/MK5684, an investigational CYP11A1 inhibitor, in combination with hormone replacement therapy (HRT), for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).

Key Points: 
  • Orion Corporation (“Orion”) and MSD (known as Merck & Co., Inc., Rahway, N.J., USA in the United States and Canada) have initiated two pivotal Phase 3 clinical trials evaluating ODM-208/MK5684, an investigational CYP11A1 inhibitor, in combination with hormone replacement therapy (HRT), for the treatment of certain patients with metastatic castration-resistant prostate cancer (mCRPC).
  • Patients are now enrolling in the trials, named OMAHA1 (NCT06136624) and OMAHA2a (NCT06136650).
  • The primary endpoints are overall survival (OS) and radiographic progression-free survival (rPFS) by AR LBD mutation status.
  • Secondary endpoints include time to first subsequent therapy (TFST), objective response rate (ORR) and duration of response (DOR).

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

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Martedì, Gennaio 2, 2024
Marketing, Platinum, Artery, INN, HER2, Histology, Hypertension, Cancer, Neoplasm, Anatomy, Paclitaxel, IIA, Diarrhea, Breast, Fatigue, Breast cancer, ATC, Embolism, Bleeding, VEGF, Weakness, Abdomen, Capecitabine, Pregnancy, Human, Safety, Gynaecology, NSCLC, Patient, Medical Subject Headings, Peritoneum, EGFR, Carboplatin, International, FIGO, Nutrient, Language, Blood, Cisplatin, Rectum, Oxygen, Anthracycline, Select, Ovary, Lung cancer, Allergy, Recurrence, European Medicines Agency, Growth, Doxorubicin, Taxane

Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Vegzelma, bevacizumab, Date of authorisation: 17/08/2022, Revision: 5, Status: Authorised

G1 Therapeutics Presents New Post Hoc Analyses Indicating That Patients Who Previously Received Trilaciclib Have Improved Overall Survival with Subsequent Anticancer Therapy

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Martedì, Dicembre 5, 2023
Patient, TNBC, Survival, Tumor microenvironment, Neoplasm, CD8, Immune system, Death, Bone marrow, Gemcitabine, G1 Therapeutics, PD-1, Trilaciclib, Carboplatin, Progression-free survival, Mouse, Therapy, Metastasis, Capecitabine, Poster, SACT, CDK, OS, Taxane, PFS, Pharmaceutical industry

RESEARCH TRIANGLE PARK, N.C., Dec. 05, 2023 (GLOBE NEWSWIRE) -- G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, today announced the presentation of new data describing the long-term positive survival impact of previous treatment with trilaciclib and cytotoxic chemotherapy (gemcitabine/carboplatin; GCb) in patients with metastatic triple negative breast cancer (mTNBC) who participated in G1’s Phase 2 trial (NCT02978716). The poster is being presented at the 2023 San Antonio Breast Cancer Symposium (SABCS), held December 5th to 9th in San Antonio, TX, and is available on the G1 Therapeutics website here.

Key Points: 
  • Administering trilaciclib with cytotoxic chemotherapy also led to improved survival in patients unable to receive SACT.
  • “These new analyses indicate that trilaciclib can protect the bone marrow and immune system against the harmful effects of cytotoxic therapy, leading to significantly improved survival outcomes among patients who receive subsequent anticancer therapies,” said Raj Malik, M.D., Chief Medical Officer at G1 Therapeutics.
  • After a median follow-up of 12.7 months on study, deaths were observed in 22/43 patients in the trilaciclib plus GCb group and 17/20 patients in the GCb-only group (no trilaciclib).
  • Median time on treatment was 5.5 months in the trilaciclib plus GCb group and 3.3 months in the GCb-only group.

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

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Mercoledì, Dicembre 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.

BioXcel Therapeutics Reports Positive Overall Survival Results from Single-Arm, Open-Label Phase 2 Trial of BXCL701 in Patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) of Adenocarcinoma Phenotype

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Mercoledì, Novembre 8, 2023
Adenocarcinoma, FDA, Intelligence, Taxane, Progression-free survival, Trial of the century, MCRPC, Lymph, Pembrolizumab, Data, Prostate cancer, Liver, BID, Phenotype, Disease, Rectum, Neoplasm, Partnership, Histology, September 6, RECIST, Tumor microenvironment, Safety, SCNC, Therapy, Patient, OS, CTC, Pharmaceutical industry, HAVEN

NEW HAVEN, Conn., Nov. 08, 2023 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced positive overall survival (OS) data from its Phase 2 trial of BXCL701, the Company's investigational oral innate immune activator, in combination with KEYTRUDA® (pembrolizumab) in patients with metastatic castration-resistant prostate cancer (mCRPC) of adenocarcinoma phenotype, the most common form of the disease. As of a September 6, 2023 data cutoff, evaluable patients with adenocarcinoma (n=29) showed a median OS of 15.5 months (95% CI 9.6–NR), and a 12-month survival rate of 59%.

Key Points: 
  • As of a September 6, 2023 data cutoff, evaluable patients with adenocarcinoma (n=29) showed a median OS of 15.5 months (95% CI 9.6–NR), and a 12-month survival rate of 59%.
  • “Therefore, we are highly encouraged by these combination data bearing in mind historical data with checkpoint inhibitor monotherapy.
  • Approximately 80% of mCRPC cases are of the adenocarcinoma phenotype, which represent approximately 46,128 patients.
  • The Company is continuing to actively evaluate strategic options for OnkosXcel Therapeutics, including potential financing, strategic partnership, or M&A.

Fulgent Shares Data from Two Poster Presentations at SITC 2023 Annual Meeting

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Venerdì, Novembre 3, 2023
Technology, Genetics, Health Technology, Software, Biotechnology, Health, Pharmaceutical, General Health, Oncology, SNV, Taxane, Plasma, Stomach, Paclitaxel, Bladder cancer, Research, Cancer, Poster, HNSCC, Pharmacokinetics, SITC, Immunotherapy, Drug discovery, Biopsy, Annual general meeting, Head and neck cancer, RECIST, Biliary tract, Society, Therapy, Liquid biopsy, Patient, Neoplasm, Prostate, PR, Pharmaceutical industry, Medical imaging, Illumina

Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.

Key Points: 
  • Fulgent Genetics, Inc. (NASDAQ: FLGT) (“Fulgent” or the “Company”), a technology-based company with a well-established clinical diagnostic business and a therapeutic development business, today announced data from two poster presentations being presented tomorrow, November 4, 2023, at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting in San Diego, CA.
  • The study calls for the involvement of certified labs, highlighting the need for stringent quality management and regulatory alignment.
  • The poster titled, “FID-007: Nanoencapsulated Paclitaxel Derived from a Novel Nano-Drug Delivery Platform,” highlights progress for Fulgent Pharma’s lead therapeutic oncology candidate, FID-007, in various cancers.
  • Preliminary clinical data suggests FID-007 may have anti-tumor activity in heavily pre-treated patients across various tumor types.

Ambrx Announces ARX517, a PSMA-Targeted ADC, Demonstrates a Promising 52% PSA50 (≥50% Reduction) and a Highly Differentiated Safety and PK Profile in Patients with mCRPC, who Progressed on Multiple FDA-Approved Treatments

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Lunedì, Ottobre 23, 2023
Patient, FDA, Șaeș, Lymphocytopenia, Taxane, PSA, ESMO, Trae Elston, Infrared spectroscopy correlation table, Congress, HIV disease progression rates, Prostate cancer, Poster, ADC, Clinical trial, PK, Oncology, Immunotherapy, Serum, RECIST, UCLA, Safety, European Society for Medical Oncology, PSMA, Neoplasm, SAN, Pharmaceutical industry, Vaccine, Nursing, Generic drug, Airline

SAN DIEGO, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that in biomarker unselected patients ARX517 monotherapy demonstrated a strong antibody-drug conjugate (ADC) safety profile at all doses tested with promising early efficacy signals that included PSA50 declines, ctDNA reductions, and RECIST v1.1 tumor response. The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 (NCT04662580).   Posters were made available as part of the 2023 European Society for Medical Oncology (ESMO) Congress 2023 meeting, taking place in Madrid, Spain, October 20-24, 2023, and are summarized below.

Key Points: 
  • The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 ( NCT04662580 ).
  • APEX-01 is a Phase 1 / 2, first-in-human, open label dose escalation and dose expansion trial enrolling patients with metastatic castration-resistant prostate cancer (mCRPC).
  • APEX-01 opened for enrollment in July 2021 and is the only on-going clinical trial in the United States targeting PSMA with an ADC.
  • The two primary objectives of APEX-01 are to analyze the safety and tolerability of ARX517 and establish a recommended Phase 2 dose.