Bayer to Present New Data from Evolving Oncology Portfolio at ESMO 2020

  • Long-term efficacy and safety results of an integrated data set for Vitrakvi® (larotrectinib), as well as sub-analyses, to be presented in poster sessions
  • Tolerability and treatment response data from the Phase III ARAMIS trial investigating NUBEQA® (darolutamide) in men with non-metastatic castration-resistant prostate cancer (nmCRPC)
  • Continued research to explore potential of marketed products, evaluating the investigational use of Stivarga® (regorafenib) and Xofigo® (radium Ra 223 dichloride) in combination with immunotherapies 

Posters: 1955P, 1916P, 1289P, 542P, 604TiP, 132P, 633P, 694TiP, 631P, LBA68, 990P, 465P, 1010P, 1009P, 829P, 1918P, 1420TiP, 637P, 639P

San Francisco, California (UroToday.com) Data from Bayer’s evolving oncology portfolio will be presented at the ESMO Virtual Congress 2020, taking place on September 19-21, 2020. Presentations will highlight therapies from Bayer that evaluate patient outcomes as well as safety and efficacy in different tumor types. Other presentations include investigational use of therapies in combination with immunotherapies. Information on the registration as well as the virtual scientific program can be found here.


Updated efficacy and continued safety data with longer follow-up for Vitrakvi® (larotrectinib) from an integrated set of adult and pediatric patients with tropomyosin receptor kinase (TRK) fusion cancer will be presented. In addition, new efficacy and safety analyses in patients with lung and thyroid cancers harboring neurotrophic receptor tyrosine kinase (NTRK) gene fusions, as well as a growth modulation index study evaluating larotrectinib compared to prior systemic treatments will be shared at the meeting.

Vitrakvi is approved in the U.S., Canada, Brazil, and the European Union (EU). Vitrakvi is approved in the U.S. for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Additional filings in other regions are underway or planned.

New findings from the Phase III ARAMIS trial highlighting the treatment response and tolerability data of NUBEQA® (darolutamide) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) will be presented. Information on a Phase III trial in progress evaluating the addition of darolutamide to androgen deprivation therapy and definitive or salvage radiation in men with high-risk prostate cancer will also be shared at this congress.

Final results from the Nexavar® (sorafenib) RIFTOS MKI study, evaluating the use of multikinase inhibitors (MKIs) for the treatment of patients with asymptomatic radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC) will be shared at the meeting. Additional research on investigational uses of Bayer’s established products in combination with immuno-oncology (IO) approaches, including Stivarga® (regorafenib) and Xofigo® (radium Ra 223 dichloride), for first-line treatment of advanced hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC) respectively, will be presented at the meeting.’

Notable presentations at the ESMO Virtual Congress 2020 are listed below. Abstracts accepted as posters (P) or Trial in Progress (TiP) will be available online beginning September 14, 2020, at 00:05 CEST / September 13, 2020, at 6:05 PM ET, and full presentations will be available online from September 17-21, 2020.

Larotrectinib
  • Survival benefits of larotrectinib in an integrated dataset of patients with TRK fusion cancer
    • Session: Translational Research (Agnostic)
    • Poster: 1955P
  • Larotrectinib treatment of advanced TRK fusion thyroid cancer
    • Session: Thyroid Cancer
    • Poster: 1916P
  • Efficacy and safety of larotrectinib in patients with tropomyosin receptor kinase (TRK) fusion lung cancer
    • Session: NSCLC, Metastatic
    • Poster: 1289P
  • Growth modulation index (GMI) of larotrectinib versus prior systemic treatments in patients with tropomyosin receptor kinase (TRK) fusion cancer
    • Session: Developmental Therapeutics
    • Poster: 542P
  • The “ON-TRK”: a non-interventional study of larotrectinib in patients with TRK fusion cancer – Trial in Progress
    • Session: Developmental Therapeutics
    • Poster: 604TiP
  • TRKing PTC patients: NTRK gene fusion frequency and clinical characteristics of a Finnish papillary thyroid cancer cohort
    • Session: Biomarkers (Agnostic)
    • Poster: 132P

Darolutamide
  • Tolerability and treatment response to darolutamide (DARO) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) in the phase 3 ARAMIS trial
    • Session: Genitourinary Tumours, Prostate
    • Poster: 633P
  • DASL-HiCaP: Darolutamide And Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801). A randomised phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation –Trial in Progress
    • Session: Genitourinary Tumours, Prostate
    • Poster: 694TiP
  • Darolutamide (D), enzalutamide (E) and apalutamide (A), the risk of adverse events (Aes) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC): Number Needed to Harm (NNH)
    • Session: Genitourinary Tumours, Prostate
    • Poster: 631P

Regorafenib
  • Results of the randomized, placebo (PL)-controlled phase II study evaluating the efficacy and safety of regorafenib (REG) in patients (pts) with metastatic relapsed Ewing sarcoma (ES), on behalf of the French Sarcoma Group (FSG) and Unicancer – Investigator-Initiated Research (IIR)
    • Session: Proffered Paper – Sarcoma
    • Late-Breaking Abstract: LBA68
  • Updated results of a phase 1b study of regorafenib (REG) plus pembrolizumab (PEMBRO) for first-line treatment of advanced hepatocellular carcinoma (HCC)
    • Session: Hepatocellular Carcinoma
    • Poster: 990P
  • Single nucleotide polymorphism (SNP) analysis identifies potential prognostic and predictive biomarker in patients (pts) with metastatic colorectal cancer (mCRC) treated with regorafenib in the phase III CORRECT trial
    • Session: Colorectal Cancer
    • Poster: 465P
  • Real-world dosing of regorafenib (REG) in patients (pts) with unresectable hepatocellular carcinoma (uHCC): Interim analysis (IA) of the observational REFINE study
    • Session: Hepatocellular Carcinoma
    • Poster: 1010P
  • Regorafenib in patients (pts) with unresectable hepatocellular carcinoma (uHCC) in real-world practice in Asia: Interim results from the observational REFINE study
    • Session: Hepatocellular Carcinoma
    • Poster: 1009P
  • Regorafenib (R) or Tamoxifen (T) for platinum-sensitive recurrent ovarian cancer (PSROC) with rising CA125 and no evidence of clinical or radiological disease progression: a GINECO randomized phase II trial
    • Session: Gynaecological Cancers
    • Poster: 829P

Sorafenib
  • Final analysis of RIFTOS MKI, a global, non-interventional study assessing the use of multikinase inhibitors (MKIs) for the treatment of patients with asymptomatic radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC)
    • Session: Thyroid Cancer
    • Poster: 1918P 

Radium Ra 223 dichloride
  • A phase 1/2 trial of radium-223 (Ra-223) in combination with pembrolizumab in patients (pts) with stage IV non-small cell lung cancer (NSCLC) ​– Trial in Progress
    • Session: NSCLC, Metastatic
    • Poster: 1420TiP
  • The prognostic value of the baseline neutrophil-to-lymphocyte ratio (NLR) in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving radium-223 (Ra-223): a post-hoc analysis of the ALSYMPCA Phase-III trial​ – Investigator-Initiated Research (IIR)
    • Session: Genitourinary Tumours, Prostate
    • Poster: 637P
  • 223Ra in asymptomatic patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) who progressed to 1st line abiraterone acetate or enzalutamide – Investigator-Initiated Research (IIR) ​
    • Session: Genitourinary Tumours, Prostate
    • Poster: 639P

Source: WIRE, BUSINESS. 2020. "Bayer To Showcase New Data From Evolving Oncology Portfolio At ESMO Virtual Congress 2020". Businesswire.Com


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