Bayer to Present Key Data Across Oncology Portfolio Showcasing Significant Advances in Cancer Care at 2022 ASCO Annual Meeting

  • Prostate cancer remains a key focus area with NUBEQA® (darolutamide) investigational data in non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), and Xofigo® (radium Ra 223 dichloride) research in metastatic castration-resistant prostate cancer (mCRPC)
  • Presentations of Vitrakvi® (larotrectinib) include long-term efficacy and safety data for patients with TRK fusion cancer from integrated and expanded analyses, updated health-related quality of life (QoL) of patients with TRK fusion cancer and sub-analyses for TRK fusion cancer patients with primary central nervous system (CNS) tumors and lung cancer, respectively
  • Investigator-initiated research (IIR) featuring Stivarga® (regorafenib) and Nexavar® (sorafenib) will also be displayed
Abstracts: 5078, 5044, TPS5111, 5038, 5040, 5041, 10030, 3100, 9024, 2010, 6563, 6597, 10006, 4060, 3561, TPS11585, 4125, 11555, 12040

Reno, Nevada (UroToday.com) -- Bayer will present new data across its oncology portfolio at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7, 2022. These presentations continue to reinforce Bayer’s position as an innovator in oncology and ongoing dedication to advancing oncology treatments for patients on a global scale.

NUBEQA® (darolutamide) data presented will include overall survival (OS) and prostate-specific antigen (PSA) results from the investigational Phase III ARASENS trial in metastatic hormone-sensitive prostate cancer (mHSPC) and results of a post-hoc analysis from the Phase III ARAMIS trial in non-metastatic castration-resistant prostate cancer (nmCRPC). NUBEQA is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. NUBEQA is indicated in the U.S. for the treatment of men with nmCRPC.1 The U.S. Food and Drug Administration (FDA) has recently accepted a supplemental New Drug Application (sNDA) and granted Priority Review for NUBEQA in combination with docetaxel for the treatment of mHSPC.

Research on Xofigo® (radium Ra 223 dichloride) will also be highlighted, including results from an interim analysis of the RALU study, which evaluated safety and survival outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with lutetium-177-prostate-specific membrane antigen (177Lu-PSMA) after Xofigo. Additionally, alkaline phosphatase (ALP) decline and OS data in mCRPC patients treated with Xofigo in the REASSURE study will be presented. Xofigo is indicated for the treatment of patients with mCRPC, symptomatic bone metastases, and no known visceral metastatic disease.2

Efficacy and safety findings of Vitrakvi® (larotrectinib) for patients with TRK fusion cancer from an integrated pooled analysis per an independent review committee (IRC) assessment, efficacy and safety data from an expanded dataset, updated health-related quality of life (QoL) of adult and pediatric patients with TRK fusion cancer, and sub-analyses for TRK fusion cancer patients with primary central nervous system (CNS) tumors and lung cancer, respectively, will be shared. Additional data for Vitrakvi include an analysis in adult and pediatric patients evaluating Vitrakvi compared to standard of care using a matching-adjusted indirect comparison (MAIC). MAIC is an alternative method for comparative data when a randomized control trial (RCT) is not available and/or possible, as for a rare condition like TRK fusion cancer.3 Results from these studies further support Vitrakvi’s existing clinical profile in TRK fusion cancer across a variety of tumor types and ages. Vitrakvi is approved for the treatment of adult and pediatric patients with solid tumors that have a 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. Patients should be selected for therapy based on a Food and Drug Administration (FDA)-approved test. This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.4

Other research includes investigator-initiated research (IIR) for Stivarga® (regorafenib) and Nexavar® (sorafenib) in several areas of oncology.

Presentations from Bayer projects for the 2022 ASCO Annual Meeting are listed below:

Darolutamide
  • Abstract title: Association of prostate-specific antigen (PSA) response and overall survival (OS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase 3 ARASENS trial
    • Abstract 5078; June 6, 2:15pm EDT
  • Abstract title: Progression patterns by types of metastatic spread, prostate-specific antigen (PSA), and clinical symptoms: Post-hoc analyses of ARAMIS
    • Abstract 5044; June 6, 2:15pm EDT
  • Abstract title: Open-label study of androgen receptor inhibition with darolutamide plus androgen-deprivation therapy (ADT) versus ADT in men with metastatic hormone-sensitive prostate cancer using an external control arm (ARASEC) – Trial in Progress (TiP)
    • Abstract TPS5111; June 6, 2:15pm EDT
  • Abstract title: Influence of darolutamide on cabazitaxel systemic exposure – Investigator-Initiated Research (IIR)
    • Abstract 5038; June 6, 2:15pm EDT
Radium-223 dichloride (Ra-223)
  • Abstract title: Safety and survival outcomes in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with lutetium-177-prostate-specific membrane antigen (177Lu-PSMA) after radium-223 (223Ra): Interim analysis of the RALU study
    • Abstract 5040; June 6, 2:15pm EDT
  • Abstract title: Alkaline phosphatase (ALP) decline and overall survival (OS) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated with radium-223 (Ra-223) in the REASSURE Study
    • Abstract 5041; June 6, 2:15pm EDT
Larotrectinib
  • Abstract title:Efficacy and safety of larotrectinib in pediatric patients with tropomyosin receptor kinase (TRK) fusion-positive cancer: An expanded dataset
    • Abstract 10030; June 6, 9:00am EDT
  • Abstract title:Long-term efficacy and safety of larotrectinib in a pooled analysis of patients with tropomyosin receptor kinase (TRK) fusion cancer
    • Abstract 3100; June 5, 9:00am EDT
  • Abstract title:Updated efficacy and safety of larotrectinib in patients with tropomyosin receptor kinase (TRK) fusion lung cancer
    • Abstract 9024; June 6, 2:15pm EDT
  • Abstract title:Long-term control and safety of larotrectinib in a cohort of adult and pediatric patients with tropomyosin receptor kinase (TRK) fusion primary central nervous system (CNS) tumors
    • Abstract 2010; June 5, 12:30pm EDT
  • Abstract title: Updated health-related quality of life of patients with TRK-fusion cancer treated with larotrectinib in clinical trials
    • Abstract 6563; June 6, 2:15pm EDT
  • Abstract title: Overall survival (OS) of patients with TRK fusion-positive cancer receiving larotrectinib versus standard of care (SoC): A matching-adjusted indirect comparison (MAIC) using real-world data (RWD)
    • Abstract 6597; June 6, 2:15pm EDT
  • Abstract title: Securing access to innovative anticancer therapies for children, adolescents and young adults outside clinical trials: The SACHA study of the French Society of Pediatric Oncology (SFCE) – Investigator-Initiated Research (IIR)
    • Abstract 10006; June 6, 5:36pm EDT
Regorafenib
  • Abstract title: REGOMUNE: A phase II study of regorafenib plus avelumab in solid tumors—Results of the oesophageal or gastric carcinoma (OGC) cohort – Investigator-Initiated Research (IIR)
    • Abstract 4060; June 4, 9:00am EDT
  • Abstract title: Regorafenib (REGO) plus FOLFIRINOX as frontline treatment in patients (pts) with RAS-mutated metastatic colorectal cancer (mCRC): A phase I/II, dose-escalation and dose-expansion study – Investigator-Initiated Research (IIR)
    • Abstract 3561; June 4, 9:00am EDT
  • Abstract title: REGOMAIN: A randomized, placebo-controlled, double-blinded, multicenter, comparative phase II study of the efficacy of regorafenib as maintenance treatment in patients (pts) with high-grade bone sarcomas (HGBS) at diagnosis or relapse and without complete remission after standard treatment – Investigator-Initiated Research (IIR); Trial in Progress (TiP)
    • Abstract TPS11585; June 5, 9:00am EDT
  • Abstract title: REGOMUNE: Phase II study of regorafenib plus avelumab in solid tumors—Results of the gastroenteropancreatic neuroendocrine carcinomas (GEP-NEC) cohort – Investigator-Initiated Research (IIR)
    • Abstract 4125; June 4, 9:00am EDT
  • Abstract title: Activity of regorafenib in patients with non-adipocytic soft tissue sarcoma (NASTS): Evaluation of heterogeneity of treatment effect on the updated analysis of pooled cohorts – Investigator-Initiated Research (IIR)
    • Abstract 11555; June 5, 9:00am EDT
Sorafenib
  • Abstract title: Deficit Accumulation Frailty Index (DAFI) scores and acute myeloid leukemia outcomes – Investigator-Initiated Research (IIR)
    • Abstract 12040; June 4, 2:15pm EDT 
Source: WIRE, BUSINESS. 2022. "Bayer To Present Key Data Across Oncology Portfolio Showcasing Significant Advances In Cancer Care At 2022 ASCO Annual Meeting". Businesswire.Com.
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