- Bayer remains focused on prostate cancer care with NUBEQA® (darolutamide) data in non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic hormone-sensitive prostate cancer (mHSPC), and Xofigo® (radium Ra 223 dichloride) data in metastatic castration-resistant prostate cancer (mCRPC)
- Continuing to spotlight precision oncology efforts with Vitrakvi® (larotrectinib), a post-hoc subgroup analysis and efficacy and safety data from the expanded data set will be presented at the meeting in patients with TRK fusion lung and thyroid cancer, in addition to data from investigator-initiated research in pediatric patients with newly diagnosed infantile fibrosarcoma (IFS)
Reno, Nevada (UroToday.com) -- Bayer will highlight scientific research in oncology at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from June 2-6, 2023. These presentations continue to underscore the company’s commitment to drive treatment approaches through science and innovation in the oncology space.
Data featuring NUBEQA® (darolutamide) and Xofigo® (radium Ra 223 dichloride) will be showcased at ASCO. NUBEQA data includes results from the DEAR trial, a retrospective, observational study evaluating real-world evidence (RWE) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC). Additionally, investigational NUBEQA data includes ARASEC, an ongoing U.S.-based open-label study evaluating NUBEQA versus androgen deprivation therapy (ADT), as well as ARAMON, an ongoing, randomized open-label Phase II study on serum testosterone levels in patients with hormone-naive prostate cancer, will be featured. NUBEQA is currently indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients with nmCRPC.1
Real-world safety and effectiveness data from the prospective, observational REASSURE study involving patients with metastatic castration-resistant prostate cancer (mCRPC) treated with Xofigo will also be presented. Xofigo is indicated for the treatment of patients with mCRPC, symptomatic bone metastases, and no known visceral metastatic disease.2
Updated results from NAVIGATE and SCOUT studies will be presented for Vitrakvi® (larotrectinib) in TRK fusion cancer in adult and pediatric patients across solid tumor types. Long-term efficacy and safety data of Vitrakvi in adult patients with TRK fusion lung cancer and thyroid carcinoma (TC) will also be presented. Additionally, an oral presentation of Phase II investigator-initiated research featuring pediatric patients with newly diagnosed infantile fibrosarcoma (IFS) treated with Vitrakvi will be highlighted. 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 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.3
Additional data featuring Bayer’s oncology pipeline will include an oral presentation on the initial results from a first-in-human, Phase I study of immunomodulatory aryl hydrocarbon receptor (AhR) inhibitor BAY2416964 in patients with advanced solid tumors. The six-year safety and efficacy results from CHRONOS-1 study analyzing Aliqopa® (copanlisib) in patients with relapsed or refractory follicular lymphoma (FL) will also be presented. Aliqopa is indicated for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies. Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.4
Bayer presentations at the 2023 ASCO Annual Meeting are listed below:
Darolutamide
- Abstract title: Comparative real-world (RW) evidence on darolutamide (Daro), enzalutamide (Enza), and apalutamide (Apa) for patients (Pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC) in the United States: DEAR
- Abstract 5097; June 3, 8:00am CDT
- Abstract title: Open-label study of darolutamide plus androgen-deprivation therapy (ADT) vs ADT in metastatic hormone-sensitive prostate cancer using an external control arm (ARASEC)
- Abstract TPS5112; June 3, 8:00am CDT
- Abstract title: A phase 2, randomized, open-label study comparing the effects of darolutamide versus enzalutamide monotherapy on serum testosterone levels in patients with hormone-naive prostate cancer: ARAMON study
- Abstract TPS5111; June 3, 8:00am CDT
- Abstract title: Real-world safety and effectiveness of radium-223 (223Ra) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) treated in the US: The non-interventional REASSURE study
- Abstract 5050; June 3, 8:00am CDT
- Abstract title: Larotrectinib long-term efficacy and safety in adult patients (pts) with tropomyosin receptor kinase (TRK) fusion cancer
- Abstract 3141; June 3, 8:00am CDT
- Abstract title: Long-term efficacy and safety of larotrectinib in patients with tropomyosin receptor kinase (TRK) fusion lung cancer
- Abstract 9056; June 4, 8:00am CDT
- Abstract title: Larotrectinib (laro) long-term efficacy and safety in patients (pts) with tropomyosin receptor kinase (TRK) fusion thyroid carcinoma (TC)
- Abstract 6091; June 5, 1:15pm CDT
- Abstract title: Phase 2 study of larotrectinib in children with newly diagnosed infantile fibrosarcoma (IFS): Children’s Oncology Group (COG) ADVL1823 cohort A
- Abstract 10008; June 4, 12:09pm CDT
- Abstract title: Initial results from a first-in-human, phase I study of immunomodulatory aryl hydrocarbon receptor (AhR) inhibitor BAY2416964 in patients with advanced solid tumors
- Abstract 2502; June 4, 9:57am CDT
- Abstract title: Six-year safety and efficacy results from the CHRONOS-1 study of the PI3K inhibitor copanlisib in patients with relapsed or refractory follicular lymphoma
- Abstract 7555; June 5, 8:00am CDT
- Abstract Title: Using real-world evidence (RWE) in regulatory decision making: A study of 6 oncology approvals with RWE included in the product label
- Abstract 6611; June 3, 1:15pm CDT