Updated analyses for Vitrakvi™ (larotrectinib) reaffirm sustained clinical benefits for patients with TRK fusion cancer / Breadth of prostatic adenocarcinoma portfolio on display, including presentations for Nubeqa™ (darolutamide) in non-metastatic castration-resistant prostatic adenocarcinoma (nmCRPC), and Xofigo™ (radium-223 dichloride) in metastatic castration-resistant prostatic adenocarcinoma (mCRPC) / public speaking on analysis from CHRONOS-3 study evaluating Aliqopa™ (copanlisib) plus rituximab in patients with marginal zone lymphoma (MZL) / Ongoing investigator-initiated research featuring StivargaTM (regorafenib) in various indications and difficult-to-treat tumors
Presentations: 535P, 536P, 534P, 104P, 1534P, 444P, 630P, LBA26, 623P, 603P, 593P, 594P, 1309P, 606P, 590P, 826O, 530P, LBA58, 1520O, 48P, 508TiP, 505TiP, 509TiP, 1438TiP
Bayer will present new data from its established portfolio of approved oncology therapies at the upcoming ESMO Congress 2021 from September 16-21, 2021. Presentations will focus on Bayer’s ongoing focus in addressing patient needs through expanded research with existing therapies in certain cancers also as studies in new tumor types and together with other therapies.
Among the featured research presented are going to be four distinct analyses for Bayer’s precision oncology treatment Vitrakvi™ (larotrectinib), including updated long-term efficacy and safety findings from an integrated dataset of adult TRK fusion cancer patients. Additional data for larotrectinib include an analysis in adult and pediatric patients consistent with prior therapy and performance status, also as an summary on the incidence of fractures in larotrectinib-treated patients. An analysis evaluating larotrectinib compared to entrectinib employing a matching-adjusted indirect comparison (MAIC) also will be presented. MAIC is an alternate method for comparative data when a randomized control trial (RCT) isn’t available and/or possible, like for TRK fusion cancer, which is an ultra-rare disease. Vitrakvi, the first-ever treatment to receive a tumor-agnostic indication at the initial approval within the U.S. and European Union (EU), is approved in additional than 40 countries, including last in Japan for adult and pediatric patients with solid tumors harboring an NTRK gene fusion. Additional filings in other regions are underway or planned.
New ARAMIS trial data for Nubeqa™ (darolutamide) in patients with non-metastatic castration-resistant prostatic adenocarcinoma (nmCRPC) on the timing of adverse events during the trial are going to be showcased, continuing to strengthen the established clinical profile of the therapy during this indication.
Additionally, the compound is evaluated in men with metastatic castration-resistant prostatic adenocarcinoma (mCRPC): within the randomized double-blind placebo-controlled phase II clinical trial trial SAKK 08/16, first data on a maintenance therapy with darolutamide in mCRPC patients previously treated with novel hormonal agents (NHA) and non-progressive disease after subsequent treatment with a taxane are going to be presented during a late-breaking public speaking . An analysis from the investigator-initiated ODENZA trial on the cognitive assessment in men with mCRPC randomly receiving darolutamide or enzalutamide also will be presented. Nubeqa is approved in several markets round the world, including the U.S., EU, Japan and China, for the treatment of patients with nmCRPC, who are at high risk of developing metastatic disease. Filings in other regions are underway or planned. The compound is developed jointly by Bayer and Orion Corporation, a globally operating Finnish drug company .
Additional data demonstrating the flexibility of the prostatic adenocarcinoma treatment Xofigo™ (radium-223 dichloride), the primary ever approved Targeted Alpha Therapy, are going to be presented. Research includes pain efficacy data in patients with mCRPC from the REASSURE and PARABO observational studies. Xofigo is approved in additional than 50 countries, including the U.S., EU, China and Japan for patients with mCRPC, symptomatic bone metastases and no known visceral metastases.
Data for Aliqopa™ (copanlisib), the sole pan class I phosphatidylinositol-3-kinase (PI3K) inhibitor, include results from a subset of the phase III clinical trial trial CHRONOS-3 analyzing copanlisib plus rituximab compared to rituximab and placebo in patients with marginal zone lymphoma (MZL). Copanlisib is currently approved within the U.S., Israel and Taiwan for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received a minimum of two prior systemic therapies. Approvals were supported the general response rate (ORR) from the open-label, single-arm phase II clinical trial CHRONOS-1 (NCT01660451) trial of copanlisib monotherapy in 104 adult patients with follicular B-cell non-Hodgkin’s Lymphoma (NHL) who had relapsed disease following a minimum of two prior systemic therapies. Recently, Bayer has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) in relapsed indolent B-cell NHL and a marketing authorization application (MAA) to the ecu Medicines Agency (EMA) in relapsed MZL for the novel combination of copanlisib and rituximab. Bayer is in discussions with health authorities worldwide regarding data from CHRONOS-3.
Investigator-initiated research highlighting regorafenib will conclude Bayer’s presence at the meeting. These investigational data, including a late-breaking abstract on the phase II clinical trial REGOBONE study assessing the efficacy and safety of regorafenib in patients with relapsed advanced or metastatic chordoma, and an public speaking on a collaborative phase II clinical trial trial with regorafenib in first-line of KIT/PDGFR wild type advanced gastrointestinal stromal tumors (GIST), continue showcasing regorafenib’s potential in difficult-to-treat tumors. Regorafenib is approved under the name Stivarga™ in additional than 100 countries surely sorts of colorectal cancer, GIST and cancer of the liver .
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