Bayer to Present Phase III Data in iNHL and Updates on Oncology Portfolio at AACR 2021

Compiled by River

On April 6, foreign media reported that Bayer planned to present new research in oncology at the 2021 virtual American Association for Cancer Research (AACR) Annual Meeting. The data were based on a Phase III randomized, double-blind, placebo-controlled clinical study evaluating intravenous Aliqopa® (copanlisib) in combination with rituximab for the treatment of patients with relapsed indolent non-Hodgkin lymphoma (iNHL) who had experienced relapse after ≥1 prior line of therapy, including rituximab (CHRONOS-3).

In 2017, based on the results of the single-arm, multicenter, Phase II clinical trial CHRONOS-1, Aliqopa was approved for the treatment of adult patients with relapsed follicular lymphoma (FL) who had previously received at least two prior systemic therapies. This indication was approved under accelerated approval based on overall response rate (ORR). Continued approval for this indication is contingent upon verification and description of clinical benefit in confirmatory trials.

At this conference, Bayer will also present data related to biomarker-driven therapy. Vitrakvi® (larotrectinib) is the first TRK inhibitor for TRK fusion cancers in solid tumors, including long-term outcomes of patients with TRK fusion cancer who received Vitrakvi, as well as an analysis of prognostic factors and survival rates in patients with tumors harboring neurotrophic receptor tyrosine kinase (NTRK) gene fusions based on genomic data from 100,000 individuals. The new data further reaffirm Bayer’s ongoing commitment to researching biomarker-driven approaches that deliver clinical impact for patients.

Vitrakvi is approved for the treatment of adult and pediatric patients with solid tumors harboring NTRK gene fusions without known acquired resistance mutations, whose disease is metastatic or where surgical resection is likely to result in severe morbidity, who have no satisfactory alternative treatments or who have progressed following treatment. Patient selection should be based on an FDA-approved test. This indication is approved under accelerated approval based on overall response rate.

At this event, the company will also present prostate cancer research on NUBEQA® (darolutamide) for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). This includes preclinical data analyzing androgen stimulation and the therapeutic effects of NUBEQA. Additionally, preclinical data demonstrating the synergistic antitumor activity of investigational Xofigo in combination with enzalutamide in an intra-tibial LNCaP prostate cancer xenograft model will be provided. Targeted Thorium Conjugates (TTCs) represent an emerging class of targeted alpha therapies that hold potential as a treatment option for cancer patients. Featured reports on investigational TTCs will highlight PSMA-TTC BAY 2315497, which targets prostate-specific membrane antigen (PSMA) in prostate cancer cells, and its antitumor activity in preclinical prostate cancer models when combined with the PARP inhibitor olaparib. PSMA-TTC is currently being evaluated in Phase I studies. These data further expand Bayer’s comprehensive research portfolio and underscore the company’s commitment to helping men access appropriate treatment options across multiple stages of prostate cancer.

NUBEQA is an androgen receptor inhibitor (ARi) with a unique chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription. NUBEQA is indicated in the United States for the treatment of non-metastatic castration-resistant prostate cancer. Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.

Bayer will also present the latest data on its differentiated early-stage pipeline in other key areas, including precision molecular oncology and immuno-oncology. For the first time, Bayer will provide preclinical data on BAY 2476568, an investigational small-molecule epidermal growth factor receptor (EGFR) exon 20 inhibitor discovered through the company’s strategic joint research with the Massachusetts Institute of Technology (MIT) and Harvard University. Additionally, Bayer will showcase the preclinical findings for BAY-405, an oral investigational small-molecule inhibitor.

Reference: Bayer to Present New Clinical Data in Indolent non-Hodgkin's Lymphoma and Additional Research on its Oncology Portfolio at AACR Annual Meeting 2021