On October 18, 2019 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the stage 1 of the Phase 2 study evaluating the combination therapy of its cancer immunotherapy, CV301, and Roches’s checkpoint inhibitor, atezolizumab (TECENTRIQ), for the treatment of patients with locally advanced or metastatic urothelial bladder cancer did not meet the efficacy threshold to progress into stage 2 with expanded enrollment (Press release, Bavarian Nordic, OCT 18, 2019, View Source [SID1234542361]). No serious adverse events were observed in the study to date.
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In the first stage of the trial, 27 patients were enrolled into two cohorts: the first cohort was first-line treatment of patients (n=14) with urothelial bladder cancer who were not eligible for cisplatin-containing chemotherapy; and cohort 2 was a second-line treatment of patients (n=13) who had previously been treated with cisplatin-based chemotherapies. Despite the detection of clinical efficacy in a number of patients, neither cohort met the pre-defined criteria for clinical efficacy to expand enrollment into the second stage of the trial.
The study was sponsored by Bavarian Nordic, and two other, investigator-sponsored Phase 2 trials evaluating CV301 in combination with checkpoint inhibitors, are still ongoing in colorectal and pancreatic cancer. Bavarian Nordic will continue to follow and support these ongoing trials, while the Company’s primary focus and resources will be directed towards BN-Brachyury and the new immuno-oncology strategy involving intravenous and intratumoral administration as well as new and more advanced constructs.
The Company’s novel vaccine candidate, BN-Brachyury, is currently being evaluated in a Phase 2 trial in patients with advanced chordoma. This trial, which also uses a two-stage design, indicated clinical activity in the first stage, allowing for expansion of enrollment, which was recently completed. Conclusive data from this study are expected within 12 months. Another trial of BN-Brachyury administered intravenously is planned and will initiate shortly.
"We have diversified our immuno-oncology strategy over the past years, which is reflected in smaller studies seeking to evaluate different aspects of our technology. While the results of this study are disappointing, they contribute to our overall understanding of our platform and provide important learnings to refine our approach to equip the body’s immune system with more weapons to fight cancer from within," said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic.