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HOOKIPA Pharma | 8-K: Current report

HOOKIPA Pharma | 8-K: Current report

HOOKIPA Pharma | 8-K：重大事件
美股SEC公告 ·  06/05 04:58

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On June 4, 2024, HOOKIPA Pharma Inc. announced positive updated results from its Phase 2 clinical trial of HB-200 in combination with pembrolizumab for treating patients with HPV16+ recurrent/metastatic head and neck cancer. The data, presented at the American Society for Clinical Oncology 2024 Annual Meeting, included 46 first line patients and demonstrated a favorable safety profile and promising clinical activity. Among 35 evaluable patients, there were 4 complete responses, 9 partial responses, and 11 stable disease cases. Notably, in a subset of patients with high PD-L1 levels, the objective response rate was 53%, with a disease control rate of 82%. The preliminary progression-free survival for this subgroup was 16.3 months, and the overall survival rate was 88% at 9 months, with median overall survival not yet reached. The median follow-up time...Show More
On June 4, 2024, HOOKIPA Pharma Inc. announced positive updated results from its Phase 2 clinical trial of HB-200 in combination with pembrolizumab for treating patients with HPV16+ recurrent/metastatic head and neck cancer. The data, presented at the American Society for Clinical Oncology 2024 Annual Meeting, included 46 first line patients and demonstrated a favorable safety profile and promising clinical activity. Among 35 evaluable patients, there were 4 complete responses, 9 partial responses, and 11 stable disease cases. Notably, in a subset of patients with high PD-L1 levels, the objective response rate was 53%, with a disease control rate of 82%. The preliminary progression-free survival for this subgroup was 16.3 months, and the overall survival rate was 88% at 9 months, with median overall survival not yet reached. The median follow-up time was 8.4 months. HOOKIPA Pharma also plans to initiate a pivotal Phase 2/3 trial in the fourth quarter of 2024. The company's CEO, Joern Aldag, highlighted the potential of HB-200 plus pembrolizumab as a targeted therapeutic option and emphasized the alignment with the FDA on a clinical development strategy that could lead to accelerated approval.
2024年6月4日，hookipa pharma inc宣佈了其HB-200輔以pembrolizumab治療HPV16+復發轉移頭頸癌二期臨牀試驗積極的更新結果。這些數據在美國臨牀腫瘤學會2024年年會上發表，包括46個一線患者，顯示出良好的安全性和有前景的臨牀活性。在35名可評估的患者中，有4例完全緩解，9例部分緩解和11例穩定的疾病病例。值得注意的是，在高PD-L1水平的一部分患者中，客觀反應率為53%，疾病控制率為82%。該亞組的初步無進展生存期為16.3個月，9個月的總體生存率為88%，中位總體生存期尚未達到。中位隨訪時間為8.4個月。HOOKIPA Pharma還計劃在2024年第四季度開始一項關鍵性的二/三期試驗。公司的CEO Joern Aldag強調了HB-200加pembrolizumab作為靶向治療方案的潛力，並強調其與FDA在臨牀發展策略上的一致，這可能導致加速批准。
2024年6月4日，hookipa pharma inc宣佈了其HB-200輔以pembrolizumab治療HPV16+復發轉移頭頸癌二期臨牀試驗積極的更新結果。這些數據在美國臨牀腫瘤學會2024年年會上發表，包括46個一線患者，顯示出良好的安全性和有前景的臨牀活性。在35名可評估的患者中，有4例完全緩解，9例部分緩解和11例穩定的疾病病例。值得注意的是，在高PD-L1水平的一部分患者中，客觀反應率為53%，疾病控制率為82%。該亞組的初步無進展生存期為16.3個月，9個月的總體生存率為88%，中位總體生存期尚未達到。中位隨訪時間為8.4個月。HOOKIPA Pharma還計劃在2024年第四季度開始一項關鍵性的二/三期試驗。公司的CEO Joern Aldag強調了HB-200加pembrolizumab作為靶向治療方案的潛力，並強調其與FDA在臨牀發展策略上的一致，這可能導致加速批准。
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