On November 7, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported results of additional efficacy analysis of the interim results from its Phase 2 trial of VB10.16 in combination with atezolizumab in advanced cervical cancer (Press release, Nykode Therapeutics, NOV 7, 2022, View Source [SID1234623266]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"This additional analysis confirms our belief in VB10.16’s competitive strength and its potential to improve outcomes in patients with advanced cervical cancer," said Michael Engsig, Chief Executive Officer of Nykode. "Our C-02 trial enrolled heavily pre-treated patients with about one third having received three or more prior treatments. The additional analysis shows an increased response rate and competitive efficacy in patients receiving up to two prior therapies, which increases our confidence in our vaccine platform’s ability to induce clinically relevant immune responses in patients with recurrent and metastatic diseases. The data will help inform our clinical strategy as we further define the patient population for our next study of VB10.16 in advanced cervical cancer."
Interim data from 39 patients were announced in May 2022. The trial enrolled patients pre-treated with 1-5 lines of prior systemic therapy in recurrent or metastatic setting and showed a 21% Objective Response Rate (ORR) on average across all lines. This new analysis reviewed patient outcomes based on the number of previous lines of systemic therapy and number of extrapelvic metastases, showing a robust clinical benefit with partial and complete responses in 30% of patients treated with up to two prior lines of therapy. The response rate was similarly higher in patients with lower metastatic burden. A high disease control rate (DCR) was observed across all patient groups. Importantly, the T cell responses continue to show association with clinical outcomes. The data were reviewed as part of the Company’s presentation at the Credit Suisse Annual Healthcare Conference on Tuesday, November 8, 2022. The presentation can be accessed in the Investors section of the Company’s website here.
About Cervical Cancer
Cervical cancer is the fourth leading cause of cancer death in women worldwide and is most frequently diagnosed between the ages of 35 and 44. Each year around 600,000 women are diagnosed with cervical cancer worldwide. Almost all cases are caused by human papillomavirus (HPV) infection and HPV16 accounts for more than half of all cervical cancer cases. Approximately 80% of patients with cervical cancer have squamous cell carcinoma (arising from cells lining the bottom of the cervix) and most other patients have adenocarcinomas (arising from glandular cells in the upper cervix). Cervical cancer is often curable when detected early and effectively managed, but treatment options are more limited in advanced disease stages or when the cancer has spread.