7th ICHNO Abstract book

7th ICHNO 7 th ICHNO Conference International Conference on innovative approaches in Head and Neck Oncology 14 – 16 March 2019 Barcelona, Spain __________________________________________________________________________________________ page 45

addition of chemotherapy and the emergence of the HPV positive demographic, the current approach is observation in lieu of surgery, in the presence of negative interval PET imaging and clinical findings. However, very little data exists for the N3 subgroup of disease. Aim: to determine the efficacy of (chemo)radiotherapy alone in the treatment of N3 nodal disease for patients with HPV positive head and neck SCC Material and Methods Data sources: A review of contemporary English medical literature via MedLine, EMBASE using all combinations of terms, Squamous cell carcinoma; radiotherapy; neck; HPV; human papilloma virus; chemoradiotherapy; head and neck neoplasms; dissection; PET; papilloma; HNSCC; OPSCC; stage N1,N2,N3; SCC ; p16 , was performed. Selected articles were then secondarily searched for references and cross-referenced. Study Selection: Abstracts were reviewed and relevant articles were then evaluated. Exclusion criteria included editorials, non-English language, comments, letters, studies pre-2008. Data Extraction: Level of evidence was assigned in accordance with the Oxford Centre for Evidence-based Medicine guidance (Levels I-V) Results Results: Eighteen articles met the inclusion criteria, of which, 3 were level I, 8 level II and 7 level IV. Overall risk of bias was moderate to high in view of underpowered studies, selection bias, lack of N3 and HPV subgroup stratification and analysis. The lack of standardised nomenclature and outcome measures was also detrimental. P16 status was typically not stated. Many studies group N2 and N3 disease together precluding further analysis. Conclusion Conclusions: The management of N3 patients remains unclear and caution is urged in de-escalating of treatment, particularly by extrapolating data from N2 subgroups. Further prospective studies are required. Staged neck dissection following primary (chemo)radiotherapy in the N3 subrgroup of HNSCC patients remains a valid option. PO-086 Buparlisib (AN2025) as a potential treatment for anti-PD-1 non-responding tumor J. Wang 1 , P. Chen 1 , Z. Chen 1 , T. Kaiyang 2 1 Department of Biology, Adlai Nortye Biopharma Co.- Ltd., Hangzhou, China; 2 Clinical Development Operations, Adlai Nortye Biopharma Co.- Ltd., Hangzhou, China Purpose or Objective Head and neck squamous cell carcinoma (HNSCC) is one of the most common cancer in the world. Although PD-1 blockage treatments have been approved by FDA in 2016, the response rates of Nivolumab and pembrolizumab are both lower than 20%. The treatment of anti-PD-1 non- responding HNSCC patients remains to be an unmet medical need. Buparlisib (AN2025, also known as BKM120), an oral pan-PI3K inhibitor, has shown promising efficacy in combination with paclitaxel in HNSCC BERIL-1 study. Considering the different mechanisms of Buparlisib and PD-1 antibody, we evaluated efficacy of Buparlisib in anti- PD-1 non-responding tumors. Poster: Innovative treatments

Material and Methods To generate the anti-PD-1 non-responding tumor model, CT26 bearing mice were treated with PD-1 Antibody from day-2 post cell inoculation. After 10 days of PD-1 Ab treatment, the mice with weak response to anti-PD-1 Ab were regrouped for next stage treatment by either anti- PD1 Ab or Buparlisib (AN2025). Tumor volume was measured as endpoint of efficacy. Results In those regrouped tumor-bearing mice, Buparlisib (AN2025) demonstrated robust efficacy. The T/C ratio of AN2025 at day-19 post-treatment were 36.30%, 46.22% and 62.60 at 30 mg/kg, 45 mg/kg and 60 mg/kg, respectively. While continuous PD-1 Ab only dosing displayed similar tumor growth curve, T/C%=115.72%, as vehicle control mice. Conclusion This study suggested Buparlisib (AN2025) could potentially be a treatment option for anti-PD-1 non-responding tumors. Taking together, with the promising outcome from BERIL-1 study, the sponsor is planning a PhIII trial to evaluate Buparlisib (AN2025) efficacy in anti-PD-1 non- responding HNSCC patients. PO-087 Apatinib combined with oral chemotherapy in patients with recurrent/metastatic head and neck cancer S. Dou 1 , R. Li 1 , L. Xie 2 , Z. Wang 1 , C. Zhang 1 , L. Zhang 1 , G. Zhu 1 1 Shanghai Ninth People's Hospital-College of Stomatology- Shanghai Jiao Tong University School of Medicine, Department of Oral and Maxillofacial-Head Neck Oncology, Shanghai, China; 2 Shanghai Jiao Tong University School of Medicine, Clinical Research Center, Shanghai, China for recurrent/metastatic(R/M) squamous cell carcinoma of the head and neck (SCCHN) was still generally last than 10 months. Additional clinical trials are warranting for new treatment options. Apatinib is an oral tyrosine kinase inhibitor that selectively inhibits VEGF receptor 2, which has demonstrated encouraging anticancer activity across a broad range of malignancies. In this a phase 2 trial, we assessed the efficacy and safety of the combination therapy of apatinib and an oral fluoropyrimidine anticancer agent combining tegafur, gimeracil, and oteracil potassium (TGO), in patients with R/M SCCHN. Material and Methods In this a phase 2, single-arm, prospective study, we recruited patients aged 18–75 years with R/M SCCHN in Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine (China). Patients had to have an Eastern Cooperative Oncology Group performance status of 0 or 1, life expectancy of at least 3 months, and adequate bone marrow, liver, and renal function, without other uncontrolled medical disorders. The treatment consisted of apatinib at an initial dose of 500 mg once daily on a continuous basis, and oral TGO at a dose of 20 mg twice daily on days 1–14 of a 21-day cycle. Treatment was continued until disease progression, patient withdrawal, or unacceptable toxic effects. The primary endpoint was 6-month progression-free survival (PFS). We analysed efficacy in the intention-to-treat and per-protocol populations. Safety analyses included enrolled patients who had received at least one dose of study medication. Purpose or Objective The median overall survival