At the 2024 European Society for Medical Oncology (ESMO) Congress, Kangfang Biotech (HKG: 9926) unveiled the impressive Phase II clinical study results of its self-developed PD-1/VEGF bispecific antibody, Yivoxi, used in combination or alone with the next-generation CD47 monoclonal antibody, Laifali, for the first-line treatment of PD-L1 positive (CPS≥1) recurrent and metastatic head and neck squamous cell carcinoma (R/M HNSCC).
The Phase III study comparing Yivoxi in combination with Laifali versus pembrolizumab as a first-line treatment for PD-L1 positive R/M HNSCC has already been initiated. As of March 19, 2024, the results indicated that Yivoxi demonstrated excellent tumor shrinkage effects, particularly for HNSCC patients with urgent needs for rapid tumor reduction. The addition of Laifali further enhanced the tumor reduction and survival benefits. Both Yivoxi monotherapy and the combination with Laifali achieved preliminary efficacy data higher than that of previously disclosed PD-1 monoclonal antibody studies.
Pembrolizumab has become the first-line standard treatment for R/M HNSCC, yet it offers limited overall survival benefits, and some patients show poor response. Therefore, there remains a significant unmet clinical need for first-line treatment of R/M HNSCC, calling for new therapeutic options.
The combination of Yivoxi and Laifali as a first-line treatment for PD-L1 positive R/M HNSCC holds great clinical potential. The Phase III study comparing this combination to pembrolizumab as a first-line treatment for PD-L1 positive R/M HNSCC has been launched, promising to provide a new and highly effective immunotherapy option for these patients and further advancing the era of tumor immunotherapy 2.0. – Flcube.com
