Piqray ( apelisib) for HEad and Neck cacner – pro
Razak et al showed that Alpelisib in combination with cetuximab showed synergistic anti-tumour activity in head and neck squamous cell carcinoma (HNSCC) models.A potentially treatable mutation is not sufficient without supporting evidence of effectiveness. Tsang et al. performed the first trial of this drug for head and neck cancer, a Phase 1 B trial. The addition of alpelisib to cisplatin demonstrated responses among patients with solid tumor malignancies and platinum resistance, but toxicities limited treatment time. The addition of alpelisib to cetuximab did not demonstrate a PFS benefit in cetuximab-naïve patients with advanced HNSCC. The alpelisib-cetuximab combination showed moderate activity in cetuximab-resistant patients, with a consistent safety profile.
Tsang ES, Aggarwal RR, Dhawan MS, Bergsland EK, Alvarez EA, Calabrese S, Pacaud R, Garcia J, Fattah D, Thomas S, Grabowsky J, Moasser MM, Munster PN. A Phase IB Trial of the PI3K Inhibitor Alpelisib and Weekly Cisplatin in Patients with Solid Tumor Malignancies. Cancer Res Commun. 2022 Jul 1;2(7):570-576.
Razak ARA, Wang HM, Chang JY, Ahn MJ, Munster P, Blumenschein G Jr, Solomon B, Lim DW, Hong RL, Pfister D, Saba NF, Lee SH, van Herpen C, Quadt C, Bootle D, Blumenstein L, Demanse D, Delord JP. A Phase 1b/2 Study of Alpelisib in Combination with Cetuximab in Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma. Target Oncol. 2023 Nov;18(6):853-868.