Objectives Advanced/recurrent cervical cancer has limited therapeutic options, with a median progression-free survival (PFS) after the failure of systemic treatments ranging between 3.5 and 4.5 months. Here, we reported our preliminary experience in the use of BUL719 (alpelisib) in advanced/recurrent cervical cancer after failure of at least 2 lines of treatment.

Methods The Istituto Nazionale dei Tumori di Milano (Italy) approved this prospective investigation. From 04/01/2020 to 09/01/2020, 17 consecutive patients with recurrent cervical cancer underwent NGS to assess the presence of PIK3CA mutation/alteration.

Results Six patients were included in the study. All patients had been treated with at least 2 previous lines of systemic treatment: 3 patients received >2 prior lines of treatment in the recurrent or metastatic setting; 60% had received prior bevacizumab in combination with chemotherapy. All patients started alpelisib at the daily dosage of 300 mg. Investigator-assessed confirmed objective response rate (ORR) was 33%. The disease control rate (DCR) was 100%. According to the RECIST 1.1, two patients had a partial response (PR), and four patients had stable disease (SD). No complete response was observed. The mean duration of response (DOR) was 6.6 (SD 3.75) months; four patients had PR lasting for >6 months. One patient stopped the treatment at 0.82 months due to the onset of a grade 2 adverse event (AE) (skin rash). Grade 3 treatment-related AEs included: lymphoedema (n=1, 20%) and rash (n=1, 20%). No treatment-related grade 4–5 AEs occurred.

Conclusions Further trials are needed to assess the safety and effectiveness of alpelisib in PIK3CA-mutated recurrent/advanced cervical cancer.