18P The role of BYL719 in PIK3CA-mutated cervical cancer

BackgroundAdvanced/recurrent cervical cancer has limited therapeutic options, with a median progression-free survival after the failure of systemic treatments ranging between 3.5 and 4.5 months. Here, we reported our preliminary experience in use BYL719 (alpelisib) advanced/recurrent at least 2 lines treatment.MethodsThis is prospective trial testing role alpelisib PIK3CA mutated patients. The Fondazione IRCCS Istituto Nazionale dei Tumori di Milano (Italy) approved this investigation (IRB number 20205720).ResultsFrom April 2020 to September 2020, 17 consecutive patients recurrent had next-generation sequencing (NGS). Patients harboring mutation were included study. Overall, six All been treated previous treatment: 3 received >2 prior treatment or metastatic setting; 60% bevacizumab combination chemotherapy. started daily dosage 300 mg. Investigator-assessed confirmed objective response rate (ORR) was 33%. disease control (DCR) 100%. According RECIST 1.1, two partial (PR), four stable (SD). No complete observed. mean duration (DOR) 11.5 (SD 3.75) months; five PR lasting for >9 One patient stopped 0.82 months due onset grade adverse event (AE) (skin rash). Grade treatment-related AEs included: lymphoedema (n=1, 20%) rash 20%). 4-5 occurred.ConclusionsAlpelisb seems associated promising anti-tumor activity mutation. Further trials are needed assess safety effectiveness PIK3CA-mutated pre-treated cancer.Legal entity responsible studyThe authors.FundingHas not any funding.DisclosureAll authors have declared no conflicts interest. treatment. Advanced/recurrent MethodsThis 20205720). This ResultsFrom occurred. From ConclusionsAlpelisb cancer. Alpelisb