According to the phase 2 PACS study, sintilimab, a PD-1 inhibitor, plus paclitaxel and cisplatin in the neoadjuvant setting demonstrated encouraging antitumor activity and manageable toxicity among patients with locally advanced cervical cancer.

These results were first presented by Jihong Liu, Sun Yet Sen University Cancer Center, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

In this study, 47 patients with newly confirmed locally advanced cervical cancer received neoadjuvant paclitaxel and cisplatin, plus 200 mg sintilimab intravenous once every 3 weeks for 3 cycles, followed by radical surgery. Those patients who had progressive disease without any distant metastases after 2 cycles of neoadjuvant therapy underwent immediate surgery. The primary end point of this study was pathological complete remission (pCR) rate, with secondary end points including objective response rate (ORR), disease-free survival (DFS), OS, and adverse events.

Of the 47 patients enrolled, 44 received 3 cycles of neoadjuvant therapy. There were then 43 who underwent radical surgery and were evaluable. At the data cutoff date of May 6, 2024, the median follow-up duration was 19 months. The pCR rate was 36.2%, with an optimal remission (defined as residual tumor cells with a depth of >3mm) rate of 53.2%. There were 42 objective responses (ORR, 97.7%) and only 1 patient with stable disease. There were 3 patients who were evaluated as partial responses after neoadjuvant therapy who recurred (1 distant lymph node recurrence, 1 lung metastasis). The median DFS and OS had not yet been reached, with a 12-month and 24-month DFS of 94.4% and 91.2%, respectively, and a 12-month and 24-month OS both of 94.5%.

There were 15 patients who presented with grade 3/4 neutropenia and no other grade 3/4 adverse events. Possible immune-related side effects reported were skin rash, alanine aminotransferase increased, hypothyroidism, creatinine increased, and hyperlipidemia.

Dr Liu concluded, “Sintilimab plus paclitaxeland cisplatin as neoadjuvant therapy had encouraging antitumor activity in patients with locally advanced cervical cancer, resulting in a 32.6% pCR rate and 53.2% optimal remission rate, which may result in a potential survival benefit.” She added, “This regimen…dramatically reduced post-operative radiation rate.”

Source:

Wan T, Huang H, Feng Y, et al. Efficacy and safety of sintilimab plus paclitaxel and cisplatin as neoadjuvant therapy for locally advanced cervical cancer: A phase II trial. Presented at the 2024 ASCO Annual Meeting. May 31-June 4, 2024; Chicago, IL. Abstract #5512