The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.

Adding sintilimab to chemotherapy improved responses, but not survival outcomes, in patients with advanced pancreatic adenocarcinoma, according to data from the phase 3 CISPD3 trial.

These results were presented at the ASCO Gastrointestinal Cancers Symposium 2022 by Tingbo Liang, MD, PhD, of the First Affiliated Hospital/Zhejiang University School of Medicine in Hangzhou, China.

Dr Liang noted that pancreatic cancers seem to be resistant to PD-1/PD-L1 antibodies when used as monotherapy. With the CISPD3 study, Dr Liang and colleagues attempted to determine if the PD-1 inhibitor sintilimab would be effective when combined with chemotherapy.


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The study (ClinicalTrials.gov Identifier: NCT03977272) included 110 patients who were randomly assigned 1:1 to receive sintilimab plus modified FOLFIRINOX (leucovorin, fluorouracil, irinotecan, and oxaliplatin) or modified FOLFIRINOX alone.

The median age was 62 years in both arms (overall range, 44-74 years). Most patients were men (76.3% in the sintilimab arm and 63.6% in the control arm), had primary tumors in the neck/body/tail (70.9% and 61.8%, respectively), and had liver metastasis (81.8% and 70.1%, respectively).

Results showed a significant improvement in objective response rate (ORR) for patients assigned to sintilimab plus modified FOLFIRINOX. The ORR was 50% in this group and 23.9% in the control group (P <.05). There was 1 complete response in the sintilimab arm and none in the control arm.

There were no significant differences between the sintilimab and control arms with regard to disease control rate (84.0% and 71.7%, respectively) or median duration of response (7.85 months and 4.63 months, respectively).

Similarly, there were no significant differences in progression-free survival (PFS) or overall survival (OS) between the arms. The median OS was 10.9 months with sintilimab and 10.8 months with chemotherapy alone (hazard ratio [HR], 1.09; 95% CI, 0.70-1.69; P >.05). The median PFS was 5.9 months and 5.7 months, respectively (HR, 0.93; 95% CI, 0.62-1.41; P >.05).

The most common grade 3 or higher adverse events (in the sintilimab and control arms, respectively) were neutropenia (58.5% and 44.4%), thrombocytopenia (17.0% and 11.1%), anemia (13.2% and 13.0%), vomiting (13.2% and 11.1%), and increased aminotransferase (11.3% and 5.6%).

Grade 3 or higher immune-related adverse events occurred in 5.7% of patients in the sintilimab arm.

These data suggest that PD-1 blockade may expand the benefit of chemotherapy in pancreatic adenocarcinoma, according to Dr Liang.

Disclosures: The study authors had no conflicts of interest.

Read more of Cancer Therapy Advisor’s coverage of ASCO GI 2022 by visiting the conference page.

Reference

Fu Q, Chen Y, Huang D, et al. Randomized phase III study of sintilimab in combination with modified folfrinox versus folfrinox alone in patients with metastatic and recurrent pancreatic cancer in China: The CISPD3 trial. Presented at ASCO GI 2022; January 20-22, 2022. Abstract 560.