Sintilimab plus FOLFIRINOX may provide benefits in metastatic pancreatic cancer

The health outcomes of patients with metastatic and recurrent pancreatic cancer may improve when sintilimab is added to the standard treatment regimen of modified FOLFIRINOX chemotherapy. Moreover, the phase 3 CISPD3 trial displayed a manageable safety profile of the combination therapy [1].

“(Modified) FOLFIRINOX is the standard first-line therapy for patients with metastatic pancreatic adenocarcinoma,” said Dr Qihan Fu (Zhejiang University School of Medicine, China). “The anti-PD1 monoclonal antibody sintilimab may provide additional benefits for this difficult-to-treat patient population.” The phase 3 CISPD3 trial (NCT03977272) randomised 110 patients with metastatic pancreatic cancer 1:1 to sintilimab plus modified FOLFIRINOX chemotherapy or chemotherapy alone. Patients in the sintilimab arm received 200 mg sintilimab every 3 weeks. The treatment was continued until disease progression or unacceptable toxicity occurred. The primary endpoint was overall survival (OS).

Patients in the sintilimab plus chemotherapy arm displayed a higher objective response rate compared with patients who received chemotherapy alone (50.0% vs 23.9%; P<0.05). In addition, the response duration was numerically higher in the sintilimab plus chemotherapy arm than in the chemotherapy alone arm (7.85 vs 4.63 months; see Figure). However, the median OS in the intention-to-treat population was comparable between the 2 treatment arms (10.9 vs 10.8 months). Similarly, there was no notable difference in median progression-free survival (5.9 vs 5.7 months).

Figure: Tumour response results in CISPD3 trial [1]



According to Dr Fu, the safety profile of sintilimab plus chemotherapy was acceptable and manageable. Nonetheless, more grade 3 or higher adverse events (AEs) were reported in patients who received sintilimab plus chemotherapy compared with patients who received chemotherapy alone (84.9% vs 74.1%). In particular, neutropenia (58.5% vs 44.4%), thrombocytopenia (17.0% vs 11.1%), increased aminotransferase (11.3% vs 5.6%), and immune-related AEs (5.7% vs 0.0%) were more frequently observed in patients receiving sintilimab.

Dr Fu concluded that this data suggests that the benefits of (modified) FOLFIRINOX may be expanded with the addition of an antibody that is blocking PD-1, but it is not yet practice-changing; we need more data.

1. Fu Q, et al. Randomized Phase 3 study of Sintilimab in combination with modified FOLFRINOX versus modified FOLFRINOX alone in patients with metastatic and recurrent pancreatic cancer in China: the CISPD3 trial. Rapid abstract session B, ASCO GI 2022, 20–22 January.

 

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Posted on 21 March, 202221 March, 2022