The addition of galunisertib to gemcitabine demonstrated improved overall and progression-free survival as compared with gemcitabine alone in patients with pancreatic cancer, a study presented at the American Academy for Cancer Research (AACR) Annual Meeting 2016 has shown.1
Because the transforming growth factor-beta (TGFβ) signaling pathway is active in pancreatic cancer, researchers sought to evaluate the efficacy and safety of galunisertib, which selectively blocks TGFβ signaling, in combination with gemcitabine for the treatment of patients with unresectable pancreatic cancer.
For the study, researchers enrolled 156 patients with unresectable stage II to IV pancreatic cancer. Participants were randomly assigned 2:1 to receive galunisertib 150 mg orally twice daily for 14 days on, 14 days off, plus gemcitabine, or gemcitabine plus placebo.
Results showed that median overall survival was 9.10 months (95% CI, 7.43 – 12.2) with galunisertib plus gemcitabine compared with 7.59 months (95% CI, 4.04 – 9.92) with gemcitabine and placebo. Median progression-free survival was 3.65 months (95% CI, 2.86 – 5.39) and 2.79 months (95% CI, 1.81 – 3.68), respectively (P = .084).
Of the 104 patients who received galunisertib, 8.7% (95% CI, 4.0 – 15.8) achieved a response vs 1.9% (95% CI, 0.1 – 10.3) of those who did not.
Researchers also found that among patients with baseline TGFβ1 levels of 4224 pg/mL or less, overall survival was 10.9 months with the combination compared with 7.2 months with gemcitabine and placebo (HR, 0.68; 95% CI, 0.44 – 1.04; P = .076). Median progression-free survival was 3.9 months and 2.8 months, respectively (HR, 0.64; 95% CI, 0.42 – 0.96; P = .033). This finding suggest that patients with lower TGFβ1 levels may obtain a greater benefit from treatment with galunisertib.
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The most common grade 3 or 4 treatment-related adverse events were anemia (7.8% with galunisertib vs 13.5% with placebo), neutropenia (32.0% vs 26.9%), and thrombocytopenia (7.8% vs 9.6%).
- Melisi D, Garcia-Carbonero R, Macarulla T, et al. A randomized phase II, double-blind study to evaluate the efficacy and safety of galunisertib+gemcitabine (GG) or gemcitabine+placebo (GP) in patients with unresectable pancreatic cancer (PC). Oral presentation at: AACR Annual Meeting 2016; April 16-20, 2016; New Orleans, LA.