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Elraglusib plus gemcitabine and nab-paclitaxel lead to an OS benefit vs chemotherapy alone in treatment-naive metastatic PDAC.
Elraglusib Plus Chemo in PDAC |
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The GSK-3β inhibitor elraglusib (9-ING-41) in combination with gemcitabine and nab-paclitaxel (Abraxane) led to overall survival (OS) and other efficacy benefits vs chemotherapy alone for the first-line treatment of patients with metastatic pancreatic adenocarcinoma (PDAC), according to data from part 3B of the phase 2 Actuate-1801 trial (NCT03678883).1
The median OS among patients who completed at least 1 cycle of treatment in the elraglusib arm (n = 116) was 12.5 months vs 8.5 months in the chemotherapy-only arm (n = 58), leading to a 43% reduction in the risk of death (P = .018). Elraglusib was also superior compared with chemotherapy alone in terms of disease control rate (DCR; 53.4% vs 44.8%), overall response rate (ORR; 37.9% vs 29.3%), and median progression-free survival (PFS; 6.9 vs 5.6 months).
Additionally, data from a subgroup analysis of Actuate-1801 showed that patients with liver metastases treated in the investigational arm (n = 87) experienced a significant OS benefit with the addition of elraglusib vs those who received chemotherapy alone (n = 44; HR, 0.62; 95% CI, 0.42-0.93). The 18-month OS rates were 13.6% and 0%, respectively. The ORR (29.8% vs 19.7%), DCR (36.8% vs 27.9%), and median PFS (4.9 months vs 3.9 months) also all favored the investigational arm. Notably, an OS benefit with elraglusib plus chemotherapy vs chemotherapy alone was observed across prespecified patient subgroups.
“We are highly encouraged by the significant clinical benefit provided by elraglusib demonstrated in this study,” Daniel Schmitt, president and chief executive officer of Actuate, stated in a news release. “Patients who received at least one cycle – or 4 weeks – of elraglusib showed a rapid and meaningful survival benefit, including a near doubling of the 1-year OS and 43% reduction in the risk of death compared to control. Separately, in the subgroup of patients with liver metastases, a population with historically poor prognosis, we observed a more than 2.5-fold improvement in 1-year OS with a 38% reduction in risk of death. These results underscore the potential of elraglusib to generate rapid and durable benefit in high-risk patients, which could be highly impactful in future development and commercial pathways.”
Part 3B of Actuate-1801enrolled adult patients with metastatic PDAC who received no prior therapy for metastatic disease.2Patients were also required to have measurable disease per RECIST 1.1 criteria.
Eligible patients were randomly assigned 2:1 to receive elraglusib at 9.3 mg/kg weekly plus gemcitabine at a dose of 1000 mg/m2 and nab-paclitaxel at 125 mg/m2, both on days 1, 8, and 15 of each 28-day cycle, or only gemcitabine plus nab-paclitaxel.
The primary end points were 1-year OS rate during the run-in period and median OS for the full study. Secondary end points included ORR, DOR, PFS, DCR, and time to treatment failure.
Additional data presented during the 2025 ASCO Annual Meeting demonstrated that patients in the safety population who received elraglusib (n = 155) experienced any-grade treatment-emergent adverse effects (TEAEs) at a rate of 100% compared with 98.7% of patients in the control arm (n = 78). Any-grade serious TEAEs (55.5% vs 56.4%), TEAEs leading to stoppage of study treatment (27.1% vs 25.6%), TEAEs leading to death (12.3% vs 16.7%), and treatment-related TEAEs leading to death (0.05% vs 0.02%) were reported in both arms.
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