New Drug: Daraxonrasib for Previously Treated Pancreatic Cancer

In this phase 3 randomized trial in patients with previously treated metastatic pancreatic ductal adenocarcinoma, treatment with daraxonrasib significantly improved overall survival and progression-free survival compared to investigator’s choice chemotherapy. The response rate was higher with daraxonrasib, and patients reported longer times to deterioration in pain and quality of life. Daraxonrasib treatment was associated with fewer grade 3 or higher adverse events, fewer treatment discontinuations, and a generally manageable safety profile.

Study

Phase 3, international, open-label, randomized trial [RASolute 302]

Previously treated metastatic pancreatic ductal adenocarcinoma

Daraxonrasib (n=248) vs chemotherapy of investigator’s choice (gemcitabine plus nab-paclitaxel, liposomal irinotecan plus fluorouracil and leucovorin, modified FOLFIRINOX, FOLFOX) (n=252)

Efficacy

ORR: 33% vs 12% (daraxonrasib vs. chemotherapy)

mOS in RAS G12 population: 13.2 mos vs 6.6 mos (HR 0.40 [0.30-0.54])

mOS overall population: 13.2 mos vs 6.7 mos (HR 0.40 [0.30-0.53])

mPFS in RAS G12 population: 7.3 mos vs 3.5 mos (HR 0.45 [0.34-0.59])

mPFS overall population: 7.2 mos vs 3.6 mos (HR 0.49 [0.38-0.64])

Safety

Grade>=3 treatment-related AE: rash (14% vs 0%), stomatitis (12% vs 3%), neutropenia (2% vs 28%), anemia (4% vs 16%), diarrhea (5% vs 7%), fatigue (4% vs 6%)

Serious TRAE: 11% vs 19%

Treatment-related AE leading to discontinuation: 1% vs 11%