ERAS-0015

Aug. 24, 2026: Erasca, Inc. (NASDAQ: ERAS) said the FDA granted Fast Track Designation to ERAS-0015 for metastatic pancreatic adenocarcinoma. ERAS-0015 is an oral pan-RAS molecular glue being studied in the AURORAS-1 Phase 1 trial in RAS-mutant solid tumors.

The designation follows preliminary July 2026 AURORAS-1 data showing a 57% 8-week unconfirmed overall response rate in second-line-or-later KRAS G12X pancreatic ductal adenocarcinoma patients treated with ERAS-0015 monotherapy at the 32 mg once-daily recommended dose for expansion. The company said all responding patients across doses remained on treatment as of the May 25, 2026 data cutoff, and tolerability remained favorable.

Erasca said it plans three potentially registration-enabling trials: a Phase 3 trial in pancreatic cancer and two additional potentially pivotal trials in lung cancer. Additional AURORAS-1 monotherapy expansion and combination dose-escalation data, including from the panitumumab combination cohort, are expected in H1 2027.

The release also notes earlier Phase 1 dose-escalation findings of favorable safety/tolerability, linear PK, and confirmed and unconfirmed partial responses across multiple tumor types and RAS mutations, including confirmed partial responses at doses as low as 8 mg once daily.