Erasca announced updated preliminary Phase 1 AURORAS-1 data showing a 57% uORR8wk in 2L+ KRAS G12X PDAC at the 32 mg recommended dose and generally consistent safety with prior disclosures.
Key Highlights:
- Monotherapy in 2L+ KRAS G12X PDAC: 57% uORR8wk (N=7) at 32 mg QD RDE, with most responders remaining on treatment.
- Safety consistent with prior report: mostly low-grade TRAEs, no DLTs, low dose interruptions/reductions, no TRAE-related discontinuations.
- Combination with panitumumab shows tolerability: no DLTs in 16 mg cohort dose escalation; backfill and 24 mg escalation ongoing.
- Development plan accelerated: potential registration-enabling NSCLC 2L+ trial in H1 2027 and Phase 3 pivotal PDAC first-line trial in 2027.
Original SEC Filing:
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