FDA Grants Fast Track Status to Pan-RAS Molecular Glue for mPDAC

The FDA has granted fast track designation (FTD) to ERAS-0015, an oral pan-RAS molecular glue, clearing an expedited regulatory pathway for the investigational agent in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).¹

ERAS-0015 is designed to inhibit RAS signaling, including signaling driven by mutant RAS. In the ongoing AURORAS-1 phase 1 trial (NCT06983743), patients with KRAS G12X-mutant pancreatic ductal adenocarcinoma (PDAC) who had progressed on at least 1 prior line of therapy and received ERAS-0015 monotherapy at the recommended dose for expansion (RDE) of 32 mg once daily achieved an 8-week unconfirmed objective response rate (uORR) of 57%, as of a data cutoff of May 25, 2026. Every patient who responded to treatment remained on therapy at that point, and responses had already been observed at doses as low as 8 mg once daily earlier in dose escalation.¹

“Receiving FTD is an important milestone for ERAS-0015 and reflects the urgent need for new therapies for patients with metastatic pancreatic cancer,” Jonathan E. Lim, MD, chairman, CEO, and co-founder of Erasca, the developer of ERAS-0015, stated in a news release.¹ "Together with the encouraging clinical activity and favorable tolerability observed to date, this FTD helps to position us to rapidly advance the clinical development of ERAS-0015, including working closely with FDA on a planned phase 3 trial in pancreatic cancer, alongside two additional potentially pivotal trials in lung cancer. We look forward to reporting additional monotherapy and combination data in the first half of 2027.”

Data from AURORAS-1 disclosed separately from the fast track announcement point to activity beyond the pancreatic cohort. Among 37 patients with KRAS G12X-mutant non-small cell lung cancer treated at 16 mg to 32 mg once daily, investigators reported a uORR of 62%, rising to 64% among patients treated at the RDEs of 24 mg or 32 mg once daily.² A combination cohort pairing ERAS-0015 with panitumumab (Vectibix) in colorectal cancer cleared the 16-mg dose-escalation cohort without dose-limiting toxicities.³

Pharmacodynamic testing has also shown evidence of target engagement: all 14 evaluable patients had at least a 75% reduction in KRAS G12X circulating tumor DNA variant allele fraction, and 5 achieved complete clearance.²

Safety and Tolerability of ERAS-0015

ERAS-0015 has been generally well tolerated across the doses studied to date. Treatment-related adverse events (TRAEs) have skewed low-grade, and no patient has stopped treatment because of a TRAE. Dose interruptions and reductions linked to TRAEs have also been infrequent, and median relative dose intensity has held at 100% at both the 24 mg and 32 mg once-daily dose levels.³ Pharmacokinetic data collected during dose escalation showed well-behaved, linear drug exposure, while preclinical studies demonstrated favorable absorption, distribution, metabolism, and excretion properties.¹

AURORAS-1 Trial Design

ERAS-0015 is being tested in AURORAS-1, an open-label, US-based phase 1 study enrolling patients with RAS-mutant solid tumors.¹ The study is structured into dose-escalation and dose-expansion portions and includes both single-agent and combination cohorts, the latter pairing ERAS-0015 with panitumumab.⁴ The pancreatic cohort supporting the fast track application enrolled patients with KRAS G12X-mutant PDAC who had received at least one prior line of systemic therapy.

Erasca plans 3 potentially registration-enabling trials: a phase 3 study in pancreatic cancer and 2 trials in lung cancer. Additional monotherapy and combination results from the program are expected in the first half of 2027.¹

References

1. Erasca, Inc. Erasca granted FDA fast track designation for pan-RAS molecular glue ERAS-0015 in patients with metastatic pancreatic adenocarcinoma. News release. Erasca, Inc; August 24, 2026. Accessed August 25, 2026. https://tinyurl.com/2ejcrt26

2. Erasca, Inc. Erasca announces positive preliminary phase 1 dose escalation data for potentially best-in-class pan-RAS molecular glue ERAS-0015 in KRAS-mutant solid tumors. News release. Erasca, Inc; April 27, 2026. Accessed August 25, 2026. https://tinyurl.com/4s548khy

3. Erasca, Inc. Erasca announces updated preliminary phase 1 data and registration-enabling plans for potentially best-in-class pan-RAS molecular glue ERAS-0015 in KRAS-mutant solid tumors. News release. Erasca, Inc; July 13, 2026. Accessed August 25, 2026. https://tinyurl.com/4jv37ktu

4. ClinicalTrials.gov. A study of ERAS-0015 in patients with advanced or metastatic solid tumors (AURORAS-1). NCT06983743. Accessed August 25, 2026. https://tinyurl.com/4fm6rpmy