The oral pan-RAS molecular glue ERAS-0015 has received FDA fast track designation for the management of metastatic pancreatic adenocarcinoma.
The FDA has granted fast track designation to ERAS-0015, an oral pan-RAS molecular glue, for the treatment of patients with metastatic pancreatic adenocarcinoma.¹
This designation follows reports of preliminary phase 1 activity of ERAS-0015 across multiple tumor types, including in patients with second-line or later KRAS G12–mutated pancreatic ductal adenocarcinoma (PDAC).
Erasca, the developer of ERAS-0015, is working with the FDA to plan a phase 3 trial of the molecular glue in patients with pancreatic cancer, alongside 2 additional potentially pivotal trials in patients with lung cancer. Additional monotherapy and combination data from the ongoing phase 1 program are expected to be released in the first half of 2027.
“Receiving fast track designation 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, chief executive officer, and cofounder of Erasca, stated in a news release. “Together with the encouraging clinical activity and favorable tolerability observed to date, this fast track designation helps to position us to rapidly advance the clinical development of ERAS-0015.”
ERAS-0015 is an investigational, oral, potent pan-RAS molecular glue that was designed to block RAS signaling. The inhibition of RAS wild-type variants via this molecular glue is intended to help prevent resistance that can emerge against mutant-selective inhibitors. In preclinical studies, ERAS-0015 demonstrated favorable absorption, distribution, metabolism, and excretion, as well as pharmacokinetic properties, across multiple animal species.
ERAS-0015 in RAS-Mutant Solid Tumors: Preliminary Phase 1 Highlights
The agent is being evaluated in the phase 1/1b AURORAS-1 trial (NCT06983743), a first-in-human, open-label, multicenter study assessing ERAS-0015 as monotherapy and in combination with other cancer therapies in patients with advanced or metastatic solid tumors harboring RAS mutations.² ERAS-0015 is being developed in parallel with a phase 1/2 dose-escalation trial (JYP0015M101; NCT06895031) in China.3
In July 2026, updated preliminary data from AURORAS-1 demonstrated an unconfirmed objective response rate (uORR) at 8 weeks of 57% in patients with second-line or later KRAS G12–mutated PDAC who received ERAS-0015 monotherapy at the recommended dose for expansion of 32 mg once daily.¹ All responding patients across dose levels were still receiving treatment as of the data cutoff, and the agent continued to have favorable tolerability.
These findings build on preliminary dose-escalation data reported in April 2026 from AURORAS-1 and the China-based trial. In that pooled analysis, ERAS-0015 produced a uORR of 62% (n = 37) in patients with second-line or later KRAS G12–mutated non–small cell lung cancer (NSCLC) and 40% (n = 20) in those with second-line KRAS G12–mutated PDAC at pharmacologically active doses of 16 mg to 32 mg once daily.3 Among patients with NSCLC who had received a prior immune checkpoint inhibitor and platinum-based therapy, the uORR was 75% (n = 16). The company cautioned that the data come from separate trials and are not based on head-to-head comparisons.
On the pharmacodynamic front, substantial reductions in KRAS G12 circulating tumor DNA were observed at pharmacologically active doses, with all evaluable patients showing at least a 75% reduction in KRAS G12 variant allele fraction. Preliminary data also suggested that ERAS-0015 may combine safely with standard-of-care doses of panitumumab (Vectibix), an anti-EGFR monoclonal antibody, with no dose-limiting toxicities reported in 3 safety-evaluable patients and 1 unconfirmed partial response among evaluable patients with metastatic colorectal cancer.
The fast track designation for ERAS-0015 adds to a growing body of regulatory activity targeting RAS-driven pancreatic cancer. In August 2026, the FDA
