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Erasca Begins HERKULES-2 Trial of ERAS-007, Tagrisso in EGFR-mutated NSCLC

NEW YORK – San Diego-based Erasca said on Thursday that it had dosed the first non-small cell lung cancer patient in the HERKULES-2 platform trial exploring the investigational ERK1/2 inhibitor ERAS-007 in combination with other treatments.

The Phase Ib/II study will initially evaluate the activity of ERAS-007 with the EGFR inhibitor osimertinib (AstraZeneca's Tagrisso) in advanced, EGFR-mutated NSCLC. After researchers settle on a Phase II dose of ERAS-007, they will study the ERAS-007-osimertinib combination in NSCLC patients who have developed resistance to initial treatment with osimertinib. Future sub-studies within HERKULES-2 will pair ERAS-007 or Erasca's SHP2 inhibitor ERAS-601 with other drugs in NSCLC patients with KRAS G12C or other mutations in their tumors.

Preclinical studies suggest ERAS-007, which is designed to target the terminal node of the RAS/MAPK pathway, has anti-tumor activity in cancers with BRAF, KRAS, NRAS, HRAS, and KRAS mutations.

"Erasca's series of HERKULES trials also includes tissue-specific master protocols in gastrointestinal cancers and hematological malignancies as well as a tissue-agnostic trial, tailored to evaluate promising combinations to inhibit oncogenic signaling and prevent the emergence of resistance," Erasca CEO Jonathan Lim said in a statement.

In addition to HERKULES-2, Erasca will launch two other Phase Ib/II trials, dubbed HERKULES-3 and HERKULES-4, in which ERAS-007 will be studied in combination with various agents in patients with gastrointestinal cancers and hematologic malignancies, respectively. The company expects to begin HERKULES-3 by year-end and HERKULES-4 in the first quarter of 2022.

Earlier this week, Erasca announced plans to evaluate ERAS-007 with Pfizer's encorafenib (Braftovi) and Eli Lilly's cetuximab (Erbitux) for metastatic, BRAF V600E-mutated colorectal cancer.