Erasca, Inc. a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, announced that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly and Company for Lilly’s anti-EGFR antibody cetuximab (ERBITUX).
This agreement will support the ongoing Phase 1b/2 HERKULES-3 trial, a clinical proof-of-concept study evaluating ERAS-007, an oral ERK1/2 inhibitor, in various combinations, including with the BRAF inhibitor encorafenib (BRAFTOVI) and cetuximab for the treatment of patients with BRAF V600E-mutant metastatic colorectal cancer (mCRC). Erasca will sponsor the study, and Lilly will supply cetuximab at no cost. The two companies will form a joint committee to review the clinical trial results.
“We are grateful to Lilly for their collaboration as we explore the therapeutic potential of adding ERAS-007, our intermittently-dosed ERK1/2 inhibitor, to the current standard of care regimen for this patient population,” said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. “We expect the long-term benefits seen with current standard of care may be limited due to resistance mechanisms, particularly through MAPK reactivation. ERAS-007 inhibits the terminal node of the MAPK pathway and, based on preclinical models, offers more robust inhibition of MAPK reactivation over MEK and other ERK inhibitors. Additionally, ERAS-007’s pharmacokinetic and tolerability profile positions it well for combinations.”
There are approximately 180,000 people, representing approximately 10% of all patients with CRC globally, who have BRAF V600E mutations. The combination of encorafenib plus cetuximab significantly improved overall survival in patients with mCRC with a BRAF V600E mutation compared to the control arm. Those clinical results also showed that 20% of patients experience an objective response and half of these responses last more than four months. Therefore, emergence of resistance is a major therapeutic barrier to long-term clinical benefit. Erasca is exploring whether ERK inhibition with ERAS-007 in combination with encorafenib plus cetuximab can reduce the emergence of resistance and further improve treatment benefit for patients with BRAF V600E CRC.