On July 18, 2022 Erasca, Inc. (Nasdaq: ERAS), a clinical-stage precision oncology company singularly focused on discovering, developing, and commercializing therapies for patients with RAS/MAPK pathway-driven cancers, reported that it has entered into a clinical trial collaboration and supply agreement (CTCSA) with Eli Lilly and Company for Lilly’s anti-EGFR antibody cetuximab (ERBITUX) (Press release, Erasca, JUL 18, 2022, View Source [SID1234639377]).
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This agreement will support Erasca’s ongoing Phase 1/1b FLAGSHP-1 trial, a clinical proof-of-concept trial evaluating ERAS-601, an oral SHP2 inhibitor, in various combinations, including with cetuximab for the treatment of triple wildtype (KRAS/NRAS/BRAF wildtype) metastatic colorectal cancer (CRC) and human papillomavirus (HPV)-negative advanced head and neck squamous cell carcinoma (HNSCC). Erasca is the sponsor of the trial, and Lilly is supplying cetuximab at no cost. Erasca previously signed CTCSAs with Lilly and Pfizer, respectively, to evaluate cetuximab and encorafenib (BRAFTOVI) in combination with Erasca’s ERK1/2 inhibitor, ERAS-007, as part of Erasca’s HERKULES-3 Phase 1b/2 trial.
"We are pleased to enter another clinical trial collaboration with Lilly to explore cetuximab in combination with ERAS-601, our SHP2 inhibitor, in EGFR-driven cancers that are highly dependent on RAS/MAPK signaling," said Jonathan E. Lim, M.D., Erasca’s chairman, CEO, and co-founder. "Dual inhibition of EGFR and SHP2, a convergent RTK signaling node, has the potential to broaden and deepen responses relative to cetuximab monotherapy and delay onset of resistance in cancers like triple wildtype metastatic CRC and HPV-negative advanced HNSCC."
Approximately 1.5 million cases of CRC are diagnosed annually worldwide, with triple wildtype CRC, representing nearly 50% of all cases. HNSCC is one of the most common cancers worldwide, with around 0.7 million new cases annually of which 70-75% are HPV-negative HNSCC. While there are treatment options available in these tumor types, treatment resistance continues to limit long-term durability. The clinical development of this combination was supported by preclinical data Erasca presented at the 2022 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting demonstrating ERAS-601 in combination with cetuximab enhanced anti-proliferative activity and inhibited tumor growth over either agent alone in models of HPV-negative HNSCC and triple wildtype CRC.
About ERAS-601
ERAS-601 is a potential best-in-class oral, selective SHP2 inhibitor being investigated alone or in combination. SHP2 acts as a convergent node for receptor tyrosine kinase (RTK) signaling, relaying growth and survival signals from RTKs to intracellular signaling pathways. ERAS-601 is being investigated across a series of clinical trials that span multiple tumor types and include both monotherapy and combinations with approved and investigational agents. FLAGSHP-1 is a Phase 1/1b dose escalation trial evaluating ERAS-601 as a monotherapy in advanced solid tumors and in combination in triple wildtype CRC and HPV-negative HNSCC. HERKULES-2 is a Phase 1b/2 master protocol clinical trial that includes evaluation of ERAS-601 in combination with various agents in patients with non-small cell lung cancer.