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Jul 03, 2023

Erasca Starts Tissue

NEW YORK – Erasca on Tuesday said it began dosing patients within a Phase Ib trial testing the tissue-agnostic activity of its pan-RAF inhibitor naporafenib with Novartis' MEK inhibitor Mekinist

NEW YORK – Erasca on Tuesday said it began dosing patients within a Phase Ib trial testing the tissue-agnostic activity of its pan-RAF inhibitor naporafenib with Novartis' MEK inhibitor Mekinist (trametinib) in RAS Q61X-mutated solid tumors.

In the SEACRAFT-1 study, investigators will assess the safety, tolerability, and preliminary efficacy of naporafenib and Mekinist in about 100 patients with locally advanced unresectable or metastatic RAS Q61X-positive solid tumors that either lack standard treatment options or haven't responded to standard therapies. Erasca will exclude patients with central nervous system tumors from this trial. Researchers will primarily track patients' objective response rate on the combination regimen and measure secondary endpoints such as adverse events, duration of response, time to response, and progression-free survival.

Mekinist in combination with Novartis' BRAF inhibitor Tafinlar (dabrafenib) can already be given in a tissue-agnostic fashion in the US to patients with refractory solid tumors harboring BRAF V600E mutations, except colorectal cancer.

According to Erasca, more than 150,000 patients in the US and Europe have RAS Q61X-mutated solid tumors, and data from Novartis in melanoma and non-small cell lung cancer patients with NRAS Q61X and KRAS Q61X mutations has bolstered Erasca's confidence in pursuing the SEACRAFT-1 trial. "We look forward to sharing signal-seeking efficacy data in relevant tumor types from SEACRAFT-1 between the second and fourth quarters of 2023," Erasca CEO and Cofounder Jonathan Lim said in a statement.

San Diego-based Erasca plans to begin a pivotal Phase III trial, SEACRAFT-2, to evaluate naporafenib and Mekinist in patients with NRAS-mutant melanoma in the first half of 2024. The firm also recently began the Phase Ib HERKULES-1 trial of its ERK1/2 and SHP2 inhibitors, ERAS-007 and ERAS-601, respectively, in patients with RAS/MAPK pathway-altered solid tumors. And in Nov 2022, Erasca partnered with Pierre Fabre to evaluate ERAS-007 with Pfizer's BRAF inhibitor Braftovi (encorafenib) for BRAF V600E-mutant metastatic colorectal cancer.