On October 24, 2024, Erasca, Inc. (the Company) reported preliminary data from its SEACRAFT-1 Phase 1b trial in an oral presentation at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium (Press release, Erasca, OCT 24, 2024, View Source [SID1234647365]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In the Phase 1b trial of naporafenib plus trametinib (MEKINIST) in patients with locally advanced unresectable or metastatic solid tumor malignancies with RAS Q61X mutations, the preliminary clinical activity of naporafenib plus trametinib in the melanoma cohort include, as of the efficacy cutoff date*:
•
40% (4/10) response rate observed in the efficacy-evaluable patients with NRAS Q61X melanoma, including three confirmed partial responses and one unconfirmed partial response; the melanoma cohort in SEACRAFT-1 is generally representative of the patient population currently being enrolled in the pivotal SEACRAFT-2 trial
•
70% (7/10) of patients remained on treatment as of the data cutoff, including all four responders
*Safety data cutoff date was September 3, 2024. Efficacy data cutoff date was September 5, 2024.
Naporafenib plus trametinib has been generally well tolerated as of the safety cutoff date, with mostly low-grade adverse events in the majority of patients. The Company believes that the use of mandatory primary rash prophylaxis helped reduce the frequency and severity of skin toxicities, reduced drug discontinuation rate due to adverse events, and improved the observed tolerability as measured by the increased relative dose intensity, as compared to the prior clinical trials of naporafenib plus trametinib conducted by Novartis, which did not include the use of mandatory primary rash prophylaxis.
The Company believes that the preliminary SEACRAFT-1 data reinforce the potential of the ongoing Phase 3 SEACRAFT-2 trial in patients with NRAS-mutant (NRASm) melanoma. The Company expects to read out randomized dose optimization data from Stage 1 of the SEACRAFT-2 Phase 3 trial in 2025.