Hot on the heels of trimming its pipeline, Erasca is pushing ahead with its pan-RAF inhibitor naporafenib programme. The company has initiated a Phase III trial investigating the drug in combination with Novarits’ Mikinist (trametinib) to treat patients with a form of melanoma.
The global SEACRAFT-2 Phase III trial (NCT0634606) is expected to enrol 470 participants with NRAS-mutant (NRASm) melanoma. The randomised study will assess the efficacy and safety of naporafenib and Mikinist. The combination will be compared with two other physician-chosen drugs – Pfizer’s DTIC-Dome (dacarbazine) or MSD’s Temodar (temozolomide) – or Mikinist alone.
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NRASm melanoma patients eligible for the trial are those who have not responded to or cannot take anti-programmed death-1 ligand 1 (PD-1/L1) medication.
A readout from the dose optimisation first stage of the trial comparing the therapy to Mikinist alone is scheduled for 2025.
The study’s primary endpoints include objective response rate, progression free survival and plasma concentration assessments. The incidence and severity of treatment-emergent adverse events (AEs) up to six months after the last dose is the primary outcome measure for safety.
Naporafenib, which has received fast track designation from the US Food and Drug Administration (FDA), has demonstrated positive efficacy in a pooled analysis of Phase Ib and Phase II (NCT02974725) data.
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By GlobalDataPan-RAF inhibitors work by blocking the RAF (Rapidly Accelerated Fibrosarcoma) pathway, which is often dysregulated in cancers such as melanoma. Overexpression of the protein components in the pathway have roles in tumour initiation, progression and metastasis.
Erasca said naporafenib’s initial focus will be in NRASm melanoma as well as RAS Q61X solid tumours – the latter indication is being evaluated in the ongoing SEACRAFT-1 Phase Ib trial (NCT05907304).
Erasca shuffled its pipeline earlier this year, discontinuing pan-KRAS programme ERAS-4, ERK inhibitor ERAS-007 and EGFR inhibitor ERAS-801.
The company has continued development of Naporafenib, as well as two assets licensed from Joyo Pharmatech and Medshine Discovery. As part of the pipeline trim, Erasca reduced its workforce by around 18%.
