Dose escalation of RG6344 demonstrates safety and promising activity in BRAF V600E solid tumours

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Published: 1 Sep 2025
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Dr Maria Vieito - Vall d'Hebron Institute of Oncology, Barcelona, Spain

Dr Maria Vieito speaks to ecancer about a phase I study evaluating safety, pharmacokinetics, and clinical activity of the novel, paradox breaker BRAF inhibitor RG6344 in patients with BRAF V600-mutant solid tumours.

The study evaluated the RG6344 inhibitor, focusing on its safety, pharmacokinetics, and clinical activity.

It included a monotherapy escalation of RG6344, as a single agent and in combination with standard dose of cobimetinib in solid tumours harbouring a BRAF V600E mutation up to the protocol specified maximum daily dose.

Dr Vieito highlights that the inhibitor showed a well-tolerated safety profile with mild cutaneous toxicity and demonstrates antitumour activity, achieving one complete response and 15 partial responses among 66 patients.

She says that in addition to this, a new generation treatment is also being developed.