Clinical-stage biotech company Lytix Biopharma ASA (Euronext Growth Oslo:LYTIX) announced on Tuesday that its Phase II NeoLIPA study evaluating ruxotemitide in combination with pembrolizumab in patients with resectable melanoma has met its primary endpoint of pathological complete response (pCR).
The pCR rate in the evaluable patient population met the study's prespecified success threshold of at least 40%, indicating no viable cancer cells were detected in tumour tissue removed during surgery. No new safety signals were identified in the available data.
Full results, including the exact pCR rate for the complete evaluable population, will be presented at an upcoming international oncology conference.
NeoLIPA is a single-arm, non-randomised Phase II study. Lytix plans to advance ruxotemitide plus pembrolizumab into a randomised Phase III trial comparing the combination with pembrolizumab alone, using event-free survival as the primary endpoint.
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