Risovalisib for PIK3CA-mutated recurrent or persistent ovarian clear cell carcinoma: a single-arm, multicentre, phase 2 trial.

Risovalisib achieved an objective response rate of 35% (95% CI 25–46) in 84 patients with recurrent or persistent PIK3CA-mutated ovarian clear cell carcinoma.

• Why it matters: After platinum chemotherapy failure, treatment options for advanced ovarian clear cell carcinoma are limited, and PIK3CA mutations are common but not yet well served by targeted therapies.
• What they did: In a single-arm phase 2 trial across 27 centers in China and 12 in Japan, adults with ECOG 0–1 received oral risovalisib 40 mg daily in 21-day cycles until progression or discontinuation.
• The result: Grade 3+ treatment-related adverse events included rash (32%) and hyperglycaemia (30%), with no treatment-related deaths; these findings support risovalisib as a potential option and justify exploring combinations.

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