Azenosertib in combination with chemotherapy is evaluated in patients with platinum-resistant ovarian cancer. Credit: Chinnapong / Shutterstock.

Zentalis Pharmaceuticals has reported positive data from a Phase Ib trial evaluating its WEE1 inhibitor, azenosertib combined with chemotherapy in patients with platinum-resistant ovarian cancer.

The trial enrolled a total of 115 patients across all chemotherapy combination groups.

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Azenosertib was well tolerated in combination with multiple chemotherapy types and demonstrated significant clinical activity.

Improvements were observed in objective response rates (ORRs) and median progression-free survival (mPFS) in all patients.

Patients with Cyclin E1+ tumours, a subgroup having a poor prognosis and refractory to chemotherapy, benefited most in chemotherapy combination arms.

Azenosertib plus paclitaxel demonstrated the highest ORR of 50% followed by an ORR of 38.5% for azenosertib plus gemcitabine in all dosing schedules.

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ORR of 35.7% was also observed when patients received azenosertib plus carboplatin and 19.4% in azenosertib plus PLD.

All azenosertib intermittent dosing groups showed Grade ≥3 treatment-related adverse events including neutropenia, fatigue, thrombocytopenia and anaemia.

Zentalis Pharmaceuticals CEO Kimberly Blackwell said: “We are very encouraged by our robust chemotherapy combination data, particularly the strong efficacy and tolerability results when dosing azenosertib intermittently.

“These data provide a compelling rationale to advance azenosertib into a registrational study in combination with either carboplatin or paclitaxel in Cyclin E1+ ovarian cancer.”

A recommended Phase II dose was also determined for each of the azenosertib combinations with carboplatin, paclitaxel, and PLD.

The company also plans to start a Phase III study comparing azenosertib dosed intermittently along with either paclitaxel or carboplatin in Cyclin E1+ platinum-sensitive ovarian cancer patients.

The study is anticipated to start in the first quarter of next year.