CBP501: Preliminary Phase II data

Preliminary data from an open-label, international Phase II trial in 65 chemotherapy-naïve patients with unresectable MPM showed that 25 mg/m 2 IV CBP501 plus cisplatin and pemetrexed on day 1 of a 21-day cycle met the primary endpoint of a >55% PFS rate at 4 months. Specifically, the combination produced a 4-month PFS rate of 68%. Additionally, CBP501 plus cisplatin and pemetrexed led to median PFS of 6.4 months vs. 4.7 months for cisplatin and pemetrexed alone (HR=0.506, p=0.03), while median OS was 15 months for CBP501 plus chemotherapy vs. 11.2 months for chemotherapy alone (p>0.05). Best ORR was 32% in patients receiving CBP501 plus chemotherapy vs. 14% for chemotherapy alone. CanBas said the sample size of the trial was insufficient to determine statistical significance between treatment arms for the median PFS, OS and ORR endpoints. The most common adverse events were grade 1/2 infusion reactions. CanBas said the data suggest that a Phase III trial may be warranted, but did not disclose details. ...