PSMA ADC: Phase II data

Progenics said 2 patients with advanced disease who each received 1 cycle of 2.5 mg/kg IV PSMA ADC died due to sepsis in the open-label, U.S. Phase II PSMA ADC 2301 trial to treat metastatic CRPC. The trial enrolled 80 CRPC patients with progressive disease despite treatment with >=1 taxane-containing chemotherapy to receive IV PSMA ADC given every 3 weeks for up to 8 doses. The company said 1 of the patients that died had been hospitalized a couple of weeks prior to enrollment due to an infection that recurred. The other patient that died had an infection upon enrollment in addition to several co-morbidities, including heart failure. Progenics said the deaths were due in part to a drop in white blood cell count as a result of treatment with PSMA ADC. The company said an independent DMB, the trial investigators and FDA agreed that the trial could move forward with a 2.3 mg/kg dose of PSMA ADC. Progenics also said it will now implement criteria in which patients with a serious infection within 1 month prior to enrollment will be excluded from the trial. In the trial, 35 patients began treatment with PSMA ADC at the 2.5 mg/kg dose. However due to neutropenia, the remaining 35 patients began treatment at a dose of 2.3 mg/kg. The most common adverse events reported were neutropenia and peripheral neuropathy. ...