Cabozantinib: Interim Phase II data
Updated interim data from 490 evaluable patients with various solid tumors in the lead-in stage of an ongoing, adaptive, international Phase II trial showed that once-daily oral cabozantinib led to 12-week overall disease control rates (DCRs) of 73%, 68%, 53%, 47%, 45% and 40% for patients with hepatocellular carcinoma (HCC), castration-resistant prostate cancer (CRPC), ovarian cancer, melanoma, breast cancer and non-small cell lung cancer (NSCLC), respectively. Lower 12-week DCRs were observed in patients with small cell lung cancer (SCLC) (38%), pancreatic adenocarcinoma (35%) and gastric/gastroesophageal junction cancer (33%), and as a result the trial will no longer evaluate these tumor cohorts. There was 1 complete response and 39 partial responses (PRs) in the lead-in stage of the trial.
The most common grade 3 or 4 adverse events were fatigue, palmar-plantar erythrodysesthesia (PPE), diarrhea and hypertension. There were 6 cabozantinib-related deaths reported following the lead-in stage of the trial and included respiratory compromise in a breast cancer patient; hemorrhage in a NSCLC patient; enterocutaneous perforation and intestinal perforation each in an ovarian cancer patient; gastrointestinal hemorrhage in a pancreatic cancer patient; and an additional death in a CRPC patient. ...