By repeating therapy cycles, clivatuzumab tetraxetan labeled with 90Y plus low-dose gemcitabine improve overall survival (OS) over single-cycle therapy in patients with locally advanced or metastatic pancreatic cancer, according to updated data presented at the Gastrointestinal Cancers Symposium. Researchers also found that as the 90Y labeld clivatuzumab tetraxetan dose increased so did median OS.
The updated results from this open-label, phase 1/2 study included 50 evaluable patients treated with 90Y labeled clivatuzumab tetrxetan once weekly for 3 weeks in combination with gemcitabine. Increasing the number of cycles increased median OS from 5.4 to 11.6 months.
For all dose groups, the overall disease control rate was 60%, with 14% achieving a partial response by RECIST criteria and 46% disease stabilization. In addition, increasing the dose of 90Y-labeled clivatuzumab from 9 mCi/m2 to 12 mCi/m2 or higher improved median OS from 6 to 8 months.
Increased 90Y-labeled clivatuzumab did not significantly alter nonhematologic side effect. Hematologic events included suppression; however, it was transient and occurred without major infections or bleeding events.
The continuing study will enroll patients to receive 90Y-labeled clivatuzumab tetraxetan at 12 mCi/m2 once weekly for 3 weeks, and gemcitabine at higher doses, including the standard-of-care dose of 1000 mg/m2.