Immunotherapy of advanced pancreatic carcinoma with the monoclonal antibody BW 494

In the course of a phase I study monoclonal antibody BW 494 was injected i.v. at a dose of 180-340 mg to 18 patients with advanced ductal pancreatic carcinoma. The murine IgG1-antibody is directed against a pancreatic carcinoma-associated glycoprotein. The antibody inhibits the functions of human pancreatic carcinoma cells. Diffuse muscle pain, which disappeared spontaneously, was noted by two patients 14 days after injection. Other side-effects were anaphylactoid reactions in two patients 12 and 19 days, respectively, on repeat antibody infusions. This event led to changes in the administration schema so that the total amount was given within ten days, after which there were no further allergic side-effects. Terminal antibody half-life was 47.8 h (initial half-life 0.2 h). Human anti-mouse antibodies in all eight patients tested for them developed within two to three weeks of the end of treatment. There were no tumour remissions. Progression of the tumour after treatment occurred in 12 patients (67%). In five patients the course was stable for at least three months after treatment, i.e. unchanged clinical status, unchanged tumour extent (CT), and stable tumour markers (CEA, CA 19-9) in serum. One female patient with a T3N1M0 carcinoma has so far lived for 16 months in full employment. The results justify the use of the monoclonal antibody in future controlled trials.