There are often no definitive answers in medicine other than playing the odds. However, the results of new chemoimmunotherapy trial have found the odds are decidedly stacked on the side of the patient.
The study, using Immutep S.A.’s lead product, IMP321, and first-line paclitaxel, achieved a clinical benefit in 90% of patients suffering from metastatic breast carcinoma. The study, led by clinicians at the René Huguenin Cancer Centre in Saint Cloud, France,
was an open-label, fixed-dose-escalation trial. The other cancer centers in the study were Tenon Hospital and the Georges Pompidou European Hospital in Paris. The immuno-monitoring was carried out by Immutep at its laboratories near Paris.
The breast cancer patients received a dose of IMP321 every two weeks over 24 weeks. The repeated single doses were administered the day after chemotherapy at day two and day 16 of the 28-day cycles of paclitaxel; 30 patients received IMP321 in three cohorts (doses: 0.25, 1.25 and 6.25 mg).
The overall clinical benefit was observed for 90% of patients with only three progressors at 6 months. The objective tumor response rate of 50% compared favorably to the 25% rate reported in the historical control group.
With the conclusion of the trial, the company is currently in partnering discussions to carry out the phase IIb/III pivotal trial leading to conditional marketing authorization in Europe and further trials in other cancers and with other chemotherapies, according to Immutep CEO John Hawken, in a company press release.
(Source: Press Release)
