Australian biotech announces positive interim results in metastatic prostate cancer

Biotech News: Starpharma announced positive interim results from its ongoing phase 2 trial of DEP^® cabazitaxel for patients with hormone refractory, stage IV metastatic prostate cancer.

These interim efficacy results are very encouraging, especially given that the prostate cancer patients enrolled in the study were very heavily pre-treated, each having received an average of four prior cancer treatment regimens and an average of more than 70 cycles/months of prior anti-cancer treatment, in addition to surgeries and radiotherapy.

Many had also already received marketed taxane chemotherapies, including up to 14 cycles of Taxotere (docetaxel) and 10 cycles of Jevtana (conventional cabazitaxel). One patient had 10 prior treatment regimens, and almost half of the patients had received more than 90 cycles/months of therapy prior to DEP^® cabazitaxel treatment.

Professor Anthony Joshua, Study Investigator from the Kinghorn Cancer Centre in Sydney, commented “The trial results to date for DEP^® cabazitaxel in heavily pre-treated prostate cancer patients are highly encouraging and indicate the potential of the product compared to standard cabazitaxel. The anti-cancer activity, together with less myelosuppression than standard cabazitaxel and a generally well-tolerated safety profile, mean this novel form of dendrimer-enhanced cabazitaxel represents a useful option for prostate cancer patients, including in older patients in whom DEP^® cabazitaxel has been particularly well tolerated.”

Patients treated with DEP^® cabazitaxel also experienced significantly less severe bone marrow toxicity (myelosuppression), significantly lower rates of severe neutropenia and no instances of neutropenic sepsis, which are all significant risks associated with conventional cabazitaxel (Jevtana). Further, the absence of detergent-like polysorbate 80 in the DEP^® cabazitaxel formulation eliminated the need for prophylactic corticosteroids and antihistamines, with no anaphylaxis or severe hypersensitivity reactions observed.

Commenting on the results, Starpharma CEO, Dr Jackie Fairley, said “These positive results for DEP^® cabazitaxel in stage IV prostate cancer patients are really exciting news for Starpharma and our DEP^® platform. They include high rates of efficacy across three measures of disease – tumour size, PSA, and bone metastases, and compare favourably with published data for conventional cabazitaxel, e.g., Jevtana, particularly given the heavily pre-treated status of the patients in this trial and their older average age. These highly encouraging results include responses in patients who had previously received taxanes.”

Starpharma has a number of partnered DEP^® programs including with AstraZeneca and MSD.