Melbourne, Australia; 16 October 2023: Starpharma (ASX: SPL, OTCQX: SPHRY) today provides a copy of the DEP® irinotecan clinical poster, highlighting the recently announced1 positive interim clinical data from Starpharma’s Phase 1/2 clinical trial, which demonstrated durable anti-tumour responses in advanced colorectal cancer (CRC) and platinum-resistant/refractory ovarian cancer.

The poster also includes new positive data for DEP^® irinotecan in the platinum-resistant ovarian cancer patient cohort, where the objective response rate (ORR2) in patients dosed every 2 weeks (Q2W) has increased from the previously reported 29%1 to 43%. In addition to this impressive efficacy, the duration of responses to DEP^® irinotecan treatment in these heavily pre-treated ovarian cancer patients, with tumour shrinkage of up to 60%, now have durations of up to 45 weeks, compared with 36 weeks reported previously¹. Several patients with ovarian cancer remain on DEP^® irinotecan treatment.

DEP^® irinotecan’s impressive ORR of 43% in these heavily pre-treated patients compares very favourably to standard-of-care single-agent therapies for platinum-resistant ovarian cancer, including paclitaxel (Taxol^®), topotecan (Hycamtin^®), gemcitabine (Gemzar^®) or pegylated liposomal doxorubicin (Caelyx^®), which report ORRs ranging from ~9 to 16%^3,4,5.

This DEP^® irinotecan poster was presented over the weekend in Boston, US, by Dr Jenny Liu, MD, PhD, FRACP, Medical Oncologist and Principal Investigator of the study at the Kinghorn Cancer Centre, St Vincent’s Hospital in Sydney, at the International Conference on Molecular Targets and Cancer Therapeutics, co-hosted by the American Association of Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) from 11 to 15 October 2023.

Dr Jenny Liu commented:

“The results of the DEP^® irinotecan trial to date have been very promising for patients with advanced colorectal cancer who have exhausted standard treatment options, with prolonged responses and excellent tolerance of the product, including in patients who could not previously tolerate standard irinotecan or had failed prior therapy.

“Our experience in treating more than 20 patients on the trial to date have shown promisingly low rates of severe gastrointestinal adverse events and absence of cholinergic toxicity, which are both common and problematic side effects of standard irinotecan therapy. I am also getting consistent feedback from several patients in the trial that they far prefer DEP^® irinotecan plus 5-FU/LV compared to the standard FOLFIRI regimen, which uses conventional irinotecan.

“In this heavily pre-treated group of CRC patients, prolonged disease control seen with DEP^® irinotecan is an excellent outcome and a significant clinical benefit and warrants ongoing development.”

Patients with platinum-resistant/refractory ovarian cancer represent a significant unmet medical need and a potential expansion of the current market for irinotecan, given conventional irinotecan is not approved for the treatment of ovarian cancer, either alone or in combination.

The anti-tumour activity of DEP^® irinotecan, including prolonged disease control in heavily pre-treated CRC and ovarian cancer patients, is encouraging as it demonstrates the promising clinical utility of DEP^® irinotecan and its potential for application in colorectal and platinum-resistant/refractory ovarian cancers.

The poster is appended.

View or download the ASX Announcement, here.

¹ ASX Announcement dated 13 September 2023: Positive DEP^® irinotecan clinical results presentation
² ORR = partial responses (PR) + complete responses (CR).
³ Taxol^® (paclitaxel) Injection label, https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020262s049lbl.pdf
⁴ Mutch et al., J Clin Oncol, 2007;25(19):2811-2818.
⁵ Pujade-Lauraine et al., J Clin Oncol, 2014;32(13):1302-1308.