Posted: 20 December 2023
Starpharma today announces positive final results from the completed Phase 2 clinical program of DEP® docetaxel. The clinical program included a monotherapy arm and two combination arms. The Phase 2 trial objectives were met, with endpoints demonstrating encouraging anti-tumour activity of DEP® docetaxel when administered as a monotherapy or in combination with other anti-cancer agents, nintedanib or gemcitabine, in multiple advanced, metastatic cancers, including pancreatic, gastro-oesophageal, non-small cell lung cancer (NSCLC) and cholangiocarcinoma.
The safety and tolerability of DEP® docetaxel were also confirmed, with DEP® docetaxel demonstrating an improved tolerability profile versus conventional docetaxel in terms of key adverse events, including myelosuppression (severe neutropenia), oedema (fluid retention), alopecia (hair loss) and allergic reactions (anaphylaxis/hypersensitivity).
Developed by Starpharma, DEP® docetaxel is a patented, dendrimer nanoparticle version of the chemotherapy drug docetaxel (Taxotere®[1]), which achieved peak sales of US$3.1B before patent expiry and is widely used for the treatment of a number of common cancers, including lung, gastro-oesophageal, head and neck, breast, and prostate.
The clinical trial also demonstrated the ability of DEP® docetaxel to effectively target tumours, with treated patient biopsies showing that tumour tissue achieved tissue levels of docetaxel up to 60 times higher than levels in blood (Figure 1). This tumour targeting effect was demonstrated across multiple cancer types. These findings confirm the ability of DEP® to increase the delivery of drug to tumours, as also demonstrated in multiple preclinical models.
Commenting on the results, Starpharma CEO, Dr Jackie Fairley, said:
“We are pleased to announce positive results of the Phase 2 clinical program for DEP® docetaxel. This product has shown encouraging results in multiple difficult-to-treat cancers, both as a monotherapy and in combination with gemcitabine or nintedanib. DEP® docetaxel also demonstrated lower rates of key adverse events, including severe neutropenia, hypersensitivity, fluid retention and hair loss, all of which are problematic side effects for patients treated with conventional docetaxel. In the trial, DEP® docetaxel achieved clinically meaningful disease control in multiple patients with advanced metastatic cancer who had no other treatment options available.
“These clinical findings, in addition to Starpharma’s recently reported results from the DEP® cabazitaxel and DEP® irinotecan programs, will feed into Starpharma’s ongoing commercial discussions for the products. These discussions will continue at the upcoming JP Morgan Healthcare Conference in San Francisco in January 2024, in which Starpharma will participate.
“Starpharma would like to thank the patients who participated in the DEP® docetaxel clinical trial program, as well as their families, caregivers, and the investigators and other clinical staff for their involvement in the program.”
