Rakuten Medical To Begin Phase 3 Trials of Alluminox Treatment For Head and Neck Cancers
Rakuten Medical, a global biotechnology company developing and commercializing precision, cell-targeting therapies based on its proprietary Alluminox platform, stated that the company has been granted permission from the Central Drugs Standard Control Organization (CDSCO) to conduct its global, pivotal Phase 3 clinical trial evaluating Alluminox treatment (photoimmunotherapy) using ASP-1929 in patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC) in India.
The study sites will include several leading medical institutions in India such as the Tata Memorial Centre and Narayana Health and the treatment will be administered to enrolled patients once ready. This ASP-1929-301 study is currently underway in several countries such as the U.S. and Taiwan and will enroll 275 patients globally including Indian patients.
In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25 per cent of all new head and neck cancer cases worldwide1. One of the reasons for this is the widespread use of chewing tobacco. More than 28 per cent of all adults (15 years and above) in India are users of tobacco, and approx.
75 per cent of them use smokeless tobacco, including chewing tobacco2. It has been reported that more than half of oral cancer (a type of head and neck cancer) in India is attributable to smokeless tobacco, including chewing tobacco. In addition to the high occurrence of head and neck cancer, it is known that the majority of these patients present with advanced disease, which also corresponds with poorer outcomes.
Such high volumes of advanced stage patients can present many challenges for the surgeons and medical oncologists who treat head and neck cancer. Time and treatment options are limited. Surgery, radiation, and chemotherapy are all commonly used to manage this patient population – but more options are needed.
The multi-centre randomized, open-label, global Phase 3 study of Alluminox treatment using ASP-1929 will evaluate the efficacy and safety of ASP-1929 in patients with locoregional, recurrent HNSCC who have previously failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy, and are not eligible for surgery or radiation.
Participants will be randomized to receive experimental therapy or investigator's choice of systemic therapy (2:1). The dual-primary endpoints of the study are progression-free survival and overall survival, and a key secondary endpoint includes objective response rate.
“We are very pleased to be conducting the pivotal Phase 3 study of Alluminox treatment using ASP-1929 in India, where there is a high unmet need for head and neck cancer treatment,” said Mickey Mikitani, Co-CEO of Rakuten Medical. “The addition of India to this important study will help to accelerate the development of this drug. We will continue to do our utmost to bring a new treatment option to patients with head and neck cancer around the world as soon as possible, working closely with medical institutions and regulatory authorities in each country.”
ASP-1929 is a conjugation of an antibody cetuximab and IRDye 700DX, a light activatable dye, and is Rakuten Medical’s first pipeline drug developed on its Alluminox platform. It binds to epidermal growth factor receptor (EGFR), which is highly expressed in head and neck cancers.
After binding to cancer cells, ASP-1929 is locally activated by non-thermal red light (690 nm) illumination, which leads to selective cell killing in pre-clinical observations. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the drug in January 2018.
