First patient suffering from head & neck carcinomas treated in Rakuten Medical’s global phase 3 trial in India

New Delhi: Rakuten Medical has announced that the first patient in India received study treatment in August 2023 under Rakuten Medical’s global, pivotal Phase 3 clinical trial of Alluminox treatment (photoimmunotherapy) using ASP-1929 for patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC).

The ASP-1929-301 study is currently ongoing in countries and regions including the United States, India and Taiwan, and will enroll a total of 275 patients globally. In India, six leading medical institutions are currently participating in the ASP-1929-301 study.

Alluminox treatment is gaining increasing interest in India as the trial progresses, and two physicians were invited from Japan to present their extensive experiences using this treatment at the 23rd National Conference of Foundation for Head and Neck Oncology, held in Daman, India, on December 22-24, 2023. For details, please see the press release.

In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25% of all new head and neck cancer cases worldwide1. In addition to the high occurrence of head and neck cancer, the majority of these patients present with advanced disease, which also corresponds with poorer outcomes2. Such high volumes of advanced stage patients can present many challenges for surgeons and medical oncologists who treat head and neck cancer, as treatment options for such patients are limited. Surgery, radiation, and chemotherapy are all commonly used to manage this patient population – but more options are needed.

Dr. Subramania Iyer K., an investigator for the ASP-1929-301 study at the Amrita Institute of Medical Sciences and Research Centre (Kochi), stated in an interview conducted by Rakuten Medical in July 2023, “When we had discussion about it (Alluminox treatment), we thought it was one of the most innovative ideas which we should try to implement and look at it. I hope and I’m sure that this will make a lot of difference in the way we treat cancers in the future.”

(ASP-1929-301 study / ClinicalTrials.gov Identifier: NCT03769506, CTRI Number: CTRI/2023/05/052728)