On June 1, 2019 Rakuten Medical, a clinical-stage biotechnology company developing precision-targeted cancer therapies based on its proprietary Photoimmunotherapy (PIT) platform, reported positive data results from its Phase 2a study, evaluating the safety and anti-tumor activity of RM-1929 (an EGFR-targeted antibody conjugate) PIT in patients with locoregional, recurrent head and neck squamous cell carcinoma (rHNSCC) (Press release, Rakuten Aspyrian, JUN 1, 2019, View Source [SID1234536761]). Details of its global Phase 3 study trial design were also presented.

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The Phase 2a positive data, presented during a poster presentation discussion during the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting in Chicago on Saturday, June 1, 2019, showed that treatment with RM-1929 PIT resulted in clinically meaningful activity in 30, heavily pre-treated patients with rHNSCC.

The overall response rate by independent review was 43 percent (95 percent CI 25.5‒62.6), including four (13 percent) complete responses and nine (30 percent) partial responses.
The median, progression-free survival was 5.2 months (95 percent CI 2.1‒5.5), and median overall survival was 9.3 months (95 percent CI 5.2‒16.9).
Treatment with RM-1929 PIT was generally well-tolerated.
Out of the 13 patients (43.3 percent) who experienced a serious adverse event, only three (10 percent) were considered treatment-related.
"Rakuten Medical is committed to addressing the unmet medical needs of patients with cancer, and we are encouraged by the Phase 2a trial data, which demonstrated clinically meaningful anti-tumor activity in patients with late-stage head and neck cancer," said Jeannie Hou, VP of Clinical Development at Rakuten Medical. "We look forward to enrolling patients in our global Phase 3 trial in head and neck cancer."

Phase 3 Trial Overview
Rakuten Medical has initiated its Phase 3, multicenter, randomized, double-arm, open-label trial of ASP-1929 (an EGFR-targeted antibody conjugate; analogous to RM-1929) PIT versus a physician’s choice of standard-of-care for locoregional rHNSCC patients who have failed after at least two lines of therapy, of which at least one line must be systemic, platinum-based chemotherapy for HNSCC.

An overview of the trial background, design and criteria was also presented at ASCO (Free ASCO Whitepaper) during a poster session. The primary endpoints of the study are progression-free survival and overall survival, with the key secondary endpoint being objective response rate. Rakuten Medical expects to enroll approximately 275 patients in the U.S., EU and Asia Pacific.

For more information about the Phase 3 clinical trial (NCT03769506), visit www.clinicaltrials.gov.

About Photoimmunotherapy
Photoimmunotherapy (PIT) is an investigational, anti-cancer treatment platform that is comprised of a drug and device combination that utilizes monoclonal antibodies conjugated to a dye (IRDye 700DX). Transient excitation of IRDye 700Dx with non-thermal red light (690 nm) is believed to result in anti-cancer activity, which is mediated by biophysical processes that may compromise the membrane integrity of cells. The requirement of targeted binding of antibody-IR700 conjugate to a specific antigen on the cell surface and subsequent illumination is believed to result in rapid and selective cell killing and tumor necrosis with minimal effects on surrounding normal tissue. PIT may also lead to the systemic induction of innate and adaptive immunity.