On May 24, 2024 Rakuten Medical, Inc., a global biotechnology company developing and commercializing precision, cell-targeting photoimmunotherapy based on its proprietary Alluminox platform, reported the updated safety and efficacy findings from an interim evaluation of an open-label Phase 1b/2 study (ASP-1929-181/ClinicalTrials.gov Identifier: NCT04305795) of photoimmunotherapy using ASP-1929 in combination with anti-PD-1 for recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC) (Press release, Rakuten Medical, MAY 24, 2024, View Source [SID1234643694]). The data will be presented in a poster at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2024) on June 2, 2024.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The updated interim evaluation (data cut-off: August 31, 2023) of 19 enrolled patients in ASP-1929-181 study suggests that the novel treatment approach of ASP-1929 photoimmunotherapy in combination with anti-PD-1 showed promising early results in patients with locoregional and/or metastatic HNSCC. Median overall survival (OS) was not reached at data cut-off, with an estimated survival rate of 52.4% at 24 months, and an objective response rate (ORR) of 35.3%. Adverse events were generally manageable, and the combination therapy was generally tolerated with an absence of synergistic serious adverse events.
The encouraging early efficacy and safety outcomes warrant additional clinical studies to substantiate and reinforce these interim findings. Rakuten Medical recently completed a Type B End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for the combination of ASP-1929 photoimmunotherapy and anti-PD-1 in the first-line recurrent HNSCC setting and discussed the key details for a multi-regional registrational study. Based on these results, Rakuten Medical plans to initiate this global phase 3 clinical trial with a primary endpoint of OS in the second half of 2024.
Disclaimer: These interim findings may change upon completion of follow-up and final data analysis.
Key findings
[Efficacy]
Clinically meaningful activity was observed
Median Overall Survival (OS) was not reached, with an estimated survival rate of 52.4% (95% CI: 25.9-73.4) at 24 months
The objective response rate (ORR) was 35.3% (6 patients, 95% CI: 14.2-61.7), which included 4 complete responses (CR) (23.5%, 95% CI: 6.8-49.9) and 2 partial responses (PR) (11.8%, 95% CI: 1.5-36.4)
Median time to response of 1.4 months
Median progression-free survival (PFS) was at 2.9 months (95% CI 1.4-14.6)
[Safety]
Adverse events were manageable and generally tolerated
No fatal serious adverse events (SAEs)
Two Grade 4 SAEs: laryngeal edema related to photoimmunotherapy and tumor hemorrhage unrelated to study treatment, both of which resolved
No synergistic SAEs due to ASP-1929 and anti-PD-1
Upcoming Rakuten Medical’s Poster Presentation at ASCO (Free ASCO Whitepaper)
Abstract Title: Recent safety and efficacy findings from a phase 1b/2 open-label combination study of ASP-1929 photoimmunotherapy with anti-PD-1 therapy in EGFR-expressing advanced head and neck squamous cell carcinoma (HNSCC)
Abstract Number: 6083
Abstract Link: View Source
Session Name: Poster Session – Head and Neck Cancer
Session Date: Sunday, June 2, 2024
Session Time: 9:00 a.m. – 12:00 p.m., CDT
First Author: David M. Cognetti, Department of Otolaryngology – Head and Neck Surgery, Thomas Jefferson University, US
Location: Exhibit Hall A, Poster Board #399