Ann M. Gillenwater, MD – MD Anderson, Department of Head and Neck Surgery, Division of Surgery

presents the First Safety and Efficacy Data of the Rakuten Medical Alluminox Treatment using ASP-1929 in Combination with anti-PD-1 for Recurrent and/or Metastatic Head and Neck Cancer at AHNS 2023. 

Questions:

Can you please summarize the Phase 1b/2 study ASP-1929-181 that you presented this week at the American Head & Neck Cancer Society 2023  meeting? 

Can you please explain the Alluminox technology? 

Can you provide our viewers with information about any other Alluminox ASP-1929 data in head and neck cancer?

Can you talk about the Alluminox ASP-1929 phase 3 trial?

This open-label clinical trial aims to investigate the safety and effectiveness of combining ASP-1929 photoimmunotherapy with anti-PD1 therapy in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) or advanced or metastatic cutaneous squamous cell carcinoma (cuSCC). The study involves three separate cohorts of patients with different types of squamous cell cancer who will receive either Pembrolizumab or Cemiplimab (anti-PD1 therapies) in combination with ASP-1929, an anti EGFR antibody-dye conjugate, followed by photoimmunotherapy (PIT). The primary objective is to assess the safety, tolerability, and tumor response of the combined treatment.

The study will be conducted in a non-randomized, parallel assignment design, and a total of 74 participants are estimated to be enrolled. The trial is expected to start in December 2020, with an estimated primary completion date in June 2024 and the study completion date in June 2025. The researchers will evaluate the safety and tolerability of ASP-1929 PIT in combination with anti-PD1 therapy by monitoring treatment-emergent adverse events (TEAE) and serious TEAEs.

For patients with HNSCC, they must have a positive expression of programmed cell death ligand 1 (PD-L1) with Combined Positive Score (CPS) ≥1. Cohort 1 includes patients with recurrent locally advanced and/or metastatic HNSCC who will receive 200 mg of Pembrolizumab every 3 weeks and ASP-1929 IV on Day 8 of each 6-week cycle, followed by photoimmunotherapy light treatment on Day 9, for up to 24 months.

Cohort 2 consists of patients with locally advanced or metastatic cuSCC, who will receive 350 mg of Cemiplimab every 3 weeks and the same treatment with ASP-1929 and photoimmunotherapy as described in Cohort 1.

Cohort 3 includes patients with locally advanced or metastatic cuSCC, whose disease has progressed despite at least two months of anti-PD1 therapy. They will receive the same treatment with Cemiplimab and ASP-1929, followed by photoimmunotherapy.

The study will evaluate the effect of the combined treatment on tumor response using objective response rates (ORR) as assessed by investigators and central review, based on modified RECIST 1.1 criteria. Secondary outcome measures include assessing overall survival (OS), progression-free survival (PFS), and duration of response (DOR) over a 24-month period.

To be eligible for the study, participants must provide written informed consent and meet specific inclusion criteria for their respective cancer cohorts. They should have measurable disease and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Participants in Cohort 1 must not have received prior systemic therapy in the recurrent and/or metastatic setting, except for systemic therapy completed ≥ 6 months prior as part of multimodal treatment for locally advanced disease. Adequate organ function is required, and female patients of childbearing potential must have a negative pregnancy test and use highly effective birth control during the study. Male participants must also use effective contraception during the study.

Exclusion criteria include prior therapy with anti-PD1 or anti-PD-L1, recent radiation therapy, chronic systemic steroid therapy, a history of significant cetuximab infusion reactions, prior allogeneic transplant, active central nervous system metastases, active autoimmune disease, interstitial lung disease, active infections, known HIV or AIDS-related illness, recent live vaccination, breastfeeding, recent major surgery or traumatic injury, recent participation in other investigational studies, or uncontrolled intercurrent illnesses.

In conclusion, this open-label study seeks to explore the safety and efficacy of ASP-1929 photoimmunotherapy combined with anti-PD1 therapy in different cohorts of patients with squamous cell cancer. The results of this study may provide valuable insights into the potential benefits of this novel treatment approach for patients with recurrent or metastatic head and neck and squamous cell carcinoma or advanced or metastatic cutaneous squamous cell carcinoma.