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Karl D. Lewis, MD


ASCO 2022: First-in-Human Study of RM-1995 Photoimmunotherapy in Advanced Squamous Cell Skin Cancer

By: Sarah Campen, PharmD
Posted: Wednesday, June 22, 2022

An early study of a first-in-human photoimmunotherapy, RM-1995, is currently enrolling patients with advanced cutaneous squamous cell carcinoma or with head and neck squamous cell carcinoma. The phase I dose-escalation study will evaluate RM-1995 as monotherapy and in combination with the PD-1 inhibitor pembrolizumab, according to David M. Cognetti, MD, of Thomas Jefferson University, Philadelphia, and colleagues. The trial details were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract TPS6103).

RM-1995 is a novel agent consisting of a CD25 antibody conjugated with a light-activatable dye, which can be activated by illumination with 690 nm of nonthermal red light for precise, targeted cell killing. The phase Ia portion of this trial will evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of single-agent RM-1995 photoimmunotherapy. The maximum tolerated dose or maximum administered dose of RM-1995—with a fixed light dose for tumor illumination—will also be determined. In the phase Ib portion of the trial, treatment will include combination therapy with pembrolizumab.

Enrolled patients will receive RM-1995 intravenously, followed 24 hours later by local tumor illumination; participants may be eligible to receive repeated photoimmunotherapy cycles for up to 12 months. Pembrolizumab at 200 mg will be administered 5 to 7 days prior to RM-1995 infusion and again 3 weeks later. Each study phase will include approximately 18 patients with locally advanced or locoregional cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma that has recurred or progressed on or after platinum-based chemotherapy and who are not eligible for further locoregional treatment.

Disclosure: For full disclosures of the study authors, visit

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