Sun Pharma’s UNLOXCYT (cosibelimab-ipdl) for aCSCC available in US
UNLOXCYT SUPPORT is focused on providing essential support for HCPs and Advanced Cutaneous Squamous Cell Carcinoma (aCSCC) patients
Sun Pharma announced UNLOXCYT (cosibelimab-ipdl) is now available in the US for healthcare professionals to prescribe for adults with mCSCC or laCSCC who are not candidates for curative surgery or curative radiation.
“Patients with unresectable or metastatic CSCC now have a new and important treatment option to manage their disease. UNLOXCYT is a novel anti–PD-L1 antibody that is capable of antibody dependent cellular cytotoxicity and associated with clinically meaningful efficacy, as shown by a disease control rate of 71 per cent,” said Ann W. Silk, MD, MS, medical oncologist at Dana-Farber Cancer Institute and Assistant Professor of Medicine at Harvard Medical School. “Because these patients tend to be older and have multiple comorbidities, it’s extremely valuable to have a therapy that offers durable disease control and proven tolerability.”
“UNLOXCYT is an evolution in checkpoint inhibition, combining durable efficacy with a proven tolerability profile for a group of aCSCC patients who traditionally would struggle to strike that therapeutic balance,” said Richard Ascroft, CEO of Sun Pharma North America. “Sun Pharma is committed to ensuring access from day one with the UNLOXCYT SUPPORT patient access and affordability program.”
The US Food and Drug Administration (FDA) recently approved an updated label for UNLOXCYT to reflect long-term follow-up data from the pivotal CK-301-101 clinical trial. This study showed improvements in objective response rates (including more patients who achieved a complete response [CR]) and duration of response. The safety data did not change from the original UNLOXCYT label.
Many patients in the pivotal trial experienced durable responses with UNLOXCYT. At least 50 per cent demonstrated an objective response (complete or partial response), including 13 per cent of mCSCC patients and 26 per cent of laCSCC patients who achieved complete response. 71 per cent of patients achieved disease control with UNLOXCYT, including patients with stable disease. The median duration of response has not yet been reached in either treatment group.
Immune-mediated adverse reactions, which can be severe or fatal, can occur in any organ system or tissue, during or after discontinuation of treatment. Females should use effective contraception and avoid breastfeeding during treatment.
The most common adverse reactions (ARs) were fatigue, musculoskeletal pain, rash, diarrhea, and hypothyroidism. Immune-mediated adverse reactions (imARs) were primarily Grade 1 or 2; 0.9% were Grade 3 (dermatologic only), with no Grade ≥4 imARs.
Of particular note, no patients developed Grade 3 or 4 pneumonitis. Just 0.9% (two patients) experienced pneumonitis (Grade 2).
UNLOXCYT is available through a limited distribution network of authorized specialty distributors and one contracted specialty pharmacy. Healthcare professionals can visit UNLOXCYTPro.com for additional information. Sun Pharmaceuticals does not recommend the use of any particular distributor or specialty pharmacy.
For comprehensive support, UNLOXCYT SUPPORT is dedicated to supporting healthcare professionals and patients by providing resources for their journey on UNLOXCYT.