Sun Pharma, a speciality generics company with focuses in innovative treatments and consumer healthcare, has announced that Unloxcyt (cosibelimab) is now available in the US for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced cutaneous squamous cell carcinoma (laCSCC) who cannot receive either curative surgery or curative radiation.
Unloxcyt was recently approved for an updated label from the US Food and Drug Administration (FDA): the label has been updated following results from the CK-301-101 clinical trial in patients with mCSCC and laCSCC. Unloxcyt showed durable responses in these patient groups. Overall, 50% of patients demonstrated either complete or partial response to treatment, with 13% of mCSCC patients and 26% of laCSCC patients achieving complete response.
Overall, 71% of patients treated with Unloxcyt, including those with stable disease, achieved disease control.
No new safety data was generated from the trial. The most common adverse reactions to Unloxcyt included fatigue, musculoskeletal pain and rash.
CSCC is one of the most common skin cancers globally, with around 40,000 US patients progressing to advanced CSCC annually. There are almost 15,000 deaths from CSCC in the US every year. As well as being potentially fatal, CSCC can cause deformities and functional morbidities from tumours in the head and neck area.
“Patients with unresectable or metastatic CSCC now have a new and important treatment option to manage their disease,” said Ann W Silk, medical oncologist at Dana-Farber Cancer Institute and assistant professor of medicine at Harvard Medical School.
Richard Ascroft, CEO of Sun Pharma North America, added: “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.”
