Assessing Cosibelimab’s Future in Cutaneous Squamous Cell Carcinoma

During an interview with CancerNetwork® prior to the FDA approval of cosibelimab for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or radiotherapy, Jason J. Luke, MD, FACP spoke about the current state of CSCC and how cosibelimab (Unloxcyt) fits into treatment.¹

Luke, director of the Immunotherapy and Drug Development Center at the University of Pittsburgh, and associate professor of medicine at the University of Pittsburgh and University of Pittsburgh Hillman Cancer Center, and melanoma editorial board member of ONCOLOGY®, reiterated that there are already several treatment options in the pathway, particularly anti–PD-1 and anti–PD-L1 agents, but also emphasized that there was great potential for additional growth in response rate, citing that it’s currently only 50%. Cosibelimab, in the phase 1 CK-301-101 trial (NCT03212404) that’s data informed the FDA’s decision, showed an objective response rate (ORR) of 47% (95% CI, 36%-59%).

Additionally, Luke mentioned the potential for treatment combinations as a positive because, many times, large pharmaceutical companies don’t do combination treatments with other companies, but the developer of cosibelimab is a “smaller” company.

As far as other treatments in the squamous cell carcinoma space go, Luke spoke about intratumoral therapies because much of treatment has moved into the perioperative setting. He ended by voicing his excitement for the future of treatment in CSCC.

Transcript:

On one level, we already have 2 agents in this pathway. The question goes back to, is there more activity [for cosibelimab compared with] the other agents? While anti–PD-1 or anti–PD-L1 agents have been transformative in CSCC with a response rate of 50% for the previous agents that are approved, that means 50% don’t respond. An unmet need is to expand that response rate and enhance the benefit for more patients. That’s the most obvious one that will become apparent over time.

Having multiple options in terms of potential combination partners is also a big possibility here. About 50% [of patients] don’t respond when we think about the other players in the scene. Large pharmaceutical companies that make the other drugs are going to combine with their own drugs; they’re not going to combine with other companies. Here, we have a drug being developed by a smaller company where there might be more possibilities to do other combinations that might not otherwise exist. As we think about how research may fill out this space in the future, having a third agent that’s less beholden to other solid market considerations certainly has upside that could translate, eventually, into a benefit for patients.

There are multiple agents that look promising, but I’d call attention to some of the intratumoral therapies. In this space, much of this treatment has moved into the perioperative setting, meaning the pre-surgical neoadjuvant setting, and there we’re treating locally invasive, destructive diseases. There are multiple agents that might be good additions to anti–PD-1 agents that we could locally deliver that may enhance complete response rates, that then limit recurrence. Some oncolytic viruses and cytokine therapies look good there. This is more of a research area to think about--it’s not going to impact practice in the next year or something—but there are certainly exciting things that are happening.

References

1. FDA approves cosibelimab-ipdl for metastatic or locally advanced cutaneous squamous cell carcinoma. News release. FDA. December 13, 2024. Accessed December 16, 2024. https://tinyurl.com/2wdtzrxa
2. Clingan P, Ladwa R, Brungs D, et al. Efficacy and safety of cosibelimab, an anti-PD-L1 antibody, in metastatic cutaneous squamous cell carcinoma. J Immunother Cancer. 2023;11(10):e007637. doi:10.1136/jitc-2023-007637