Cutaneous Squamous Cell Carcinoma: Pembrolizumab as Emerging Standard Treatment

KEYNOTE-629 Phase II Clinical Trial Results

• October 29, 2021
• Reading time: 1 minute

In October 2021, investigators from Royal Brisbane and Women's Hospital, including B.G.M. Hughes and colleagues, published Phase II results in Annals of Oncology evaluating pembrolizumab efficacy and safety in patients with locally advanced, recurrent, and metastatic cutaneous squamous cell carcinoma.

Trial Design and Patient Population

KEYNOTE-629 was a Phase II clinical trial enrolling 159 patients with locally advanced or recurrent/metastatic cutaneous squamous cell carcinoma.

Treatment Regimen:

• Pembrolizumab 200 mg IV
• Every 3 weeks

Primary Endpoint: Objective response rate

Secondary Endpoints: Duration of response, disease control rate, progression-free survival

Clinical Trial Results

Locally Advanced Disease Subgroup

N = 54 patients

Objective Response Rate: 50.0%

• Complete response: 16.7%
• Partial response: 33.3%

Recurrent/Metastatic Disease Subgroup

N = 105 patients

Objective Response Rate: 35.2%

• Complete response: 10.5%
• Partial response: 24.8%

Secondary Efficacy Outcomes

Duration of Response: The median duration of response was not reached in either patient subgroup, indicating sustained and durable therapeutic benefit beyond conventional median follow-up periods.

Safety Profile

Grade 3-5 Adverse Events: 11.9%

Notably, pembrolizumab demonstrated an excellent safety profile with a low incidence of severe adverse events and no unexpected or novel treatment-related toxicities observed.

Clinical Conclusions

Based on KEYNOTE-629 Phase II results, B.G.M. Hughes and colleagues concluded:

"Patients with locally advanced, recurrent, or metastatic cutaneous squamous cell carcinoma treated with pembrolizumab monotherapy demonstrate sustained and robust anti-tumor efficacy without emergence of unexpected adverse events. These results support pembrolizumab as a promising new treatment approach for this patient population."

The durable response rates observed in both patient subgroups, combined with excellent tolerability, suggest that pembrolizumab may establish a new standard-of-care treatment option for cutaneous squamous cell carcinoma patients previously limited in available therapeutic options.

Data Source

https://www.sciencedirect.com/science/article/pii/S0923753421021864

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