Merck Ends Phase 3 KeyVibe-008 Trial in Small Cell Lung Cancer

According to a story from drugs.com, pharmaceutical company Merck has recently announced its decision to discontinue the KeyVibe-008 Phase III clinical trial. The decision was based on a recommendation from an independent, external Data Monitoring Committee (DMC). This clinical trial was evaluating a combination of pembrolizumab (marketed as KEYTRUDA®), the company’s anti-PD-1 cancer therapy, and vibostolimab, which is classified as an anti-TIGIT antibody. The combination was evaluated as a treatment for extensive-stage small cell lung cancer, an uncommon form of lung cancer that is notoriously difficult to treat.

In the trial, this combination was first used in combination with platinum chemotherapy and etoposide, then on its own. It was compared against atezolizumab combined with platinum chemotherapy and etoposide. The primary endpoint was overall survival with secondary endpoints including duration of response, objective response rate, and progression-free survival. 460 patients were participating in the trial. 

The decision to end the study included factors such as primary endpoint data meeting the specified criteria of futility and a significantly higher rate of adverse events in people taking the combination versus the atezolizumab group. 

Regardless, a significant number of clinical trials for small cell lung cancer are still ongoing, including KeyVibe-003, KeyVibe-007, and KeyVibe-006, which are evaluating different dosing levels of the pembrolizumab and vibostolimab combination. In another Phase III trial that has recently begun dosing, Merck and Daiichi Sankyo are evaluating ifinatamab deruxtecan in relapsed small cell lung cancer versus physician’s choice chemotherapy. Other trials are earlier along in development.

About Small Cell Lung Cancer 

Small cell lung cancer is an aggressive type of lung cancer that is responsible for only about 10-15% of lung cancer cases. Lung cancer as a whole is not considered rare, but small cell lung cancer is. While smoking tobacco is a risk factor for lung cancers of all types, the connection between smoking and small cell carcinoma is particularly strong. In fact, it appears almost exclusively in people who have smoked. That being said, it is still possible for people who were never regular smokers to get it. Symptoms of this cancer include chest pain, coughing up blood, weight loss, and shortness of breath. This cancer metastasizes rapidly, and most patients are diagnosed when this process has already begun. This cancer relapses easily and the five-year survival rate is meager at just 20% and is even lower for metastatic disease. To learn more about small cell lung cancer, click here.

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Last modified: September 6, 2024