Trial results for the KEYNOTE-593 study (NCT03715205) evaluating the safety of pembrolizumab in participants with unresectable or metastatic melanoma or non-small cell lung cancer in India were posted on ClinicalTrials.gov on 2025-08-29. The study reported that 131 out of 150 enrolled participants experienced at least one adverse event.
Background
The KEYNOTE-593 study (MK-3475-593), also known as "Study to Evaluate the Safety of Pembrolizumab in Participants With Unresectable or Metastatic Melanoma or Non-small Cell Lung Cancer in India," was designed to assess the safety profile of pembrolizumab in participants in India. The study included individuals with unresectable or metastatic melanoma, and those with non-small cell lung cancer (NSCLC) who were either untreated (programmed cell death ligand 1 [PD-L1] ≥50%) or had progressed after platinum-containing systemic therapy (PD-L1 ≥1%).
Trial design
The KEYNOTE-593 study (NCT03715205) was a Phase 4, open-label clinical trial that enrolled 150 participants. The study investigated pembrolizumab in participants with unresectable or metastatic melanoma or non-small cell lung cancer (NSCLC) in India. All participants received pembrolizumab 200 mg IV Q3W.
Key results
The trial focused on evaluating various safety outcomes. For the pembrolizumab 200 mg IV Q3W treatment group, the following results were reported:
- The "Number of Participants With an Adverse Event (AE)" was 131 participants.
- The "Number of Participants With a Serious Adverse Event (SAE)" was 31 participants.
- The "Number of Participants With a Drug-Related AE" was 61 participants.
- The "Number of Participants With a Drug-Related SAE" was 10 participants.
- The "Number of Participants Who Discontinued Study Drug Due to an AE" was 11 participants.
- The "Number of Participants With an Adverse Event of Special Interest (AEOSI)" was 33 participants.
What this means
The results from the KEYNOTE-593 trial provide important safety data for pembrolizumab in a specific patient population in India, comprising individuals with unresectable or metastatic melanoma and non-small cell lung cancer. The reported counts of adverse events, serious adverse events, and drug-related events offer insights into the safety profile of pembrolizumab when administered at a dose of 200 mg IV Q3W in this demographic. These findings contribute to the overall understanding of the drug's safety in diverse patient groups.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT03715205, titled "Study to Evaluate the Safety of Pembrolizumab in Participants With Unresectable or Metastatic Melanoma or Non-small Cell Lung Cancer in India (MK-3475-593/KEYNOTE-593)," were posted on 2025-08-29 on clinicaltrials.gov.