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Efficacy of PD-1/PD-L1 blockade monotherapy in clinical trials
Bin Zhao1, Hong Zhao2, Jiaxin Zhao3
1The Second Affiliated Hospital and Yuying Children's Hospital, Wenzhou Medical University, 109 Xueyuan West Rd, Wenzhou, 325035, China.
Background:
Inhibitors targeting programmed cell death 1 (PD-1) and programmed death-ligand 1 (PD-L1) have unprecedented effects in cancer treatment. However, the objective response rates (ORRs), progression-free survival (PFS), and overall survival (OS) of PD-1/PD-L1 blockade monotherapy have not been systematically evaluated.
Methods:
We searched Embase, PubMed, and Cochrane database from inception to July 2019 for prospective clinical trials on single-agent PD-1/PD-L1 antibodies (avelumab, atezolizumab, durvalumab, cemiplimab, pembrolizumab, and nivolumab) with information regarding ORR, PFS, and OS.
Results:
Totally, 28,304 patients from 160 perspective trials were included. Overall, 4747 responses occurred in 22,165 patients treated with PD-1/PD-L1 monotherapy [ORR, 20.21%; 95% confidence interval (CI), 18.34-22.15%]. Compared with conventional therapy, PD-1/PD-L1 blockade immunotherapy was associated with more tumor responses (odds ratio, 1.98; 95% CI, 1.52-2.57) and better OS [hazard ratio (HR), 0.75; 95% CI, 0.67-0.83]. The ORRs varied significantly across cancer types and PD-L1 expression status. Line of treatment, clinical phase and drug target also impacted the response rates in some tumors. A total of 2313 of 9494 PD-L1 positive patients (ORR, 24.39%; 95% CI, 22.29-26.54%) and 456 of 4215 PD-L1 negative patients (ORR, 10.34%; 95% CI, 8.67-12.14%) achieved responses. For PD-L1 negative patients, the ORR (odds ratio, 0.92; 95% CI, 0.70-1.20) and PFS (HR, 1.15; 95% CI, 0.87-1.51) associated with immunotherapy and conventional treatment were similar. However, PD-1/PD-L1 blockade monotherapy decreased the risk of death in both PD-L1 positive (HR, 0.66; 95% CI, 0.60-0.72) and PD-L1 negative (HR, 0.86; 95% CI, 0.74-0.99) patients compared with conventional therapy.
Conclusion:
The efficacies associated with PD-1/PD-L1 monotherapy vary significantly across cancer types and PD-L1 expression. This comprehensive summary of clinical benefit from immunotherapy in cancer patients provides an important guide for clinicians.
Insights
Immune checkpoint inhibitors targeting programmed cell death 1 (PD-1) and programmed death-ligand 1 (PD-L1) show varied efficacy across cancer types and PD-L1 expression. This immunotherapy offers improved survival for many patients compared to conventional treatments.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Programmed cell death 1 (PD-1) and programmed death-ligand 1 (PD-L1) inhibitors have revolutionized cancer treatment.
- Systematic evaluation of objective response rates (ORRs), progression-free survival (PFS), and overall survival (OS) for PD-1/PD-L1 blockade monotherapy is crucial.
Purpose of the Study:
- To systematically evaluate the efficacy of PD-1/PD-L1 blockade monotherapy in cancer treatment.
- To analyze ORR, PFS, and OS across different cancer types and PD-L1 expression levels.
Main Methods:
- A comprehensive search of Embase, PubMed, and Cochrane databases was conducted up to July 2019.
- Prospective clinical trials of single-agent PD-1/PD-L1 antibodies (avelumab, atezolizumab, durvalumab, cemiplimab, pembrolizumab, nivolumab) were included.
- Data on ORR, PFS, and OS were extracted and analyzed.
Main Results:
- 160 trials with 28,304 patients were analyzed, showing an overall ORR of 20.21% for PD-1/PD-L1 monotherapy.
- Immunotherapy demonstrated superior tumor responses and OS compared to conventional therapy (OR=1.98, HR=0.75).
- Efficacy varied significantly by cancer type, PD-L1 expression (ORR 24.39% in PD-L1 positive vs. 10.34% in PD-L1 negative), treatment line, and clinical phase.
Conclusions:
- The clinical benefit of PD-1/PD-L1 monotherapy is highly dependent on cancer type and PD-L1 expression status.
- This comprehensive analysis provides valuable guidance for clinicians in optimizing immunotherapy use.
- Despite variations, PD-1/PD-L1 blockade monotherapy improved survival in both PD-L1 positive and negative patients.
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