Cancers · 2025
Comparison of Standard of Care with or Without a PD-1/PD-L-1 Inhibitor for the Treatment of Multiple Myeloma: A Systematic Review and Meta-Analysis of Phase II and III Randomized Controlled Trials.
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Alsaddi Zain, Younis Osama, Khasawneh Ghena, Shatnawi Yara, Ahmed Nausheen, Jafari Zahra Mahmoud, Mushtaq Muhammad Umair, Abdallah Al-Ola, Atrash Shebli, Paul Barry
Аннотация
BACKGROUND: Despite recent advances in the treatment of multiple myeloma (MM), the disease remains incurable. Agents targeting the programmed death-1 (PD-1) axis have become key treatments for many cancers; however, monotherapies with PD-1/PD-L-1 inhibitors (PD-1i) have shown a limited efficacy in MM patients. We conducted a meta-analysis to evaluate the safety and efficacy of PD-1i in combination with standard of care (SOC) therapies for MM.
METHODS: A systematic search identified phase II and III randomized clinical trials involving MM patients treated with PD-1i, using terms such as "Relapsed Multiple Myeloma" and "PD-1 inhibitors." The search included trials published in English after 2016 using the PubMed, CINAHL, and Cochrane databases. Data were analyzed using RStudio v4.4.2, with survival data assessed using Kaplan-Meier methods and Cox proportional hazards analysis.
RESULTS: Our search yielded 19 total trials, of which 5 (representing 889 unique patients) met the criteria for inclusion. A total of 488 patients received PD-1i + SOC, and 401 received SOC alone. The median progression-free survival (PFS) was 6.26 months for the PD-1i + SOC group and 7.34 months for the SOC alone group (HR, 1.2; 95% CI: 0.95-1.41; p = 0.14). The median overall survival (OS) was 22.49 months for PD-1i + SOC compared to 24.38 months for SOC alone (HR, 1.11; 95% CI: 0.87-1.42, p = 0.36). The PD-1i group showed a higher incidence of all-grade pneumonia (RR = 1.44, 95% CI: 1.03-2.02, p = 0.03), grade ≥ 3 neutropenia (RR = 1.36, 95% CI: 1.00-1.85, p = 0.05), immune-mediated adverse events (RR = 10.1, 95% CI: 0.38-271.1, p = 0.17), and grade ≥ 3 irAEs (RR = 9.59, 95% CI: 0.62-148.8, p = 0.11).
CONCLUSION: This analysis highlights the limited efficacy and increased toxicity of adding PD-1i to SOC in MM patients. Further research is needed to explore whether targeting the PD-1/PD-L1 axis in combination with novel therapies can safely enhance the therapeutic efficacy in MM patients.
METHODS: A systematic search identified phase II and III randomized clinical trials involving MM patients treated with PD-1i, using terms such as "Relapsed Multiple Myeloma" and "PD-1 inhibitors." The search included trials published in English after 2016 using the PubMed, CINAHL, and Cochrane databases. Data were analyzed using RStudio v4.4.2, with survival data assessed using Kaplan-Meier methods and Cox proportional hazards analysis.
RESULTS: Our search yielded 19 total trials, of which 5 (representing 889 unique patients) met the criteria for inclusion. A total of 488 patients received PD-1i + SOC, and 401 received SOC alone. The median progression-free survival (PFS) was 6.26 months for the PD-1i + SOC group and 7.34 months for the SOC alone group (HR, 1.2; 95% CI: 0.95-1.41; p = 0.14). The median overall survival (OS) was 22.49 months for PD-1i + SOC compared to 24.38 months for SOC alone (HR, 1.11; 95% CI: 0.87-1.42, p = 0.36). The PD-1i group showed a higher incidence of all-grade pneumonia (RR = 1.44, 95% CI: 1.03-2.02, p = 0.03), grade ≥ 3 neutropenia (RR = 1.36, 95% CI: 1.00-1.85, p = 0.05), immune-mediated adverse events (RR = 10.1, 95% CI: 0.38-271.1, p = 0.17), and grade ≥ 3 irAEs (RR = 9.59, 95% CI: 0.62-148.8, p = 0.11).
CONCLUSION: This analysis highlights the limited efficacy and increased toxicity of adding PD-1i to SOC in MM patients. Further research is needed to explore whether targeting the PD-1/PD-L1 axis in combination with novel therapies can safely enhance the therapeutic efficacy in MM patients.