George Simon, MD, FACP, FCCP, discusses the importance of enrolling diverse patient populations onto cancer clinical trials.

Dr Simon on the Utility of Novel Treatments in Diverse Patient Populations With Cancer

George Simon, MD, FACP, FCCP, medical oncologist, Molecular Medicine Program, Moffitt Cancer Center, discusses the utility of readily available technologies in the treatment of underserved patient populations with cancer, highlighting the importance of enrolling these same populations in cancer clinical trials.

The identification and rectification of disparities within the health care system stand as a readily attainable objective, Simon begins. Leveraging the existing arsenal of tools and technologies provides a compelling avenue for addressing these inequalities, and the acknowledgment that the field is already equipped with the necessary resources is crucial, he says. By extending the application of these technologies across all ethnic groups and races, oncologists have the potential to positively affect response rates and overall survival, he says.

Simon goes on to say that oncologists don’t need to make groundbreaking discoveries to lead to substantial improvements in survival rates. The key lies in the widespread and equitable implementation of the technology that is already available, he says. This approach transforms the issue of addressing disparities from an insurmountable challenge into a pragmatic solution that can be readily implemented, Simon explains.

Furthermore, it is important to acknowledge the enrollment of diverse races and ethnic groups in clinical studies, he continues. This inclusivity is not a procedural requirement but a strategic move that enhances the reliability and applicability of medical findings, Simon emphasizes. Relying on data generated from a single race or ethnic category and assuming its universality is an oversimplification that should be avoided, he adds.

Instead, a comprehensive representation of all members of society in clinical trial populations is paramount, Simon continues. In this pursuit, it becomes vital to ensure that the demographics participating in clinical trials closely mirror the broader population of a specific region, program, or city, he states. This alignment is pivotal in establishing the efficacy of drugs or combinations across diverse racial and ethnic groups, Simon concludes.

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George Simon, MD, FACP, FCCP, discusses the importance of enrolling diverse patient populations in cancer clinical trials.

George Simon, MD, FACP, FCCP, executive director, Moffitt Cancer Center-AdventHealth joint Clinical Research Unit, senior member, Chemical Biology and Molecular Medicine Program, Moffitt Cancer Center, discusses findings from an FDA pooled analysis of PD-1/PD-L1 inhibitors with or without chemotherapy in patients with non–small cell lung cancer (NSCLC).

A study evaluated the outcomes with first-line PD-1/PD-L1 inhibitors alone or with chemotherapy in patients with advanced NSCLC. For the analysis, investigators pooled overall survival (OS) and progression-free survival (PFS) data from 12 randomized clinical trials that investigated first-line PD-1/PD-L1 inhibitors with or without chemotherapy in this population.

At the 2021 ASCO Annual Meeting, it was reported that in the subset of patients with a PD-L1 score of 1% to 49%, chemotherapy plus immunotherapy provided significant exploratory PFS and OS benefits compared with immunotherapy alone, Simon explains. The median PFS was 7.7 months (95% CI, 7.1-8.4) with chemotherapy plus immunotherapy vs 4.2 months (95% CI, 4.0-4.9) with immunotherapy alone (HR, 0.60; 95% CI, 0.48-0.76). The median OS was 21.4 months (95% CI, 19.4-25.2) with the combination vs 14.5 months (95% CI, 12.2-16.9) with immunotherapy alone (HR, 0.68; 95% CI, 0.52-0.90).

At the 2022 ASCO Annual Meeting, the study investigators reported findings from the subgroup of patients with a PD-L1 score of at least 50%. Immunotherapy alone is a standard of care for this patient population, and several agents are approved for use in this setting, including pembrolizumab (Keytruda), atezolizumab (Tecentriq), and cemiplimab (Libtayo), Simon notes. Data from this updated analysis showed OS and PFS benefits with chemotherapy plus immunotherapy in the subset of patients with a PD-L1 score of 50% or greater. The median OS was 25.0 months and 20.9 months in the chemotherapy/immunotherapy and immunotherapy arms, respectively (HR, 0.82; 95% CI, 0.62-1.08). The median PFS was 9.6 months and 7.1 months in the chemotherapy/immunotherapy and immunotherapy arms, respectively (HR, 0.69; 95% CI, 0.55-0.87). This survival benefit was seen regardless of ECOG performance status and smoking status.

One subgroup of patients with a PD-L1 score of at least 50% that did not seem to derive significant benefit from the addition of chemotherapy to immunotherapy was those who were at least 75 years of age. In this subgroup, the median OS was not estimable vs 18.9 months in the chemotherapy/immunotherapy and immunotherapy arms, respectively (HR, 1.68; 95% CI, 0.69-4.06), and the median PFS was 11.8 months vs 7.2 months in the chemotherapy/immunotherapy and immunotherapy arms, respectively (HR, 1.22; 95% CI, 0.58-2.57). Patients in this age group with a PD-L1 score of 50% or greater may have better outcomes with immunotherapy alone, Simon concludes.

George Simon, MD, FACP, FCCP, discusses findings from an FDA pooled analysis of PD-1/PD-L1 inhibitors with or without chemotherapy in patients with non–small cell lung cancer.

Dr Simon on PD-L1 Inhibitors in NSCLC

George Simon, MD, FACP, FCCP, executive director, Moffitt Cancer Center-AdventHealth joint Clinical Research Unit, discusses the importance of next-generation sequencing (NGS) in patients with non–small cell lung cancer (NSCLC).

NGS should be performed for all patients with this disease, especially those with nonsquamous disease, and those who are never-smokers, according to Simon. However, a significant number of patients still do not receive this testing, Simon adds. NGS could provide an opportunity to identify those who would benefit from targeted treatment approaches, Simon concludes.

George Simon, MD, FACP, FCCP, discusses the importance of next-generation sequencing in patients with non–small cell lung cancer.

George Simon, MD, FACP, FCCP

Articles

Dr Simon on the Utility of Novel Treatments in Diverse Patient Populations With Cancer

Dr Simon on PD-L1 Inhibitors in NSCLC

Dr. Simon on the Importance of Next-Generation Sequencing in NSCLC