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Subcutaneous Pembrolizumab Matches IV in Lung Cancer Trial
Enriqueta Felip, MD, PhD, discussed the benefits of subcutaneous pembrolizumab for patients with metastatic non–small cell lung cancer.
In an interview with Pharmacy Times®, Enriqueta Felip, MD, PhD, medical oncologist at Vall d'Hebron Hospital in Barcelona, Spain, shared findings from the MK-3475A-D77 trial (NCT05722015) evaluating the pharmacokinetics (PK) and safety of subcutaneous (SC) pembrolizumab in patients with metastatic non–small cell lung cancer (mNSCLC). The data were presented at the European Lung Cancer Congress (ELCC) 2025.1
Pharmacy Times: Can you give a brief overview of this study and the key findings presented at ELCC 2025?
Enriqueta Felip, MD, PhD: We presented a randomized trial in patients with [NSCLC], treatment-naive, without oncogenic alterations, comparing chemotherapy according to the histological subtype plus pembrolizumab IV—that is the standard of care—and we compared it with chemotherapy in combination with pembrolizumab [SC]. In both cases, the immunotherapy was given every 6 weeks, and the trial had 2 primary end points that were [PK] end points in order to show noninferiority of sub-Q when compared to the IV method.
We analyzed other important points, which are efficacy endpoints and toxicity. And overall, our results show that pembrolizumab sub-Q is non-inferior to pembrolizumab IV in pharmacokinetics, in exposure. So clearly, it's positive in these end points. And also important, we observed no differences between the 2 treatment arms in progression-free survival, no differences in response rate, and no differences in duration of response.
And also, another important result is that we observed no differences in adverse events between the 2 treatment arms. And when we analyzed specifically those adverse events related to the injection site, we observed that these were reported only in 6 patients—they represent 2.4% of the patients—and in all 6 cases were grade one. So, no differences in toxicity, also very mild toxicity in the injection site.
Pharmacy Times: What was the primary motivation for evaluating SC formulation of pembrolizumab in mNSCLC?
Felip: The most important thing is that the IV formulation, the time for infusion, is 30 minutes. In the case of the [SC] formulation, it's only 2 minutes. And this is something that we have analyzed in our trial for a volume of 4.8 milliliters. There is a clear reduction in the time the patient needs in the day hospital.
Pharmacy Times: The overall survival (OS) data were not yet mature. Based on your experience, do you anticipate any differences emerging between the 2 administration routes over time?
Felip: We expect no difference. It's true that the present follow-up of the trial is 9 months in both treatment arms. Median survival was not reached, but the hazard ratio is 0.81, so we also expect similar [OS] results between the 2 treatment arms.
Pharmacy Times: How might SC pembrolizumab impact clinical workflows, particularly in settings where IV administration can be resource-intensive?
Felip: I think there are a number of agents now that we have the [SC] formulation. I think it's important that it's reducing the infusion times. I think it's also important that, in general, when we ask the patients, this is the preferred way to administer the treatment. And also in the future, perhaps, it is a way to give the treatment even at home. It's something that we need to work on, but I think it's something that is important, also for the research, but also for the day hospitals—that we have a lot of patients. It's also important to have less time of the patient in the chair. So yeah, I think it's convenient.
And also, it’s true that there are some data in which the patient receives chemotherapy that sometimes is IV and pembrolizumab. But there are also a large number of patients receiving pembrolizumab alone, and in this situation, there is no need for an IV infusion.
Pharmacy Times: Do you think SC solutions, when approved, will become preferred over IV solutions? How might cost be affected by the introduction of SC options?
Felip: I think cost is always important, so it's important to follow what you are mentioning. What I have presented is not yet approved by the agencies, but I think, yeah, this may well be also an important factor to consider. But I think what we have now—our data—what we know is that the time for administration is clearly shorter with the [SC] formulation. But I fully agree that there is a need to follow also other aspects, such as cost and also patient preferences.
Pharmacy Times: What are the next steps for this research?
Felip: But perhaps the next step is to analyze all together if there are any administrations that may be well done even near the patient. No? I think this is some of the research that we need to do. I think we have clearly shown that exposure, pharmacokinetics, pharmacodynamic results are similar between the 2 treatment arms. But yeah, there is a need also to have the patients go less to the hospital, and I think this is something important.
Pharmacy Times: Is there anything else you’d like to share?
Felip: I have perhaps only 2 comments: the first one is to always acknowledge the patients and their families that participated in the clinical trial. And also, the second one is that we’re really pleased that the full paper—the full results—is now published in the Annals of Oncology. It was a simultaneous publication the day of the presentation, so all the results are published now online.
