Pharmacists Navigate an Evolving Immunotherapy Landscape in Advanced Non–Small Cell Lung Cancer

Immunotherapy has transformed the management of advanced non–small cell lung cancer (NSCLC), offering durable responses and survival benefits for select patients. However, as the number of immune checkpoint inhibitors (ICIs) continues to expand, treatment selection has become increasingly nuanced. During a recent Pharmacy Times Clinical Forum, oncology pharmacists discussed how they are navigating the use of PD-1 and PD-L1 inhibitors in practice, with a particular focus on cemiplimab-rwlc (Libtayo; Regeneron) and the pharmacist’s role in optimizing care across institutions.

Early and Ongoing Pharmacist Involvement

Across practice settings, pharmacists described being involved early in the care of patients with newly diagnosed NSCLC, often at the point of treatment selection. Kevin Chen, PharmD, MS, BCOP, CPP, clinical pharmacy specialist at UNC Health in Chapel Hill, North Carolina, emphasized the breadth of this role. “Depending on your provider preference, [we’re involved] in a lot of discussions about therapy selection. We’ll oftentimes put in the therapy plans, do a lot of patient education, and make sure everything is appropriate for that treatment,” Chen said.

Education was consistently cited as a core responsibility, particularly as patients navigate complex biomarker-driven treatment pathways. Pharmacists also play a key role in ensuring that PD-L1 testing and molecular profiling are completed before immunotherapy initiation, especially in nonsquamous disease, where actionable mutations may alter first-line therapy.

Biomarkers Drive Treatment Decisions, But Delays Persist

The panelists agreed that histology and biomarker status remain central to treatment selection in advanced NSCLC. In particular, PD-L1 expression helps guide decisions between monotherapy and combination regimens; however, delays in molecular testing continue to pose challenges in real-world practice.

Amanda Cass, PharmD, BCPS, BCOP, a clinical pharmacist at Vanderbilt University Medical Center in Nashville, Tennessee, noted that insurance barriers can complicate even interim treatment strategies. “So I’ve noticed [for example,] a squam[ous] patient [with] PD-L1 40%, we put in a KEYNOTE 407 plan [NCT02775435], and we’re really just trying to get the ball rolling, and we’ll hold that immunotherapy for the first cycle, but then insurance [won’t] even want to approve the chemotherapy until we have molecular results back,” she explained.

Liquid biopsy has emerged as a practical solution to expedite decision-making. Cara Chang, PharmD, BCOP, a clinical pharmacy specialist at Northwestern Memorial Hospital in Chicago, Illinois, explained how her institution integrates these results. “You use them almost as often as we use a tissue biopsy. And if the liquid biopsy results have something that we can target, then we’re good [at] using that.”

Pharmacists emphasized that negative liquid biopsy results do not replace tissue testing, underscoring their role in ensuring appropriate therapy sequencing.

Where Cemiplimab Fits in the Treatment Landscape

Cemiplimab has gained traction as both a monotherapy and in combination with chemotherapy for advanced NSCLC. In patients with PD-L1 expression of at least 50%, cemiplimab monotherapy demonstrated a significant overall survival benefit in the phase 3 EMPOWER-Lung 1 trial (NCT03088540),¹ comparable to other frontline PD-1 inhibitors.² In the phase 3 EMPOWER-Lung 3 trial (NCT03409614),³ cemiplimab combined with platinum-doublet chemotherapy improved overall survival across both squamous and nonsquamous histologies.⁴

Pharmacists noted that these data have increased comfort with cemiplimab in routine practice. Emily Rux, PharmD, BCOP, an oncology clinical pharmacist at Loyola Medicine, Maywood, Illinois, shared that access considerations sometimes influence its use. “For [the] inpatient perspective, we do utilize the cemiplimab free sample program when we have needed to. I think a lot of patients end up on that. So that certainly has changed some things,” she said.

Although efficacy across PD-1 and PD-L1 inhibitors is largely similar, participants highlighted that pharmacists help contextualize subtle differences in safety data, dosing schedules, and trial populations when advising clinicians.

Practical Considerations: Dosing, Access, and Administration

Extended-interval dosing and subcutaneous formulations of ICIs were discussed as potential tools to improve efficiency, although their adoption in lung cancer treatment remains limited. Connor Roth, PharmD, BCOP, a hematology/oncology pharmacy specialist at Franciscan Alliance, Franciscan Health Indianapolis, noted that provider enthusiasm has been modest. “I don’t really think it’s on the providers’ minds. They don't really frankly care that much because it saves 15 [or] 30 minutes of share time, and physicians don’t really care about share time.” Roth also explained that patients still have to get an intravenous infusion for labs, especially if they’re getting concurrent chemotherapy.

Access and affordability remain major pharmacist-driven responsibilities. Erica Marchese, PharmD, MHA, BCPS, BCOP, BCSP, clinical pharmacy program director at City of Hope, described the importance of coordination. “We have a team that does all the paperwork and documentation, but they will just let the pharmacy team know if a patient does have a free drug patient access program. We do monitor our denials, but we are seeing a lot of…up-front approvals, which does help. I’d say the only denials [are] if we see anything…coding errors [are] what we…noticed. We haven’t seen any denials that…have flagged our attention.”

Pharmacists frequently anticipate access barriers and initiate patient assistance applications concurrently with prior authorization requests.

Combination Therapy and Dual Checkpoint Inhibition

For patients with lower PD-L1 expression or high disease burden, combination therapy remains the standard. Cemiplimab plus chemotherapy has emerged as a viable option for squamous and nonsquamous disease, supported by EMPOWER-Lung 3 outcomes.⁴ Pharmacists emphasized that tolerability, chemotherapy backbone, and patient comorbidities often outweigh marginal efficacy differences when selecting a regimen.

Roth noted that the choice of chemotherapy often drives discussions of tolerability. When tolerability is an issue, “It’s all chemo[therapy] dependent for us, not really thinking about the immunotherapy at all,” she explained.

Dual checkpoint inhibition regimens, such as nivolumab plus ipilimumab with limited chemotherapy exposure, were described as useful options in select patients, particularly those with PD-L1–negative disease who wish to minimize chemotherapy duration.

Standardizing Care Through Order Sets

As immunotherapy regimens proliferate, pharmacists are increasingly involved in designing and maintaining electronic order sets. Tammy McClellan, PharmD, a clinical oncology pharmacist at Riverside Healthcare and certified in Epic’s Beacon, Willow, and EpicCare Ambulatory applications, emphasized the importance of standardization. Having toxicity checks, take-home medications, and supportive care built into the plan helps ensure everyone is on the same page.

The discussion participants agreed that pharmacist ownership of disease-specific order sets reduces errors and improves consistency, particularly when regimens differ by histology or biomarker status.

Conclusion

As immunotherapy continues to evolve in advanced NSCLC, pharmacists remain central to translating clinical trial data into real-world practice. Through treatment selection, access navigation, patient education, toxicity management, and order-set development, pharmacists help ensure that therapies such as cemiplimab are used safely and effectively. These discussions underscore the expanding role of oncology pharmacists as essential members of the multidisciplinary lung cancer care team.

REFERENCES

1. Study of REGN 2810 compared to platinum-based chemotherapies in participants with metastatic non–small cell lung cancer (NSCLC). ClinicalTrials.gov. Updated May 4, 2025. Accessed January 8, 2026. https://clinicaltrials.gov/study/NCT03088540

2. Sezer A, Kilickap S, Gümüş M, et al. Cemiplimab monotherapy for first-line treatment of advanced non-small-cell lung cancer with PD-L1 of at least 50%: a multicentre, open-label, global, phase 3, randomised, controlled trial. Lancet. 2021;397(10274):592-604. doi:10.1016/S0140-6736(21)00228-2

3. Combinations of cemiplimab (anti–PD-1 antibody) and platinum-based doublet chemotherapy in patients with lung cancer. ClinicalTrials.gov. Updated March 13, 2025. Accessed January 8, 2026. https://clinicaltrials.gov/study/NCT03409614

4. Gogishvili M, Melkadze T, Makharadze T, et al. Cemiplimab plus chemotherapy versus chemotherapy alone in non–small cell lung cancer: a randomized, controlled, double-blind phase 3 trial. Nat Med. 2022;28(11):2374-2380. doi:10.1038/s41591-022-01977-y