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PD-1 and PD-L1 Inhibitors: A Single Center Medication Assistance Program (MAP) Experience

Sarah Tu, PharmD and Shuntao Cai, PharmD, BCOP

Robert W. Franz Cancer Center, Providence Cancer Institute, Portland, OR, USA

Background: PD-1 and PD-LI inhibitors are a large component of the growing immuno-oncology field and every year there are increasing studies investigating potential indications for these agents. This IRB approved retrospective chart review examines patients in the Medication Assistance Program (MAP) within a large tertiary medical center who are on PD-1 and PD-L1 medications due to financial barriers and/or non-FDA approved regimens (unlabeled indications). This study seeks to evaluate efficacy and safety of PD-1 and PD-L1 for unlabeled vs labeled indications within this population.

Methods: One hundred MAP patients treated with the PD-1 and PD-L1 inhibitors Opdivo (nivolumab), Keytruda (pembrolizumab) and Imfinzi (durvalumab) from October 2017- August 2019 will be analyzed in a reverse chronological order. The following data will be collected from the EMR: patient age, gender, medication, indication, duration of therapy, duration of therapy, labeled or unlabeled usage, if patient had a response, time to disease progression, concurrent therapies, total amount of drug administered, noted side effects, and if the FDA indication has changed since initiation. Labeled indications will be defined as medications that are FDA approved for the patient’s cancer type at time of medication initiation. Unlabeled medications are those not FDA approved for a patient’s cancer type at time of medication initiation. Evaluation of provider notes, lab tests and medication history records will be the primary data source for information collected. Primary objectives include evaluation of labeled vs unlabeled indications for PD-1 and PD-L1 inhibitors. Secondary objectives include determining time to disease progression, incidence of adverse drug reactions, and financial impact for institution and patient.

Results: Out of one hundred patients analyzed, 20% were on PD-1 and PD-L1 inhibitors for labeled indications and 80% patients were treated for unlabeled indications. The top three indications for PD-1 and PD-L1 inhibitors overall were head and neck (35%), gastroesophageal (17%), and breast cancer (12%) which was primarily driven by unlabeled patients. In stage IV head and neck, gastroesophageal, and NSCLC, unlabeled PD-1 and PD-L1 inhibitors demonstrated a greater average time to disease state progression compared to labeled indications (8.6 vs 7.3 months, 2.7 vs 1.1 months and 12.9 vs 0.5 months). The percentage of patients with grade 2 and 3 toxicities were comparable between the unlabeled and labeled indications with total incidence of ADR at 45% for labeled indications and 46.3% for unlabeled indications. The most common ADR requiring medications or delay of therapy was hypothyroidism (25% in labeled and 20% in unlabeled).

Conclusions: The majority of MAP patients are on PD-1 and PD-L1 inhibitors for unlabeled indications with the highest usage of Opdivo (nivolumab) at 74%. From our small sample size, there is promising data that PD-1 and PD-L1 inhibitors may prolong survival for several months longer for various indications including breast cancer, stage IV head and neck, gastroesophageal and NSCLC. These indications may later be incorporated into clinical trials as these agents seek new drug approvals.




Graduate Medical Education


Earle A. Chiles Research Institute

Conference / Event Name

Academic Achievement Day, 2020


Earle A. Chiles Research Institute Fellowship Program

PD-1 and PD-L1 Inhibitors: A Single Center Medication Assistance Program (MAP) Experience

Included in

Oncology Commons