Abstract 3368
Background
First-line therapy with pembrolizumab is the standard of care in locally advanced and metastatic non-small cell lung cancer (NSCLC) with a PD-L1 expression of ≥ 50%. However, efficacy results in patients with a PS ≥ 2, untreated brain metastases or permanent oral steroids are lacking.
Methods
Patients from six certified lung cancer centers in Berlin, Germany, presenting with stage III (non resectable, not suitable for chemoradiation) and IV NSCLC, with a PD-L1 expression of ≥ 50%, diagnosed or treated between January 1st, 2017 and December 31, 2017 were included in this retrospective study. Progression-free (PFS) and overall survival (OS) were calculated using the Kaplan-Meier method. Cox regression analyses were used to identify prognostic factors for survival. Values are given as median (range).
Results
During the observation period, 128 patients fulfilled the inclusion criteria. Median age was 68.6 years (39 – 85), 76 patients were male (59.4%). Histology was predominantly non-squamous (68.8%). 31 patients (24.2%) had an initial PS of ≥ 2. Oral steroids for ≥2 weeks (equivalent daily doses of ≥ 10 mg of prednisolone during therapy with pembrolizumab) were prescribed to 34 patients (26.6%). Pembrolizumab was initiated in 24 patients with previously untreated brain metastases (18.8%). Within a follow-up of 13.0 months (95% CI, 10.5 – 15.4), a median of 9 cycles (1 – 38) were administered corresponding to a duration of treatment of 6.9 months (95% CI, 4.6 – 9.2). Therapy was still ongoing in 30 patients (23.4%). PFS was 9.4 months (95% CI, 4.8 – 14.1) with a duration of response of 11.9 months (95%CI, 8.4 – 15.4). OS reached 18.9 months (95% CI, NE – NE). A PS ≥ 2 was associated with a reduced OS (HR 0.43, 95% CI, 0.25 – 0.75, p = 0.003), no effects were noted for brain metastases and steroids.
Conclusions
Our data from real life practice in an all comer population demonstrate the efficacy of pembrolizumab in NSCLC with a PD-L1 expression of ≥ 50%. Despite a reduced survival in PS ≥ 2, the reached OS of 8.0 months is superior to historic cohorts with cytotoxic chemotherapy. Furthermore, OS was unchanged in case of untreated brain metastases or permanent steroids.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4228 - Clinical Evaluation of Drug-Eluting Bead Transcatheter Arterial Chemoembolization(D-TACE) versus Conventional TACE in Treatment of unresectable Hepatocellular Carcinoma
Presenter: Yi Chen
Session: Poster Display session 1
Resources:
Abstract
3930 - Safety profile of tepotinib in patients with advanced solid tumors: pooled analysis of phase I and II data
Presenter: Thomas Decaens
Session: Poster Display session 1
Resources:
Abstract
5373 - Drug-drug interaction profile of tepotinib with CYP3A and P-gp substrates
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
5455 - Bioavailability of tepotinib: impact of omeprazole and food
Presenter: Juergen Heuer
Session: Poster Display session 1
Resources:
Abstract
2618 - Tislelizumab Exposure-Response Analyses of Efficacy and Safety in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2563 - Population Pharmacokinetics of Tislelizumab in Patients with Advanced Tumors
Presenter: Chi-Yuan Wu
Session: Poster Display session 1
Resources:
Abstract
2021 - The Addition of Metformin to Systemic Anticancer Therapy
Presenter: Jung Han Kim
Session: Poster Display session 1
Resources:
Abstract
5243 - Growth modulation index (GMI) as a comparative measure of clinical activity of larotrectinib versus prior systemic treatments in adult and pediatric TRK fusion cancer patients
Presenter: Antoine Italiano
Session: Poster Display session 1
Resources:
Abstract
598 - Analysis of the overall survival and main surrogates used for FDA approvals in solid and hematological malignancies.
Presenter: Maria Kleniewska-Wieczor
Session: Poster Display session 1
Resources:
Abstract
5381 - Comparison of intratumoral docetaxel exposure in cancer patients between nanoparticle entrapped docetaxel (CPC634) and conventional docetaxel (Cd): the CriTax study
Presenter: Ruben Van Eerden
Session: Poster Display session 1
Resources:
Abstract