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SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent
Hossein Borghaei1, Mary W Redman2, Karen Kelly3
1Department of Hematology and Medical Oncology and the Molecular Therapeutics Program, Fox Chase Cancer Center, Philadelphia, PA.
Introduction:
The objective of the Lung-MAP sub-study S1400A was to evaluate the response rate to durvalumab, an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with squamous non-small-cell lung cancer (SqNSCLC).
Patients And Methods:
Patients who progressed on at least 1 prior platinum-based chemotherapy were eligible. The study was designed as a phase II/III trial comparing durvalumab with docetaxel but was modified to a single-arm, phase II trial with the primary endpoint of objective response when immunotherapy became an approved treatment.
Results:
A total of 116 patients were registered to this sub-study; 78 to durvalumab and 38 to docetaxel. Of the 78 patients, 9 were ineligible, and 1 was not evaluable for endpoints. Responses were achieved in 11 patients among the 68 eligible and evaluable patients on durvalumab (overall response rate, 16%; 95% confidence interval [CI], 7%-25%). The disease control rate was 54% (95% CI, 43%-66%), the median overall survival was 11.6 months (95% CI, 10.2-14.3 months), and the median progression-free survival was 2.9 months (95% CI, 2.0-4.0 months). PD-L1 data was available for 43 patients on durvalumab, with 14 (33%) patients who were PD-L1-positive (≥ 25%) and 2 responses (overall response rate, 14%; 95% CI, 0%-33%), the disease control rate was 57% (95% CI, 31%-83%), the median overall survival and progression-free survival were 10.7 months (95% CI, 9.2-14.3 months) and 2.3 months (95% CI, 1.4-4.2 months), respectively. Grade ≥ 3 treatment-related adverse events occurred in 22 (32%) patients on durvalumab, with 6 discontinuing owing to drug-related adverse events (9%; 95% CI, 2%-16%).
Conclusions:
Durvalumab shows single-agent activity and toxicities in this sub-group of patients that is comparable with other anti-programmed cell death protein 1/PD-L1 antibodies.
Insights
Durvalumab demonstrated a 16% objective response rate in patients with squamous non-small-cell lung cancer (SqNSCLC) who progressed on chemotherapy. This anti-programmed death-ligand 1 (PD-L1) antibody showed comparable activity and toxicity to other immunotherapies.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Squamous non-small-cell lung cancer (SqNSCLC) is a major cause of cancer mortality.
- Platinum-based chemotherapy is a standard treatment, but response rates can be limited.
- Durvalumab targets the programmed death-ligand 1 (PD-L1) pathway to enhance anti-tumor immune responses.
Purpose of the Study:
- To evaluate the objective response rate of durvalumab as a single agent in patients with SqNSCLC.
- To assess the efficacy and safety of durvalumab in a pre-treated SqNSCLC population.
- To compare durvalumab with docetaxel in a modified phase II trial design.
Main Methods:
- A single-arm, phase II clinical trial (Lung-MAP sub-study S1400A) was conducted.
- Eligible patients had SqNSCLC and had progressed on at least one prior platinum-based chemotherapy regimen.
- Objective response rate was the primary endpoint, with secondary endpoints including disease control rate, overall survival, and progression-free survival.
Main Results:
- An overall response rate of 16% (95% CI, 7%-25%) was observed in 68 eligible and evaluable patients treated with durvalumab.
- The disease control rate was 54% (95% CI, 43%-66%), with a median overall survival of 11.6 months.
- Grade ≥ 3 treatment-related adverse events occurred in 32% of patients, with 9% discontinuing treatment due to adverse events.
Conclusions:
- Durvalumab exhibits single-agent activity in patients with SqNSCLC who have progressed on prior chemotherapy.
- The observed toxicities are comparable to other anti-programmed cell death protein 1/PD-L1 antibodies.
- Durvalumab represents a potential treatment option for this patient population.
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