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A. Morosky
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OA05 - Treatment Advances in SCLC (ID 373)
- Event: WCLC 2016
- Type: Oral Session
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:A. Ardizzoni, J. Pujol
- Coordinates: 12/05/2016, 14:20 - 15:50, Strauss 2
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OA05.01 - Pembrolizumab in Patients with Extensive-Stage Small Cell Lung Cancer: Updated Survival Results from KEYNOTE-028 (Abstract under Embargo until December 5, 7:00 CET) (ID 6198)
14:20 - 15:50 | Author(s): A. Morosky
- Abstract
- Presentation
Background:
Patients with extensive-stage disease (ED) small cell lung cancer (SCLC) have limited treatment options and poor survival following failure of platinum-based chemotherapy. Pembrolizumab, a humanized anti–programmed death 1 (PD-1) antibody, has demonstrated robust antitumor activity and a favorable safety profile in multiple tumor types. Here, we present updated safety and efficacy data, including survival, for patients with ED SCLC enrolled in the KEYNOTE-028 (ClinicalTrials.gov, NCT02054806) study.
Methods:
KEYNOTE-028 is a nonrandomized, multicohort phase 1b trial of pembrolizumab in patients with PD-L1–positive advanced solid tumors. Patients received pembrolizumab 10 mg/kg every 2 weeks for up to 2 years or until confirmed progression or intolerable toxicity, death, withdrawal of consent, or physician decision. Response was assessed per RECIST v1.1 by investigators every 8 weeks for the first 6 months and every 12 weeks thereafter. The primary end point was objective response rate (ORR; per RECIST v1.1, investigator assessed). Secondary end points included safety, tolerability, progression-free survival (PFS), and overall survival (OS).
Results:
24 patients with ED SCLC and tumor PD-L1 positivity were enrolled and received ≥1 dose of pembrolizumab. At the data cutoff date (June 9, 2016), median follow-up duration was 9.8 months (range, 0.5-24.0 months); 3 patients (12.5%) remain on treatment. The ORR was 37.5% (95% CI, 18.8%-59.4%), including 1 complete and 8 partial responses in 24 evaluable patients. Median duration of response was 9.0 months (range, 1.9-19.9+ months). Median PFS was 1.9 months (95% CI, 1.7-5.9 months); the 6- and 12-month PFS rates were 29.8% and 24.8%, respectively. Median OS was 9.7 months (95% CI, 4.1 months-not reached); the 6- and 12-month OS rates were 66.0% and 35.7%, respectively. No new safety concerns were noted. Sixteen of 24 (66.7%) patients experienced treatment-related AEs. Two patients experienced grade 3-5 treatment-related AEs: 1 patient had blood bilirubin increased (grade 3) and 1 patient experienced grade 3 asthenia and grade 5 colitis.
Conclusion:
Pembrolizumab demonstrated promising antitumor activity in this pretreated, PD-L1–positive ED SCLC population. The responses were found to be durable and may have led to an OS benefit for the subset of patients who achieved objective responses with pembrolizumab.
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OA13 - Immunotherapy in Malignant Pleural Mesothelioma: Current Status of Trials and New Approaches (ID 392)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
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OA13.03 - Long-Term Overall Survival for Patients with Malignant Pleural Mesothelioma on Pembrolizumab Enrolled in KEYNOTE-028 (ID 6165)
14:20 - 15:50 | Author(s): A. Morosky
- Abstract
- Presentation
Background:
Malignant pleural mesothelioma (MPM) is a highly aggressive cancer with poor prognosis and limited treatment options after progression on platinum-containing chemotherapy. Pembrolizumab, a humanized anti–programmed death 1 (PD-1) antibody, has demonstrated robust antitumor activity and a favorable safety profile in multiple tumor types. Here, we present long-term overall survival (OS) data for patients with malignant pleural mesothelioma enrolled in the KEYNOTE-028 (ClinicalTrials.gov, NCT02054806) study.
Methods:
KEYNOTE-028 is a nonrandomized, multicohort phase 1b trial of pembrolizumab in patients with PD-L1–positive advanced solid tumors. 25 patients with MPM were treated with pembrolizumab in the mesothelioma cohort. Patients received pembrolizumab 10 mg/kg every 2 weeks for up to 2 years or until confirmed progression or intolerable toxicity, death, withdrawal of consent, or physician decision. Response was assessed per RECIST v1.1 by investigators every 8 weeks for the first 6 months and every 12 weeks thereafter. Primary end point was objective response rate (ORR; per RECIST v1.1, investigator assessed). Secondary end points included safety, tolerability, progression-free survival (PFS), and OS.
Results:
As of June 9, 2016, median duration of follow-up was 18.7 months (range, 1.5-24.6 months), and 4 patients (16%) are still on treatment. ORR was 28% (n = 7); 12 (48%) patients had stable disease, resulting in a disease control rate of 76%; median duration of response was 9.2 months (range, 2.4-20.5+ months); median PFS was 5.8 months (95% CI, 3.4-8.2 months), with 6- and 12-month PFS rates of 50% and 25%, respectively. Median OS was 18.0 months (95% CI, 9.4 months-not reached) with 6- and 12-month OS rates of 83.5% and 62.6%, respectively. No new safety signals have been identified. Sixteen (64%) patients experienced a drug-related adverse event (DRAE), and 5 (20%) experienced grade 3/4 DRAEs. Three patients required dose interruption because of immune-related adverse events (1 each, ALT increased, iridocyclitis, and pyrexia/arthralgia]). There was no treatment-related mortality or discontinuation due to DRAE.
Conclusion:
Single-agent pembrolizumab has significant clinical activity in patients with PD-L1–positive MPM. Responses from pembrolizumab in patients with MPM are durable; the 62.6% 12-month OS rate in this mostly pretreated patient population warrants further investigation. Long-term administration of pembrolizumab is feasible in patients with MPM, and no new safety signals were identified.
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