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L. Blaydorn
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P3.07 - Poster Session/ Small Cell Lung Cancer (ID 223)
- Event: WCLC 2015
- Type: Poster
- Track: Small Cell Lung Cancer
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.07-008 - Phase Ib/II Study of Pembrolizumab plus Chemotherapy in Advanced Cancer: Results of Lung Cancer Patients Receiving ≥ 1 Prior Line of Therapy (ID 377)
09:30 - 09:30 | Author(s): L. Blaydorn
- Abstract
Background:
Pembrolizumab (pembro) is a selective anti-PD-1 antibody that blocks the interaction between programmed death-1 (PD-1) on T-cells and PD-L1 and PD-L2 on tumor cells. We report safety and clinical activity of pembro combined with chemotherapy in patients with advanced small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) progressing after ≥ 1 line of chemotherapy (NCT02331251).
Methods:
Patients were treated with pembro 2 mg/kg on day 1 every 21 days with either irinotecan on day 1 every 21 days or gemcitabine with or without vinorelbine on days 1 and 8 every 21 days until progression or toxicity. Eligibility included at least 1 measurable tumor lesion, Karnofsky Performance Status (KPS) of 70-100%, and adequate organ function. Tumors were assessed every 3 cycles using RECIST 1.1 and immune-related response criteria (irRC) and unconfirmed best overall response (BOR) was evaluated.
Results:
Eight lung cancer patients have been enrolled at the time of submission. Median age was 52.5 (range 33-74) and median KPS was 80%. Histology was adenocarcinoma (62.5%), including one with an EGFR T790M mutation and three SCLC (37.5%). One SCLC patient is on pembro plus gemcitabine 1,000 mg/m2, one NSCLC patient is on gemcitabine 1,000 mg/m2 and vinorelbine 25 mg/m2, and the remaining six patients were treated with irinotecan 250-300 mg/m2. Two NSCLC had prior exposure to nivolumab for ≥ 2 months. The maximum tolerated dose (MTD) was exceeded for irinotecan 300 mg/m2, and subsequently all patients receiving irinotecan are currently dosed at 250 mg/m2. Any grade drug-related treatment adverse events (AEs) occurred in 88% of patients; the most common (n>1) were skin rash, fatigue, diarrhea, anorexia, and extremity edema. No infusion-related reactions were observed. Dose limiting toxicities (DLTs) with pembro plus irinotecan were fatigue and nausea/vomiting. DLT with gemcitabine and vinorelbine was hypoxia. No grade 3 AEs were observed thus far with pembro plus gemcitabine. Five patients are currently evaluable for BOR. Two of two SCLC on pembro plus irinotecan have partial response as BOR and continue on study. One NSCLC patient on pembro plus gemcitabine and vinorelbine had stable disease, and two NSCLC patients had PD as BOR.
Conclusion:
In patients with previously treated SCLC and NSCLC, pembro plus chemotherapy appears to be safe to administer with a toxicity profile similar to the individual components of the regimen utilized. Establishment of the recommended phase 2 dose is ongoing for these treatment arms. Since the median follow-up is ~2 months, updated results including any new lung cancer patients enrolled, median progression-free survival (PFS), and overall survival will be presented at the WCLC.
