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MA09 - Immunotherapy Combinations (ID 390)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Chemotherapy/Targeted Therapy/Immunotherapy
- Presentations: 1
MA09.02 - Pembrolizumab + Carboplatin and Pemetrexed as 1st-Line Therapy for Advanced Non–Small Cell Lung Cancer: KEYNOTE-021 Cohort G (ID 5787)
14:20 - 15:50 | Author(s): J.P. Stevenson
Platinum doublet chemotherapy ± bevacizumab is standard first-line therapy for patients with advanced non–small cell lung cancer (NSCLC) without genetic aberrations. Single-agent pembrolizumab exhibits robust antitumor activity in PD-L1–positive advanced NSCLC. Cohort G of the multicenter, open-label, phase 1/2 multicohort KEYNOTE-021 study (ClinicalTrials.gov, NCT02039674) evaluated the efficacy and safety of pembrolizumab + carboplatin and pemetrexed compared with carboplatin and pemetrexed in patients with treatment-naive advanced nonsquamous NSCLC with any PD-L1 expression.
Cohort G enrollment criteria included patients with stage IIIB/IV nonsquamous NSCLC, no activating EGFR mutation or ALK translocation, no prior systemic therapy, measurable disease, ECOG performance status 0-1, and adequate tumor sample for assessment of PD-L1 status, regardless of PD-L1 expression. Patients were randomized 1:1 to 4 cycles of pembrolizumab 200 mg Q3W + carboplatin AUC 5 (5 mg/mL/min) + pemetrexed 500 mg/m Q3W or carboplatin AUC 5 (5 mg/mL/min) + pemetrexed 500 mg/m Q3W alone, followed by maintenance pemetrexed ± pembrolizumab. Pembrolizumab was given for ≤35 cycles. Randomization was stratified by PD-L1 expression (positive [tumor proportion score, or TPS, ≥1%] vs negative [TPS <1%]). Crossover to pembrolizumab monotherapy was allowed for eligible patients who experienced disease progression (RECIST v1.1) on chemotherapy. Response was assessed by central imaging vendor review every 6 weeks for first 18 weeks, every 9 weeks through year 1, and every 12 weeks in year 2. The primary end point was objective response rate (ORR); secondary end points included progression-free survival (PFS), duration of response, and overall survival (OS). Comparison between arms was assessed using the stratified Miettinen and Nurminen method (ORR) and stratified log-rank test (PFS, OS).
As of January 2016, 123 patients (60 in the pembrolizumab + chemotherapy arm, 63 in the chemotherapy arm) had been enrolled in cohort G. Data on ORR, duration of response, safety, and preliminary PFS and OS results will be available by August 2016.
The conclusion will be updated at the late-breaking submission stage.
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P2.03a - Poster Session with Presenters Present (ID 464)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Coordinates: 12/06/2016, 14:30 - 15:45, Hall B (Poster Area)
P2.03a-040 - Safety and Efficacy of Nab-Paclitaxel for 2nd Line Treatment of Elderly Patients with Stage IV Non-Small Cell Lung Cancer (ID 4209)
14:30 - 15:45 | Author(s): J.P. Stevenson
Retrospective analyses suggest benefit to 2[nd] line therapy in the fit elderly, but prospective data are lacking. Subgroup analysis of a phase III study of carboplatin and nab-paclitaxel for 1[st] line treatment of NSCLC showed superior survival in elderly patients.
This is a phase II study for patients > 70 years of age with progression on a non-taxane 1[st] line doublet. Nab-paclitaxel 100mg/m is administered intravenously, 3/4 weeks per cycle until progressive disease or intolerance. The primary endpoint is occurrence of ≥grade 3 treatment-related toxicities after 6 cycles or within 3 weeks if early treatment discontinuation occurred. Null hypothesis is a rate of 60% and alternative hypothesis is < 40%.
As of June 2016, 35/42 patients started treatment, and 31 completed. Median age is 75 (range 70 to 83). 51.4% are female. 8.6% have PS0, 68.6% PS1 and 22.9% PS2. 82.9% have adenocarcinoma, 14.3% SqCC, and 2.9% adenosquamous. 5.7% had EGFR, 28.6% kRAS. 33 patients had one prior treatment and 2 also received nivolumab. Of the 31 patients off treatment, median cycles received was 3 (range 1-22). 11/30 (37%) experienced the primary endpoint. When expanded to >=grade 3 toxicity at any time, this rose to 43% (13/30). The most common ≥G3 toxicities at any time point were fatigue (6/30), peripheral sensory neuropathy (4/30) and neutropenia (3/30). RR was 21% (1CR, 5PR, 16SD and 7PD of 29 patients evaluable). With a median FU of ongoing survivors (n=9) of 7.8 months, median progression free survival (PFS) was 5.2 months and median overall survival (OS) was 10.1 months. Figure 1
These results demonstrate efficacy and safety of nab-paclitaxel for the 2[nd] line treatment of NSCLC in elderly patients and provide prospective data to support the treatment of fit elderly in 2[nd] line. Updated PFS, OS, geriatric assessment and quality of life data will be presented.