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OA 17 - Immunotherapy II (ID 683)
- Event: WCLC 2017
- Type: Oral
- Track: Immunology and Immunotherapy
- Presentations: 1
OA 17.01 - Pemetrexed-Carboplatin Plus Pembrolizumab as First-Line Therapy for Advanced Nonsquamous NSCLC: KEYNOTE-021 Cohort G Update (ID 9059)
14:30 - 16:15 | Author(s): R.G. Martins
Cohort G of the multicenter, open-label, phase 1/2 KEYNOTE-021 study (ClinicalTrials.gov, NCT02039674) evaluated efficacy and safety of pembrolizumab + pemetrexed and carboplatin (PC) compared with PC alone as first-line therapy for patients with advanced nonsquamous NSCLC. At the primary analysis of cohort G (minimum follow up, 6 months; median, 10.6 months), pembrolizumab significantly improved ORR (estimated treatment difference, 26%; P=0.0016) and PFS (hazard ratio [HR], 0.53; P=0.010). The HR for OS was 0.90 (95% CI, 0.42‒1.91). In a subsequent analysis (median follow-up, 14.5 months), the HR for OS was 0.69 (95% CI, 0.36‒1.31). We present results from the May 31, 2017 data cutoff.
Patients with stage IIIB/IV nonsquamous NSCLC, no prior systemic therapy, and no EGFR mutation or ALK translocation were randomized 1:1 (stratified by PD-L1 TPS ≥1% versus <1%) to receive 4 cycles of carboplatin AUC 5 + pemetrexed 500 mg/m Q3W with or without pembrolizumab 200 mg Q3W. Pembrolizumab treatment continued for up to 2 years; maintenance pemetrexed was permitted in both arms. Eligible patients in the PC arm with radiologic progression could cross over to pembrolizumab monotherapy. Response was assessed by blinded, independent central review per RECIST v1.1. All P values are nominal (one-sided P<0.025).
123 patients were randomized. Median follow-up was 18.7 months (range, 0.8‒29.0 months). 40 of 53 (75%) patients in the PC arm who discontinued received subsequent anti-PD-1/anti-PD-L1 therapy (including 25 who received pembrolizumab in the on-study cross over). ORR was 57% with pembrolizumab + PC versus 32% with PC (estimated difference, 25%; 95% CI, 7%‒41%; P=0.0029). PFS was significantly improved with pembrolizumab + PC versus PC (HR, 0.54; 95% CI, 0.33‒0.88; P=0.0067) with median (95% CI) PFS of 19.0 (8.5‒NR) months versus 8.9 (6.2‒11.8) months. The HR for OS was 0.59 (95% CI, 0.34‒1.05; P=0.0344). Median (95% CI) OS was not reached (22.8‒NR) months for pembrolizumab + PC and 20.9 (14.9‒NR) months for PC alone; 18-month OS rates were 70% and 56%, respectively. Grade 3–5 treatment-related AEs occurred in 41% of patients in the pembrolizumab + PC arm versus 29% in the PC arm.
Over the course of the 3 analyses, the HR for OS continues to improve for pembrolizumab + PC versus PC (HR: 0.90 to 0.69 to 0.59). The significant improvements in PFS and ORR with pembrolizumab + PC versus PC first observed in the primary analysis have been maintained with longer follow-up (median, 18.7 months).
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P1.06 - Epidemiology/Primary Prevention/Tobacco Control and Cessation (ID 692)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Epidemiology/Primary Prevention/Tobacco Control and Cessation
- Presentations: 1
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
P1.06-009 - Barriers to Clinical Trial Participation in Lung Cancer Patients, a Single Institution Experience (ID 8903)
09:30 - 16:00 | Author(s): R.G. Martins
Multiple previous studies have revealed disparities in clinical trial (CT) participation among oncology patients. In this study, we examined the factors that affect CT participation for lung cancer (LC) patients at the University of Washington (UW). Specifically, we hypothesized that patients who spoke a primary language other than English had significantly lower CT participation.
We analyzed data from patients with stage IV LC evaluated at UW from 2004-2015. We examined patient and disease characteristics such as histologic subtype, molecular status, ECOG performance status (PS) and total lines of therapy. We analyzed multiple demographic factors including age, self-reported race, primary language and gender, as well as socioeconomic factors including marital status, employment, insurance status, zip code, distance to clinic, and presence of email address and phone number. We performed multiple logistic regression analyses to evaluate the association between the primary language and CT participation and also examined other factors independently affecting CT enrollment in this patient population.
654 patients were included in our study. 73% did not participate in clinical trials, while 27% enrolled in at least one trial. The median age was 63 and 50% were female. 69% patients self-identified as Caucasian, 11% Asian, 5% African-American and the remainder as other or unknown. 94% of patients named English as their primary language. 90% had non-small cell histology, 73% had ECOG PS score of 0 or 1 and patients had received a median of 2 prior lines of therapy. In the multiple logistic regression model, we did not observe an association between the primary language and CT participation (OR 0.96, 95% CI 0.43 – 2.14). However, factors independently associated with a greater likelihood of CT participation were: an active email address (p = 0.01), better ECOG PS at diagnosis (0-1) (p=0.001), non-adenocarcinoma histology (p = 0.02), and increased number of lines of therapy (p<0.0001).
We did not find that patients with non-English primary language had lower rates of CT participation. Our findings replicate the nationally low level of CT participation and identified surrogates for socioeconomic status as being important. Continued efforts to understand the barriers and factors affecting CT participation will be necessary to help increase access and enrollment.