The demographics and disease characteristics were well balanced. Table 9: First-Line Therapy: Summary of Patient Characteristics in Study of NSCLC Patient characteristicALIMTA plus Cisplatin (AC) (N=862)Gemcitabine plus Cisplatin (GC) (N=863) Age (yrs) Median (range) 61.1 (28.8-83.2) 61.0 (26.4-79.4) Gender Male/Female 70.2%/29.8% 70.1%/29.9% Origin Caucasian 669 (77.6%) 680 (78.8%) Hispanic 27 (3.1%) 23 (2.7%) Asian 146 (16.9%) 141 (16.3%) African descent 18 (2.1%) 18 (2.1%) Stage at Entry IIIb/IV 23.8%/76.2% 24.3%/75.7% Histology Nonsquamous NSCLCa618 (71.7%) 634 (73.5%) Adenocarcinoma 436 (50.6%) 411 (47.6%) Large cell 76 (8.8%) 77 (8.9%) Otherb106 (12.3%) 146 (16.9%) Squamous 244 (28.3%) 229 (26.5%) ECOG PSc,d 0/1 35.4%/64.6% 35.6%/64.3% Smoking Historye Ever/never smoker 83.1%/16.9% 83.9%/16.1% aIncludes adenocarcinoma, large cell, and other histologies except those with squamous cell type.Protocol ADU-CL-02-v8Aduro Biotech, Inc. CRS-207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 97 14 bThe subgroup of “other” represents patients with a primary diagnosis of NSCLC whose disease did not clearly qualify as adenocarcinoma, squamous cell carcinoma, or large cell carcinoma. cEastern Cooperative Oncology Group Performance Status. dECOG PS was not reported for all randomized patients. Percentages are representative of N=861 for the ALIMTA plus cisplatin arm, and N=861 for the gemcitabine plus cisplatin arm. eSmoking history was collected for 88% of randomized patients (N=757 for the ALIMTA plus cisplatin arm and N=759 for the gemcitabine plus cisplatin arm). Patients received a median of 5 cycles of treatment in both study arms. Patients treated with ALIMTA plus cisplatin received a relative dose intensity of 94.8% of the protocol-specified ALIMTA dose intensity and 95.0% of the protocol-specified cisplatin dose intensity. Patients treated with gemcitabine plus cisplatin received a relative dose intensity of 85.8% of the protocol-specifi ed gemcitabine dose intensity and 93.5% of the protocol-specified cisplatin dose intensity. The primary endpoint in this study was overall survival. The median survival time was 10.3 months in the ALIMTA plus cisplatin treatment arm and 10.3 months in the gemcitabine plus cisplatin arm, with an adjusted hazard ratio of 0.94. Table 10: First-Line Therapy: Efficacy in NSCLC - ITT Population ALIMTA plus Cisplatin (N=862)Gemcitabine plus Cisplatin (N=863) Median overall survival (95% CI) 10.3 mos (9.8 -11.2) 10.3 mo s (9.6-10.9) Adjusted hazard ratio (HR)a,b(95% CI) 0.94 (0.84-1.05) Median progression-free survival (95% CI) 4.8 mos (4.6-5.3) 5.1 mos (4.6-5.5) Adjusted hazard ratio (HR)a,b(95% CI) 1.04 (0.94-1.15) Overall response rate (95% CI) 27.1% (24.2 -30.1) 24.7% (21.8 -27.6) aAdjusted for gender, stage, basis of diagnosis, and performance status. bA HR that is less than 1.0 indicates that survival is better in the AC arm than in the GC arm. Alternatively, a HR that is greate r than 1.0 indicates survival is better in the GC arm than in the AC arm. Figure 1: Kaplan-Meier Curves for Overall Survival ALIMTA plus Cisplatin (AC) versus Gemcitabine plus Cisplatin (GC) in NSCLC - ITT Population. A pre-specified analysis of the impact of NSCLC histology on ove rall survival was examined. Clinically relevant differences in survival according to histology were observed and are shown in Table 11. This difference in treatment effect for ALIMTA based on histology demonstrating a lack of efficacy in squamous cell histol ogy was also observed in the single-agent, second-line study and the maintenance study [see Clinical Studies (14.2, 14.3)] . Table 11: First-Line Therapy: Overall Survival in NSCLC Histologic Subgroups Histology SubgroupMedian Overall Survival in Months (95% CI)Unadjusted Hazard Adjusted Hazard Ratio (HR)a,b,cProtocol ADU-CL-02-v8Aduro Biotech, Inc. CRS-207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 981.0 Median (95% Cl) 0.9 -AC 10.3 (9.8, 11.2) 0.8 --GC 10.3 (9.6, 10.9) 0.7 ACvsGC Adjusted HR (95% Cl) :0 0.6 0.94 (0.84, 1.05) cu .a 0 0.5 ... a. ca 0.4 .ii? 0.3 ::J CJ) 0.2 0.1 0.0 0 6 12 18 24 30 Patients at Risk Survival Time (months) AC 862 598 341 146 45 0 GC 863 590 327 139 34 0 15 ALIMTA plus Cisplatin Gemcitabine plus Cisplatin Ratio (HR)a,b (95% CI)(95% CI) Nonsquamous NSCLCd (N=1252)11.0 (10.1-12.5)N=618 10.1 (9.3-10.9)N=634 0.84 (0.74-0.96)0.84 (0.74-0.96) Adenocarcinoma (N=847)12.6 (10.7-13.6)N=436 10.9 (10.2-11.9)N=411 0.84 (0.71-0.98)0.84 (0.71-0.99) Large Cell (N=153)10.4 (8.6-14.1) N=76 6.7 (5.5-9.0)N=77 0.68 (0.48-0.97)0.67 (0.48-0.96) Othere (N=252)8.6 (6.8-10.2)N=106 9.2 (8.1-10.6)N=146 1.12 (0.84-1.49)1.08 (0.81-1.45) Squamous Cell(N=473)9.4 (8.4-10.2) N=244 10.8 (9.5-12.1)N=229 1.22 (0.99-1.50)1.23 (1.00-1.51) aA HR that is less than 1.0 indicates that survival is better in the AC arm than in the GC arm. Alternatively, a HR that is greate r than 1.0 indicates survival is better in the GC arm than in the AC arm.