Patient demographics are shown in Table 18. Table 18: Summary of Patient Characteristics in MPM Study Patient characteristicRandomized and Treated Patients Fully Supplemented Patients ALIMTA/cis (N=226)Cisplatin (N=222)ALIMTA/cis (N=168)Cisplatin (N=163) Age (yrs) Median (range) 61 (29-85) 60 (19-84) 60 (29-85) 60 (19-82) Gender (%) Male 184 (81.4) 181 (81.5) 136 (81.0) 134 (82.2) Female 42 (18.6) 41 (18.5) 32 (19.0) 29 (17.8) Origin (%) Caucasian 204 (90.3) 206 (92.8) 150 (89.3) 153 (93.9) Hispanic 11 (4.9) 12 (5.4) 10 (6.0) 7 (4.3) Asian 10 (4.4) 4 (1.9) 7 (4.2) 3 (1.8) African descent 1 (0.4) 0 1 (0.6) 0 Stage at Entry (%) I 16 (7.1) 14 (6.3) 15 (8.9) 12 (7.4) II 35 (15.6) 33 (15.0) 27 (16.2) 27 (16.8) III 73 (32.4) 68 (30.6) 51 (30.5) 49 (30.4) IV 101 (44.9) 105 (47.2) 74 (44.3) 73 (45.3) Unspecified 1 (0.4) 2 (0.9) 1 (0.6) 2 (1.2) Diagnosis/Histologya(%) Epithelial 154 (68.1) 152 (68.5) 117 (69.6) 113 (69.3) Mixed 37 (16.4) 36 (16.2) 25 (14.9) 25 (15.3) Sarcomatoid 18 (8.0) 25 (11.3) 14 (8.3) 17 (10.4) Other 17 (7.5) 9 (4.1) 12 (7.1) 8 (4.9) Baseline KPSb(%) 70-80 109 (48.2) 97 (43.7) 83 (49.4) 69 (42.3) 90-100 117 (51.8) 125 (56.3) 85 (50.6) 94 (57.7) aOnly 67% of the patients had the histologic diagnosis of malignant mesothelioma confirmed by independent review. bKarnofsky Performance Scale. Table 19 and Figure 5 summarize the survival results for all randomized and treated patients regardless of vitamin supplementation status and those patients receiving vitamin supplementation from the time of enrollment in the trial.Protocol ADU-CL-02-v8Aduro Biotech, Inc. CRS-207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 103 20 Table 19: Efficacy of ALIMTA plus Cisplatin versus Cisplatin in Malignant Pleural Mesothelioma Efficacy ParameterRandomized and Treated Patients Fully Supplemented Patients ALIMTA/cis (N=226)Cisplatin (N=222)ALIMTA/cis (N=168)Cisplatin (N=163) Median overall s urvival 12.1 mos 9.3 mo s 13.3 mos 10.0 mos (95% CI) (10.0-14.4) (7.8-10.7) (11.4-14.9) (8.4-11.9) Hazard ratio 0.77 0.75 Log rank p-valuea0.020 0.051 ap-value refers to comparison between arms. Similar results were seen in the analysis of patients (N=303) with confirmed histologic diagnosis of malignant pleural mesothelioma. There were too few non-white patients to assess possible ethnic differences. The effect in women (median survival 15.7 months with the combination versus 7.5 mo nths on cisplatin alone), however, was larger than the effect in males (median survi val 11 versus 9.4 respectively). As with any exploratory analysis, it is not clear whether this difference is real or is a chance fin ding. Figure 5: Kaplan-Meier Estimates of Survival Time for ALIMTA plus Cisplatin and Cisplatin Alone in all Randomized and Treated Patients. Objective tumor response for malignant pleural mesothelioma is difficult to measure and response criteria are not universally agreed upon. However, based upon prospectively defined criteria, the objective tumor response rate for ALIMTA plus cisplatin wa s greater than the objective tumor response rate for cisplatin alone. There was also improvement in lung function (forced vital ca pacity) in the ALIMTA plus cisplatin arm compared to the control arm. Patients who received full supplementation with folic acid and vitamin B 12during study therapy received a median of 6 and 4 cycles in the ALIMTA/cisplatin (N=168) and cisplatin (N=163) arms, respectively. Patients who never received folic acid and vitamin B 12during study therapy received a median of 2 cycles in both treatment arms (N=32 and N=38 for the ALIMTA/cisplatin and cisplatin arm, respectively). Patients receiving ALIMTA in the fully supplemented group received a relative dose intensity of 93% of the protocol specified ALIMTA dose intensity; patients treated with cisplatin in the same group received 94% of the projecte d dose intensity. Patients treated with cisplatin alone had a dose intensity of 96%. 15 REFERENCES 1. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings. NIOSH Alert 2004-165.