Expansion cohorts
NSCLC, pleural effusion, pulmonary embolism, death, fatigue, diarrhea, peripheral edema, TEAEs, PDAC, rash, vomiting, pyrexia, TRAEs
PULMONARY EMBOLISM, PLEURAL EFFUSION, SMALL INTESTINAL OBSTRUCTION, PERIPHERAL EDEMA, DISEASE, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, NSCLC
Grade 3–4 TEAEs reported in ≥ 5% of patients overall in the expansion cohorts were increased AST, blood alkaline phosphatase increased (each 6%), gamma-glutamyl transferase increased, and pleural effusion (each 5%) (Supplementary Table 1). In the MSS-CRC, PDAC, and NSCLC expansion cohorts, respectively, 60, 57, and 45% of patients reported TRAEs, including 19, 17, and 12% with Grade 3–4 TRAEs. Common TRAEs (> 5% of expansion-phase patients overall) included fatigue (15%), diarrhea (9%), rash (7%), and AST increased, pyrexia, and vomiting (each 6%). No Grade 3–4 TRAEs were reported in > 5% of patients overall in the expansion cohorts.TEAEs of special interest for oleclumab occurred in 29, 38, and 29% of patients in the MSS-CRC, PDAC, and NSCLC expansion cohorts, respectively (Supplementary Table 2). Overall, these were most commonly peripheral edema (10%), pleural effusion (9%), and pulmonary embolism (6%). TEAEs of special or possible interest for durvalumab occurred in 55, 57, and 38% patients in the MSS-CRC, PDAC, and NSCLC expansion cohorts, respectively (Supplementary Table 2). Overall, the most common were AST increased (15%), diarrhea (14%), and ALT increased (9%).Of all 192 enrolled patients, 5% discontinued treatment permanently due to TEAEs (Supplementary Table 1). Three patients died due to AEs, including 2 patients in the monotherapy dose-escalation cohort (small intestinal obstruction and the preferred term of ‘death’) and 1 in the CRC expansion cohort (systemic inflammatory response syndrome). A further 7 patients died on treatment due to their disease.