Table 3.
Potential immune-mediated AEs (safety analysis set)
| Previously treated with systemic therapy* | No prior systemic therapy for metastatic disease | Total NSCLC population (N=122) |
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| Anti-PD-(L)1 R/R | Anti-PD-(L)1 naïve | Anti-PD-(L)1 naïve | ||||
| Non-sq NSCLC (cohort A; n=24) |
Sq NSCLC (cohort F; n=23) |
Non-sq NSCLC (cohort B; n=22) |
PD-L1+, non-sq NSCLC (cohort H; n=22) |
PD-L1+, sq NSCLC (cohort I; n=24) |
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| Patients with ≥1 potential immune-mediated AEs of any Grade, n (%) | 11 (45.8) | 10 (43.5) | 10 (45.5) | 14 (63.6) | 17 (70.8) | 67 (54.9) |
| Immune-mediated AE by category,† n (%) | ||||||
| Immune-mediated hypothyroidism | 2 (8.3) | 9 (39.1) | 9 (40.9) | 10 (45.5) | 11 (45.8) | 42 (34.4) |
| Immune-mediated pneumonitis | 5 (20.8) | 1 (4.3) | 5 (22.7) | 5 (22.7) | 5 (20.8) | 25 (20.5) |
| Immune-mediated hepatitis | 2 (8.3) | 2 (8.7) | 3 (13.6) | 4 (18.2) | 2 (8.3) | 13 (10.7) |
| Immune-mediated type 1 diabetes mellitus | 1 (4.2) | 0 (0.0) | 0 (0.0) | 3 (13.6) | 6 (25.0) | 11 (9.0) |
| Immune-mediated hyperthyroidism | 2 (8.3) | 0 (0.0) | 2 (9.1) | 0 (0.0) | 2 (8.3) | 7 (5.7) |
| Immune-mediated colitis | 1 (4.2) | 1 (4.3) | 0 (0.0) | 2 (9.1) | 1 (4.2) | 6 (4.9) |
| Immune-mediated myocarditis | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
| Immune-mediated myositis/rhabdomyolysis | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.2) | 1 (0.8) |
| Immune-mediated pancreatitis | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
| Immune-mediated thyroiditis | 0 (0.0) | 0 (0.0) | 1 (4.5) | 0 (0.0) | 0 (0.0) | 1 (0.8) |
Data presented are for potential immune-mediated AEs identified by sponsor. Identification of potential AEs was based on a list of MedDRA preferred terms, derived from the from following sources: (i) immune-mediated AEs reported for other approved PD-(L)1 inhibitors; (ii) immune-mediated AEs reported in the published literature for PD-(L)1 inhibitors. Most sources of publications are late-phase clinical trial results.
*For cohorts A and F: disease progression on or after 1–3 lines of systemic therapy, including anti-PD-(L)1 therapy as the most recent treatment for metastatic NSCLC; for cohort B: disease progression on or after 1–2 lines of systemic therapy, without prior exposure to an anti-PD-(L)1 therapy; full eligibility criteria are provided in the online supplemental file,
†Patients with multiple events for a given MedDRA preferred term within a category or with AEs relating to multiple preferred terms within a category were counted once within each category. For the incidence of immune-mediated AEs by preferred term, please see online supplemental table 4.
AE, adverse event; MedDRA, Medical Dictionary for Regulatory Activities; non-sq, non-squamous; NSCLC, non-small cell lung cancer; PD-1, programmed cell death protein 1; PD-L1, programmed death-ligand 1; R/R, resistant/refractory; sq, squamous.