Abstract 3009
Background
Nivolumab (nivo), a programmed death 1 (PD-1) immune checkpoint inhibitor, is approved in the US and EU for treatment of metastatic NSCLC on or after progression of platinum-based chemotherapy. Nivo has demonstrated improved survival and a favorable safety profile versus docetaxel (doc) in two phase 3 trials, CheckMate 017 and 057, in squamous (SQ) and non-squamous (NSQ) NSCLC, respectively. Due to improved safety, nivo may bring additional benefits in terms of AE-related HCRU relative to doc.
Methods
Both trials assessed nivo 3 mg/kg Q2W versus doc 75 mg/m2 Q3W until progression or unacceptable toxicity. HCRU components (concomitant medications [categorized using Anatomical Therapeutic Chemical Classification], laboratory tests, and procedures) were evaluated in patients experiencing TR AEs, specifically grade (Gr) 2, 3–4.
Results
In CheckMate 017, 45 nivo patients and 87 doc patients experienced 356 Gr 1–4 TR AEs. In CheckMate 057, 124 nivo patients and 194 doc patients experienced 906 Gr 1–4 TR AEs (Table). In both trials, doc patients experienced more TR AEs than nivo patients, especially Gr 3/4 AEs (77 vs 6 in 017; 165 vs 29 in 057). Doc patients were generally treated with anti-infectives, immunostimulants, and/or corticosteroids, while nivo patients mostly received corticosteroids for TR AEs. Patients only underwent laboratory testing for serious TR AEs, most commonly hematology tests in patients receiving doc. Nivo patients underwent more procedures (lung-related) for Gr 2 TR AEs than doc patients. With Gr 3/4 TR AEs, chest x-rays were common in doc patients in both 017 and 057 and lung-related evaluations in nivo patients in 057.
| CheckMate 017a | Nivo (n = 45) | Doc (n = 87) | ||||
|---|---|---|---|---|---|---|
| Gr 2 | Gr 3–4 | All Gr | Gr 2 | Gr 3–4 | All Gr | |
| TR AEs, n | 46 | 6 | 98 | 95 | 77 | 258 |
| Patients with concomitant medications, n | 17 | 3 | 30 | 18 | 48 | 85 |
| Laboratory tests,b n | 9 | 9 | 20 | 4 | 75 | 79 |
| Procedures, n | 18 | 3 | 33 | 12 | 28 | 47 |
| CheckMate 057c | Nivo (n = 124) | Doc (n = 194) | ||||
| Gr 2 | Gr 3–4 | All Gr | Gr 2 | Gr 3–4 | All Gr | |
| TR AEs, n | 128 | 29 | 304 | 205 | 165 | 602 |
| Patients with concomitant medications, n | 29 | 19 | 76 | 34 | 106 | 181 |
| Laboratory tests,b n | 54 | 49 | 103 | 72 | 263 | 336 |
| Procedures, n | 38 | 40 | 78 | 23 | 49 | 78 |
aTreated patients: nivo N = 131; doc N = 129. bLaboratory tests were categorized based on values (eg, coagulation, electrolytes, hematology I and II, immunology, and liver and kidney function). cTreated patients: nivo N = 287; doc N = 268.
Conclusions
HCRU associated with nivo in CheckMate 017 and 057 was lower compared to doc for patients experiencing Gr 3/4 TR AEs and generally lower for Gr 2 events. These data are consistent with the lower rate of TR AEs and a better tolerability profile of nivo vs doc.
Clinical trial identification
CheckMate 017 = NCT01642004 CheckMate 057 = NCT01673867
Legal entity responsible for the study
Bristol-Myers Squibb
Funding
Bristol-Myers Squibb
Disclosure
M. Venkatachalam: Employment & consulting/advisory role: PAREXEL; travel, accommodations, expenses: BMS. D. Stenehjem: Consulting/advisory role & research funding: BMS. G. Pietri: Employment: Parexel. J.R. Penrod, B. Korytowsky: Employment and stock options: BMS.