Abstract 277P
Background
Cisplatin (cis)-based chemotherapy has been the preferred first-line (1L) standard of care (SOC) for cis-eligible patients (pts) with u/mUC in China; there remains a high unmet need for treatments with durable efficacy benefit. In the phase III CheckMate 901 global trial (NCT03036098), NIVO + GC demonstrated statistically significant and clinically meaningful improvements in overall survival (OS) and progression-free survival (PFS) vs GC alone as 1L treatment for u/mUC in the intent-to-treat (ITT) population. Here we report results for the Chinese population in CheckMate 901.
Methods
In this open-label, randomized, multicenter trial, pts received NIVO 360 mg + GC Q3W (up to 6 cycles) followed by NIVO 480 mg Q4W until disease progression/unacceptable toxicity or up to a maximum of 2 years, or GC Q3W (up to 6 cycles). Stratification factors were programmed death ligand 1 status < 1% and liver metastasis. Primary endpoints were OS and PFS by blinded independent central review (BICR). Objective response rate (ORR) per BICR and safety were key exploratory endpoints.
Results
A total of 91 Chinese pts were randomized (44 to NIVO + GC; 47 to GC). With a median follow-up of 26.2 months (mo) in the NIVO + GC arm and 28.3 mo in the GC arm, median OS was 22.6 mo with NIVO + GC vs 18.9 mo with GC (HR, 0.70; 95% CI, 0.41–1.21); median PFS was 7.8 vs 6.9 mo (HR, 0.54; 95% CI, 0.30–0.94). ORR and complete response (CR) rate were 50.0% and 15.9% with NIVO + GC vs 34.0% and 4.3% with GC; median duration of response (DoR; 95% CI) was 12.5 (3.9–not estimable [NE]) vs 6.7 (3.9–7.5) mo. Similar rates of any adverse events (AEs; 97.7% and 97.7%) and treatment-related AEs (95.5% and 97.7%) were seen in NIVO + GC and GC arms, respectively. Table: 277P
| NIVO + GC (n = 44) | GC (n = 47) | HR (95% CI) | |
| Median OS (95% CI), mo | 22.6 (13.1–35.6) | 18.9 (11.7–24.4) | 0.70 (0.41–1.21) |
| 12-mo OS rate (95% CI), % | 74.0 (58.0–84.7) | 61.9 (44.8–75.1) | |
| Median PFS (95% CI), mo | 7.8 (6.2–14.2) | 6.9 (4.4–7.8) | 0.54 (0.30–0.94) |
| 12-mo PFS rate (95% CI), % | 33.3 (17.3–50.3) | 6.2 (0.5–23.6) | |
| ORR (95% CI), % | 50.0 (34.6–65.4) | 34.0 (20.9–49.3) | - |
| CR, n (%) | 7.0 (15.9) | 2 (4.3) | |
| Median DoR (95% CI), mo | 12.5 (3.9–NE) | 6.7 (3.9–7.5) |
Conclusions
Consistent with ITT analysis findings, NIVO + GC demonstrated a positive benefit-risk profile in Chinese cis-eligible pts with u/mUC, supporting its use as a new SOC.
Clinical trial identification
CA209901, NCT03036098.
Editorial acknowledgement
Writing and editorial assistance were provided by Noopur Mandrekar, PhD, of Parexel, funded by Bristol Myers Squibb.
Legal entity responsible for the study
Bristol Myers Squibb.
Funding
Bristol Myers Squibb.
Disclosure
W. Kang, J. Filian, L. Wang: Financial Interests, Personal, Full or part-time Employment: Bristol Myers Squibb. All other authors have declared no conflicts of interest.