Abstract 1027P
Background
This is a double-blind, randomised, Phase 3 study to compare efficacy, PK, and overall safety of candidate bevacizumab biosimilar CT-P16 and European Union-approved reference bevacizumab (BV), avastin®, in patients with metastatic or recurrent non-squamous non-small cell lung cancer (nsNSCLC). Here we report time-to-event analysis, including response duration (RD), time to progression (TTP), progression-free survival (PFS), and overall survival (OS), and safety analysis followed up to 1 year from enrollment of the last patient.
Methods
Patients with stage IV or recurrent nsNSCLC were randomised (1:1) to receive CT-P16 or BV with carboplatin and paclitaxel up to 6 cycles (Induction Period), followed by a Maintenance Period of CT-P16 or BV monotherapy until disease progression or intolerable toxicity. The Kaplan-Meier method was used to estimate survival rates of RD, TTP, PFS, and OS.
Results
A total of 689 patients were randomised: 342 patients to CT-P16 and 347 to BV. Overall, the proportion of the patients with events for RD, TTP, PFS and OS were similar between CT-P16 ad BV treatment groups (RD: 112 [72.7%] in CT-P16 vs 118 [74.7%] in BV, TTP: 186 [54.4%] vs 188 [54.2%], PFS: 248 [72.5%] vs 246 [70.9%], OS:164 [48.0%] vs 168 [48.4%]). All time-to-event endpoints (RD, TTP, PFS and OS) were comparable between the CT-P16 and BV treatment. The median PFS and OS were comparable between the 2 treatment groups with hazard ratio of 0.92 (95% CI: 0.77, 1.10) and 0.95 (95% CI: 0.77, 1.19), respectively. The safety profile including the incidence of positive ADA results of CT-P16 up to 1 year from enrollment of the last patient was similar to that of BV. Table: 1027P
| ITT Population | ||
| CT-P16 n=342 | BV n=347 | |
| Response Duration * | ||
| Survival Rate at 12 Months (95% CI) | 0.16 (0.10, 0.23) | 0.23 (0.16, 0.31) |
| Median Time (Months) (95% CI) | 7.2 [6.3, 8.2) | 6.3 [5.8, 7.5) |
| Time to Progression * | ||
| Survival Rate at 12 Months (95% CI) | 0.28 (0.22, 0.35) | 0.33 (0.27, 0.40) |
| Median Time (Months) (95% CI) | 8.5 [8.3, 10.0) | 8.3 [7.4, 9.1) |
| Progression Free Survival * | ||
| Survival Rate at 12 Months (95% CI) | 0.23 (0.18, 0.28) | 0.27 (0.22, 0.32) |
| Median Time (Months) (95% CI) | 7.9 [6.9, 8.3) | 7.2 [6.5, 8.3) |
| Overall Survival | ||
| Survival Rate at 12 Months (95% CI) | 0.66 (0.60, 0.71) | 0.62 (0.56, 0.67) |
| Median Time (Months) (95% CI) | 17.1 [14.6, 18.7) | 15.6 [13.4, 18.0) |
*Evaluated by Central Review.
Conclusions
The time-to-event analysis up to 1 year from enrollment of the last patient is comparable between CT-P16 and BV in terms of RD, TTP, PFS, and OS. The safety profile of CT-P16 was also similar to that of BV.
Clinical trial identification
NCT03676192.
Editorial acknowledgement
Legal entity responsible for the study
Celltrion Inc.
Funding
Celltrion Inc.
Disclosure
C. Verschraegen, Y. Ohe: Financial Interests, Personal, Advisory Board: Celltrion Inc. F.V. Moiseenko: Other, Personal and Institutional, Principal Investigator: Celltrion Inc. S.H. Kim, S.J. Lee: Financial Interests, Personal, Member of the Board of Directors: Celltrion Inc. K.Y. Ahn, T.H. Park, S. Park, E.H. Baek, S. Kwon, H.A. Ju, S.H. Kim, H.A. Kim, E.K. Lee: Financial Interests, Personal, Full or part-time Employment: Celltrion Inc. All other authors have declared no conflicts of interest.