Abstract 652P
Background
CT-P16 (Vegzelma®) was approved by both US FDA and European Commission as a biosimilar to reference bevacizumab (BV). This double-blind, randomised, phase III study compared the efficacy, safety, pharmacokinetics, and immunogenicity of CT-P16 to BV in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Here we present results of secondary efficacy variables; this represents a median follow-up duration of approximately 12.86 months. Primary efficacy results from this study have been previously reported.
Methods
Patients were randomised (1:1) to receive CT-P16 or BV with paclitaxel and carboplatin every 3 weeks up to 6 cycles, followed by CT-P16 or BV monotherapy until disease progression or intolerable toxicity. Study endpoints included objective response rate (ORR), duration of response (DoR), time to progression (TTP), progression free survival (PFS), overall survival (OS), and safety. The Kaplan-Meier method was used to estimate survival rates of DoR, TTP, PFS, and OS.
Results
A total of 689 patients were randomised: CT-P16 (n=342) or BV (n=347). Overall, the proportion of patients achieving an ORR was similar across CT-P16 and BV (45.61% [95% CI: 40.34, 50.89] and 46.11% [95% CI: 40.86, 51.35], respectively), with a median DoR of 7.2 months (95% CI: 6.3, 8.2) and 6.5 months (95% CI: 5.9, 7.6). All other time-to-event endpoints were comparable between CT-P16 and BV, with hazard ratio for TTP of 0.91, for PFS of 0.94, and for OS of 0.98. Overall, the safety profiles of CT-P16 were consistent with that of BV, no new safety signals or noticeable trends were observed. Table: 652P
| ITT Population | ||
| CT-P16 n=342 | BV n=347 | |
| Time to Progression | ||
| Median Time (Months) (95% CI) | 8.5 (8.3, 10.0) | 8.3 (7.4, 9.1) |
| Hazard Ratio (95% CI) | 0.91 (0.74, 1.12) | |
| Survival Rate at 36 Months (95% CI) | 0.10 (0.06, 0.16) | 0.06 (0.03, 0.12) |
| Progression Free Survival | ||
| Median Time (Months) (95% CI) | 7.9 (6.9, 8.3) | 7.3 (6.7, 8.3) |
| Hazard Ratio (95% CI) | 0.94 (0.79, 1.13) | |
| Survival Rate at 36 Months (95% CI) | 0.06 (0.03, 0.10) | 0.04 (0.02, 0.08) |
| Overall Survival | ||
| Median Time (Months) (95% CI) | 17.0 (14.7, 18.7) | 15.6 (13.8, 17.4) |
| Hazard Ratio (95% CI) | 0.98 (0.81, 1.18) | |
| Survival Rate at 36 Months (95% CI) | 0.19 (0.14, 0.24) | 0.21 (0.16, 0.26) |
Conclusions
The efficacy results were comparable between CT-P16 and BV in terms of ORR, DoR, TTP, PFS, and OS. Along with the primary efficacy results of this study, these data are further evidence of clinical equivalence between CT-P16 and BV in this patient population.
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. Z.G. Andric, F.V. Moiseenko, T. Makharadze, A. Oleksiienko, E.P. Yanez Ruiz: Other, Personal and Institutional, Principal Investigator: Celltrion Inc. S.H. Kim, S.J. Lee, I. Chang: Financial Interests, Personal, Member of Board of Directors: Celltrion Inc. K. Ahn, T.H. Park, H.A. Ju, E.H. Baek, S. Kwon, S.H. Kim, H.A. Kim, E. Lee: Financial Interests, Personal, Full or part-time Employment: Celltrion Inc.