Looks like we will finally get a peek at the FINAL SUNRISE results - September 9th
ESMO 2017 Congress, 09.09.2017, 13:15 - 14:15, Hall 8
1364P - Final clinical results from SUNRISE: A phase III, randomized, double-blind, placebo-controlled multicenter trial of bavituximab plus docetaxel in patients with previously treated stage IIIb/IV nonsquamous non-small cell lung cancer R. Palmero (Barcelona, Spain) P. Bidoli (Monza, Italy) I. M. Bondarenko (Dnepropetrovsk, Ukraine) M. Boyer (Camperdown, Australia) P. Germonpre (Gent, Belgium) D. Ghizdavescu (Ploiesti, Romania) A. Kotsakis (Heraklion, Greece) H. Lena (Rennes, France) G. Losonczy (Budapest, Hungary) K. Park (Seoul, Korea, Republic of) M. Reck (Grosshansdorf, Germany) W. Su (Tainan, Taiwan) N. Kallinteris (Tustin, United States of America) M. Tang (Tustin, United States of America) J. Lai (Tustin, United States of America) J. Shan (Tustin, United States of America) D. R. Spigel (Nashville, United States of America)
1364P - Final clinical results from SUNRISE: A phase III, randomized, double-blind, placebo-controlled multicenter trial of bavituximab plus docetaxel in patients with previously treated stage IIIb/IV nonsquamous non-small cell lung cancer
Background
Exposed phosphatidylserine (PS) in the tumor microenvironment is highly immunosuppressive. Bavituximab targets PS and repolarizes M2 macrophages to M1 resulting in production of pro-inflammatory cytokines such as IFN-? and IL-12, maturation of dendritic cells, and tumor specific cytotoxic T lymphocyte immunity. In a prior blinded Phase II trial in 2nd-line nonsquamous NSCLC, bavituximab + docetaxel was well-tolerated and demonstrated 60% improvement (11.7 vs 7.3 months) in median overall survival (mOS) (HR, 0.66; P=0.11) compared to control.
Methods
597 patients with Stage IIIb/IV nonsquamous NSCLC that progressed on platinum-doublet chemotherapy were randomized 1:1 to receive up to six 21-day cycles of docetaxel in combination with weekly 3?mg/kg bavituximab (B+D) or placebo (D) until progression or toxicity. The primary endpoint was OS. Secondary endpoints included progression-free survival (PFS), objective response rate (ORR) and safety.
Results
With 12 months follow-up from the last patient randomized and ~85% of the targeted OS events reached, mOS was 10.5 months (95% confidence interval [CI], 8.4-11.9) among 297 patients in B+D and 10.9 months (95% CI, 9.2-12.1) among 300 patients in D (HR, 1.06; P=0.533). PFS was 4.2 months (95% CI, 3.9-4.6) in B+D and 4.1 months (95% CI, 3.2-4.8) in D (HR, 1.02; P=0.876). The ORR was 15% in B+D vs. 11% in D (odds ratio, 0.7; P=0.15). The safety profile was similar between groups. Grade 3 or higher adverse events occurred in 68% of patients in B+D and 60% in D. In an exploratory analysis of OS for patients who received subsequent immune checkpoint inhibitors (ICI), the mOS was not reached (95% CI, 15.2-NA) in B+D (n=46) and 12.6 months (95% CI, 10.4-17.8) in D (n=47) (HR, 0.46; P=0.006).
Conclusions
The combination of B+D was well-tolerated though no OS difference was observed compared to D alone in the ITT population of previously treated nonsquamous NSCLC. An exploratory analysis of patients who received subsequent ICI found significantly longer OS in patients who received prior B+D than those who received D and support further clinical investigation of B+ICI in NSCLC.
Clinical trial identification
NIH = NCT01999673 EudraCT = 2013-003953-13
Legal entity responsible for the study
Peregrine Pharmaceuticals Inc.
Funding
Peregrine Pharmaceuticals Inc. Disclosure
P. Bidoli: Eli Lilly personal fees and advisory board BMS personal fees and advisory board Boehringer personal fees and advisory board. M. Reck: Honoraria for lectures and consultancy with Hoffmann-La Roche, Lilly, MSD, Merck, BMS, AstraZeneca, Celgene, Boehringer-Ingelheim, Pfizer, Novartis. N. Kallinteris, J. Lai: Peregrine Pharmaceuticals Inc. = employee, stock ownership M. Tang: Peregrine = Employee, stock owner. J. Shan: Employee, officer and stock owner for Peregrine Pharmaceuticals Inc. All other authors have declared no conflicts of interest.
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