AI
Friday, September 01, 2017 9:58:32 AM
9-9-17/ESMO’17: Final SUNRISE Ph3 Data, Poster #1364P
Sept8-12 2017: “42nd ESMO European Cancer Congress”, Madrid
http://www.esmo.org/Conferences/ESMO-2017-Congress
ESMO = European Society for Medical Oncology
ECCO = European CanCer Organization
Pgm: http://www.esmo.org/Conferences/ESMO-2017-Congress/Programme
PEREGRINE EXHIBITING: BOOTH #257
9-9-17 1:15-2:15pm Poster #1364P:
“Final Clinical Results from SUNRISE: A Phase III Multicenter Trial of Bavituximab+Docetaxel in Patients with Prev. Treated Stage IIIb/IV nonsquamous NSCLC”
R. Palmero (Barcelona, Spain) P. Bidoli (Italy) I.M. Bondarenko (Ukraine) M. Boyer (Australia) P. Germonpre (Belgium) D. Ghizdavescu (Romania) A. Kotsakis (Greece) H. Lena (France) G. Losonczy (Hungary) K. Park (Korea) M. Reck (Germany) W. Su (Taiwan) N. Kallinteris (Tustin) M. Tang (Tustin) J. Lai (Tustin) J. Shan (Tustin) D.R. Spigel (Nashville TN)
ABSTRACT: https://cslide.ctimeetingtech.com/library/esmo/browse/search/5uD#2Bb5o
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-y 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 7.3mos.) in mOS (HR=.66; P=.11) compared to control. [2-19-16/Clin-Lung-Cancer-Jrnl: Ph2 Final Data, Dr. David Gerber etal http://tinyurl.com/z5a7fwu ]
METHODS:
597 patients with Stage IIIb/IV nonsquamous NSCLC that progressed on platinum-doublet chemotherapy were randomized 1:1 to receive up to 6 21-day cycles of docetaxel in combination with weekly 3mg/kg bavituximab (B+D) or placebo (D) until progression or toxicity. The primary endpoint was OS. Secondary endpoints included PFS, ORR, and safety.
RESULTS:
With 12mos. follow-up from the last patient randomized and ~85% of the targeted OS events reached, mOS was 10.5mos. (95% CI, 8.4-11.9) among 297 patients in B+D and 10.9mos. (95% CI, 9.2-12.1) among 300 patients in D (HR, 1.06; P=.533). PFS was 4.2mos. (95% CI, 3.9-4.6) in B+D and 4.1mos. (95% CI, 3.2-4.8) in D (HR, 1.02; P=.876). The ORR was 15% in B+D vs. 11% in D (odds ratio, 0.7; P=.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 12.6mos. (95% CI, 10.4-17.8) in D (n=47) (HR=.46; P=.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 prev. 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.
= = = = = = = = = = = = = = = = =
Sunrise Biomarker studies - 4 announced thru ASCO'17, see http://tinyurl.com/ydhf6tfx
......#1 10-10-16/ESMO’16: B2GPI/200-240(30%pts) StatSig MOS 7.7=>13.2mos. http://tinyurl.com/hp73njt
......#2 12-7-16/WCLC’16(IASLC): “Complement & IL-10 Pathways: Pts Benefiting from Bavi+Doce” <=Presentation CANCELLED/”Anal.Not.Finished(IR)” http://tinyurl.com/z8cq8vx
......#3 4-3-17/AACR'17: "IFN-y Analysis In Blood & Tissue as a Potential Prognostic and/or Predictive Biomarker” See: http://tinyurl.com/ktzr782
......#4 6-3-17/ASCO'17: "Prelim. Correlative Analysis of PD-L1 Expression from the Sunrise Study” See ASCO'17: http://tinyurl.com/y93upatl
Sept8-12 2017: “42nd ESMO European Cancer Congress”, Madrid
http://www.esmo.org/Conferences/ESMO-2017-Congress
ESMO = European Society for Medical Oncology
ECCO = European CanCer Organization
Pgm: http://www.esmo.org/Conferences/ESMO-2017-Congress/Programme
PEREGRINE EXHIBITING: BOOTH #257
9-9-17 1:15-2:15pm Poster #1364P:
“Final Clinical Results from SUNRISE: A Phase III Multicenter Trial of Bavituximab+Docetaxel in Patients with Prev. Treated Stage IIIb/IV nonsquamous NSCLC”
R. Palmero (Barcelona, Spain) P. Bidoli (Italy) I.M. Bondarenko (Ukraine) M. Boyer (Australia) P. Germonpre (Belgium) D. Ghizdavescu (Romania) A. Kotsakis (Greece) H. Lena (France) G. Losonczy (Hungary) K. Park (Korea) M. Reck (Germany) W. Su (Taiwan) N. Kallinteris (Tustin) M. Tang (Tustin) J. Lai (Tustin) J. Shan (Tustin) D.R. Spigel (Nashville TN)
ABSTRACT: https://cslide.ctimeetingtech.com/library/esmo/browse/search/5uD#2Bb5o
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-y 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 7.3mos.) in mOS (HR=.66; P=.11) compared to control. [2-19-16/Clin-Lung-Cancer-Jrnl: Ph2 Final Data, Dr. David Gerber etal http://tinyurl.com/z5a7fwu ]
METHODS:
597 patients with Stage IIIb/IV nonsquamous NSCLC that progressed on platinum-doublet chemotherapy were randomized 1:1 to receive up to 6 21-day cycles of docetaxel in combination with weekly 3mg/kg bavituximab (B+D) or placebo (D) until progression or toxicity. The primary endpoint was OS. Secondary endpoints included PFS, ORR, and safety.
RESULTS:
With 12mos. follow-up from the last patient randomized and ~85% of the targeted OS events reached, mOS was 10.5mos. (95% CI, 8.4-11.9) among 297 patients in B+D and 10.9mos. (95% CI, 9.2-12.1) among 300 patients in D (HR, 1.06; P=.533). PFS was 4.2mos. (95% CI, 3.9-4.6) in B+D and 4.1mos. (95% CI, 3.2-4.8) in D (HR, 1.02; P=.876). The ORR was 15% in B+D vs. 11% in D (odds ratio, 0.7; P=.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 12.6mos. (95% CI, 10.4-17.8) in D (n=47) (HR=.46; P=.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 prev. 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.
= = = = = = = = = = = = = = = = =
Sunrise Biomarker studies - 4 announced thru ASCO'17, see http://tinyurl.com/ydhf6tfx
......#1 10-10-16/ESMO’16: B2GPI/200-240(30%pts) StatSig MOS 7.7=>13.2mos. http://tinyurl.com/hp73njt
......#2 12-7-16/WCLC’16(IASLC): “Complement & IL-10 Pathways: Pts Benefiting from Bavi+Doce” <=Presentation CANCELLED/”Anal.Not.Finished(IR)” http://tinyurl.com/z8cq8vx
......#3 4-3-17/AACR'17: "IFN-y Analysis In Blood & Tissue as a Potential Prognostic and/or Predictive Biomarker” See: http://tinyurl.com/ktzr782
......#4 6-3-17/ASCO'17: "Prelim. Correlative Analysis of PD-L1 Expression from the Sunrise Study” See ASCO'17: http://tinyurl.com/y93upatl
