Replies to post #310564 on Avid Bioservices Inc (CDMO)

[cjgaddy]

10-17-17: Sunrise Subset Results presented at WCLC/IASLC’17/Japan. I believe this data was taken from the 9-9-17 ESMO’17 presentation of Final SUNRISE results (Madrid http://tinyurl.com/yb9kjutp ), which stated, “In an exploratory analysis of OS for pts who received subsequent immune checkpoint inhibitors (ICI), mOS was not reached.”...

Oct15-18 2017: “WCLC’17 - IASLC’s 18th World Conf. on Lung Cancer”, Yokohama, Japan
“Medical doctors, scientists, nurses, health professionals, government officials, partners from the industry, health advocacy groups and patients will come together in order to obtain and exchange information on advances in the management of lung cancer and other thoracic malignancies, while considering both global & regional aspects..”
http://wclc2017.iaslc.org
IASLC = Intl. Association for the Study of Lung Cancer - http://iaslc.org
WCLC = World Conference on Lung Cancer (IASLC)
Pgm: https://library.iaslc.org/conference-program?product_id=7
Track: Immunology & Immunotherapy
Presentation: Mini-Oral #MA 10
Moderators: S. Wang, Robert Pirker (http://tlcr.amegroups.com/user/view/750 )
10-17-17 11:30-11:35pm #MA 10.05 (Mini-Oral):
“Improved Outcome for Immune Checkpoint Inhibitors (ICI) in Patients Previously Treated with Bavituximab in the SUNRISE Trial”
Michael Boyer (presenting author*), David R Spigel, P. Mainwaring, H. Lena, M. McCleod, G. Losonczy, R.E. Sanborn, R. Natale, M. Tang, J. Lai, N.L. Kallinteris, Joseph Shan, David E Gerber (senior author, UTSW)
- - - - - - -
*MICHAEL BOYER (MBBS, PhD, IASLC’13 Conf. President): professor at the Sydney CC in Sydney, Australia. His research interests include new agents for the treatment of lung cancer. http://sydney.edu.au/medicine/people/academics/profiles/michael.boyer.php
ABSTRACT:
BACKGROUND: Bavituximab targets exposed phosphatidylserine (PS) in the tumor microenvironment, resulting in repolarization of myeloid suppressor cells/M2 macrophages to M1, production of pro-inflammatory cytokines such as IFN? and IL-12, dendritic cell maturation, and tumor specific cytotoxic T-cell activation. SUNRISE was a Phase III trial of docetaxel with bavituximab (D+B) or placebo (D+P) in patients with treated Stage IIIb/IV non-squamous NSCLC. Recent correlative analyses from SUNRISE suggest bavituximab is more active in PD-L1 negative, immune cold tumors and thus may complement PD-1/PD-L1 ICI.
METHODS: This subgroup analysis included all patients who received subsequent ICI after discontinuing SUNRISE study drug. We calculated overall survival (OS) both from randomization and start of subsequent ICI.
RESULTS: 93 of 597 randomized patients (16%) received ICI as next line of therapy after SUNRISE assigned treatment. Baseline characteristics were balanced between the treatment groups and consistent with the ITT population. From randomization, mOS was not reached (95% CI, 15.2-NA) in D+B (N=46) and 12.6mos. (95% CI, 10.4-17.8) in D+P (N=47) (HR, 0.46; P=0.006). From start of ICI, mOS was not reached (95% CI, 10.2-NA) in D+B and 6.2mos. (95% CI, 3.9-8.7) in D+P (HR, 0.42; P=0.002). The mPFS was 6.0mos. (95% CI, 3.5-6.5) in D+B and 4.4mos. (95% CI, 2.6-6.3) in D+P (HR, 1.00; P=0.991). ORR was 20% vs. 13% (Odds ratio 0.6; P=0.41) for D+B and D+P, respectively. The safety profile was similar between groups and no immune related (IR) toxicities (colitis, pneumonitis, hypothyroidism) were reported.
CONCLUSIONS: Within the limits of a subgroup analysis, a significant improvement in OS was observed for patients previously treated with D+B. Furthermore, bavituximab has not been associated with IR toxicities and might serve as a useful drug in combination with ICI for the treatment of immune cold tumors.
Fig.1:


= = = = = = = = = = = = =
BAVITUXIMAB "SUNRISE" PHASE III TRIAL: http://www.SunriseTrial.com (Start=Dec'13 EstPrimComp=Dec’16)
A. Phase III Bavi+Doce vs. 2nd-Line NSCLC "SUNRISE" (randomized, double-blind, placebo-ctl'd, n=582)
USA Protocol: http://www.clinicaltrials.gov/ct2/show/NCT01999673 <=chgd. to "Active, Not Recruiting." 2-1-16
...2 ARMS: A=BAVI/3mg+DOCE(Weekly), B=Doce+Placebo(Weekly)
...ECOG's: Ph3SUNRISE/0-1, Ph2Bavi+Doce(n=120)/0-1-2, Ph2Bavi+Durva(AZN)/0-1, Ph3Herbst2010/0-1 (2L/NSCLC)
...161 sites a/o 7-9-15 (USA/39 Aus/9 Bel/7 Fr/9 Ger/15 Greece/10 Hungary/7 Italy/10 Korea/9 Rom/6 Rus/8 Spain/16 Taiwan/10 Ukraine/6) - Growth: http://tinyurl.com/qbemrr2
...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
9-9-17/ESMO’17(Madrid): Final SUNRISE Ph3 Data to be presented (poster# 1364P) http://tinyurl.com/yb9kjutp
..."In an exploratory analysis of OS for pts who received subsequent immune checkpoint inhibitors (ICI), mOS was not reached.”
2-25-16: IDMC Halts SUNRISE at 1st Look-in. Bavi+Doce arm “OS performing as expected”; Doce arm “dramatically outperforming OS expectations” http://tinyurl.com/jbg48vs
...CC Replay: http://edge.media-server.com/m/p/xfa9fy5v 12:22/Q&A: RahulJasuja/Noble, “You said that the performance of the Doce/Ctl arm was higher than ever seen in such a trial?” - SK “Yes, we've never seen these #'s reported. It's quite perplexing… at this point, the performance of the Doce arm was just completely out in left field.”
2-1-16: SUNRISE Trial status updated: “Study ongoing, but not recruiting.” http://www.clinicaltrials.gov/ct2/show/NCT01999673
12-10-15: “Sunrise >90% enrolled; sufficient to allow the 2 planned interim looks (33%/50%) & final readout based on PrimEndPt=OS” http://tinyurl.com/jkp885g
5-31-14 ASCO’14: David Gerber/Joe Shan Poster on Ph3/SUNRISE Trial (#TPS8129) http://tinyurl.com/nv4jloo
3-7-14: PR & Conf-Call: "first patients enrolled and dosed." http://tinyurl.com/kh9cnrg
1-6-14: FDA grants FAST TRACK status to Bavi in 2ndLine NSCLC http://tinyurl.com/l799ukk
12-30-13: Pivotal Ph.3 ‘SUNRISE’ NSCLC Trial Initiated (n=~600, sites=100+) http://tinyurl.com/kdjb9qz
5-20-13: FDA Approves Bavituximab Ph.III Design for 2L/NSCLC; 600-pt trial to begin by y/e’13 http://tinyurl.com/n3dxtm6
...S.King: “We will now focus on starting the Ph.III trial while continuing ongoing partnering discussions.”
…R.Garnick: “This was a highly collaborative effort with the FDA; this trial, when combined with Bavi’s supporting data to date, could be sufficient to support a future BLA submission."

[biopharm]

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).

Looks like we have CTOs / patents filed to keep other Biomarkers classified / Roche another CTO that can't be made public till 2021 and Roche ties into Halozyme ... an Avid Bioservices client

One should always wonder why Avid was chosen for the start of HALO contracts and as I always said.... just a new twist into how Big Pharma can pay to delay new, paradigm shifting medical treatment that rocks the boat

Historic MOS survival rates and not a peep from Avid or Oncologie or UTSWM or Lonza