Cure Alveolar Soft Part Sarcoma International (iCureASPS)

Breelyn Wilky to speak of axitinib / pembro and results that is taking place in Miami inclusive of patients with advanced ASPS and other soft tissue sarcomas .


"ANTITUMOR ACTIVITY OF AXITINIB PLUS PEMBROLIZUMAB IN A PHASE II TRIAL FOR
PATIENTS WITH ADVANCED ALVEOLAR SOFT PART SARCOMA (ASPS) AND OTHER SOFT TISSUE SARCOMAS"

PAPER-009-#2762964
https://www.ctos.org/Portals/0/PDF/2017 ... rogram.pdf

Breelyn Wilky , doctor heading up the Miami pembro /axitinib clinical trial writes from the CTOS 2017 conference

“Great day for ASPS research- kind of took front center at #CTOS2017. Neeta Somaiah from MD Anderson presented beautiful data showing 3/6 patients with ASPS having responses to durvalumab plus tremelimumab, and our axitinib and pembrolizumab study showed 44% of ASPSers with responses- looks like immunotherapy is here to stay! Finally NCI showed 2/6 Asps with responses to cabazantanib! Manny Alvarez Foundation #kickASPS”

Breely Wilky linked



Axitinib-pembrolizumab combination shows promise in advanced alveolar soft part sarcoma

https://www.healio.com/hematology-oncol ... rt-sarcoma

Md Anderson clinical trial with 6 ASPS

durvalumab-plus-tremelimumab-shows-modest-activity-for-advanced-sarcoma

Paper 009 #2762964
ANTITUMOR ACTIVITY OF AXITINIB PLUS
PEMBROLIZUMAB IN A PHASE II TRIAL FOR
PATIENTS WITH ADVANCED ALVEOLAR SOFT PART
SARCOMA (ASPS) AND OTHER SOFT TISSUE
SARCOMAS
Breelyn A. Wilky, MD1
; Eric Wieder1
; Despina Kolonias1
;
Ty Subhawong2
; Matteo Trucco3
; Andrew Rosenberg4
;
Darcy Kerr4
; Deukwoo Kwon5
; Efrosyni Sfakianaki2
;
Krishna Komanduri1
; Jonathan Trent1
1
Hematology/Oncology, Sylvester Comprehensive
Cancer Center - University of Miami Miller School of
Medicine, Miami, FL, USA; 2
Radiology, University of
Miami Miller School of Medicine, Miami, FL, USA;
3
Pediatrics, University of Miami Miller School of Medicine,
Miami, FL, USA; 4
Pathology, University of Miami Miller
School of Medicine, Miami, FL, USA; 5
Biostatistics, Sylvester
Comprehensive Cancer Center, Miami, FL, USA
Objective: Inhibition of programmed-death 1 (PD1) by
pembrolizumab (P) monotherapy produced overall response
rates (ORR) of 19% in SARC028, a Phase II
study in advanced soft tissue sarcomas (STS). Vascular
endothelial growth factor (VEGF) promotes accumulation
of suppressive immune cell phenotypes and cytokines.
Combinations of anti-VEGF receptor tyrosine kinase inhibitors
(VEGFR-TKI) with checkpoint inhibitors increased
immune cell infiltration and showed promising anti-tumor
activity in other solid cancers. Axitinib (Ax) is a pan-VEGFR
TKI with favorable progression-free survival (PFS) reported
in Axi-STS, with acceptable toxicity in combination
with P in renal cell carcinoma. We report initial toxicity and
efficacy results of combination Ax plus P for patients (pts)
with advanced STS.
Methods: We designed an open-label single institution
Phase II trial of Ax plus P in 30 pts with advanced or
metastatic STS, requiring radiographically progressing
disease, adequate end-organ function and performance
status. Pts received Ax at 5 mg PO twice daily with intrapatient
dose escalation according to predefined toxicity
thresholds, and concurrent P 200mg IV q21 days. Primary
endpoint was progression-free rate at 3 months (PFR),
with secondary endpoints of toxicity, ORR, PFS, and
overall survival. All patients underwent mandatory tumor
biopsies and peripheral blood sampling for correlative immunoprofiling
at baseline, 12 weeks and at progression.
Results: 28 of 30 pts have accrued to date. Enrolled subtypes:
ASPS (29%), UPS (18%), LMS (21%), and other
(29%). 3-month PFR by RECIST 1.1 for 18 evaluable
pts was 56%, and 4 pts (22%) achieved partial response
(PR). Responders include 3/3 (100%) currently evaluable
ASPS pts (median tumor size decrease of 70%), and
1 pt with non-uterine LMS (tumor size decrease 55%).
Clinical benefit was observed in 3 pts with RECIST progression
at 3 months, suggesting a need for alternative
response criteria such as Choi criteria. Ax plus P was
overall well-tolerated, with P-related grade 3/4 toxicities in
3 pts (autoimmune hepatitis, arthritis and hyperglycemia),
and Ax-related grade 3/4 toxicities in 2 pts (hypertriglyceridemia,
spontaneous pneumothorax). Updated response
and toxicity data will be presented. Correlative immunoprofiling
is ongoing.
Conclusion: Combination Ax plus P is feasible and
well-tolerated, and shows early evidence of activity,
particularly in ASPS pts. Clinical trial information:
NCT02301039.