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CX-072, a PD-L1 Probody therapeutic, as monotherapy in patients with advanced solid tumors: Preliminary results of PROCLAIM-CX-072.

Sub-category:
New Targets and New Technologies (IO)

Category:
Developmental Immunotherapy and Tumor Immunobiology

Meeting:
2019 ASCO Annual Meeting

Abstract No:
2513

Poster Board Number:
Poster Discussion Session (Board #157)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 2513)

Author(s): Aung Naing, Fiona C. Thistlethwaite, Alexander I. Spira, Javier Garcia-Corbacho, Manreet Randhawa, Ferry Eskens, Bert O'Neil, Javier Lavernia, Nataliya Volodymyrivna Uboha, Omid Hamid, Anthony B. El-Khoueiry, Beverly A. Benson, William Garner, Vanessa Jessica Huels, Hendrik-Tobias Arkenau, Patricia LoRusso; MD Anderson Cancer Center, Houston, TX; The Christie NHS Foundation Trust and The University of Manchester, Manchester, United Kingdom; Virginia Cancer Specialists, Fairfax, VA; Hospital Clinic Barcelona, Barcelona, Spain; Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Erasmus University Medical Center, Rotterdam, Netherlands; Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; Instituto Valenciano de OncologĂ­a, Valencia, Spain; University of Wisconsin, Carbone Cancer Center, Madison, WI; The Angeles Clinic and Research Institute, Los Angeles, CA; USC Norris Comprehensive Cancer Center, Los Angeles, CA; CytomX Therapeutics, Inc, South San Francisco, CA; Sarah Cannon Research Institute UK Limited, London, United Kingdom; Yale University School of Medicine, Yale Cancer Center, New Haven, CT

Abstract Disclosures
Abstract:

Background: Anti-programmed cell death ligand 1 (PD-L1) immunotherapies have improved survival in many cancers, but immune-related adverse events (irAEs) have been observed, especially in combination therapy. CX-072 is an investigational Probody therapeutic directed against PD-L1, designed to be preferentially activated in the tumor microenvironment and to reduce irAEs. Methods: This is an ongoing phase 1/2a study (PROCLAIM-CX-072; NCT03013491) evaluating CX-072 in patients (pts) with metastatic or unresectable solid tumors with no further standard curative treatment options and with no prior anti-PD1, PD-L1 or anti-CTLA4 treatment. Pts were unselected for PD-L1 expression. We report preliminary results from expansion cohorts in anal squamous cell carcinoma (SCCA), cutaneous squamous cell carcinoma (cSCC), small bowel adenocarcinoma (SBA), triple-negative breast cancer with skin lesions (TNBC), or undifferentiated pleomorphic sarcoma (UPS). Pts were treated with CX-072 monotherapy 10 mg/kg intravenously every 14 days. Results: As of 30 Nov 2018, 51 pts received CX-072 10 mg/kg monotherapy: SCCA (n = 9), cSCC (n = 5), SBA (n = 9), TNBC (n = 9), and UPS (n = 19). Median age was 63 y (range, 32-80), 67% were female, and pts had a median of 3 prior regimens (range, 1-12). Median treatment duration was 1.8 mo (range, 0.3-14.7). A grade 3/4 treatment-related adverse event (AE) was observed in 1 pt (2%; gr 3 generalized rash). No grade 3/4 irAEs were observed. Two pts discontinued treatment due to AEs: nausea (pt with SCCA) and sepsis (pt with SBA), neither treatment-related. Partial responses (confirmed and unconfirmed) were observed in cSCC (n = 1), TNBC (n = 2), and UPS (n = 1) (Table). Conclusions: CX-072 10 mg/kg monotherapy demonstrated anticancer activity in heavily pretreated pts with advanced solid tumors, including responses in cSCC, TNBC with skin lesions, and UPS, with a safety profile that compares favorably to historical controls. Clinical trial information: NCT03013491
Best Available Response
(efficacy evaluable* pts), n SCCA
(n = 3) cSCC
(n = 3) SBA
(n = 4) TNBC
(n = 2) UPS
(n = 16)
Confirmed or unconfirmed partial response 0 1 0 2 1
Stable disease 1 1 2 0 3
Progressive disease 2 1 2 0 12

*Required postbaseline assessment.
 
aus der Diskussion: CytomX - ein bahnbrechender Ansatz in der Tumortherapie
Autor (Datum des Eintrages): 007coolinvestor  (16.05.19 11:36:26)
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