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Attend this session at the
2019 ASCO Annual Meeting!


Session: Developmental Immunotherapy and Tumor Immunobiology

Type: Poster Session

Time: Saturday June 1, 8:00 AM to 11:00 AM

Location: Hall A


Session: Developmental Immunotherapy and Tumor Immunobiology

Type: Poster Discussion Session

Time: Saturday June 1, 1:15 PM to 2:45 PM

Location: Hall D1

First-in-human first-in-class phase I trial of murlentamab, an anti-Mullerian-hormone receptor II (AMHRII) monoclonal antibody acting through tumor-associated macrophage (TAM) engagement, as single agent and in combination with carboplatin (C) and paclitaxel (P) in AMHRII-expressing advanced/metastatic gynecological cancer patients (pts).

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

Category:
Developmental Immunotherapy and Tumor Immunobiology

Meeting:
2019 ASCO Annual Meeting

Abstract No:
2521

Poster Board Number:
Poster Discussion Session (Board #165)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 2521)

Author(s): Alexandra Leary, Ahmad Awada, Jean-Pierre Delord, Anne Floquet, Isabelle Laure Ray-Coquard, Cyril Abdeddaim, Michel Fabbro, Elsa Kalbacher, Ignace Vergote, Susana N. Banerjee, François-Xavier Frenois, Grégory Noël, Olivier Lantz, Lydie Cassard, Agnès Coste, Marine Villard, Fanny Lemee, Isabelle Marie Tabah-Fisch, Christophe Le Tourneau; Gustave-Roussy Cancer Campus, Villejuif, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, France; Jules Bordet Institute, Université Libre de Bruxelles, Brussels, Belgium; Toulouse University Cancer Institute IUCT-Oncopole, Toulouse, France; Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, and Groupe d’Investigateurs Nationaux pour l’Etude des Cancers Ovariens, Bordeaux, France; GINECO Group and Centre Léon Bérard, Lyon, France; Centre Oscar Lambret, Lille, France; GINECO & Institut du Cancer de Montpellier, Montpellier, France; CHU Jean Minjoz, Besançon, France; University Hospital Leuven, Leuven Cancer Institute, Leuven, Belgium; The Royal Marsden Hospital, London, United Kingdom; Institut Universitaire du Cancer Toulouse, CHU Toulouse, Toulouse, France; Institut Jules Bordet - Université Libre de Bruxelles, Brussels, Belgium; Institut Curie, Paris, France; Laboratory of Immunomonitoring in Oncology, Gustave Roussy, Villejuif, France; UMR152 UPS-IRD, Toulouse, France; Hospices Civils de Lyon, Pierre-Bénite, France; GamaMabs Pharma, Toulouse, France

Abstract Disclosures

Abstract:

Background: Membranous expression of AMHRII is found in ~70% of gynecological tumors. Murlentamab (M) binds with high affinity both AMHRII (at cell membrane) and CD16 (on macrophage, via its low fucose Fc). M reprograms TAMs, restoring their antitumoral functions (phagocytosis) resulting in cytotoxic T cell reactivation. Methods: Pts with advanced/metastatic AMHRII-expressing ovarian, cervical or endometrial cancer with measurable disease and performance status ≤ 1 received M as single agent (SA) in 8 dose escalating and 2 expansion cohorts. Combination with CP was studied in 2 escalating cohorts. Safety, recommended dose determination, antitumor activity, pharmacodynamics (PD) effects (circulating immune cells and tumor microenvironment (TME) from paired biopsies) were assessed. Results: 68 heavily pretreated (median 4 prior lines) pts received M for 0.5 to 11 months (mo) (59 pts M SA and 9 pts M + CP). No dose limiting toxicity was reported. Most common toxicity was G1-2 asthenia (29 %). Eight pts (12%) had G ≥ 3 reversible toxicities (asthenia, nausea/vomiting, anorexia, arthralgia). No antidrug antibody was detected. One partial response (PR) was achieved with M SA in a granulosa pt. In CP combination, 4/9 pts (44%) responded to treatment (1 Complete Response and 3 PRs). Overall, 22/67 (33%) pts were progression-free at 4 mos. Among 17 pts treated ≥ 6 mos, 6/9 (67%) granulosa pts with M SA and 4/5 (80%) endometrium and cervix with CP combination had a longer PFS than under previous regimen. PD blood assessment of 25 pts treated with M SA showed an increase in classical monocytes, and T cells and neutrophils activation. Changes in TME under M will be presented. Conclusions: Murlentamab was very well tolerated, demonstrated immune PD effects and showed hints of antitumor activity. These results together with its innovative immunological mode of action support development of M in AMHRII-expressing cancers, in combination with chemotherapy or other immune oncology drugs. Clinical trial information: NCT02978755

 
Other Abstracts in this Sub-Category:

 

1. A phase II, randomized, double-blind, placebo-controlled trial evaluating efficacy and safety of namodenoson (CF102), an A3 adenosine receptor agonist (A3AR), as a second-line treatment in patients with Child-Pugh B (CPB) advanced hepatocellular carcinoma (HCC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 2503 First Author: Salomon M. Stemmer
Category: Developmental Immunotherapy and Tumor Immunobiology - New Targets and New Technologies (IO)

 

2. Results from a first-in-man, open label, safety and tolerability trial of CAN04 (nidanilimab), a fully humanized monoclonal antibody against the novel antitumor target, IL1RAP, in patients with solid tumor malignancies.

Meeting: 2019 ASCO Annual Meeting Abstract No: 2504 First Author: Ahmad Awada
Category: Developmental Immunotherapy and Tumor Immunobiology - New Targets and New Technologies (IO)

 

3. Determination of the recommended phase II dose of birinapant in combination with pembrolizumab: Results from the dose-escalation phase of BPT-201.

Meeting: 2019 ASCO Annual Meeting Abstract No: 2506 First Author: Russell J. Schilder
Category: Developmental Immunotherapy and Tumor Immunobiology - New Targets and New Technologies (IO)

 

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