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Attend this session at the
2018 ASCO Annual Meeting!


Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics

Type: Oral Abstract Session

Time: Friday June 1, 2:45 PM to 5:45 PM

Location: S406

Biomarker-driven access to crizotinib in ALK, MET, or ROS1 positive (+) malignancies in adults and children: The French National AcSé Program.

Sub-category:
Small Molecules

Category:
Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics

Meeting:
2018 ASCO Annual Meeting

Abstract No:
2504

Citation:
J Clin Oncol 36, 2018 (suppl; abstr 2504)

Author(s): Gilles Vassal, Nathalie Cozic, Gilbert Ferretti, Sophie Taieb, Roch Houot, Laurence Brugieres, Thomas Aparicio, Jean-Yves Blay, Ivan Bieche, Sylvie Lantuejoul, Celine Mahier - Ait Oukhatar, Natalie Hoog Labouret, Denis Moro-Sibilot; Gustave Roussy, Villejuif, France; Biostatistics Unit, Gustave Roussy Cancer Campus, Villejuif, France; Centre Hospitalier Universitaire, Grenoble, France; Centre Oscar Lambret, Lille, France; Centre Hospitalier Universitaire Pontchaillou, Rennes, France; Department of Gastroenterology, Saint Louis Hospital, Paris, France; Centre Léon Bérard, Lyon, France; Institut Curie, Paris, France; Centre Léon Bérard, Lyon, FR; Unicancer, Paris, France; French National Cancer Institute (INCa), Boulogne-Billancourt, France; Grenoble University Hospital, Grenoble, France

Abstract Disclosures

Abstract:

Background: Crizotinib (czb) is registered for the treatment of patients (pts) with ALK+ or ROS1+ lung cancer. Czb targets (ALK, MET, ROS1) are also altered (translocation [tlc], amplification [amp], mutation [mut]) in a wide range of malignancies (malg.) in adults and children. To generate high evidenced-based knowledge and to prevent off-label use, the French National Cancer Institute (INCa) launched the AcSé Program: equal access to tumor molecular diagnosis along with an exploratory phase II trial, to allow for a nationwide safe and controlled access to czb outside its indication. Methods: Biomarker identification was proposed to pts ≥ 1 year old (yo) with an advanced disease among more than 15 malg. known to harbor a czb target alteration. If not eligible for any other trial, pts may enter one of the 22 cohorts defined by the type of tumor and target. Tumor response was evaluated every 2 months (mo) using RECIST criteria v1.1. The primary endpoint is the objective response rate (ORR) at 2 mo [complete + partial response]. A two-stage Simon design is applied to each cohort. Results: From 08/2013 to 12/2017, 12836 pts from 186 centers have entered the biomarker program. Alterations found in pts were: ALK tlc, mut, amp in 14/2053, 8/306, 10/1846; MET amp ( > 6 copies/diploid genome) in 392/7847 [250/4127 NSCLC, 60/1232 glioblastomas, 28/939 colon, 33/546 esogastric, 7/635 ovarian, 3/82 kidney cancers]; MET mut in 98/2697; ROS1 tlc in 80/4625 [NSCLC, cholangiocarcinoma, inflammatory myofibroblastic tumor (IMT)]. Clinical trial information: NCT02034981 Overall, 235 pts (median age, 58 yo [1–92]) received czb (adult 250 mg bid; child 280 mg/m² bid). Conclusions: Czb displayed a wide antitumor activity in several MET, ALK and ROS1+ malg. Equal and safe access across France to molecular testing and targeted therapies outside their approved indication is feasible.

Positive cohortsPts analyzedCR/PRORR % [IC95%]
ALCL ALK tlc221254 [34-75]
NSCLC MET amp25624 [7-40]
ROS1 tlc372054 [40-70]
MET mut27622 [7-38]
Esogastric MET amp8337 [10-74]
IMT ALK tlc / ROS1 tlc7128 [5-70]

 
Other Abstracts in this Sub-Category:

 

1. Results from molecular analysis for therapy choice (MATCH) arm I: Taselisib for PIK3CA-mutated tumors.

Meeting: 2018 ASCO Annual Meeting Abstract No: 101 First Author: Ian E. Krop
Category: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics - Small Molecules

 

2. A phase 1 study of LOXO-292, a potent and highly selective RET inhibitor, in patients with RET-altered cancers.

Meeting: 2018 ASCO Annual Meeting Abstract No: 102 First Author: Alexander E. Drilon
Category: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics - Small Molecules

 

3. Molecular analysis for therapy choice (MATCH) arm W: Phase II study of AZD4547 in patients with tumors with aberrations in the FGFR pathway.

Meeting: 2018 ASCO Annual Meeting Abstract No: 2503 First Author: Young Kwang Chae
Category: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics - Small Molecules

 

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