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Attend this session at the
2019 ASCO Annual Meeting!


Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Type: Poster Session

Time: Monday June 3, 8:00 AM to 11:00 AM

Location: Hall A


Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Type: Poster Discussion Session

Time: Monday June 3, 4:30 PM to 6:00 PM

Location: E450

Treatment-free remission (TFR) following frontline (1L) nilotinib (NIL) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP): 192-week data from the ENESTfreedom study.

Sub-category:
Chronic Leukemia—CML and Hairy Cell

Category:
Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant

Meeting:
2019 ASCO Annual Meeting

Abstract No:
7013

Poster Board Number:
Poster Discussion Session (Board #388)

Citation:
J Clin Oncol 37, 2019 (suppl; abstr 7013)

Author(s): Francis J. Giles, Tamas Masszi, María Teresa Gómez Casares, Andrzej Hellmann, Jesper Stentoft, Eibhlin Conneally, Valentin García Gutierrez, Norbert Gattermann, Phillipp D. Le Coutre, Bruno Martino, Susanne Saussele, Jerald P. Radich, David M. Ross, Giuseppe Saglio, Manu Sondhi, Suddhasatta Acharyya, Paola Aimone, Andreas Hochhaus; Developmental Therapeutics Consortium, Chicago, IL; Semmelweis University, Budapest, Hungary; Hospital Universitario Doctor Negrin, Las Palmas De Gran Canaria, Spain; Medical University of Gdańsk, Gdańsk, Poland; Aarhus University Hospital, Aarhus, Denmark; St. James's Hospital, Dublin, Ireland; Hospital Universitario Ramón y Cajal, IRYCIS, Madrid, Spain; Universitätsklinikum Düsseldorf, Düsseldorf, Germany; Charité - Universitätsmedizin Berlin, Berlin, Germany; Azienda Ospedaliera Bianchi Melacrino Morelli, Reggio Calabria, Italy; III. Med. Klinik, Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim, Germany; Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; SA Pathology, Adelaide, Australia; University of Turin, Orbassano, Italy; Novartis Pharmaceuticals Corporation, East Hanover, NJ; Novartis Pharma AG, Basel, Switzerland; Abteilung Hämatologie/Onkologie, Universitätsklinikum Jena, Jena, Germany

Abstract Disclosures

Abstract:

Background: In ENESTfreedom (NCT01784068), which evaluated TFR following 1L NIL in CML-CP pts, 51.6% remained in TFR 48 wks after stopping treatment (primary endpoint) and durability of TFR was demonstrated at 144 wks. Data from longer follow-up (192 wks) evaluating maintenance of TFR are reported. Methods: Pts with MR4.5 (BCR-ABL1IS≤0.0032%) and ≥2y of 1L NIL entered a 1y consolidation; pts with sustained deep molecular response (MR) were eligible for TFR. NIL was resumed after loss of major MR (MMR; BCR-ABL1IS≤0.1%). At the latest data cut-off (Sep 17 2018), all pts had completed ≥192 wks of TFR, resumed NIL, or discontinued the study. Results: By the data cut-off, of 190 pts entering TFR, 87 were ongoing, 91 had resumed NIL, and 12 had permanently discontinued. The TFR rate at 192 wks was 44.2% (84/190, 95% CI: 37.0–51.6%). Of 89 pts with successful TFR at 144 wks, 5 were not assessable for TFR at 192 wks as 2 had discontinued by 192 wks due to pt/physician decision, and 3 with MR4.5 previously did not have 192 wk PCR data. Of 91 pts who resumed NIL, 90 (98.9%) regained MMR and 84 (92.3%) regained MR4.5. 75/90 and 73/84 pts, respectively, had stable MMR and MR4.5 at 48 wks later. There were no cases of disease progression or new deaths. 10 deaths were reported in the 144-wk analysis, none due to CML. The 192-wk treatment-free survival rate was 48.7% (95% CI 41.4–55.6%). Of 89 pts remaining in TFR for > 144 wks (including 87 pts for > 192 wks), all-grade AE rates during consolidation and each subsequent 48 wk period of TFR were 84.3%, 77.5%, 70.8%, 48.3%, and 52.8%, respectively. All-grade musculoskeletal pain AE rates were 15.7%, 40.4%, 9.0%, 3.4% and 3.4%, respectively; cardiovascular event rates were low across these periods. Among pts who resumed NIL, most common AEs were nasopharyngitis (18.7%) and pruritus, fatigue, and increased lipase (14.3% each); the majority of AEs were grade 1/2. Conclusions: Results continue to support the long-term durability and safety of TFR at 192 wks after stopping 1L NIL; overall AE rates declined during the TFR phase and musculoskeletal pain AEs were transient. Pts should continue to be regularly monitored during TFR. Clinical trial information: NCT01784068

 
Other Abstracts in this Sub-Category:

 

1. Randomized phase II study of cladribine with simultaneous or delayed rituximab in patients with untreated hairy cell leukemia.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7003 First Author: Dai Chihara
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Chronic Leukemia—CML and Hairy Cell

 

2. Frontline flumatinib versus imatinib in patients with chronic myeloid leukemia in chronic phase: Results from the China randomized phase III study.

Meeting: 2019 ASCO Annual Meeting Abstract No: 7004 First Author: Zhang Li
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Chronic Leukemia—CML and Hairy Cell

 

3. ENESTop 192-week results: Treatment-free remission (TFR) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after stopping second-line (2L) nilotinib (NIL).

Meeting: 2019 ASCO Annual Meeting Abstract No: 7005 First Author: Timothy P. Hughes
Category: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant - Chronic Leukemia—CML and Hairy Cell

 

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