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1701 Real-World Data Analysis of the Molecular Response Kinetics within the Two First Years of the RELMC-NOVA Study in Newly Diagnosed Spanish CML-CP Patients Treated with Tirosin Kinasa Inhibitors (TKIs) in First Line

Program: Oral and Poster Abstracts
Session: 632. Chronic Myeloid Leukemia: Clinical and Epidemiological: Poster I
Hematology Disease Topics & Pathways:
Clinical Practice (Health Services and Quality), CML, Chronic Myeloid Malignancies, Diseases, Myeloid Malignancies
Saturday, December 10, 2022, 5:30 PM-7:30 PM

Luis Felipe Casado Montero, MD1, Nuria Garcia-Ormeña1*, Manuel Perez Encinas, MD2*, Santiago Osorio-Prendes, MD3*, Francisca Ferrer Marin, MD, PhD4, Miguel Sagüés, MD5*, Valentín Garcia-Gutiérrez, MD, PhD6, Fernando Marco De Lucas7*, Concepcion Boque, MD. PhD8*, Soledad Noya, MD9*, María Teresa Gomez Casares, MD, PhD10*, Natalia Estrada11*, Maria Angeles Goñi12*, Angel Ramírez Payer, MD13*, Maria Jose Requena14*, Sunil Lakhwani15*, Marcio Miguel Andrade Campos, MD, PhD16*, Natalia De las Heras, MD17*, María Ángeles Foncillas, MD18* and Juan Luis Steegmann, Prof., MD.19*

1Hospital General Universitario de Toledo, Toledo, Spain
2Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain
3Hospital General Universitario Gregorio Marañón, Madrid, Spain
4Morales Meseguer Hospital, IMIB, CIBERER, UCAM, Murcia, Spain
5ICO Hospital Universitari de Girona Dr. Josep Trueta, Girona, Spain
6Ramón y Cajal University Hospital, Madrid, Spain
7Basurto University Hospital, Bizkaia, ESP
8ICO Bellvitge H. Durán i Reynals, Barcelona, Spain
9University Hospital Complex A Coruña, A Coruña, Spain
10Hospital Universitario de Gran Canaria Dr Negrín, Las Palmas de Gran Canaria, Spain
11Josep Carreras Leukemia Research Institute. Institut Català d'Oncologia (ICO)-Hospital Germans Trias i Pujol, Barcelona, Spain
12Complejo Hospitalario de Navarra, Navarra, Spain
13Central University Hospital of Asturias, Asturias, Spain
14Severo Ochoa Hospital, Madrid, Spain
15University Hospital of the Canary Islands, Santa Cruz de Tenerife, Spain
16Hospital del Mar, Barcelona, Spain
17Complejo Asistencial Universitario de León, Leon, Spain
18Infanta Leonor Universitary Hospital, Madrid, Spain
19La Princesa University Hospital, Madrid, Spain

Introduction: The RELMC-Nova study analyses first line treatments in patients with chronic myeloid leukemia (CML) in chronic phase (CP) in standard clinical practice in two cohorts, before (retrospective) and after (prospective) the introduction of generic imatinib in 25 hospitals throughout Spain with special emphasis on the molecular kinetics of the initial response (studied as halving time [HT] and with logarithmic reduction [log red] between 2 times).

METHODS: 311 patients were registered (171 in the retrospective cohort and 140 in the prospective cohort), all of them treated with TKIs according to standard clinical practice. Molecular Response (MR) was analyzed at 3, 6, 12, 18 and 24 months of treatment in local laboratories according to local clinical practice. HT and log red were calculated between diagnosis and molecular response at 1, 2, 3 and 6 months.


Clinical characteristics at diagnosis: total (retrospective (R)/prospective(P)) were the following: Median age 56 years (55/61), Body mass index 24.2 (24.2/24.2), Male-Female 58%-42% (56%-44%/60%-40%), Sokal Index (L-I-H) 44%-43%-13% (50%-37%-13%/37%-51%-12%) and ELTS (L-I-H) 57%-33%-10% (63%-30%-7%/50%-37%-13%). First line TKI: Imatinib (GlivecÒ): 35% (65%/0%), generic Imatinib: 34% (0%/75%), 2nd generation (2nd G) TKIs 30.3% (35%-25%): Nilotinib 20% (22%/17%), Dasatinib 10% (13%/7%), Ponatinib 0.3% (0%/1%). In the retrospective cohort 26.3% of Low o Intermediate Sokal Index patients were treated with 2nd GTKIs versus only 18.2% in the prospective cohort.

Overall response rate, total (R/P): See table 1. A statistically significance difference in major molecular response (MMR) between the retrospective and prospective cohorts was only seen at 3 months.

Deep molecular response (>MR4), total (R/P): See table 1. No statistically significant differences were observed between cohorts at any time point.

Overall response rate, total (Imatinib/2nd GTKIs): See table 1. A statistically significance difference in MMR between imatinib and 2nd GTKIs was only seen at 3 months.

Deep molecular response (>MR4), total (Imatinib/2nd GTKIs): See table 1. No statistically significant differences were observed between cohorts at any time point.

Only 1 patient (0.32%) showed progression to accelerated phase.

Response kinetics: See table 1. Halving time at 3 and 6 months was lower in patients treated with 2nd GTKIs, but without statistical significance.

Patients with deep molecular response at 24 months showed a lower HT being statistically significant only at 6 months.

Log red: No significant differences were found between patients treated with imatinib and 2nd GTKIs, although results were initially higher in patients treated with 2nd GTKIs.

Patients with a deep molecular response at 24 months showed statistically significant differences in log reduction at 3 and 6 months.


  1. Generic imatinib has cornered 1st line treatment increasing from 65% to 75% in the retrospective and prospective cohorts respectively, relegating 2ndGTIKs to high-risk patients.
  2. The responses obtained in the first months were higher and faster with the 2nd GTKIs but evened out after 12 months and remained similar at 2 years.
  3. Molecular response kinetics (HT or log red) can predict future response and should be assessed in patients with poor early responses.
  4. A rapid decline (HR or log red) at the start of treatment guarantees a deep response at 2 years.
  5. 2nd GTKIs produce faster molecular response kinetics but final outcomes were similar to that obtained with imatinib.

Disclosures: Casado Montero: Janssen: Consultancy, Research Funding; Roche: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; BMS: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Takeda: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Incyte: Consultancy, Research Funding; Abbvie: Consultancy, Research Funding; GSK: Consultancy, Research Funding; Sanofi: Consultancy, Research Funding; Beigene: Consultancy, Research Funding; Loxo: Research Funding. Ferrer Marin: Incyte: Research Funding. Lakhwani: Janssen: Honoraria, Other: Advisory board; Novartis: Honoraria.

*signifies non-member of ASH