SOHO 2026 Annual Meeting

Superior 96-Weeks MMR Rates And Safety With Generic Dasatinib-50mg in Newly Diagnosed CML : Large Real-World Multicentre Study From India

S. Rainchwar1, R. Halder2, R. Singh3, M. Soni 2, S. Tripathi 2, A. Singh 2, S. Bhatnagar 2, N. Agrawal 2,

V. Sheth 2, D. Bhurani 2

1. Shashwat Hospital, Rajkot, Gujarat, India.

2. Rajiv Gandhi Cancer Institute and Research Centre(RGCIRC), New Delhi, India 3.School of Pharmacy, Lingaya's Vidyapeeth, Faridabad, Delhi, India

INTRODUCTION

•Dasatinib is a 2nd-generation tyrosine-kinase-inhibitor(TKI) approved for frontline use in chronic-myeloid-leukemia(CML).

•Prolonged use of dasatinib 100 and 140mg has been associated with pleural effusion, leading to poor compliance and TKI switching.

•However, dasatinib 50 mg has been shown to balance the side-effects profile with efficacy.

AIM

• To study the efficacy of Dasatinib in terms of MMR(major-molecular-response) and DMR (deep-molecular-response) at 48 weeks and 96 weeks.

•To study side effects profile of Dasatinib 50mg.

•Incidence of TKI switching.

METHOD

•Design: Retrospective study of newly-diagnosed CML-CP patients from January 2021 to march 2025 who were initiated on dasatinib as a first line TKI.

•Outcome measures:

1. To assess MMR and DMR at 48 weeks and 96 weeks.

2. Reasons for change of TKI and side effects profile.

RESULTS

1. This was a multicentre study involving 147 patients.

2. The median age was 46.5yrs(range:19-73yrs).

3. There were 100(68%) males and 47(32%) female patients.

4. ELTS score categorized patients as - 79(53.7%) low risk, 49(33.3%) intermediate, 19(12.9%) high risk.

5. The median duration of follow up is 22.8months.

6. At the last follow up, 81.65% were on Dasatinib, suggestive of lesser need of TKI switching.

7. Pleural effusion was seen only in 4.8% patients.

8. Molecular progression was seen in 4.1% patients.

9. Only 2 patients progressed to blast crisis.

10. Based on high DMR rates, 59.4% patients would become eligible for TFR.

CONCLUSIONS

•Dasatinib-50mg has shown to achieve superior MMR and DMR rates at 48 and 96weeks, with favorable safety and tolerability.

•This is the next best TKI after imatinib for low-medium-income-countries(LMIC) where accessibility to newer costlier TKIs is limited.

Superior 96-weeks MMR rates and safety with generic Dasatinib-50mg in newly diagnosed CML : Large Real-world multicentre study from India